How digital is the German outpatient healthcare system? A review on past and future measures, challenges and opportunities

How digital is the German outpatient healthcare system? 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A review on past and future measures, challenges and opportunities Alice Beatrix König, Manuel Spitschan, Anna M Biller This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7409565/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background The introduction of the electronic health card in 2015 marked the start of the German Telematic Infrastructure (TI), a nation-wide e-health infrastructure aimed at digitally connecting healthcare providers, insurers, and patients within the statutory health insurance system. The expansion of the TI within the German healthcare system is progressing but still slow by international comparison. The German government seeks to incrementally enhance this infrastructure to align with the demands of the digital age, thus creating new opportunities for patients and service providers. In this literature review, we critically examined the current status of the TI in Germany, focusing on the implemented and planned measures, challenges encountered, and opportunities available for providers and insured individuals to help inform stakeholders in the field. Methods A comprehensive literature search was conducted across PubMed, Journal of Medical Internet Research, relevant governmental websites, and the library catalogues of the Technical University of Munich and Ludwig-Maximilian-University Munich. The review included both qualitative and quantitative studies, as well as governmental publications and internet sources from gematik GmbH and other providers. Results The analysis indicates that TI elements are increasingly integrated into routine care within medical facilities, but Germany lags behind in international comparisons. Despite Germany's leading role in certifying and distributing digital health applications, their utilisation remains far from optimal especially for prevention purposes for which they are currently not licensed. The deployment of new digital health services and national-wide rollout of TI applications is particularly hindered by technical, financial, and organisational challenges affecting service providers, patients, and key stakeholders such as statutory health insurance companies. Nevertheless, the digital health infrastructure offers clear benefits, including improved healthcare delivery, as well as time and cost savings. Conclusion Germany remains significantly behind other nations in developing a comprehensive digital health infrastructure. To address this lag and the associated challenges, further initiatives, such as the 2025 introduced nationwide implementation of the electronic patient record with an opt-out option, are crucial. However, significant work remains, particularly in enhancing training and education for both healthcare professionals and patients, overcoming technical challenges and addressing the unfavourable cost-benefit ratio. Scientific community and society/Business and industry Health sciences/Health care Health sciences/Medical research eHealth telematics German healthcare infrastructure digital health telemedicine electronic patient records digital adoption health apps Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction The German healthcare system is increasingly confronted with long-trailing challenges, such as demographic changes, exploding costs, and personnel shortages which place additional demands on its structure and functioning 1 , 2 . Another specific challenge of the German system is that healthcare structures and players are not widely connected leading to incomplete information transfer, double treatments, inefficient treatments and other negative impacts on the treatment journey 3 – 6 . In response to these challenges, the expansion of the digital health infrastructure, aimed at digitising healthcare in Germany, has gained growing significance. Additionally, the COVID-19 pandemic played a pivotal role in reinforcing the need to digitally enhance the healthcare system 7 . During the pandemic, many people used health-related digital applications, such as the Corona-Warn-App (Germany’s official COVID-19 digital contact tracing app) and the digital vaccination certificate on their smartphones, for the first time 7 , 8 . Consequently, there was a significant increase in the use of telemedicine applications 9 . Building on the lessons learned from the pandemic, along with the demonstrated acceptance and willingness of the population to use digital technologies, offers a crucial opportunity to further expand and strengthen the German healthcare system 10 . Yet, Germany lags significantly behind other countries in the digitalisation of its healthcare system. In an international comparative study on the state of healthcare digitisation in 2018, Germany ranked second to last, significantly trailing behind the other selected countries 11 . This is hardly surprising, as Germany has only made significant progress in digitalisation and the expansion of digital health infrastructure in recent years. In countries like Estonia and Denmark, the widespread use of eHealth like the electronic patient record or the e-prescription has been established for years 12 . Despite this, a study by Klar et al. (2023) compared ten European countries, revealing that none of the examined countries " had fully realised a digital patient pathway from prevention through acute treatment to billing " 13 . However, other countries focus on specific stages of the care pathway from prevention measures to the payment process with a 'First Scale, then Scope' strategy, meaning they aim to reach a critical mass before optimising and expanding the offering during ongoing operations helping them to roll out technical solutions more quickly 13 . Therefore, approaches of successful countries could potentially serve as a guide for areas in Germany that need further development in digital health. Reasons for the slow digital expansion in the German healthcare system, according to an analysis by the Fraunhofer Institute for Experimental Software Engineering IESE and the Fraunhofer Institute for Systems and Innovation Research ISI in 2023, include the lack of acceptance among healthcare providers, inadequate technical infrastructure, strict data protection and security requirements, and the lack of incentives for healthcare stakeholders 12 . The absence of nationwide health initiatives for digitalisation also plays a role; some projects, like the e-prescription, have not been fully and widely implemented at the national level 13 . The importance of increasing knowledge about the telematic infrastructure (TI), Germany’s digital health infrastructure, among its users was underscored by a quantitative online survey conducted by gematik GmbH in 2024 14 . Many of the surveyed institutions expressed a need for more information on using digital applications, with many feeling only moderately informed about the TI and its various applications 14 . This review is thus motivated by the need to provide stakeholders in the German healthcare system and the wider research community with a clear and comprehensive summary of the developments related to the TI and its broader implications. The primary objective of this study is to explore the current status of Germany's digital health infrastructure, focusing on the extent of its expansion as of the present date. This investigation will examine the specific measures that have been implemented to advance the digital health infrastructure within the German healthcare system. Additionally, we critically assess the challenges and opportunities that have emerged as a result of these initiatives. By addressing these aspects, we provide a comprehensive and up-to-date overview of the development of digital health infrastructure in Germany, while also offering practical insights into its implications for healthcare provision. The following research questions arise for this study: Where does Germany stand in terms of expanding its digital health infrastructure? What measures have been implemented in this context so far? What challenges and opportunities for various stakeholders have these implemented measures brought about? Methods Search Strategy A comprehensive literature review was conducted using the online catalogues of the Technical University of Munich and Ludwig Maximilian University of Munich, as well as the PubMed database and the Journal of Medical Internet Research (JMIR). To ensure a comprehensive and up-to-date overview, several relevant websites, including those of the National Association of Statutory Health Insurance Physicians and gematik GmbH, were also consulted, integrating official publications from key healthcare organisations. The search was limited to publications from the last ten years and included both German and English literature. An initial screening of the literature was conducted in April 2024, followed by systematic research in May and June 2024 and an update in July 2025. The initial search focused on identifying relevant articles and publications using keywords translated from German, including "telematics infrastructure," "TI," "telematics," "e-health," "digitalisation," "digitalisation and health," "digital healthcare," "German healthcare system," and "German healthcare services." At a later stage, the search was refined with additional terms such as "electronic health services," "telemedicine," "digital health applications," "DiGAs," "electronic prescription," "e-prescription," "electronic patient record," "ePA," "electronic sick note," and "eAU." In JMIR, a broad search was conducted within the categories "E-Health / Health Services Research and New Models of Care," "Telehealth and Telemonitoring," "Digital Health," and "E-Health Policy and Health Systems Innovation." Selection and Evaluation of Literature The selection and evaluation of literature were guided by criteria such as relevance to the research questions, scientific rigour, and alignment with the study's focus on the German TI and its impact on healthcare. Preference was given to peer-reviewed scientific articles and studies that directly addressed these topics, as well as official publications from health organisations and federal government agencies. Non-scientific sources were included selectively, only when they provided essential contextual information that was critical for addressing the research questions. The literature management software Zotero version 6.0.36 was utilised for literature categorisation, citation, and retrieval of sources throughout the research process. During the data collection phase, the selected literature was thoroughly read and critically evaluated to extract key insights and perspectives. The "Three-Pass Approach" method, as outlined by Srinivasan Keshav (2007), was employed to systematically analyse the literature 15 . This method involves three sequential reading passes, each designed to progressively deepen the understanding of the material. In the first pass, a general overview of each article was obtained by reading the title, abstract, introduction, and subheadings. A more detailed content analysis was conducted in the second pass, during which the key sections and arguments were examined in greater detail and initial notes were taken. The third and final pass involved a comprehensive analysis of each study, capturing and questioning all details holistically. Manuscript translation The manuscript was initially drafted in German by the first author in 2024 and subsequently translated into English using ChatGPT and DeepL. Following the translation, the manuscript underwent significant rewriting and thorough review by all authors to ensure accuracy and clarity and was updated in June and July 2025 to reflect the current developments in Germany. Results Overview of the telematic infrastructure in Germany In Germany, the Telematics infrastructure (TI), described as the "data highway of healthcare" by the National Association of Statutory Health Insurance Physicians, is the cornerstone of the digitalisation within the statutory health insurance system 16 . The term ‘telematics’, derived from the words ‘telecommunications’ and ‘informatics,’ refers to " the networking of various IT systems and the ability to link information from different sources " 17 . The TI thus represents a national digital health infrastructure aimed to bridge eHealth (provider-focused systems) and digital health (patient-focused tools) with the involvement of various stakeholders (Fig. 1 ; Text Box 1 ). Text Box 1. Germany’s telematic infrastructure at a glance. Only registered healthcare providers and institutions can access the TI and its applications via VPN-secured internet connections and a connector . The technical components and applications of the TI are subject to strict data and information security requirements . The Federal Office for Information Security (BSI) oversees the development of the TI and regularly audits its technical and security-related components. Certain patient data may only be accessed or modified with the explicit consent of the insured individual . According to the Federal Office for Information Security, the purpose of TI is to enable fast, secure, and digital exchange of sensitive health data among actors including patients in the healthcare sector through a dedicated, closed infrastructure, aiming to achieve efficient and high-quality patient care in Germany 18 . The successful implementation and utilisation of the digital health infrastructure in Germany involves collaboration among several key stakeholders. The legal and regulatory framework governing this infrastructure is established by the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). Since 2005, gematik GmbH (Society for Telematics Applications of the Health Card) has been tasked with the introduction and continuous advancement of the TI 19 . Gematik GmbH is a collaborative entity composed of shareholders representing a broad spectrum of the healthcare sector, including the German Medical Association (Bundesärztekammer; BÄK), the German Dental Association (Bundeszahnärztekammer; BZÄK), the National Association of Statutory Health Insurance Physicians (Kassenärztlichen Bundesvereinigung; KBV), the National Association of Statutory Health Insurance Dentists (Kassenzahnärztlichen Bundesvereinigung; KZBV), the German Hospital Federation (Deutschen Krankenhausgesellschaft; DKG), the German Pharmacists' Association (Deutschen Apothekerverbandes; DAV), the Association of German Private Healthcare Insureres (Verband der Privaten Krankenversicherungen e.V.; PKV) and the National Association of Statutory Health Insurance Funds (Spitzenverband Bund der Krankenkassen; GKV-Spitzenverband), which represents the interests of health insurance funds (Fig. 1 ) 20 , 21 . The distribution of shares among the shareholders at the shareholders' meeting is regulated by law 21 . The largest share, 51%, goes to the Federal Ministry of Health. The remaining shares are distributed as follows: The National Association of Statutory Health Insurance Funds holds 22.05%, the National Association of Statutory Health Insurance Funds receives 7.35%, the German Hospital Association holds 5.88%, the Chamber of Pharmacists holds 3.92% and the private health insurance providers, BÄK, BZÄK and KZBV each have 2.45% of the meeting shares 21 . The Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik; BSI), in collaboration with federal and state data protection authorities, ensures that all participants in the TI adhere to stringent security standards and data protection regulations. Other critical stakeholders include healthcare service providers and statutory health insurance funds, both of which play essential roles in the financing and implementation of the TI. Currently, connection to the TI is mandatory for medical practices, medical care centres (Medizinische Versorgungszentren; MVZ), hospitals, and pharmacies 19 . For other healthcare providers, such as midwives, connection remains voluntary at present, although mandatory participation is expected in the coming years (see also Discussion ). Patients, as recipients of healthcare services, are also considered vital stakeholders in the evolving TI. Connecting to the TI requires specific components and applications to ensure that only authenticated individuals and institutions have access 17 . The registration process mandates the use of an electronic health professional card (elektronischer Heilberufsausweis; eHBA) for the authentication of individual service providers, and a practice or institutional card (SMC-B) for the authentication of medical facilities (Fig. 2 ) 22 . The eHBA is also essential for facilitating electronic signatures, which are required for various TI applications, including the issuance of e-prescriptions 22 . To interact with the TI, healthcare providers need an e-health card terminal, which is used to log in with the eHBA and read patients' electronic health cards 22 . A crucial component for connecting to the TI is the TI connector, a high-performance router that is supposed to securely encrypt and transmit sensitive data over a Virtual Private Network (VPN) 19 . This connector is integrated with a practice management software (Praxisverwaltungssoftware; PVS) or hospital management software (Krankenhausverwaltungssoftware; KVS), ensuring secure data exchange within the healthcare setting. Healthcare facilities are free to select their provider of practice or hospital management software, which can result in compatibility issues due to the diversity of systems. To support informed decision-making, facilities can consult the websites of their respective professional associations, where they may find guidance on recommended software programmes and their developers. The VPN network, a non-public network, is vital for maintaining the confidentiality and integrity of health data by preventing third parties from tracking internet activities. Given the stringent data protection requirements for medical data, the BSI certifies critical TI components after thorough evaluation by recognised testing bodies 23 . Since 2024, the connection to the TI is supposed to be established either through a device located on the premises of a healthcare practice or via a connector housed in a data centre 22 . However, the gematik has recently announced that the use of connectors will be terminated by 2030 and is planned to be replaced by a cloud-based version TI-gateway 24 . Timeline of important (legal) steps The legal framework for Germany's TI was first established in § 291 of the Fifth Social Security Code, which introduced the electronic health card 25 . The foundational legislation for the TI was further developed with the enactment of the Act for Secure Digital Communication and Applications in Healthcare (E-Health Act) on December 29, 2015 (Fig. 3 ). This Act aimed to " establish the legal prerequisites for the medium- to long-term development of a comprehensive digital infrastructure in healthcare " 26 , marking the first formal legal framework for the introduction of eHealth and the initial digital applications within the German healthcare system. The E-Health Act has since been supplemented by additional regulations to expand and refine the digital health landscape in Germany. Notably, the Act for Better Care through Digitalisation and Innovation (Digitale-Versorgung-Gesetz; DVG), enacted in December 2019, introduced key regulations for prescribing digital health applications (Digitale Gesundheitsanwendungen; DiGAs) and conducting video consultations 27 . Further advancements were made with the Digital Care and Nursing Modernisation Act (Digitale-Versorgung-und-Pflege-Modernisierungs-Gesetz; DVPMG), which came into force on June 9, 2021. This legislation expanded telemedicine services and digital health applications, including, for the first time, digital nursing applications (DiPAs) (Fig. 3 ) 28 . On 26 March 2024, two additional laws were enacted by the Federal Ministry of Health to further advance healthcare digitalisation: the Digital Law (Digital-Gesetz; DigiG) and the Health Data Usage Act (Gesundheitsdatennutzungsgesetz; GDNG). The Digital Law aims to simplify daily medical practices for both doctors and patients through the implementation of digital solutions 29 . A central element of this law is the 'electronic patient record (ePA) for all,' which was implemented for all statutory health insurance holders by the beginning of 2025 29 . Meanwhile, the Health Data Usage Act seeks to enhance healthcare research by establishing a “ central data access and coordination center for the use of health data ,” thereby facilitating easier access to research data 30 . These legislative frameworks are further supported by regulations such as Article 9 of the General Data Protection Regulation (GDPR), which governs the processing of special categories of personal data, and the Federal Data Protection Act (Bundesdatenschutzgesetz; BDSG), which provides " fundamental legal bases for the processing of health data " 31 , 32 . Additionally, the Patient Data Protection Act (Patientendaten-Schutz-Gesetz; PDSG) ensures that the use of electronic health data within the eHealth infrastructure is secure, compliant with data protection regulations, and user-friendly 32 . While the above laws and regulations form the core of the legal framework governing the TI, there are numerous other legal provisions that also play a role. However, a comprehensive list of these would exceed the scope of this work. TI elements The German TI is supposed to facilitate secure digital networking within the German healthcare system. Central to this infrastructure is the electronic health card (elektronische Gesundheitskarte; eGK), first introduced in 2011, which underpins a range of critical applications. These include insured master data management, emergency data management, electronic medication plans, the electronic patient record (elektronische Patientenakte; ePA), communication in medical settings (such as electronic doctor letters and electronic sick notes), and e-prescriptions. The most significant of these applications will be discussed in more detail in the following sections. The Electronic Health Card and Insured Person Master Data Management One of the first elements of the German eHealth infrastructure is the introduction of the electronic health card (elektronische Gesundheitskarte; eGK) and the insured person master data management (Versichertenstammdatenmanagement; VSDM). The legal framework for these components was primarily established through Sections 291a to 291c of the Fifth Social Security Code (SGB V) as part of the 2004 health reform that introduced the eHealth infrastructure and the eGK 20 . The eGK has been in use since 2011 32 . It is issued by health insurance companies to each insured person, credit card sized, serving both as proof of insurance and as a means of billing for services 32 . The eGK must be read by the health care provider for the utilisation of services covered by statutory health insurance 33 . This process is required in practices, medical care centres (MVZ), and hospitals and must be documented for quarterly billing purposes but is not necessary for privately insured people. The eGK contains personal data such as the insured person’s name, date of birth, gender, and address, as well as insurance details. With the insured person’s consent, it can also store medical data, including the ePA and emergency data management (Notfalldatenmanagement; NFDM). To facilitate online verification and updating of the data stored on the eGK with the health insurance companies, the insured master data management (VSDM) was introduced in 2019. VSDM represents the "first legally mandated online application of the eGK" 34 . Data synchronisation is performed by reading the insurance card through the eGK card terminal via the TI connector 33 . When the card is inserted, the connector verifies the card’s validity and checks the accuracy of the stored data with the insured master data service of the relevant health insurance company 33 . This verification, crucial for billing, is recorded on the eGK and transferred into the practice management software (PVS/KVS) 33 . If necessary, the insured data on the eGK is updated, and the new information is saved in the software 33 . For the process to function smoothly, it is essential that the insured person informs their health insurance company of any changes so that the information can be reflected in the health insurance company’s system 33 . The eGK and VSDM, as central components of the TI, form the foundation upon which all other TI applications are built. The eGK has been an integral part of the German healthcare system for several years. The card can usually be read without any problems, but functionality may be limited if there is no stable internet connection and therefore no connection to the TI. Emergency Data Management (NFDM) and the Electronic Medication Plan (eMP) In 2020, two additional components of the eHealth infrastructure were introduced, the i) emergency data management (Notfalldatenmanagement; NFDM) and ii) the electronic medication plan (elektronischer Medikationsplan; eMP). The NFDM allows doctors to store critical personal health information on the eGK that is necessary for emergency care, including current medications, important contact details, and information about chronic illnesses, pregnancies, or implants 19 , 32 . The eMP, also stored on the eGK, lists the insured person's prescribed medications. This feature ensures that healthcare providers can reliably access up-to-date information on a patient’s current medications, reducing the risk of forgetting, misplacing, or duplicating medication plans 32 , 33 . This eMP not only represents a significant reduction in workload for healthcare providers but also contributes to the prevention of serious errors, as allergies and intolerances are also stored there, helping to avoid interactions and contraindications 32 . Insured individuals are entitled to have an eMP maintained by healthcare providers and pharmacy staff when they are prescribed " three permanently systemically acting medications " or more 35 . The eMP must be continuously updated to ensure accuracy 35 . Both the NFDM and eMP can alternatively be stored in the ePA 32 . According to a publication of health data by the National Association of Statutory Health Insurance Physicians from 2024, eMP is significantly more used than NFDM in patient care. 64.2% of respondents from the field of general medicine use eMP in patient care, whereas NFDM is only used by 19.5% of respondents in patient care 36 . The Electronic Patient Record (ePA) The ePA is considered the most important element of the German eHealth infrastructure because it serves as a central repository where all insured persons' information and a significant portion of other eHealth elements converge 19 . According to Birkert et al. (2022), the ePA also ensures TI interoperability by enabling the necessary data exchange among healthcare actors and integrating the procedural standards needed for the smooth import and export of data 32 . Until the end of 2024, the ePA was a voluntary, insured-led electronic record that can be used by insured persons who apply for it through their health insurance company 32 . Upon application, Section 337(3) of the Fifth Social Security Code (SGB V) grants the insured the right to determine who is authorised to access their data and the extent of those access rights 32 . Additionally, Sections 337(1) and (2) SGB V give insured persons the right to read, transmit, and process data within the ePA and to delete any data, except for the eMP and emergency data 32 . Insured persons also have the right to have their treatment data transferred to the ePA by healthcare providers, providing them with significantly more autonomy compared to the limited access typically afforded to the analogue patient records held by healthcare providers 32 . The ePA can be accessed and managed by patients via apps provided by their health insurance companies, allowing them to grant access to healthcare providers, who authenticate themselves using their electronic health professional cards to obtain the necessary authorisations (Fig. 2 ) 19 . Healthcare providers could benefit from the ePA as it allows them to access previous findings and other health data collected and stored by third parties, which are essential for effective medical care 32 . The ePA consolidates all the information that would otherwise be part of the local healthcare provider’s (hard copy) records, such as findings, diagnoses, therapeutic measures, and treatment reports 32 . In theory, the ePA would allow that hard copy documents would no longer need to be exchanged between providers or carried by patients, reducing the risk of duplicate examinations and ensuring that no previous findings are lost 32 . Although health insurance companies have been required to offer the ePA to insured persons since 1 January 2021, its usage remained extremely low, with only 1% of all statutory insured persons in Germany using it as of the end of September 2023 32,37 . To increase uptake, the ePA transitioned to the 'ePA for all' at the beginning of 2025, introducing an opt-out procedure rather than the current opt-in option that aimed to achieve coverage for 80% of statutory insured persons 37 . This shift represents a significant change in the usage principle, potentially leading to much broader adoption in the future. However, as of mid-2025, the ePA still has low adoption among the general population, with only about 1% of the over 74 million statutorily insured individuals in Germany actively using it 38 . As can be seen from the current usage figures, the ePA remains controversial. In addition to fundamental data protection concerns, many stakeholders also criticise the functional design of the ePA. At present, it is a passive storage facility where medically relevant information that is not yet automatically integrated in the ePA – such as historic vaccination records or current maternity pass logs – can only be stored as PDF or scan files (or need to be entered manually) 39 . In general, the files are uploaded either by the insured persons themselves or by service providers with the prior consent of the insured persons. This limited functionality is regularly criticised 40 . Sebastian Krammer states in an article published by the ÄrzteZeitung in April 2025 “ that many doctors find the ePA unhelpful so fa r” 41 . He claims the “ lack of focus on structured data and interoperability ” as a reason, which means that the ePA is “ a digital repository with no added value for everyday clinical practice […] – “ a Dropbox for health data ” 41 . The ePA thus needs structured data, improved interoperability and consistent integration into clinical workflows 41 . The former Federal Data Protection Commissioner Ulrich Kelber also expressed clear criticism in March 2025 42 . He warned that the opt-out regulation introduced this year constituted a significant encroachment on the fundamental right to informational self-determination. In addition, there was a risk that the disclosure of sensitive health data, for example on mental illness, could restrict the rights of insured persons 42 . Two high-profile demonstration hacks by the Chaos Computer Club (CCC) in 2024 and 2025 provided also clear evidence that data protection concerns with regards to the ePA were not unfounded 43 . The CCC deliberately manipulated electronic patient files to highlight potential weaknesses in the system (see chapter: Challenges for higher-level actors ). Communication in the Medical Field (KIM), the Electronic Doctor's Letter (eArztbrief), and the Electronic Sick Note (eAU) Since 2020, the KIM communication service has enabled the secure electronic exchange of medical documents and treatment-related information as part of the eHealth infrastructure 18 . The long-term goal is for all communication between healthcare providers and institutions within the German healthcare system to be conducted exclusively through KIM services 44 . To use KIM services, both communicating parties must use the KIM standard. This involves signing a contract with an approved KIM provider and installing the necessary software update on their connector 44 . The gematik lists available KIM providers on their websites and assigns them a score (“TI-score”) from A-D with regards to usability (A is best score) 45 , 46 . Additionally, healthcare providers must possess an electronic health professional card (eHBA) of at least generation 2.0 to perform the qualified electronic signature required for sending electronic doctor's letters 44 . The integration of KIM into practice management software (PVS) and hospital management software (KVS) is a crucial prerequisite for implementing the electronic sick note (eAU) and the electronic doctor's letter (eArztbrief) 44 . Since 2021, doctors have been required to transmit sick notes directly to health insurance companies via KIM through the eHealth infrastructure, eliminating the need for employees to submit them manually 19 . In 2023, the issuance of sick notes has become mostly paperless, with employers now receiving sick note data electronically from health insurance companies. A printed copy is provided only to the patient, and to the employer only upon the patient's explicit request 44 . By 2023, the eAU was being utilised by 92% of respondents 48 . A survey conducted by the National Association of Statutory Health Insurance Physicians (2024) revealed that uniform use had already been achieved by 2024, with 100% of all respondents from the general practice sector stating that they were working paperless with the eAU 36 . The electronic doctor's letter is also sent via the KIM service. The security of KIM messages is ensured by end-to-end encryption, meaning that the message is encrypted upon leaving the practice or clinic, travels securely through the TI, and is only decrypted upon arrival at its destination 44 . This provides a significantly higher security standard compared to most traditional email services. 83.4% of general practitioners surveyed stated that they use electronic doctor's letters 36 . Even though satisfaction with KIM was still relatively low in 2023 at only 29%, there has nevertheless been a significant increase in the use of the KIM service in recent years 47 . According to the TI dashboard of gematik GmbH, more than 500 million KIM messages were sent each month from the beginning to the middle of 2025, indicating widespread and regular use in doctors' offices 48 . No data leaks have been reported to KIM to date, but in 2023 there was an incident in which KIM messages were accidentally forwarded to a single doctor's office instead of to a health insurance company as originally intended 49 . The Electronic Prescription (eRezept) The electronic prescription (e-prescription) is another core element of the German healthcare digitisation efforts and represents the digital transition from previously paper-based prescriptions to electronic formats for prescription drugs covered by statutory health insurance 32 , 50 , 51 . Since September 2022, pharmacies across Germany have been able to redeem e-prescriptions 12 . The nationwide mandatory implementation of e-prescriptions in medical facilities, after several delays, was finally enforced on 1 January 2024, with the enactment of the Digital Law, abbreviated as “DigiG” (original: Digital-Gesetz) 37 , 51 . Following the necessary software update, doctors continue to prescribe medications via practice or hospital management software (PVS/KVS). However, instead of printing the prescription on paper, it is now electronically signed using the electronic health professional card (eHBA) and transmitted to the TI server 51 . Pharmacies can then retrieve the prescription data from the server by reading the patient's electronic health card (eGK), using the patient's e-prescription app, or scanning a printed receipt with a prescription code 51 . In an ad hoc survey conducted by the Health Foundation, almost half of the doctors surveyed stated that overall the launch of e-prescriptions went rather well 52 . If issuing an e-prescription is not possible due to technical constraints or because the prescription type is not yet compatible with TI – such as currently for medical aids or bandages – a paper prescription is still used 51 . According to Götz et al., the adoption of e-prescriptions " can not only speed up access to medications and improve drug safety " but also " foster the broader adoption of other digital health services, such as telemedicine " 37 . Overall, the e-prescription shows a positive trend in adoption. While only 8% of practices used the e-prescription in 2022, by 2023, one-third of contract doctors had adopted this digital solution 53 . Following the mandatory introduction of the e-prescription on 1 January 2024, the number of e-prescriptions issued surged significantly to approximately 113.5 million in the first quarter of 2024 35 . Additionally, a survey by the National Association of Statutory Health Insurance Physicians in 2024 found that 96,3% of respondents use e-prescriptions in patient care 36 . The TI-Messenger (TIM) The TIM is a standardised and interoperable messenger system for players in the TI, including physicians, nurses, pharmacies, hospitals, etc 54 . Its goal is to enable GDPR-compliant, zero-trust, and real-time communication as a replacement for fax, phone, or email communication 21 , 55 . A zero-trust approach is a modern security paradigm that does not assume that users or devices inside a network are safe (as in traditional perimeter security). Instead, zero-trust models require continuous authentication and authorization — no implicit trust is given, even if a user is “logged in” to the system. The TIM is based on a Matrix protocol (decentralised, interoperable, end-to-end encryption) and users are supposed to freely choose their gematik-certified provider 21 , 54 , 55 . Envisioned features are to i) exchange text messages, voice messages, photos and documents in PDF, ii) create case-related chat groups for several health care providers, iii) locate all users in a nationwide address book, vi) archive case-related communication in the local electronic health record, and v) issue individual authorisations, e.g. for doctors and nurses 21 . The gematik so far as certified several providers since 2024 with several new products being certified in June 2025 (for their current list see: https://fachportal.gematik.de/zulassungs-bestaetigungsuebersichten#c2946 ). All providers run Matrix servers, which are federated. This means they allow cross-provider messaging if standards are followed. Current available features include 1:1 chats between healthcare providers, group chats, and attachments (e.g. photos and documents as PDF). However, integration into PVS/KIS systems is currently mostly missing, patient communication was announced but not yet provided and archivable message history is only available as a provider-specific add-on 56 . Current barriers are the low awareness and adoption among stakeholders, which might also be connected to a lack of integration into clinical workflows. Stakeholders in the healthcare sector are not required to use it and do not have clear incentives to adopt such a system (which is linked with additional costs). The patient communication feature with health care professionals (“TI-Messenger ePA”) and among healthcare professionals (“TI-Messenger Pro”) is planned to be rolled out in 2025 and early 2026 respectively while the mandatory use in specific care pathways is currently being discussed 21 , 57 . Support for DiGAs and other products and platforms from third parties is envisioned for 2026 (“TI-Messenger Connect”) 21 . Long-term, integration of interfaces such as KIM, e-prescriptions, eAU etc. is planned. While the TI-Messenger is thus legally anchored under § 311 SGB V, it is currently not widely adopted in practice and might need mandatory regulations to become effective. Telemedicine Telemedicine can be described as “delivery of health-care services over distance” 58 and is as such a key aspect of digital health. It can be understood as an umbrella term for medical care concepts that involve providing medical services in diagnostics, therapy, rehabilitation, and medical decision support across time or distance gaps using electronic communication systems 32 . Telemedicine applications can be broadly categorised into three areas: teleconsultations, telemonitoring, and teletherapy 32 . Telemedicine can be delivered through telephone, apps, or the internet, making it particularly valuable for providing care to people who are less mobile or live in rural areas 59 . As such, its key advantage is that patients and treating doctors do not need to be in the same location, a feature that proved especially useful during the COVID-19 pandemic by helping to maintain care amidst contact restrictions and reduce the risk of infection during the treatment of COVID patients 9 . Even though telemedicine applications have proven to offer advantages, the level of information among patients appears to be insufficient. Although some medical institutions and health insurance companies actively promote their telemedicine services, in many cases those affected have to seek information on their own. A more proactive approach to bringing these services to patients therefore appears to be a sensible step towards promoting their use 60 . Teleconsultations and teletherapy Teleconsultations facilitate easier and more efficient information (and digital data) exchange between medical colleagues, allowing them to consult on diagnoses, therapy choices, or to discuss X-rays, external findings, and similar medical data 59 . Teletherapy applications enable the remote provision of treatments, such as video consultations for explaining further treatment plans or providing psychotherapeutic care both to other doctors or patients 59 . A relatively new approach in telemedicine is the tele-home visit, where a specially trained healthcare professional conducts the home visit on-site with the patient, and a doctor can join via video if needed 59 . The COVID-19 pandemic in particular has contributed significantly to the acceptance and spread of digital health solutions such as teleconsultation 12 . According to the PraxisBarometer Digitalisierung (Practice Barometer on Digitalisation) published by the National Association of Statutory Health Insurance Physicians (2022), 61% of outpatient doctors already offered digital services to patients in 2021, with 37% using telemedicine applications 61 . Teleconsultations were used extensively in 2020 and 2021 in particular: around 2.7 million teleconsultations took place in 2020 and as many as 3.5 million in 2021 62 . Online doctor's appointments are now an integral part of healthcare. Statista (2024) predicted that online doctor's appointments could generate revenue of €461.32 million in 2025, which would represent a 6.4% increase in revenue 63 . Legislation is also adapting to the renewed upward trend: After the reimbursement of teleconsultations was initially limited from an unlimited number during the COVID-19 pandemic to 30% of total consultations at a doctor's practice in April 2022, this was increased again to 50% in April 2025 37,64 . The planned integration of TI Messenger Connect into applications for video consultations could give a further boost to the use of telemedicine services and interoperability in healthcare in the coming years 55 . Applications for video consultations are provided by various video service providers 65 . The information page of the National Association of Statutory Health Insurance Physicians lists all certified providers that have been checked in advance by independent, accredited bodies and meet the requirements of the National Association of Statutory Health Insurance Physicians and the GKV-Spitzenverband. Apart from the choice of provider, a video consultation for service providers is usually similar to a regular consultation. The technical equipment required is limited to standard devices: an internet connection with a firewall, a screen, a camera, a microphone and speakers 65 . Video consultations are also relatively straightforward for patients to use. They require the same basic technical equipment as the medical facility, i.e. an internet connection, camera, microphone, loudspeaker and a suitable device. The application can be used flexibly on a PC, tablet or smartphone. People with statutory health insurance usually receive the necessary apps free of charge from their health insurance companies, such as the TK-Doc app for members of the Techniker Krankenkasse 66 . Statutory health insurance companies have continuously expanded their digital service offerings in recent years. In a study conducted by the German Financial Services Institute in 2021, eight of the 13 best-rated health insurance companies already offered informative video chats at that time 67 . In the latest survey from 2025, nine out of 10 health insurance funds stated that they now offer ‘extended online or video consultations’ as part of their service portfolio 68 . According to the National Association of Statutory Health Insurance Physicians, almost all groups of doctors are now allowed to offer video consultations, with the exception of laboratory doctors, pathologists and radiologists 65 . Telemonitoring Telemonitoring is another crucial aspect of telemedicine, involving the remote monitoring of health parameters 59 . It is particularly useful for managing patients with chronic conditions such as heart rhythm disorders, chronic heart failure, high blood pressure, asthma, or diabetes but also for identifying sleep-related diseases and rhythm disorders 59 . Telemonitoring typically employs portable measuring devices or apps, allowing patients to enter and track their measured values, such as blood pressure, blood sugar levels, body temperature, or sleep times from the comfort of their homes 59 . According to Stachwitz and Debatin (2023), telemonitoring enables the early detection of deteriorating health in outpatients 4 . Timely telemedical interventions, such as adjusting medication, can avert critical developments, prevent hospitalisations, improve patient well-being and relieve the burden on the healthcare system. Telemonitoring measures for the treatment of chronic heart failure were transferred to standard care from 2022 onwards following a decision by the Joint Federal Committee (G-BA) 4 . With this decision, Germany took on an international pioneering role and was the first country in Europe to offer telemonitoring as part of standard care 69 . Since then, telemedical monitoring of heart patients and its billing have been further developed, and corresponding measures have also been initiated in other medical areas 70 . One example of this is the ‘Telementor COPD’ project, which supports patients with chronic obstructive pulmonary disease (COPD). It combines preventive, motivational content for physical training and respiratory therapy via an app with telemonitoring of vital parameters 69 . People with diabetes are also increasingly benefiting from telemedical care: they can keep an electronic diabetes diary, record their blood sugar levels and share them directly with their doctor – with the aim of improving glycaemic control in the long term 71 . In addition, concepts are already being discussed on how telemonitoring could also be used to support the treatment of obesity or sleep-related breathing disorders 69 . In the future, the use of artificial intelligence to evaluate large amounts of vital data and the integration of wearables will open up additional possibilities for an expanded, patient-centred care model 69 . There is also a telemedicine service available for long-term patients in intensive care units: tele-intensive care medicine. The aim of this application is to enable ‘an increase in the quality of treatment by providing consultative support with special intensive care expertise for treating physicians’ 4 . This ensures that specialised intensive care can be provided even in cases where transfer is not possible. This form of support has already proven its worth, particularly during the COVID-19 pandemic 4 . Digital Health Applications (DiGAs) and Digital Care Applications (DiPAs) A DiGA is a secure, data-protected, and interoperable medical product available as an app, web application, or software with a digital primary function 72 . DiGAs enhance patient care by allowing insured persons to actively participate in their own treatment outcomes, either independently or with the involvement of a healthcare provider 72 , 73 . Introduced in Germany in December 2019 with the enactment of the Digital Healthcare Act (DVG), DiGAs are designed to support the “ detection, monitoring, treatment, or alleviation of diseases, injuries, or disabilities, as well as to assist healthcare providers in delivering care ” 12 , 32 . While DiGAs are not core components of the TI, they are increasingly being integrated into the broader digital health ecosystem through interoperability with TI services such as the ePA. Their certification pathway is regulated by BfArM rather than gematik, and their technical connection to the TI depends on individual implementation and use cases. Apps that primarily or only serve for prevention are currently not eligible for inclusion as DiGAs 32 . Additionally, only apps and applications listed in the official DiGA directory maintained by the Federal Institute for Drugs and Medical Devices (BfArM) and classified under risk class 1 or 2a according to the Medical Device Regulation are eligible to be DiGAs and reimbursable by health insurance 72 . To be included in the DiGA directory – and thus qualify for coverage under statutory health insurance – a DiGA must undergo a successful evaluation process conducted by the BfArM 74 . This evaluation process, known as the 'DiGA Fast-Track,' is limited to a maximum of three months from the receipt of a complete application 75 . The Fast-Track process evaluates a DiGA based on the manufacturer's provided information on key product features, including data protection, user-friendliness, and evidence of the DiGA's positive effect on patient care 76 . The right to coverage of digital health applications for statutory health insurance holders is established under Section 33a of the Fifth Social Security Code (SGB V), as regulated by the Digital Healthcare Act (DVG) 32 . Further details regarding the requirements for safety, functionality, data protection, and security, as well as the quality standards and inclusion procedures in the DiGA directory, are stipulated by the Digital Health Applications Ordinance (DiGAV) issued by the Federal Ministry of Health 32 . Patients can access these ‘apps on prescription’ through two routes: i) by receiving a prescription from their treating physician, followed by approval from their health insurance company, or ii) by applying directly to their health insurance company 77 . In both cases, once approved, users receive an activation code from their health insurance company to use the DiGA 77 . Users can find comprehensive information in the official DiGA directory and select a suitable application for their health problem. Several apps are now available for many indications, from which users can choose according to their personal preferences. The advantage here is that those affected can choose the application that appeals to them most in terms of usability, design and therapeutic focus. The DiGA directory itself does not control the selection and does not make any recommendations. The search can be carried out either by entering a specific search term or by browsing through the entire directory, optionally supported by various filter functions 78 . A key criterion for a DiGA is demonstrating its ability to produce a positive health effect 79 . This effect can be either a direct medical benefit or a significant improvement in the structure and process of patient care, which must be demonstrated by the manufacturer through a scientific study 79 . DiGAs are already available for a wide range of medical fields, including digestion, mental health, metabolic and cardiovascular diseases, as well as bone, muscle, and joint conditions and sleep-related problems 12 . As of August 2024, a search in the DiGA directory identified 64 available digital health applications of which 26 were categorised for mental health (“Psyche” in German). Digital care applications (DiPA) are apps or web applications that people in need of care can use together with their relatives or a care service in everyday life 80 . Their main goal is to make everyday care easier by providing guidance and support. In addition, there are DiPAs that help to better organise everyday care and promote health in a targeted manner through guided exercises 80 . After approval of the provision of a DiPA, the long-term care insurance fund covers costs of up to €53 per month. Any additional costs must be borne by the insured person 81 . Challenges and Opportunities of the TI for the German Healthcare System and its Stakeholders Challenges and Opportunities for Healthcare Providers Challenges for Healthcare Providers The challenges and opportunities of the TI are especially relevant for healthcare providers – practices, medical care centres, hospitals, and pharmacies – all of which are legally required to connect. A major challenge lies in the high technical and organisational demands, including strict data security requirements and the need to establish entirely new IT infrastructures. Many facilities must make extensive workflow adjustments, placing additional strain on healthcare personnel 82 . Healthcare workers not only have to restructure their work to establish new workflows, but also have to deal with the technical problems of IT in their everyday practice. For example, issuing e-prescriptions is often tricky, so paper forms like the Muster 16 still have to be used 83 . The transition to e-prescriptions is also hampered by the fact that restrictions remain in place, particularly in the area of home care, which means that Form 16 is still necessary 83 . Even though the eAU and eArztbrief work much better via KIM, many users continue to experience a high error rate when using IT: Between May and August 2024, only 7% of practices reported trouble-free operation, while 43% experienced weekly technical problems such as necessary restarts of card readers or connectors (73%), disruptions to practice organisation (58%) and difficulties reading patient data (54%) 83 . Furthermore, the implementation and operation of the TI require healthcare personnel, including medical, therapeutic, and administrative staff, to have greater technical know-how. However, according to Fraunhofer IESE, many medical professionals lack the necessary technical understanding and critical information needed to keep pace with the digital transformation of the medical field 12 . To address this gap, extensive training for healthcare providers and medical staff is essential. Such training requires not only significant time but also financial investment. Finally, educating patients about TI applications – although officially the responsibility of insurers – often falls to healthcare providers, adding further to their workload 53 . Financial burdens also pose a major issue. Monthly TI allowance from the BMG often do not cover the actual implementation and maintenance costs 84 . Additionally, allowance amounts depend on whether all legally required TI applications have been installed 85 . The KBV PraxisBarometer on digitalisation reported that 64% of surveyed physicians considered the cost-benefit ratio of the TI to be unfavourable 47 . Opportunities for Healthcare Providers Digitalising the healthcare infrastructure can improve efficiency, communication, and patient care. A 2022 survey found that doctors largely support digitalisation, with about three-quarters viewing it as a positive opportunity for the healthcare system 86 . A major benefit is enhanced interdisciplinary collaboration via digital networking with other stakeholders, such as health insurers and the National Association of Statutory Health Insurance Physicians – for example, through online billing and the submission of treatment and cost plans 17 . Improved data exchange can reduce waiting times, prevent redundant diagnostics, support faster diagnoses, and improve treatment efficiency by enabling a more comprehensive understanding of medical histories 19 . Digital infrastructure also reduces the workload of healthcare providers. Tools like teleconsultations and simple digital applications can support routine care 82 . For instance, e-prescriptions ease administrative burden by allowing patients to receive their prescriptions digitally instead of in person 87 . Similarly, the ePA reduces redundant documentation, helping relieve providers of repetitive tasks 87 . By streamlining care, only patients with actual medical needs are likely to visit clinics, increasing system-wide efficiency 87 . Challenges and Opportunities for Patients Challenges for Patients The digital transformation of the healthcare system imposes new demands on the technical competencies of insured individuals. A telephone survey found that 8.6% of respondents lacked internet access, with usage decreasing with age 88 . Older adults or those with limited technical skills or access may struggle to use the TI effectively. Additional operational challenges may arise for patients with physical disabilities or language barriers. For some, using digital solutions requires purchasing devices or internet access, adding financial burden 89 . Despite a " great openness to digital transmission " 88 , many users lack sufficient knowledge about digital health tools. Half of those surveyed were unaware of the ePA, and 75% were unfamiliar with digital health applications 88 , 90 . This low awareness, partly due to insufficient information from insurers and policymakers, requires patients to invest considerable effort in self-education and could overwhelm patients 91 . Technical support and guidance are thus essential to ease the use of TI, address data privacy concerns, and build trust. There is also concern that digitalisation could reduce personal interaction in care. Excessive reliance on digital processes may compromise attention to individual needs 82 . Weißenfeld et al. caution that telemedicine’s greatest risk lies in potential misdiagnoses 92 . Finally, uneven TI implementation presents a major challenge 13 . Infrastructure disparities may result in unequal access, particularly in rural or underserved areas – precisely where digital health could be most beneficial. For the TI to be used efficiently, nationwide implementation and usage are crucial 13 . Opportunities for Patients Despite challenges, a digital health infrastructure would offer notable advantages. Key benefits include " comfort and time savings in the doctor's office " 19 and a high level of information content, benefiting both patients and providers 93 . TI applications simplify daily processes: electronic sick notes and repeating prescriptions reduce unnecessary practice visits 87 . DiGAs and telemedicine services expand access and flexibility in care, supporting patients with chronic illness, limited mobility, or those in underserved areas, and helping overcome stigma when disclosing sensitive symptoms 32 , 59 , 94 . Remote care also lowers infection risks, as emphasised during the COVID-19 pandemic 12 . Telemonitoring enables continuous observation of physiological indicators – such as blood sugar, oxygen saturation, blood pressure, heart rate, activity, and sleep – supporting long-term health management 95 . It facilitates earlier detection of deterioration and enables timely interventions, especially in emergencies 12 . Clinical studies show positive effects for chronic conditions like heart failure, including reduced hospitalisations 12 . Zhang et al. also found that telemedicine improved glycaemic control in children with type 1 diabetes, enhancing quality of life and reducing hemoglobin A1C levels 95 . However, such interventions should complement, not replace, conventional care 95 . A review by Dhunnoo et al. similarly found benefits for mental health and adherence in chronic disease treatment 93 . Digital tools also offer potential in sleep medicine, e.g. through broad screening for sleep disorders like sleep apnea 96 . DiGAs have also shown positive effects in healthcare. Mäder et al. found that the most frequently reported medical benefit of DiGAs listed in the official DiGA directory was an improvement in overall health status 79 . For example, DiGAs targeting hormonal and metabolic diseases promote user self-management and can help change unhealthy habits. 12 Additionally, the use of digital health tools like health apps and wearables has been shown to positively influence health awareness and education 97 . Overall, digital tools strengthen patient autonomy and engagement. The ePA is central to this shift, enabling individuals to access and manage their health data 19 . In a gematik GmbH survey from 2024, 78% of insured respondents valued having control over who accesses their health data – indicating growing health literacy and patient sovereignty 14 , 87 . Challenges and Opportunities for Higher-Level Stakeholders Challenges for Higher-Level Stakeholders Financial challenges The financial challenges posed by the telematics infrastructure are immense – both the government and health insurance companies have had to make significant investments in its expansion, and the ongoing costs for maintenance and further development are substantial. Additionally, inefficient integration and use of digital solutions can diminish the anticipated savings. Therefore, it is crucial to ensure a careful evaluation and monitoring of digital applications so that the intended savings and benefits are realised and financial resources are used optimally. Furthermore, there is a risk that DiGAs in particular will be "unnecessarily prescribed, or that the apps will only add to the financial burden on health insurance companies without offsetting costs through the elimination of other paid services " 91 . Legal and Data Protection Challenges Another significant hurdle is the high demands of TI on data protection and security. Ensuring the protection of sensitive health data requires specific legal frameworks and regulations that must be overseen by the government 18 . These regulations are essential for maintaining trust in the system and ensuring compliance with national and European data protection laws. Data security concerns represent a major impediment to the widespread adoption of the ePA. According to a report by the National Association of Statutory Health Insurance Physicians from January 2025, the Chaos Computer Club (CCC) had already uncovered serious security gaps in the ePA at the end of 2024 and demanded that the protective measures be improved 98 . The CCC gained remote access via electronic replacement certificates for insurance cards – in combination with the insurance number, a coding key, an illegally obtained practice ID card (SMC-B) and access to the telematics infrastructure 99 . The hackers purchased used card readers online, some of which still contained practice ID cards (SMC-B cards) including the corresponding PINs, which were disclosed to them 100 . This made it possible to access individual patient files 99 . In response, it was decided to require additional card features in future 99 . Nevertheless, in May 2025, the CCC once again managed to circumvent the improved protection mechanisms – despite official assurances that the ePA was ‘secure’ 43 . Subsequent measures could not be verified at the time of writing. Educational challenges Education and training of healthcare providers and patients remain major challenges. Responsibility for patient education lies primarily with the government and insurers. Birkert et al. stress the importance of promoting digital health literacy to increase uptake of digital tools 32 . With the introduction of the ‘ePA for all’ in 2025, educating statutory insured members is particularly urgent. A study by Haug et al. in 2023 found that nearly half of respondents were unfamiliar with the ePA, yet many indicated they would use it 88 . This reflects "very high untapped potential for information campaigns" 88 . Healthcare providers also require continuous training. Many facilities surveyed by gematik in 2024 requested more information, as many questions arise only in everyday use 14 . Although gematik GmbH now provides free information material on electronic patient records for doctors' practices, care facilities, hospitals and pharmacies, there is no guarantee that these institutions will actually use the material, and the quantity that can be ordered is insufficient. By way of comparison, only five information packs can be ordered per institution, with each pack containing only two copies of the same information poster – a total of only ten posters per institution 101 . This is insufficient for large institutions such as hospitals. On a positive note, however, supplementary material is available for download, including information brochures and videos for waiting rooms, some of which are available in several languages 102 . The information provided by the Federal Ministry of Health and the National Association of Statutory Health Insurance Physicians has also improved, but it must be actively sought out, which continues to make access to information difficult. Opportunities for Higher-Level Stakeholders For higher-level stakeholders, two significant advantages can be identified: first, a significant improvement in the healthcare system for insured individuals, and second, long-term cost reductions through more efficient processes in healthcare, such as by avoiding redundant examinations. The further expansion of the TI and the successful implementation of digital applications would help the German healthcare system not only keep pace with the digital age but also improve its standing in international comparisons. For the German state, the primary focus is on achieving " improved and cost-effective public health " 91 . In contrast, health insurance companies are primarily interested in " efficient and effective patient care with as low a cost structure as possible ," as they must operate according to economic principles 91 . According to Zhang et al., digital access to telemedicine can ensure continuity of care while enabling cost reductions in healthcare 95 . During the COVID-19 pandemic, telemedicine applications proved particularly effective and cost-efficient, especially in reducing infections, as well as saving on protective clothing, masks, and disinfectants 92 . Mäder et al. also emphasise that the meaningful integration of digital health applications can improve healthcare cost-effectively 79 . Text Box 2. Practical Implications The findings show several areas for improvement in practice. Although growing usage numbers indicate that TI-applications are increasingly being integrated into everyday care 53 , there is still room for optimisation. A key aspect is the development of a unifying element that ensures a comprehensive overview of applications and their usage–an aim pursued through the BMG's digitalization strategy with the 'ePA for all' initiative 7 . Further progress depends on resolving persisting software issues in practice and hospital management systems 84 and achieving nationwide implementation to reduce regional disparities 13 . This also applies to the differences between privately (~ 8.7%) 103 and statutory insured persons, as the existing infrastructure currently, with few exceptions, only serves statutory health insurance holders. Since the legal obligations of TI only apply to statutory health insurance companies, private health insurance companies receive no financial support for the expansion of the telematics infrastructure and therefore have little incentive to offer their insured TI applications. However, some private health insurance companies have now begun to provide health applications like the ePA to their insured. Equally important is the comprehensive training and education of medical staff and patients to optimally utilise the TI and its applications. Stakeholders must provide targeted educational resources, and statutory insurers should enhance informational services to reduce the burden on providers. Better-informed users could increase adoption of digital and e-Health applications, improve care quality, and generate time and cost savings – benefits that could also translate into higher provider reimbursement and greater professional satisfaction. Lastly, data security concerns need to be adequately addressed to increase trust and enhance adoption. Discussion In this review, we have discussed past and planned measures on the German digitalisation strategy and its digital infrastructure for outpatient care. Following a slow start, the political will to integrate digital technologies has become evident in recent years and Germany has seen a wave of new laws and measures aimed at digitising the German healthcare system 4 . The BMG has laid out several key initiatives for the upcoming years including removal of the 30% cap on telemedical services, the introduction of assisted telemedicine, Digital Disease Management Programs, research pseudonyms, interoperable nursing documentation, and the transformation of gematik into a digital health agency 7 . By 2026, government targets include assisted telemedicine access in 60% of underserved regions, 80% paperless communication across healthcare settings, and the launch or completion of 300 eHealth research projects 7 . But these are future plans and promises – how successful are the measures implemented so far, and what effects have they had on the German healthcare system? According to the KBV's "PraxisBarometer Digitalisierung" survey in 2023, digital health applications are indeed increasingly becoming an integral part of everyday healthcare 53 . By 2023, the eAU was being utilised by 92% of respondents, and there were also notable increases in the use of the eMP, NFDM, and the ePA 53 . A 2023 survey revealed that 45.2% of doctors, psychotherapists, and staff encountered technical problems with practice software several times per week 84 . Instead of streamlining workflows, TI-related issues – particularly those involving electronic health cards or issuing eAUs – have increased administrative burdens, disrupted clinical processes, and extended patient waiting times 84 . Issues with practice/hospital management software (PVS/KVS) arise mainly when reading the eGK or when using TI applications like issuing an eAU 84 . Problems also often occur due to software updates 84 . Since uninterrupted use of PVS/KVS is essential in daily practice, a framework agreement with new requirements for software manufacturers was published by the KBV in March 2024 35 . However, manufacturers are not required to join this agreement 35 . To improve user-friendliness and more efficient use of ePA content, additional regulations and legal requirements from the government are thus being called for 35 . A further barrier to successful implementation is underfunding. Although the BMG allocates a monthly TI allowance, this funding is often insufficient to cover the true cost of integration. Full reimbursement is only granted when all mandated TI applications are installed; otherwise, financial penalties apply 85 . While the BMG claims that the allowances reflect historical costs and aim to ensure financial neutrality, only 18% of practices report full compensation for connector replacements 53 . Despite these funding shortfalls, 98% of medical practices are now connected to the TI 47 . Still, concerns persist that cost-benefit ratios remain unfavourable, especially in smaller or rural practices. Digital health applications – particularly DiGAs – are gaining traction. In September 2023, 48 DiGAs were officially listed, with 214,000 prescriptions issued that year, marking a 53% increase from 2022 103 . In July 2025, 44 digital health applications were permanently included in the DiGA directory of the Federal Institute for Drugs and Medical Devices, with 13 additional DiGA applications provisionally listed 78 . According to the DiGA report of the National Association of Statutory Health Insurance Funds for 2024, a total of over one million DiGA had been prescribed by doctors or approved by health insurance funds by the end of 2024 104 . According to the report, this also means that usage has risen significantly – to a total of 85%. The most commonly used DiGA are “ those for the treatment of mental illnesses (30%), but also DiGA that address metabolic diseases (28%) and DiGA for diseases of the musculoskeletal system (16%) ” 104 . Among users, 58% reported that DiGAs were a meaningful addition to their therapy 105 . Yet, their integration into standard care remains limited, and no DiGAs are currently licensed for disease prevention 89 . This represents a significant gap, considering their potential for early intervention and long-term cost savings. In contrast, telemedicine services, which saw a surge during the COVID-19 pandemic, have stagnated post-pandemic 86 . A key reason may be the low reimbursement rate for video consultations compared to in-person visits, despite an estimated €4.3 billion in annual savings through telemonitoring-driven hospital avoidance 91 , 106 . Usage figures indicate that DiGAs are significantly more popular than telemedicine. This could be due to the different reimbursement rates: video consultations are reimbursed at a much lower rate than in-person visits with a doctor 91 . DiGAs, however, are offered only as a complement to therapy, not as an alternative. They support early detection, treatment, and follow-up, but are not yet completely adopted in routine care 89 , 107 . From a policy perspective, Germany, along with the UK, remains a leader in digital health application governance 13 . Germany is particularly advanced in comparison, especially in approval and reimbursement processes (DiGA Fast-Track) and offers legal evidence standards 13 . France has already adopted the German model, and other European countries are monitoring the rollout with interest 75 , 79 . A key structural limitation of Germany’s digital infrastructure is the insufficient interoperability between systems. Many providers cite the lack of integrated health data as the greatest barrier to meaningful use 87 . The ePA is central to overcoming this issue. The “ePA for all” initiative introduces a default enrolment (opt-out) model, shifting away from the previous opt-in procedure that led to slow uptake 37 . While Estonia has demonstrated the effectiveness of the opt-out model, public support in Germany remains low 12 . Although 70 million ePAs have now been issued, only a fraction of these are actively used 38 . Germany's largest statutory health insurer, Techniker Krankenkasse, stated that it had created 11 million ePAs, but only 750,000 of these are actively used. Barmer, another big statutory health insurer, reports similar figures: of the 7.8 million ePAs created, only around 250,000 are actively used 38 . Nevertheless, the new ePA version offers significant advances, including the integration of e-prescriptions, new vaccination records, diagnostic reports, imaging data, emergency information, and digital health application data 14 . Götz et al. emphasise that this could position the ePA as the “ centrepiece of digital healthcare and a catalyst for further e-health applications ” – but only if it is routinely used in clinical practice 37 . Persistent criticism remains, however, that the ePA functions as a passive document archive rather than a dynamic, interoperable system. Concerns about data leakage and system intelligence continue to undermine user trust and slow adoption. With “TI 2.0,” the government has laid out a more ambitious and future-oriented vision for the telematics infrastructure. Planned expansions include the integration of additional healthcare stakeholders – such as outpatient care providers, therapists, rehabilitation centres, and long-term care facilities – and the deployment of a mobile-accessible digital health ID 108 . This is expected to simplify access to services such as the ePA and video consultations, while physical health cards remain available as an alternative. At the technical level, TI 2.0 proposes a shift to cloud-based access via standard internet connections, replacing the costly and maintenance-heavy connector infrastructure. A unified digital identity will also replace current SMC-B and eHBA cards, allowing secure mobile login, especially in ambulatory care. However, cybersecurity remains a key concern and is to be addressed through a “zero-trust” architecture designed to improve system resilience. The Federal Ministry of Health has aligned these plans with its Digitalisation Strategy for Healthcare and Nursing, which outlines goals through 2030 7 . Priorities include ePA expansion, assisted telemedicine via pharmacies and health kiosks, and the promotion of equitable, affordable access across all regions. Yet, implementation remains slow. Fragmented infrastructures, complex governance, limited digital literacy, and continued scepticism among both providers and patients hamper progress. Many elements of TI 2.0 are still in pilot phases or face long lead times before nationwide rollout. In this context, TI 2.0 appears less a technological reinvention and more a necessary course correction. While the foundations for a modern digital health ecosystem are being laid, success will depend on political continuity, pragmatic implementation, sustainable funding, and improved coordination across all levels of the healthcare system. As emphasised by the recent McKinsey report, Germany must focus on three priorities: scalability, integration of TI applications, and the structured exchange and use of health data 37 . Conclusion This narrative review showed that the telematics infrastructure in German outpatient care is progressing but must accelerate to realise its full potential. Various digital health components have already been implemented, including the electronic health card, insurance master data management, emergency data management, medication plan, patient record, KIM communication, electronic doctor's letter, sick note, and e-prescription. Telemedicine and DiGAs have further expanded digital care. These developments bring both challenges and opportunities for providers, patients, and stakeholders. A key hurdle is making the use of digital solutions more efficient and appealing. Providers and patients must better adapt to digital workflows and improve their digital literacy. Higher-level stakeholders must create frameworks that promote acceptance, offer training, and provide incentives or opt-out options to support implementation. TI applications offer clear benefits, including improved care with time and cost savings. Statutorily insured individuals may benefit from shorter waiting times and broader service access, while providers could gain relief in daily practice. In the long term, improved care may reduce healthcare costs and enhance population health, benefiting political and insurance stakeholders. Digital health also supports research by enabling the use of aggregated health data 7 . The 'ePA for all' could play a central role through its opt-out design and integration with DiGAs, offering users greater transparency and better health data use – if its full potential is rolled out 87 . Although further integration steps are needed, acceptance and utilisation of digital solutions are increasing. Still, improvements in cybersecurity remain essential to build trust among sceptical users. In conclusion, the expansion of the TI will hopefully " gain significant speed after a slow start [...] with new laws and measures surrounding TI " 19 . Abbreviations Abbreviation German Term English Term BÄK Bundesärztekammer German Medical Association BZÄK Bundeszahnärztekammer German Dental Association BMG Bundesministerium für Gesundheit Federal Ministry of Health BSI Bundesamt für Sicherheit in der Informationstechnik Federal Office for Information Security CCC Chaos Computer Club Chaos Computer Club DAV Deutscher Apothekerverband German Pharmacists' Association DiGA(s) Digitale Gesundheitsanwendungen Digital Health Application(s) DiPA(s) Digitale Pflegeanwendungen Digital Care Application(s) DigiG Digital-Gesetz Digital Law DKG Deutschen Krankenhausgesellschaft German Hospital Federation DVG Digitale-Versorgung-Gesetz Act for Better Care through Digitalisation and Innovation GKV-Spitzenverband Spitzenverband Bund der Krankenkassen National Association of Statutory Health Insurance Funds eArztbrief Elektronischer Arztbrief Electronic doctor’s letter eAU Elektronische Arbeitsunfähigkeitsbescheinigung Electronic sick note eGK Elektronische Gesundheitskarte Electronic health card E-Health Elektronische Gesundheit Electronic Health eHBA Elektronischer Heilberufsausweis Electronic health professional card eMP Elektronischer Medikationsplan Electronic medication plan ePA Elektronische Patientenakte Electronic health record eRezept Elektronisches Rezept Electronic prescription gematik GmbH Gesellschaft für Telematikanwendungen der Gesundheitskarte mit beschränkter Haftung Company for Telematics Applications of the Health Insurance Card, limited liability KBV Kassenärztlichen Bundesvereinigung National Association of Statutory Health Insurance Physicians KIM Kommunikation im Medizinwesen Communication in the Medical Field KVS Krankenhausverwaltungssoftware Hospital management software KZBV Kassenzahnärztlichen Bundesvereinigung National Association of Statutory Health Insurance Dentists MVZ Medizinisches Versorgungszentrum Medical care centres NFDM Notfalldatenmanagement Emergency data management PKV Verband der Privaten Krankenversicherungen e.V. Association of German Private Healthcare Insurers PVS Praxisverwaltungssoftware Practice management software SGB Sozialgesetzbuch Social Security Code SMC-B Security Module Card–Betriebsstätte Security Mobile Card “Work” TI Telematikinfrastruktur Telematic Infrastructure TIM TI-Messenger TI-Messenger VPN Virtuelles Privates Netzwerk Virtual Private Network VSDM Versichertenstammdatenmanagement Insured person master data management Declarations Ethics approval and consent to participate Not applicable. Consent for publication Not applicable. Availability of data and materials Not applicable. Competing interests The ABK and AMB declare that they have no competing interests related to this work. MS declares the following potential conflicts of interest in the past five years (2021–2025). Academic roles: Member of the Board of Directors, Society of Light, Rhythms, and Circadian Health (SLRCH) ; Chair of Joint Technical Committee 20 (JTC20) of the International Commission on Illumination (CIE) ; Member of the Daylight Academy ; Chair of Research Data Alliance Working Group Optical Radiation and Visual Experience Data . Remunerated roles: Speaker of the Steering Committee of the Daylight Academy ; Ad-hoc reviewer for the Health and Digital Executive Agency of the European Commission ; Ad-hoc reviewer for the Swedish Research Council ; Associate Editor for LEUKOS , journal of the Illuminating Engineering Society ; Examiner, University of Manchester ; Examiner, Flinders University ; Examiner, University of Southern Norway . Funding: Received research funding and support from the Max Planck Society , Max Planck Foundation , Max Planck Innovation , Technical University of Munich , Wellcome Trust , National Research Foundation Singapore , European Partnership on Metrology , VELUX Foundation , Bayerisch-Tschechische Hochschulagentur (BTHA) , BayFrance (Bayerisch-Französisches Hochschulzentrum) , BayFOR (Bayerische Forschungsallianz) , and Reality Labs Research . Honoraria for talks: Received honoraria from the ISGlobal , Research Foundation of the City University of New York and the Stadt Ebersberg, Museum Wald und Umwelt . Travel reimbursements : Daimler und Benz Stiftung . Patents: Named on European Patent Application EP23159999.4A (“ System and method for corneal-plane physiologically-relevant light logging with an application to personalized light interventions related to health and well-being ”). With the exception of the funding source supporting this work, MS declares no influence of the disclosed roles or relationships on the work presented herein. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. Funding Not applicable. Authors' contributions (CRediT roles) Conceptualization: ABK, AMB Data curation: not applicable Formal analysis: ABK, AMB Funding acquisition: not applicable Investigation: ABK, AMB Methodology: ABK, AMB Project administration: AMB Resources: MS Software: not applicable Supervision: MS, AMB Validation: AMB Visualization: ABK, AMB Writing – original draft: AMB Writing – review & editing: ABK, MS, AMB Acknowledgements Not applicable. References Niedermann, F. & Deetjen, U. Future-proofing German healthcare: Three catalysts to accelerate change. McKinsey & Company https://www.mckinsey.de/publikationen/2025-04-02-future-proofing-german-healthcare (2025). D’Onofrio, S. 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Wissen und Einstellung zur Speicherung und Nutzung von Gesundheitsdaten: Ergebnisse einer Bevölkerungsbefragung. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 184 , 50–58 (2024). doi:10.1016/j.zefq.2023.11.001. Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen. Digitalisierung für Gesundheit . (Hogrefe, 2021). doi:10.1024/86199-000. FGW Forschungsgruppe Wahlen Telefonfeld GmbH. Versichertenbefragung der Kassenärztlichen Bundesvereinigung 2021 - Ergebnisse einer repräsentativen Bevölkerungsumfrage. https://www.kbv.de/media/sp/2021_KBV-Versichertenbefragung_Berichtband.pdf (2021). Friesendorf, C. & Lüttschwager, S. Digitale Gesundheitsanwendungen: Assessment Der Ärzteschaft Zu Apps Auf Rezept . (Springer Fachmedien Wiesbaden, Wiesbaden, 2021). doi:10.1007/978-3-658-33983-8. Weißenfeld, M. M., Goetz, K. & Steinhäuser, J. Facilitators and barriers for the implementation of telemedicine from a local government point of view - a cross-sectional survey in Germany. BMC Health Serv Res 21 , 9 (2021). doi:10.1186/s12913-021-06929-9. Dhunnoo, P. et al. Evaluation of Telemedicine Consultations Using Health Outcomes and User Attitudes and Experiences: Scoping Review. J Med Internet Res 26 , (2024). doi:10.2196/53266. Riepe, C. & Von Schwanenflügel, M. Ethische Herausforderungen und Chancen von Telematik und Telemedizin. GuS 67 , 52–54 (2013). doi:10.5771/1611-5821-2013-4-52. Zhang, K. et al. Telemedicine in Improving Glycemic Control Among Children and Adolescents With Type 1 Diabetes Mellitus: Systematic Review and Meta-Analysis. J Med Internet Res 26 , (2024). doi:10.2196/51538. Schöbel, C. & Woehrle, H. Pneumologie out of the box – intersektorale moderne Diagnostik und Therapie in der Schlafmedizin. Z Pneumologie 21 , 73–87 (2024). doi:10.1007/s10405-024-00547-y. Heidel, A. & Hagist, C. Potential Benefits and Risks Resulting From the Introduction of Health Apps and Wearables Into the German Statutory Health Care System: Scoping Review. JMIR Mhealth Uhealth 8 , (2020). doi:10.2196/16444. Kassenärztliche Bundesvereinigung. Schwachstellen bei der ePA: Hinweise zur Datensicherheit. https://www.kbv.de/praxis/tools-und-services/praxisnachrichten/2025/01-30/Schwachstellen%20bei%20der%20ePA-%20Hinweise%20zur%20Datensicherheit (2025). Bundesgesundheitsministerium. ePA-Sicherheitslücke geschlossen. BMG https://www.bundesgesundheitsministerium.de/presse/pressemitteilungen/epa-sicherheitsluecke-geschlossen-pm-30-04-25.html (2025). Banse, P. & Buermeyer, U. LdN414 Elektronische Patientenakte mit Problemen, Habecks Vorschlag für Sozialversicherung, Wahlversprechen der Parteien nicht finanzierbar, DFL muss für Hochrisikospiele zahlen, Auslandsdeutsche befürchten Wahl-Probleme, Korrektur: Ältestenrat im Bundestag. Lage der Nation, Folge 414 https://lagedernation.org/podcast/ldn414-elektronische-patientenakte-mit-problemen-habecks-vorschlag-fuer-sozialversicherung-wahlversprechen-der-parteien-nicht-finanzierbar-dfl-muss-fuer-hochrisikospiele-zahlen-auslandsdeutsche-be/ (2025). gematik GmbH. Gematik-Shop. Informationsmaterial ePA für alle. https://shop.gematik.de/ (n. d.). gematik GmbH. Download: ePA-Infopaket. https://www.gematik.de/anwendungen/epa-fuer-alle/download-infopaket (2025). Schmachtenberg, S., Heymann, D. & de Salaberry, J. Hat Deutschland alle Bausteine für ein zukunftsfähiges digitales Gesundheitsökosystem? in E-Health Monitor 2023/24. Deutschlands Weg in die digitale Gesundheitsversorgung – Status quo und Perspektiven (Eds. McKinsey & Company, Padmanabhan, P., Redlich, M., Richter, L., Silberzahn, T.) 37–52 (Medizinisch Wissenschaftliche Verlagsgesellschaft, 2024). GKV-Spitzenverband. DiGA-Bericht Des GKV-Spitzenverbandes - 2024 - Bericht Über Inaspruchnahme Und Entwicklung Der Versorgung Mit Digitalen Gesundheitsanwendungen . https://www.gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/telematik/digitales/2024_DiGA-Bericht_final.pdf (2025). Maier, L. et al. Akzeptanz und Nutzung digitaler Lösungen. in E-Health Monitor 2023/24. Deutschlands Weg in die digitale Gesundheitsversorgung – Status quo und Perspektiven (Eds. McKinsey & Company, Padmanabhan, P., Redlich, M., Richter, L., Silberzahn, T.) 87–102 (Medizinisch Wissenschaftliche Verlagsgesellschaft, 2024). Ballarin, S. et al. E-Health Monitor 2023/24: Deutschlands Weg in die digitale Gesundheitsversorgung – Status quo und Perspektiven . (Medizinisch Wissenschaftliche Verlagsgesellschaft, 2024). Gerlinger, G., Mangiapane, N. & Sander, J. Digitale Gesundheitsanwendungen (DiGA) in der ärztlichen und psychotherapeutischen Versorgung. Chancen und Herausforderungen aus Sicht der Leistungserbringer. Bundesgesundheitsbl. 64 , 1213–1219 (2021). doi:10.1007/s00103-021-03408-8. Gematik GmbH. TI 2.0. https://www.gematik.de/telematikinfrastruktur/ti-2-0 (2025). Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7409565","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Systematic Review","associatedPublications":[],"authors":[{"id":504264880,"identity":"b20d3cc9-c8f0-405a-b92c-a1ad868e8624","order_by":0,"name":"Alice Beatrix König","email":"","orcid":"","institution":"Technical University of Munich","correspondingAuthor":false,"prefix":"","firstName":"Alice","middleName":"Beatrix","lastName":"König","suffix":""},{"id":504264882,"identity":"42ec0a37-847a-48b6-9a56-16b2acc4f369","order_by":1,"name":"Manuel Spitschan","email":"","orcid":"","institution":"Technical University of Munich","correspondingAuthor":false,"prefix":"","firstName":"Manuel","middleName":"","lastName":"Spitschan","suffix":""},{"id":504264884,"identity":"65a63819-f911-4664-98a1-f0c47302ce6e","order_by":2,"name":"Anna M Biller","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAyklEQVRIiWNgGAWjYLACxgYJGT4g9QDMO0CkFh42BgZmgwMkaGEAaWGTIEoL/+zegx8Yd1jwsLH3Pqv+2LaNge94A34tEnfOJUswngE6jOe42Y2DbbcZJM8QsuZGjoEEYxtQi0QaG1iLwY0E/Drkb+QY/wBrkX/GVgDWcv8Bfi0GN3LMoLawsTFAbCHgLkOgFotEsF/SmCXOnLvNI3mGgMPkgA678XFHnRw/+zHGDxVlt+X4jh8gYA0IIBvLQ4T6UTAKRsEoGAWEAABLG0DVUhs92wAAAABJRU5ErkJggg==","orcid":"","institution":"Technical University of Munich","correspondingAuthor":true,"prefix":"","firstName":"Anna","middleName":"M","lastName":"Biller","suffix":""}],"badges":[],"createdAt":"2025-08-19 14:23:23","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7409565/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7409565/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":89990207,"identity":"15597075-6812-4b71-b3d1-1cb7f196e921","added_by":"auto","created_at":"2025-08-27 07:10:12","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":81532,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eOverview of the key players within the telematic infrastructure in Germany.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"image1.png","url":"https://assets-eu.researchsquare.com/files/rs-7409565/v1/2831de8030952183d0c938f0.png"},{"id":89990209,"identity":"f97b64d6-99bc-46b3-a680-15858c5600a6","added_by":"auto","created_at":"2025-08-27 07:10:12","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":282819,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eArchitecture of the telematic infrastructure. \u003c/strong\u003e\u003cem\u003eAbbreviations\u003c/em\u003e: SMC-B, Security Module Card–Betriebsstätte (Security Mobile Card “Work”); eHBA, elektronischer Heilberufsausweis (e-health professional card); eGK, elektronische Gesundheitskarte (e-health card); NFDM, Notfalldatenmanagement (emergency data management); eMP, elektronischer Medikationsplan (e-medication plan); VPN, Virtual Private Network; TI, telematic infrastructure; ePA, elektronische Patientenakte (e-health record); eRezept (e-prescriptions); KIM, Kommunikation im Medizinwesen (Communication in the Medical Field); VSDM, Versichertenstammdatenmanagement (insured person master data management); TIM, TI-Messenger; eAU, elektronische Arbeitsunfähigkeitsbescheinigung (e-sick note); eArztbrief (e- doctor’s letter).\u003c/p\u003e","description":"","filename":"image2.png","url":"https://assets-eu.researchsquare.com/files/rs-7409565/v1/c8b216f434705bd72ca57b37.png"},{"id":89990131,"identity":"5ea5e355-c424-4e24-8cfb-0eeaa13ac0d4","added_by":"auto","created_at":"2025-08-27 07:10:06","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":195717,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTimeline of the introduction of Telematic Infrastructure elements in Germany.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"image3.png","url":"https://assets-eu.researchsquare.com/files/rs-7409565/v1/569829d2d40f572898b7b6dc.png"},{"id":89990224,"identity":"ded1ae09-4aeb-43b0-a83e-4d90640e2f73","added_by":"auto","created_at":"2025-08-27 07:10:14","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":408464,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChallenges and Opportunities for the Telematics Infrastructure in Germany.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"image4.png","url":"https://assets-eu.researchsquare.com/files/rs-7409565/v1/b127b627e3c294c7a19920d8.png"},{"id":90464439,"identity":"a54dc8c9-30e2-4826-9cac-87d5e849e62e","added_by":"auto","created_at":"2025-09-03 05:09:15","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2063613,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7409565/v1/cb262e5f-fbfb-4ca9-9ae2-53adc6fb81f0.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"How digital is the German outpatient healthcare system? A review on past and future measures, challenges and opportunities","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe German healthcare system is increasingly confronted with long-trailing challenges, such as demographic changes, exploding costs, and personnel shortages which place additional demands on its structure and functioning\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. Another specific challenge of the German system is that healthcare structures and players are not widely connected leading to incomplete information transfer, double treatments, inefficient treatments and other negative impacts on the treatment journey\u003csup\u003e\u003cspan additionalcitationids=\"CR4 CR5\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. In response to these challenges, the expansion of the digital health infrastructure, aimed at digitising healthcare in Germany, has gained growing significance. Additionally, the COVID-19 pandemic played a pivotal role in reinforcing the need to digitally enhance the healthcare system\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. During the pandemic, many people used health-related digital applications, such as the Corona-Warn-App (Germany\u0026rsquo;s official COVID-19 digital contact tracing app) and the digital vaccination certificate on their smartphones, for the first time\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. Consequently, there was a significant increase in the use of telemedicine applications\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e. Building on the lessons learned from the pandemic, along with the demonstrated acceptance and willingness of the population to use digital technologies, offers a crucial opportunity to further expand and strengthen the German healthcare system\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eYet, Germany lags significantly behind other countries in the digitalisation of its healthcare system. In an international comparative study on the state of healthcare digitisation in 2018, Germany ranked second to last, significantly trailing behind the other selected countries\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. This is hardly surprising, as Germany has only made significant progress in digitalisation and the expansion of digital health infrastructure in recent years. In countries like Estonia and Denmark, the widespread use of eHealth like the electronic patient record or the e-prescription has been established for years\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. Despite this, a study by Klar et al. (2023) compared ten European countries, revealing that none of the examined countries \"\u003cem\u003ehad fully realised a digital patient pathway from prevention through acute treatment to billing\u003c/em\u003e\"\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. However, other countries focus on specific stages of the care pathway from prevention measures to the payment process with a 'First Scale, then Scope' strategy, meaning they aim to reach a critical mass before optimising and expanding the offering during ongoing operations helping them to roll out technical solutions more quickly\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Therefore, approaches of successful countries could potentially serve as a guide for areas in Germany that need further development in digital health.\u003c/p\u003e\u003cp\u003eReasons for the slow digital expansion in the German healthcare system, according to an analysis by the Fraunhofer Institute for Experimental Software Engineering IESE and the Fraunhofer Institute for Systems and Innovation Research ISI in 2023, include the lack of acceptance among healthcare providers, inadequate technical infrastructure, strict data protection and security requirements, and the lack of incentives for healthcare stakeholders\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. The absence of nationwide health initiatives for digitalisation also plays a role; some projects, like the e-prescription, have not been fully and widely implemented at the national level\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. The importance of increasing knowledge about the telematic infrastructure (TI), Germany\u0026rsquo;s digital health infrastructure, among its users was underscored by a quantitative online survey conducted by gematik GmbH in 2024\u003csup\u003e14\u003c/sup\u003e. Many of the surveyed institutions expressed a need for more information on using digital applications, with many feeling only moderately informed about the TI and its various applications\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eThis review is thus motivated by the need to provide stakeholders in the German healthcare system and the wider research community with a clear and comprehensive summary of the developments related to the TI and its broader implications. The primary objective of this study is to explore the current status of Germany's digital health infrastructure, focusing on the extent of its expansion as of the present date. This investigation will examine the specific measures that have been implemented to advance the digital health infrastructure within the German healthcare system. Additionally, we critically assess the challenges and opportunities that have emerged as a result of these initiatives. By addressing these aspects, we provide a comprehensive and up-to-date overview of the development of digital health infrastructure in Germany, while also offering practical insights into its implications for healthcare provision.\u003c/p\u003e\u003cp\u003eThe following research questions arise for this study:\u003c/p\u003e\u003cp\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eWhere does Germany stand in terms of expanding its digital health infrastructure?\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eWhat measures have been implemented in this context so far?\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eWhat challenges and opportunities for various stakeholders have these implemented measures brought about?\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eSearch Strategy\u003c/p\u003e\u003cp\u003eA comprehensive literature review was conducted using the online catalogues of the Technical University of Munich and Ludwig Maximilian University of Munich, as well as the PubMed database and the Journal of Medical Internet Research (JMIR). To ensure a comprehensive and up-to-date overview, several relevant websites, including those of the National Association of Statutory Health Insurance Physicians and gematik GmbH, were also consulted, integrating official publications from key healthcare organisations. The search was limited to publications from the last ten years and included both German and English literature. An initial screening of the literature was conducted in April 2024, followed by systematic research in May and June 2024 and an update in July 2025.\u003c/p\u003e\u003cp\u003eThe initial search focused on identifying relevant articles and publications using keywords translated from German, including \"telematics infrastructure,\" \"TI,\" \"telematics,\" \"e-health,\" \"digitalisation,\" \"digitalisation and health,\" \"digital healthcare,\" \"German healthcare system,\" and \"German healthcare services.\" At a later stage, the search was refined with additional terms such as \"electronic health services,\" \"telemedicine,\" \"digital health applications,\" \"DiGAs,\" \"electronic prescription,\" \"e-prescription,\" \"electronic patient record,\" \"ePA,\" \"electronic sick note,\" and \"eAU.\" In JMIR, a broad search was conducted within the categories \"E-Health / Health Services Research and New Models of Care,\" \"Telehealth and Telemonitoring,\" \"Digital Health,\" and \"E-Health Policy and Health Systems Innovation.\" Selection and Evaluation of Literature\u003c/p\u003e\u003cp\u003eThe selection and evaluation of literature were guided by criteria such as relevance to the research questions, scientific rigour, and alignment with the study's focus on the German TI and its impact on healthcare. Preference was given to peer-reviewed scientific articles and studies that directly addressed these topics, as well as official publications from health organisations and federal government agencies. Non-scientific sources were included selectively, only when they provided essential contextual information that was critical for addressing the research questions. The literature management software Zotero version 6.0.36 was utilised for literature categorisation, citation, and retrieval of sources throughout the research process.\u003c/p\u003e\u003cp\u003eDuring the data collection phase, the selected literature was thoroughly read and critically evaluated to extract key insights and perspectives. The \"Three-Pass Approach\" method, as outlined by Srinivasan Keshav (2007), was employed to systematically analyse the literature\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. This method involves three sequential reading passes, each designed to progressively deepen the understanding of the material. In the first pass, a general overview of each article was obtained by reading the title, abstract, introduction, and subheadings. A more detailed content analysis was conducted in the second pass, during which the key sections and arguments were examined in greater detail and initial notes were taken. The third and final pass involved a comprehensive analysis of each study, capturing and questioning all details holistically.\u003c/p\u003e\u003cp\u003eManuscript translation\u003c/p\u003e\u003cp\u003eThe manuscript was initially drafted in German by the first author in 2024 and subsequently translated into English using ChatGPT and DeepL. Following the translation, the manuscript underwent significant rewriting and thorough review by all authors to ensure accuracy and clarity and was updated in June and July 2025 to reflect the current developments in Germany.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eOverview of the telematic infrastructure in Germany\u003c/p\u003e\n\u003cp\u003eIn Germany, the Telematics infrastructure (TI), described as the \u0026quot;data highway of healthcare\u0026quot; by the National Association of Statutory Health Insurance Physicians, is the cornerstone of the digitalisation within the statutory health insurance system\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e. The term \u0026lsquo;telematics\u0026rsquo;, derived from the words \u0026lsquo;telecommunications\u0026rsquo; and \u0026lsquo;informatics,\u0026rsquo; refers to \u0026quot;\u003cem\u003ethe networking of various IT systems and the ability to link information from different sources\u003c/em\u003e\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. The TI thus represents a national digital health infrastructure aimed to bridge eHealth (provider-focused systems) and digital health (patient-focused tools) with the involvement of various stakeholders (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e; \u003cstrong\u003eText Box 1\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eText Box 1. Germany\u0026rsquo;s telematic infrastructure at a glance.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable style=\"width: 100%;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 100.0000%;\"\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003eOnly \u003cstrong\u003eregistered healthcare providers\u003c/strong\u003e and \u003cstrong\u003einstitutions\u003c/strong\u003e can access the TI and its applications via \u003cstrong\u003eVPN-secured internet connections\u003c/strong\u003e and a \u003cstrong\u003econnector\u003c/strong\u003e.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eThe \u003cstrong\u003etechnical components and applications\u003c/strong\u003e of the TI are subject to \u003cstrong\u003estrict data and information security requirements\u003c/strong\u003e.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eThe \u003cstrong\u003eFederal Office for Information Security (BSI)\u003c/strong\u003e oversees the development of the TI and \u003cstrong\u003eregularly audits\u003c/strong\u003e its technical and security-related components.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eCertain \u003cstrong\u003epatient data\u003c/strong\u003e may only be accessed or modified \u003cstrong\u003ewith the explicit consent of the insured individual\u003c/strong\u003e.\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\u003cbr\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eAccording to the Federal Office for Information Security, the purpose of TI is to enable fast, secure, and digital exchange of sensitive health data among actors including patients in the healthcare sector through a dedicated, closed infrastructure, aiming to achieve efficient and high-quality patient care in Germany\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. The successful implementation and utilisation of the digital health infrastructure in Germany involves collaboration among several key stakeholders. The legal and regulatory framework governing this infrastructure is established by the Federal Ministry of Health (Bundesministerium f\u0026uuml;r Gesundheit, BMG). Since 2005, gematik GmbH (Society for Telematics Applications of the Health Card) has been tasked with the introduction and continuous advancement of the TI\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eGematik GmbH is a collaborative entity composed of shareholders representing a broad spectrum of the healthcare sector, including the German Medical Association (Bundes\u0026auml;rztekammer; B\u0026Auml;K), the German Dental Association (Bundeszahn\u0026auml;rztekammer; BZ\u0026Auml;K), the National Association of Statutory Health Insurance Physicians (Kassen\u0026auml;rztlichen Bundesvereinigung; KBV), the National Association of Statutory Health Insurance Dentists (Kassenzahn\u0026auml;rztlichen Bundesvereinigung; KZBV), the German Hospital Federation (Deutschen Krankenhausgesellschaft; DKG), the German Pharmacists\u0026apos; Association (Deutschen Apothekerverbandes; DAV), the Association of German Private Healthcare Insureres (Verband der Privaten Krankenversicherungen e.V.; PKV) and the National Association of Statutory Health Insurance Funds (Spitzenverband Bund der Krankenkassen; GKV-Spitzenverband), which represents the interests of health insurance funds (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e. The distribution of shares among the shareholders at the shareholders\u0026apos; meeting is regulated by law\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e. The largest share, 51%, goes to the Federal Ministry of Health. The remaining shares are distributed as follows: The National Association of Statutory Health Insurance Funds holds 22.05%, the National Association of Statutory Health Insurance Funds receives 7.35%, the German Hospital Association holds 5.88%, the Chamber of Pharmacists holds 3.92% and the private health insurance providers, B\u0026Auml;K, BZ\u0026Auml;K and KZBV each have 2.45% of the meeting shares\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe Federal Office for Information Security (Bundesamt f\u0026uuml;r Sicherheit in der Informationstechnik; BSI), in collaboration with federal and state data protection authorities, ensures that all participants in the TI adhere to stringent security standards and data protection regulations. Other critical stakeholders include healthcare service providers and statutory health insurance funds, both of which play essential roles in the financing and implementation of the TI. Currently, connection to the TI is mandatory for medical practices, medical care centres (Medizinische Versorgungszentren; MVZ), hospitals, and pharmacies\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. For other healthcare providers, such as midwives, connection remains voluntary at present, although mandatory participation is expected in the coming years (see also \u003cstrong\u003eDiscussion\u003c/strong\u003e). Patients, as recipients of healthcare services, are also considered vital stakeholders in the evolving TI.\u003c/p\u003e\n\u003cp\u003eConnecting to the TI requires specific components and applications to ensure that only authenticated individuals and institutions have access\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. The registration process mandates the use of an electronic health professional card (elektronischer Heilberufsausweis; eHBA) for the authentication of individual service providers, and a practice or institutional card (SMC-B) for the authentication of medical facilities (Fig. \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e. The eHBA is also essential for facilitating electronic signatures, which are required for various TI applications, including the issuance of e-prescriptions\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e. To interact with the TI, healthcare providers need an e-health card terminal, which is used to log in with the eHBA and read patients\u0026apos; electronic health cards\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e. A crucial component for connecting to the TI is the TI connector, a high-performance router that is supposed to securely encrypt and transmit sensitive data over a Virtual Private Network (VPN)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. This connector is integrated with a practice management software (Praxisverwaltungssoftware; PVS) or hospital management software (Krankenhausverwaltungssoftware; KVS), ensuring secure data exchange within the healthcare setting. Healthcare facilities are free to select their provider of practice or hospital management software, which can result in compatibility issues due to the diversity of systems. To support informed decision-making, facilities can consult the websites of their respective professional associations, where they may find guidance on recommended software programmes and their developers. The VPN network, a non-public network, is vital for maintaining the confidentiality and integrity of health data by preventing third parties from tracking internet activities. Given the stringent data protection requirements for medical data, the BSI certifies critical TI components after thorough evaluation by recognised testing bodies\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e. Since 2024, the connection to the TI is supposed to be established either through a device located on the premises of a healthcare practice or via a connector housed in a data centre\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e. However, the gematik has recently announced that the use of connectors will be terminated by 2030 and is planned to be replaced by a cloud-based version TI-gateway\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eTimeline of important (legal) steps\u003c/p\u003e\n\u003cp\u003eThe legal framework for Germany\u0026apos;s TI was first established in \u0026sect;\u0026nbsp;291 of the Fifth Social Security Code, which introduced the electronic health card\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e. The foundational legislation for the TI was further developed with the enactment of the Act for Secure Digital Communication and Applications in Healthcare (E-Health Act) on December 29, 2015 (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e). This Act aimed to \u0026quot;\u003cem\u003eestablish the legal prerequisites for the medium- to long-term development of a comprehensive digital infrastructure in healthcare\u003c/em\u003e\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e, marking the first formal legal framework for the introduction of eHealth and the initial digital applications within the German healthcare system.\u003c/p\u003e\n\u003cp\u003eThe E-Health Act has since been supplemented by additional regulations to expand and refine the digital health landscape in Germany. Notably, the Act for Better Care through Digitalisation and Innovation (Digitale-Versorgung-Gesetz; DVG), enacted in December 2019, introduced key regulations for prescribing digital health applications (Digitale Gesundheitsanwendungen; DiGAs) and conducting video consultations\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e. Further advancements were made with the Digital Care and Nursing Modernisation Act (Digitale-Versorgung-und-Pflege-Modernisierungs-Gesetz; DVPMG), which came into force on June 9, 2021. This legislation expanded telemedicine services and digital health applications, including, for the first time, digital nursing applications (DiPAs) (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eOn 26 March 2024, two additional laws were enacted by the Federal Ministry of Health to further advance healthcare digitalisation: the Digital Law (Digital-Gesetz; DigiG) and the Health Data Usage Act (Gesundheitsdatennutzungsgesetz; GDNG). The Digital Law aims to simplify daily medical practices for both doctors and patients through the implementation of digital solutions\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e\u003c/sup\u003e. A central element of this law is the \u0026apos;electronic patient record (ePA) for all,\u0026apos; which was implemented for all statutory health insurance holders by the beginning of 2025\u003csup\u003e29\u003c/sup\u003e. Meanwhile, the Health Data Usage Act seeks to enhance healthcare research by establishing a \u0026ldquo;\u003cem\u003ecentral data access and coordination center for the use of health data\u003c/em\u003e,\u0026rdquo; thereby facilitating easier access to research data\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThese legislative frameworks are further supported by regulations such as Article 9 of the General Data Protection Regulation (GDPR), which governs the processing of special categories of personal data, and the Federal Data Protection Act (Bundesdatenschutzgesetz; BDSG), which provides \u0026quot;\u003cem\u003efundamental legal bases for the processing of health data\u003c/em\u003e\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Additionally, the Patient Data Protection Act (Patientendaten-Schutz-Gesetz; PDSG) ensures that the use of electronic health data within the eHealth infrastructure is secure, compliant with data protection regulations, and user-friendly\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. While the above laws and regulations form the core of the legal framework governing the TI, there are numerous other legal provisions that also play a role. However, a comprehensive list of these would exceed the scope of this work.\u003c/p\u003e\n\u003cp\u003eTI elements\u003c/p\u003e\n\u003cp\u003eThe German TI is supposed to facilitate secure digital networking within the German healthcare system. Central to this infrastructure is the electronic health card (elektronische Gesundheitskarte; eGK), first introduced in 2011, which underpins a range of critical applications. These include insured master data management, emergency data management, electronic medication plans, the electronic patient record (elektronische Patientenakte; ePA), communication in medical settings (such as electronic doctor letters and electronic sick notes), and e-prescriptions. The most significant of these applications will be discussed in more detail in the following sections.\u003c/p\u003e\n\u003cp\u003eThe Electronic Health Card and Insured Person Master Data Management\u003c/p\u003e\n\u003cp\u003eOne of the first elements of the German eHealth infrastructure is the introduction of the electronic health card (elektronische Gesundheitskarte; eGK) and the insured person master data management (Versichertenstammdatenmanagement; VSDM). The legal framework for these components was primarily established through Sections 291a to 291c of the Fifth Social Security Code (SGB V) as part of the 2004 health reform that introduced the eHealth infrastructure and the eGK\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e. The eGK has been in use since 2011\u003csup\u003e32\u003c/sup\u003e. It is issued by health insurance companies to each insured person, credit card sized, serving both as proof of insurance and as a means of billing for services\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe eGK must be read by the health care provider for the utilisation of services covered by statutory health insurance\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e. This process is required in practices, medical care centres (MVZ), and hospitals and must be documented for quarterly billing purposes but is not necessary for privately insured people. The eGK contains personal data such as the insured person\u0026rsquo;s name, date of birth, gender, and address, as well as insurance details. With the insured person\u0026rsquo;s consent, it can also store medical data, including the ePA and emergency data management (Notfalldatenmanagement; NFDM).\u003c/p\u003e\n\u003cp\u003eTo facilitate online verification and updating of the data stored on the eGK with the health insurance companies, the insured master data management (VSDM) was introduced in 2019. VSDM represents the \u0026quot;first legally mandated online application of the eGK\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e\u003c/sup\u003e. Data synchronisation is performed by reading the insurance card through the eGK card terminal via the TI connector\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e. When the card is inserted, the connector verifies the card\u0026rsquo;s validity and checks the accuracy of the stored data with the insured master data service of the relevant health insurance company\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThis verification, crucial for billing, is recorded on the eGK and transferred into the practice management software (PVS/KVS)\u003csup\u003e33\u003c/sup\u003e. If necessary, the insured data on the eGK is updated, and the new information is saved in the software\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e. For the process to function smoothly, it is essential that the insured person informs their health insurance company of any changes so that the information can be reflected in the health insurance company\u0026rsquo;s system\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e. The eGK and VSDM, as central components of the TI, form the foundation upon which all other TI applications are built. The eGK has been an integral part of the German healthcare system for several years. The card can usually be read without any problems, but functionality may be limited if there is no stable internet connection and therefore no connection to the TI.\u003c/p\u003e\n\u003cp\u003eEmergency Data Management (NFDM) and the Electronic Medication Plan (eMP)\u003c/p\u003e\n\u003cp\u003eIn 2020, two additional components of the eHealth infrastructure were introduced, the i) emergency data management (Notfalldatenmanagement; NFDM) and ii) the electronic medication plan (elektronischer Medikationsplan; eMP). The NFDM allows doctors to store critical personal health information on the eGK that is necessary for emergency care, including current medications, important contact details, and information about chronic illnesses, pregnancies, or implants\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe eMP, also stored on the eGK, lists the insured person\u0026apos;s prescribed medications. This feature ensures that healthcare providers can reliably access up-to-date information on a patient\u0026rsquo;s current medications, reducing the risk of forgetting, misplacing, or duplicating medication plans\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e. This eMP not only represents a significant reduction in workload for healthcare providers but also contributes to the prevention of serious errors, as allergies and intolerances are also stored there, helping to avoid interactions and contraindications\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Insured individuals are entitled to have an eMP maintained by healthcare providers and pharmacy staff when they are prescribed \u0026quot;\u003cem\u003ethree permanently systemically acting medications\u003c/em\u003e\u0026quot; or more\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e. The eMP must be continuously updated to ensure accuracy\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e. Both the NFDM and eMP can alternatively be stored in the ePA\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eAccording to a publication of health data by the National Association of Statutory Health Insurance Physicians from 2024, eMP is significantly more used than NFDM in patient care. 64.2% of respondents from the field of general medicine use eMP in patient care, whereas NFDM is only used by 19.5% of respondents in patient care\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe Electronic Patient Record (ePA)\u003c/p\u003e\n\u003cp\u003eThe ePA is considered the most important element of the German eHealth infrastructure because it serves as a central repository where all insured persons\u0026apos; information and a significant portion of other eHealth elements converge\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. According to Birkert et al. (2022), the ePA also ensures TI interoperability by enabling the necessary data exchange among healthcare actors and integrating the procedural standards needed for the smooth import and export of data\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Until the end of 2024, the ePA was a voluntary, insured-led electronic record that can be used by insured persons who apply for it through their health insurance company\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Upon application, Section 337(3) of the Fifth Social Security Code (SGB V) grants the insured the right to determine who is authorised to access their data and the extent of those access rights\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Additionally, Sections 337(1) and (2) SGB V give insured persons the right to read, transmit, and process data within the ePA and to delete any data, except for the eMP and emergency data\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eInsured persons also have the right to have their treatment data transferred to the ePA by healthcare providers, providing them with significantly more autonomy compared to the limited access typically afforded to the analogue patient records held by healthcare providers\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. The ePA can be accessed and managed by patients via apps provided by their health insurance companies, allowing them to grant access to healthcare providers, who authenticate themselves using their electronic health professional cards to obtain the necessary authorisations (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eHealthcare providers could benefit from the ePA as it allows them to access previous findings and other health data collected and stored by third parties, which are essential for effective medical care\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. The ePA consolidates all the information that would otherwise be part of the local healthcare provider\u0026rsquo;s (hard copy) records, such as findings, diagnoses, therapeutic measures, and treatment reports\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eIn theory, the ePA would allow that hard copy documents would no longer need to be exchanged between providers or carried by patients, reducing the risk of duplicate examinations and ensuring that no previous findings are lost\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Although health insurance companies have been required to offer the ePA to insured persons since 1 January 2021, its usage remained extremely low, with only 1% of all statutory insured persons in Germany using it as of the end of September 2023\u003csup\u003e32,37\u003c/sup\u003e. To increase uptake, the ePA transitioned to the \u0026apos;ePA for all\u0026apos; at the beginning of 2025, introducing an opt-out procedure rather than the current opt-in option that aimed to achieve coverage for 80% of statutory insured persons\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e. This shift represents a significant change in the usage principle, potentially leading to much broader adoption in the future. However, as of mid-2025, the ePA still has low adoption among the general population, with only about 1% of the over 74\u0026nbsp;million statutorily insured individuals in Germany actively using it\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e38\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eAs can be seen from the current usage figures, the ePA remains controversial. In addition to fundamental data protection concerns, many stakeholders also criticise the functional design of the ePA. At present, it is a passive storage facility where medically relevant information that is not yet automatically integrated in the ePA \u0026ndash; such as historic vaccination records or current maternity pass logs \u0026ndash; can only be stored as PDF or scan files (or need to be entered manually)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e39\u003c/span\u003e\u003c/sup\u003e. In general, the files are uploaded either by the insured persons themselves or by service providers with the prior consent of the insured persons. This limited functionality is regularly criticised\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e\u003c/sup\u003e. Sebastian Krammer states in an article published by the \u003cem\u003e\u0026Auml;rzteZeitung\u003c/em\u003e in April 2025 \u0026ldquo;\u003cem\u003ethat many doctors find the ePA unhelpful so fa\u003c/em\u003er\u0026rdquo;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e\u003c/sup\u003e. He claims the \u0026ldquo;\u003cem\u003elack of focus on structured data and interoperability\u003c/em\u003e\u0026rdquo; as a reason, which means that the ePA is \u0026ldquo;\u003cem\u003ea digital repository with no added value for everyday clinical practice\u003c/em\u003e [\u0026hellip;] \u0026ndash; \u0026ldquo;\u003cem\u003ea Dropbox for health data\u003c/em\u003e\u0026rdquo;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e\u003c/sup\u003e. The ePA thus needs structured data, improved interoperability and consistent integration into clinical workflows\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e\u003c/sup\u003e. The former Federal Data Protection Commissioner Ulrich Kelber also expressed clear criticism in March 2025\u003csup\u003e42\u003c/sup\u003e. He warned that the opt-out regulation introduced this year constituted a significant encroachment on the fundamental right to informational self-determination. In addition, there was a risk that the disclosure of sensitive health data, for example on mental illness, could restrict the rights of insured persons\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e. Two high-profile demonstration hacks by the Chaos Computer Club (CCC) in 2024 and 2025 provided also clear evidence that data protection concerns with regards to the ePA were not unfounded\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e43\u003c/span\u003e\u003c/sup\u003e. The CCC deliberately manipulated electronic patient files to highlight potential weaknesses in the system (see chapter: \u003cem\u003eChallenges for higher-level actors\u003c/em\u003e).\u003c/p\u003e\n\u003cp\u003eCommunication in the Medical Field (KIM), the Electronic Doctor\u0026apos;s Letter (eArztbrief), and the Electronic Sick Note (eAU)\u003c/p\u003e\n\u003cp\u003eSince 2020, the KIM communication service has enabled the secure electronic exchange of medical documents and treatment-related information as part of the eHealth infrastructure\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. The long-term goal is for all communication between healthcare providers and institutions within the German healthcare system to be conducted exclusively through KIM services\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eTo use KIM services, both communicating parties must use the KIM standard. This involves signing a contract with an approved KIM provider and installing the necessary software update on their connector\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e. The gematik lists available KIM providers on their websites and assigns them a score (\u0026ldquo;TI-score\u0026rdquo;) from A-D with regards to usability (A is best score)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e45\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e\u003c/sup\u003e. Additionally, healthcare providers must possess an electronic health professional card (eHBA) of at least generation 2.0 to perform the qualified electronic signature required for sending electronic doctor\u0026apos;s letters\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe integration of KIM into practice management software (PVS) and hospital management software (KVS) is a crucial prerequisite for implementing the electronic sick note (eAU) and the electronic doctor\u0026apos;s letter (eArztbrief)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e. Since 2021, doctors have been required to transmit sick notes directly to health insurance companies via KIM through the eHealth infrastructure, eliminating the need for employees to submit them manually\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. In 2023, the issuance of sick notes has become mostly paperless, with employers now receiving sick note data electronically from health insurance companies. A printed copy is provided only to the patient, and to the employer only upon the patient\u0026apos;s explicit request\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e. By 2023, the eAU was being utilised by 92% of respondents\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e48\u003c/span\u003e\u003c/sup\u003e. A survey conducted by the National Association of Statutory Health Insurance Physicians (2024) revealed that uniform use had already been achieved by 2024, with 100% of all respondents from the general practice sector stating that they were working paperless with the eAU\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe electronic doctor\u0026apos;s letter is also sent via the KIM service. The security of KIM messages is ensured by end-to-end encryption, meaning that the message is encrypted upon leaving the practice or clinic, travels securely through the TI, and is only decrypted upon arrival at its destination\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e. This provides a significantly higher security standard compared to most traditional email services. 83.4% of general practitioners surveyed stated that they use electronic doctor\u0026apos;s letters\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eEven though satisfaction with KIM was still relatively low in 2023 at only 29%, there has nevertheless been a significant increase in the use of the KIM service in recent years\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e\u003c/sup\u003e. According to the TI dashboard of gematik GmbH, more than 500\u0026nbsp;million KIM messages were sent each month from the beginning to the middle of 2025, indicating widespread and regular use in doctors\u0026apos; offices\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e48\u003c/span\u003e\u003c/sup\u003e. No data leaks have been reported to KIM to date, but in 2023 there was an incident in which KIM messages were accidentally forwarded to a single doctor\u0026apos;s office instead of to a health insurance company as originally intended\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e49\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe Electronic Prescription (eRezept)\u003c/p\u003e\n\u003cp\u003eThe electronic prescription (e-prescription) is another core element of the German healthcare digitisation efforts and represents the digital transition from previously paper-based prescriptions to electronic formats for prescription drugs covered by statutory health insurance\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e50\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e51\u003c/span\u003e\u003c/sup\u003e. Since September 2022, pharmacies across Germany have been able to redeem e-prescriptions\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. The nationwide mandatory implementation of e-prescriptions in medical facilities, after several delays, was finally enforced on 1 January 2024, with the enactment of the Digital Law, abbreviated as \u0026ldquo;DigiG\u0026rdquo; (original: Digital-Gesetz)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e37\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e51\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eFollowing the necessary software update, doctors continue to prescribe medications via practice or hospital management software (PVS/KVS). However, instead of printing the prescription on paper, it is now electronically signed using the electronic health professional card (eHBA) and transmitted to the TI server\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e51\u003c/span\u003e\u003c/sup\u003e. Pharmacies can then retrieve the prescription data from the server by reading the patient\u0026apos;s electronic health card (eGK), using the patient\u0026apos;s e-prescription app, or scanning a printed receipt with a prescription code\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e51\u003c/span\u003e\u003c/sup\u003e. In an ad hoc survey conducted by the Health Foundation, almost half of the doctors surveyed stated that overall the launch of e-prescriptions went rather well\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e52\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eIf issuing an e-prescription is not possible due to technical constraints or because the prescription type is not yet compatible with TI \u0026ndash; such as currently for medical aids or bandages \u0026ndash; a paper prescription is still used\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e51\u003c/span\u003e\u003c/sup\u003e. According to G\u0026ouml;tz et al., the adoption of e-prescriptions \u0026quot;\u003cem\u003ecan not only speed up access to medications and improve drug safety\u003c/em\u003e\u0026quot; but also \u0026quot;\u003cem\u003efoster the broader adoption of other digital health services, such as telemedicine\u003c/em\u003e\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eOverall, the e-prescription shows a positive trend in adoption. While only 8% of practices used the e-prescription in 2022, by 2023, one-third of contract doctors had adopted this digital solution\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e53\u003c/span\u003e\u003c/sup\u003e. Following the mandatory introduction of the e-prescription on 1 January 2024, the number of e-prescriptions issued surged significantly to approximately 113.5\u0026nbsp;million in the first quarter of 2024\u003csup\u003e35\u003c/sup\u003e. Additionally, a survey by the National Association of Statutory Health Insurance Physicians in 2024 found that 96,3% of respondents use e-prescriptions in patient care\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe TI-Messenger (TIM)\u003c/p\u003e\n\u003cp\u003eThe TIM is a standardised and interoperable messenger system for players in the TI, including physicians, nurses, pharmacies, hospitals, etc\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e54\u003c/span\u003e\u003c/sup\u003e. Its goal is to enable GDPR-compliant, zero-trust, and real-time communication as a replacement for fax, phone, or email communication\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e. A zero-trust approach is a modern security paradigm that does not assume that users or devices inside a network are safe (as in traditional perimeter security). Instead, zero-trust models require continuous authentication and authorization \u0026mdash; no implicit trust is given, even if a user is \u0026ldquo;logged in\u0026rdquo; to the system.\u003c/p\u003e\n\u003cp\u003eThe TIM is based on a Matrix protocol (decentralised, interoperable, end-to-end encryption) and users are supposed to freely choose their gematik-certified provider\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e54\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e. Envisioned features are to i) exchange text messages, voice messages, photos and documents in PDF, ii) create case-related chat groups for several health care providers, iii) locate all users in a nationwide address book, vi) archive case-related communication in the local electronic health record, and v) issue individual authorisations, e.g. for doctors and nurses\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe gematik so far as certified several providers since 2024 with several new products being certified in June 2025 (for their current list see: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://fachportal.gematik.de/zulassungs-bestaetigungsuebersichten#c2946\u003c/span\u003e\u003c/span\u003e). All providers run Matrix servers, which are federated. This means they allow cross-provider messaging if standards are followed. Current available features include 1:1 chats between healthcare providers, group chats, and attachments (e.g. photos and documents as PDF). However, integration into PVS/KIS systems is currently mostly missing, patient communication was announced but not yet provided and archivable message history is only available as a provider-specific add-on\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e56\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eCurrent barriers are the low awareness and adoption among stakeholders, which might also be connected to a lack of integration into clinical workflows. Stakeholders in the healthcare sector are not required to use it and do not have clear incentives to adopt such a system (which is linked with additional costs).\u003c/p\u003e\n\u003cp\u003eThe patient communication feature with health care professionals (\u0026ldquo;TI-Messenger ePA\u0026rdquo;) and among healthcare professionals (\u0026ldquo;TI-Messenger Pro\u0026rdquo;) is planned to be rolled out in 2025 and early 2026 respectively while the \u003cem\u003emandatory\u003c/em\u003e use in specific care pathways is currently being discussed\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e57\u003c/span\u003e\u003c/sup\u003e. Support for DiGAs and other products and platforms from third parties is envisioned for 2026 (\u0026ldquo;TI-Messenger Connect\u0026rdquo;)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e. Long-term, integration of interfaces such as KIM, e-prescriptions, eAU etc. is planned. While the TI-Messenger is thus legally anchored under \u0026sect;\u0026nbsp;311 SGB V, it is currently not widely adopted in practice and might need mandatory regulations to become effective.\u003c/p\u003e\n\u003cp\u003eTelemedicine\u003c/p\u003e\n\u003cp\u003eTelemedicine can be described as \u0026ldquo;delivery of health-care services over distance\u0026rdquo;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e58\u003c/span\u003e\u003c/sup\u003e and is as such a key aspect of digital health. It can be understood as an umbrella term for medical care concepts that involve providing medical services in diagnostics, therapy, rehabilitation, and medical decision support across time or distance gaps using electronic communication systems\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Telemedicine applications can be broadly categorised into three areas: teleconsultations, telemonitoring, and teletherapy\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Telemedicine can be delivered through telephone, apps, or the internet, making it particularly valuable for providing care to people who are less mobile or live in rural areas\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e\u003c/sup\u003e. As such, its key advantage is that patients and treating doctors do not need to be in the same location, a feature that proved especially useful during the COVID-19 pandemic by helping to maintain care amidst contact restrictions and reduce the risk of infection during the treatment of COVID patients\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e. Even though telemedicine applications have proven to offer advantages, the level of information among patients appears to be insufficient. Although some medical institutions and health insurance companies actively promote their telemedicine services, in many cases those affected have to seek information on their own. A more proactive approach to bringing these services to patients therefore appears to be a sensible step towards promoting their use\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e60\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eTeleconsultations and teletherapy\u003c/p\u003e\n\u003cp\u003eTeleconsultations facilitate easier and more efficient information (and digital data) exchange between medical colleagues, allowing them to consult on diagnoses, therapy choices, or to discuss X-rays, external findings, and similar medical data\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e\u003c/sup\u003e. Teletherapy applications enable the remote provision of treatments, such as video consultations for explaining further treatment plans or providing psychotherapeutic care both to other doctors or patients\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e\u003c/sup\u003e. A relatively new approach in telemedicine is the tele-home visit, where a specially trained healthcare professional conducts the home visit on-site with the patient, and a doctor can join via video if needed\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe COVID-19 pandemic in particular has contributed significantly to the acceptance and spread of digital health solutions such as teleconsultation\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. According to the PraxisBarometer Digitalisierung (Practice Barometer on Digitalisation) published by the National Association of Statutory Health Insurance Physicians (2022), 61% of outpatient doctors already offered digital services to patients in 2021, with 37% using telemedicine applications\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e61\u003c/span\u003e\u003c/sup\u003e. Teleconsultations were used extensively in 2020 and 2021 in particular: around 2.7\u0026nbsp;million teleconsultations took place in 2020 and as many as 3.5\u0026nbsp;million in 2021\u003csup\u003e62\u003c/sup\u003e. Online doctor\u0026apos;s appointments are now an integral part of healthcare. Statista (2024) predicted that online doctor\u0026apos;s appointments could generate revenue of \u0026euro;461.32\u0026nbsp;million in 2025, which would represent a 6.4% increase in revenue\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e63\u003c/span\u003e\u003c/sup\u003e. Legislation is also adapting to the renewed upward trend: After the reimbursement of teleconsultations was initially limited from an unlimited number during the COVID-19 pandemic to 30% of total consultations at a doctor\u0026apos;s practice in April 2022, this was increased again to 50% in April 2025\u003csup\u003e37,64\u003c/sup\u003e. The planned integration of TI Messenger Connect into applications for video consultations could give a further boost to the use of telemedicine services and interoperability in healthcare in the coming years\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eApplications for video consultations are provided by various video service providers\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e65\u003c/span\u003e\u003c/sup\u003e. The information page of the National Association of Statutory Health Insurance Physicians lists all certified providers that have been checked in advance by independent, accredited bodies and meet the requirements of the National Association of Statutory Health Insurance Physicians and the GKV-Spitzenverband. Apart from the choice of provider, a video consultation for service providers is usually similar to a regular consultation. The technical equipment required is limited to standard devices: an internet connection with a firewall, a screen, a camera, a microphone and speakers\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e65\u003c/span\u003e\u003c/sup\u003e. Video consultations are also relatively straightforward for patients to use. They require the same basic technical equipment as the medical facility, i.e. an internet connection, camera, microphone, loudspeaker and a suitable device. The application can be used flexibly on a PC, tablet or smartphone. People with statutory health insurance usually receive the necessary apps free of charge from their health insurance companies, such as the TK-Doc app for members of the Techniker Krankenkasse\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e66\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eStatutory health insurance companies have continuously expanded their digital service offerings in recent years. In a study conducted by the German Financial Services Institute in 2021, eight of the 13 best-rated health insurance companies already offered informative video chats at that time\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e67\u003c/span\u003e\u003c/sup\u003e. In the latest survey from 2025, nine out of 10 health insurance funds stated that they now offer \u0026lsquo;extended online or video consultations\u0026rsquo; as part of their service portfolio\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e68\u003c/span\u003e\u003c/sup\u003e. According to the National Association of Statutory Health Insurance Physicians, almost all groups of doctors are now allowed to offer video consultations, with the exception of laboratory doctors, pathologists and radiologists\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e65\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eTelemonitoring\u003c/p\u003e\n\u003cp\u003eTelemonitoring is another crucial aspect of telemedicine, involving the remote monitoring of health parameters\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e\u003c/sup\u003e. It is particularly useful for managing patients with chronic conditions such as heart rhythm disorders, chronic heart failure, high blood pressure, asthma, or diabetes but also for identifying sleep-related diseases and rhythm disorders\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e\u003c/sup\u003e. Telemonitoring typically employs portable measuring devices or apps, allowing patients to enter and track their measured values, such as blood pressure, blood sugar levels, body temperature, or sleep times from the comfort of their homes\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eAccording to Stachwitz and Debatin (2023), telemonitoring enables the early detection of deteriorating health in outpatients\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. Timely telemedical interventions, such as adjusting medication, can avert critical developments, prevent hospitalisations, improve patient well-being and relieve the burden on the healthcare system. Telemonitoring measures for the treatment of chronic heart failure were transferred to standard care from 2022 onwards following a decision by the Joint Federal Committee (G-BA)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. With this decision, Germany took on an international pioneering role and was the first country in Europe to offer telemonitoring as part of standard care\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e69\u003c/span\u003e\u003c/sup\u003e. Since then, telemedical monitoring of heart patients and its billing have been further developed, and corresponding measures have also been initiated in other medical areas\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e70\u003c/span\u003e\u003c/sup\u003e. One example of this is the \u0026lsquo;Telementor COPD\u0026rsquo; project, which supports patients with chronic obstructive pulmonary disease (COPD). It combines preventive, motivational content for physical training and respiratory therapy via an app with telemonitoring of vital parameters\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e69\u003c/span\u003e\u003c/sup\u003e. People with diabetes are also increasingly benefiting from telemedical care: they can keep an electronic diabetes diary, record their blood sugar levels and share them directly with their doctor \u0026ndash; with the aim of improving glycaemic control in the long term\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e71\u003c/span\u003e\u003c/sup\u003e. In addition, concepts are already being discussed on how telemonitoring could also be used to support the treatment of obesity or sleep-related breathing disorders\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e69\u003c/span\u003e\u003c/sup\u003e. In the future, the use of artificial intelligence to evaluate large amounts of vital data and the integration of wearables will open up additional possibilities for an expanded, patient-centred care model\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e69\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThere is also a telemedicine service available for long-term patients in intensive care units: tele-intensive care medicine. The aim of this application is to enable \u0026lsquo;an increase in the quality of treatment by providing consultative support with special intensive care expertise for treating physicians\u0026rsquo;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. This ensures that specialised intensive care can be provided even in cases where transfer is not possible. This form of support has already proven its worth, particularly during the COVID-19 pandemic\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eDigital Health Applications (DiGAs) and Digital Care Applications (DiPAs)\u003c/p\u003e\n\u003cp\u003eA DiGA is a secure, data-protected, and interoperable medical product available as an app, web application, or software with a digital primary function\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e72\u003c/span\u003e\u003c/sup\u003e. DiGAs enhance patient care by allowing insured persons to actively participate in their own treatment outcomes, either independently or with the involvement of a healthcare provider\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e72\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e73\u003c/span\u003e\u003c/sup\u003e. Introduced in Germany in December 2019 with the enactment of the Digital Healthcare Act (DVG), DiGAs are designed to support the \u0026ldquo;\u003cem\u003edetection, monitoring, treatment, or alleviation of diseases, injuries, or disabilities, as well as to assist healthcare providers in delivering care\u003c/em\u003e\u0026rdquo;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. While DiGAs are not core components of the TI, they are increasingly being integrated into the broader digital health ecosystem through interoperability with TI services such as the ePA. Their certification pathway is regulated by BfArM rather than gematik, and their technical connection to the TI depends on individual implementation and use cases.\u003c/p\u003e\n\u003cp\u003eApps that primarily or only serve for prevention are currently not eligible for inclusion as DiGAs\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Additionally, only apps and applications listed in the official DiGA directory maintained by the Federal Institute for Drugs and Medical Devices (BfArM) and classified under risk class 1 or 2a according to the Medical Device Regulation are eligible to be DiGAs and reimbursable by health insurance\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e72\u003c/span\u003e\u003c/sup\u003e. To be included in the DiGA directory \u0026ndash; and thus qualify for coverage under statutory health insurance \u0026ndash; a DiGA must undergo a successful evaluation process conducted by the BfArM\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e74\u003c/span\u003e\u003c/sup\u003e. This evaluation process, known as the \u0026apos;DiGA Fast-Track,\u0026apos; is limited to a maximum of three months from the receipt of a complete application\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e75\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThe Fast-Track process evaluates a DiGA based on the manufacturer\u0026apos;s provided information on key product features, including data protection, user-friendliness, and evidence of the DiGA\u0026apos;s positive effect on patient care\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e76\u003c/span\u003e\u003c/sup\u003e. The right to coverage of digital health applications for statutory health insurance holders is established under Section 33a of the Fifth Social Security Code (SGB V), as regulated by the Digital Healthcare Act (DVG)\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eFurther details regarding the requirements for safety, functionality, data protection, and security, as well as the quality standards and inclusion procedures in the DiGA directory, are stipulated by the Digital Health Applications Ordinance (DiGAV) issued by the Federal Ministry of Health\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. Patients can access these \u0026lsquo;apps on prescription\u0026rsquo; through two routes: i) by receiving a prescription from their treating physician, followed by approval from their health insurance company, or ii) by applying directly to their health insurance company\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e77\u003c/span\u003e\u003c/sup\u003e. In both cases, once approved, users receive an activation code from their health insurance company to use the DiGA\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e77\u003c/span\u003e\u003c/sup\u003e. Users can find comprehensive information in the official DiGA directory and select a suitable application for their health problem. Several apps are now available for many indications, from which users can choose according to their personal preferences. The advantage here is that those affected can choose the application that appeals to them most in terms of usability, design and therapeutic focus. The DiGA directory itself does not control the selection and does not make any recommendations. The search can be carried out either by entering a specific search term or by browsing through the entire directory, optionally supported by various filter functions\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e78\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eA key criterion for a DiGA is demonstrating its ability to produce a positive health effect\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e79\u003c/span\u003e\u003c/sup\u003e. This effect can be either a direct medical benefit or a significant improvement in the structure and process of patient care, which must be demonstrated by the manufacturer through a scientific study\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e79\u003c/span\u003e\u003c/sup\u003e. DiGAs are already available for a wide range of medical fields, including digestion, mental health, metabolic and cardiovascular diseases, as well as bone, muscle, and joint conditions and sleep-related problems\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. As of August 2024, a search in the DiGA directory identified 64 available digital health applications of which 26 were categorised for mental health (\u0026ldquo;Psyche\u0026rdquo; in German).\u003c/p\u003e\n\u003cp\u003eDigital care applications (DiPA) are apps or web applications that people in need of care can use together with their relatives or a care service in everyday life\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e80\u003c/span\u003e\u003c/sup\u003e. Their main goal is to make everyday care easier by providing guidance and support. In addition, there are DiPAs that help to better organise everyday care and promote health in a targeted manner through guided exercises\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e80\u003c/span\u003e\u003c/sup\u003e. After approval of the provision of a DiPA, the long-term care insurance fund covers costs of up to \u0026euro;53 per month. Any additional costs must be borne by the insured person\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e81\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eChallenges and Opportunities of the TI for the German Healthcare System and its Stakeholders\u003c/p\u003e\n\u003cp\u003eChallenges and Opportunities for Healthcare Providers\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eChallenges for Healthcare Providers\u003c/h2\u003e\n \u003cp\u003eThe challenges and opportunities of the TI are especially relevant for healthcare providers \u0026ndash; practices, medical care centres, hospitals, and pharmacies \u0026ndash; all of which are legally required to connect. A major challenge lies in the high technical and organisational demands, including strict data security requirements and the need to establish entirely new IT infrastructures. Many facilities must make extensive workflow adjustments, placing additional strain on healthcare personnel\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e82\u003c/span\u003e\u003c/sup\u003e. Healthcare workers not only have to restructure their work to establish new workflows, but also have to deal with the technical problems of IT in their everyday practice. For example, issuing e-prescriptions is often tricky, so paper forms like the Muster 16 still have to be used\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e83\u003c/span\u003e\u003c/sup\u003e. The transition to e-prescriptions is also hampered by the fact that restrictions remain in place, particularly in the area of home care, which means that Form 16 is still necessary\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e83\u003c/span\u003e\u003c/sup\u003e. Even though the eAU and eArztbrief work much better via KIM, many users continue to experience a high error rate when using IT: Between May and August 2024, only 7% of practices reported trouble-free operation, while 43% experienced weekly technical problems such as necessary restarts of card readers or connectors (73%), disruptions to practice organisation (58%) and difficulties reading patient data (54%)\u003csup\u003e83\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eFurthermore, the implementation and operation of the TI require healthcare personnel, including medical, therapeutic, and administrative staff, to have greater technical know-how. However, according to Fraunhofer IESE, many medical professionals lack the necessary technical understanding and critical information needed to keep pace with the digital transformation of the medical field\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. To address this gap, extensive training for healthcare providers and medical staff is essential. Such training requires not only significant time but also financial investment. Finally, educating patients about TI applications \u0026ndash; although officially the responsibility of insurers \u0026ndash; often falls to healthcare providers, adding further to their workload\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e53\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eFinancial burdens also pose a major issue. Monthly TI allowance from the BMG often do not cover the actual implementation and maintenance costs\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e84\u003c/span\u003e\u003c/sup\u003e. Additionally, allowance amounts depend on whether all legally required TI applications have been installed\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e85\u003c/span\u003e\u003c/sup\u003e. The KBV PraxisBarometer on digitalisation reported that 64% of surveyed physicians considered the cost-benefit ratio of the TI to be unfavourable\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eOpportunities for Healthcare Providers\u003c/p\u003e\n \u003cp\u003eDigitalising the healthcare infrastructure can improve efficiency, communication, and patient care. A 2022 survey found that doctors largely support digitalisation, with about three-quarters viewing it as a positive opportunity for the healthcare system\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e86\u003c/span\u003e\u003c/sup\u003e. A major benefit is enhanced interdisciplinary collaboration via digital networking with other stakeholders, such as health insurers and the National Association of Statutory Health Insurance Physicians \u0026ndash; for example, through online billing and the submission of treatment and cost plans\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. Improved data exchange can reduce waiting times, prevent redundant diagnostics, support faster diagnoses, and improve treatment efficiency by enabling a more comprehensive understanding of medical histories\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eDigital infrastructure also reduces the workload of healthcare providers. Tools like teleconsultations and simple digital applications can support routine care\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e82\u003c/span\u003e\u003c/sup\u003e. For instance, e-prescriptions ease administrative burden by allowing patients to receive their prescriptions digitally instead of in person\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e87\u003c/span\u003e\u003c/sup\u003e. Similarly, the ePA reduces redundant documentation, helping relieve providers of repetitive tasks\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e87\u003c/span\u003e\u003c/sup\u003e. By streamlining care, only patients with actual medical needs are likely to visit clinics, increasing system-wide efficiency\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e87\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eChallenges and Opportunities for Patients\u003c/p\u003e\n \u003cp\u003eChallenges for Patients\u003c/p\u003e\n \u003cp\u003eThe digital transformation of the healthcare system imposes new demands on the technical competencies of insured individuals. A telephone survey found that 8.6% of respondents lacked internet access, with usage decreasing with age\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e88\u003c/span\u003e\u003c/sup\u003e. Older adults or those with limited technical skills or access may struggle to use the TI effectively. Additional operational challenges may arise for patients with physical disabilities or language barriers. For some, using digital solutions requires purchasing devices or internet access, adding financial burden\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e89\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eDespite a \u0026quot;\u003cem\u003egreat openness to digital transmission\u003c/em\u003e\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e88\u003c/span\u003e\u003c/sup\u003e, many users lack sufficient knowledge about digital health tools. Half of those surveyed were unaware of the ePA, and 75% were unfamiliar with digital health applications\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e88\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e90\u003c/span\u003e\u003c/sup\u003e. This low awareness, partly due to insufficient information from insurers and policymakers, requires patients to invest considerable effort in self-education and could overwhelm patients\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e91\u003c/span\u003e\u003c/sup\u003e. Technical support and guidance are thus essential to ease the use of TI, address data privacy concerns, and build trust.\u003c/p\u003e\n \u003cp\u003eThere is also concern that digitalisation could reduce personal interaction in care. Excessive reliance on digital processes may compromise attention to individual needs\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e82\u003c/span\u003e\u003c/sup\u003e. Wei\u0026szlig;enfeld et al. caution that telemedicine\u0026rsquo;s greatest risk lies in potential misdiagnoses\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e92\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eFinally, uneven TI implementation presents a major challenge\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Infrastructure disparities may result in unequal access, particularly in rural or underserved areas \u0026ndash; precisely where digital health could be most beneficial. For the TI to be used efficiently, nationwide implementation and usage are crucial\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eOpportunities for Patients\u003c/p\u003e\n \u003cp\u003eDespite challenges, a digital health infrastructure would offer notable advantages. Key benefits include \u0026quot;\u003cem\u003ecomfort and time savings in the doctor\u0026apos;s office\u003c/em\u003e\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e and a high level of information content, benefiting both patients and providers\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e93\u003c/span\u003e\u003c/sup\u003e. TI applications simplify daily processes: electronic sick notes and repeating prescriptions reduce unnecessary practice visits\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e87\u003c/span\u003e\u003c/sup\u003e. DiGAs and telemedicine services expand access and flexibility in care, supporting patients with chronic illness, limited mobility, or those in underserved areas, and helping overcome stigma when disclosing sensitive symptoms\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e94\u003c/span\u003e\u003c/sup\u003e. Remote care also lowers infection risks, as emphasised during the COVID-19 pandemic\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eTelemonitoring enables continuous observation of physiological indicators \u0026ndash; such as blood sugar, oxygen saturation, blood pressure, heart rate, activity, and sleep \u0026ndash; supporting long-term health management\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e95\u003c/span\u003e\u003c/sup\u003e. It facilitates earlier detection of deterioration and enables timely interventions, especially in emergencies\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. Clinical studies show positive effects for chronic conditions like heart failure, including reduced hospitalisations\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. Zhang et al. also found that telemedicine improved glycaemic control in children with type 1 diabetes, enhancing quality of life and reducing hemoglobin A1C levels\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e95\u003c/span\u003e\u003c/sup\u003e. However, such interventions should complement, not replace, conventional care\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e95\u003c/span\u003e\u003c/sup\u003e. A review by Dhunnoo et al. similarly found benefits for mental health and adherence in chronic disease treatment\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e93\u003c/span\u003e\u003c/sup\u003e. Digital tools also offer potential in sleep medicine, e.g. through broad screening for sleep disorders like sleep apnea\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e96\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eDiGAs have also shown positive effects in healthcare. M\u0026auml;der et al. found that the most frequently reported medical benefit of DiGAs listed in the official DiGA directory was an improvement in overall health status\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e79\u003c/span\u003e\u003c/sup\u003e. For example, DiGAs targeting hormonal and metabolic diseases promote user self-management and can help change unhealthy habits.\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e Additionally, the use of digital health tools like health apps and wearables has been shown to positively influence health awareness and education\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e97\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eOverall, digital tools strengthen patient autonomy and engagement. The ePA is central to this shift, enabling individuals to access and manage their health data\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. In a gematik GmbH survey from 2024, 78% of insured respondents valued having control over who accesses their health data \u0026ndash; indicating growing health literacy and patient sovereignty\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e,\u003cspan class=\"CitationRef\"\u003e87\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003eChallenges and Opportunities for Higher-Level Stakeholders\u003c/p\u003e\n \u003cp\u003eChallenges for Higher-Level Stakeholders\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eFinancial challenges\u003c/h3\u003e\n\u003cp\u003eThe financial challenges posed by the telematics infrastructure are immense \u0026ndash; both the government and health insurance companies have had to make significant investments in its expansion, and the ongoing costs for maintenance and further development are substantial.\u003c/p\u003e\n\u003cp\u003eAdditionally, inefficient integration and use of digital solutions can diminish the anticipated savings. Therefore, it is crucial to ensure a careful evaluation and monitoring of digital applications so that the intended savings and benefits are realised and financial resources are used optimally. Furthermore, there is a risk that DiGAs in particular will be \u003cem\u003e\u0026quot;unnecessarily prescribed, or that the apps will only add to the financial burden on health insurance companies without offsetting costs through the elimination of other paid services\u003c/em\u003e\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e91\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003ch3\u003eLegal and Data Protection Challenges\u003c/h3\u003e\n\u003cp\u003eAnother significant hurdle is the high demands of TI on data protection and security. Ensuring the protection of sensitive health data requires specific legal frameworks and regulations that must be overseen by the government\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. These regulations are essential for maintaining trust in the system and ensuring compliance with national and European data protection laws. Data security concerns represent a major impediment to the widespread adoption of the ePA. According to a report by the National Association of Statutory Health Insurance Physicians from January 2025, the Chaos Computer Club (CCC) had already uncovered serious security gaps in the ePA at the end of 2024 and demanded that the protective measures be improved\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e98\u003c/span\u003e\u003c/sup\u003e. The CCC gained remote access via electronic replacement certificates for insurance cards \u0026ndash; in combination with the insurance number, a coding key, an illegally obtained practice ID card (SMC-B) and access to the telematics infrastructure\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e99\u003c/span\u003e\u003c/sup\u003e. The hackers purchased used card readers online, some of which still contained practice ID cards (SMC-B cards) including the corresponding PINs, which were disclosed to them\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e100\u003c/span\u003e\u003c/sup\u003e. This made it possible to access individual patient files\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e99\u003c/span\u003e\u003c/sup\u003e. In response, it was decided to require additional card features in future\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e99\u003c/span\u003e\u003c/sup\u003e. Nevertheless, in May 2025, the CCC once again managed to circumvent the improved protection mechanisms \u0026ndash; despite official assurances that the ePA was \u0026lsquo;secure\u0026rsquo;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e43\u003c/span\u003e\u003c/sup\u003e. Subsequent measures could not be verified at the time of writing.\u003c/p\u003e\n\u003ch3\u003eEducational challenges\u003c/h3\u003e\n\u003cp\u003eEducation and training of healthcare providers and patients remain major challenges. Responsibility for patient education lies primarily with the government and insurers. Birkert et al. stress the importance of promoting digital health literacy to increase uptake of digital tools\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e. With the introduction of the \u0026lsquo;ePA for all\u0026rsquo; in 2025, educating statutory insured members is particularly urgent. A study by Haug et al. in 2023 found that nearly half of respondents were unfamiliar with the ePA, yet many indicated they would use it\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e88\u003c/span\u003e\u003c/sup\u003e. This reflects \u0026quot;very high untapped potential for information campaigns\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e88\u003c/span\u003e\u003c/sup\u003e. Healthcare providers also require continuous training. Many facilities surveyed by gematik in 2024 requested more information, as many questions arise only in everyday use\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e. Although gematik GmbH now provides free information material on electronic patient records for doctors\u0026apos; practices, care facilities, hospitals and pharmacies, there is no guarantee that these institutions will actually use the material, and the quantity that can be ordered is insufficient. By way of comparison, only five information packs can be ordered per institution, with each pack containing only two copies of the same information poster \u0026ndash; a total of only ten posters per institution\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e101\u003c/span\u003e\u003c/sup\u003e. This is insufficient for large institutions such as hospitals. On a positive note, however, supplementary material is available for download, including information brochures and videos for waiting rooms, some of which are available in several languages\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e102\u003c/span\u003e\u003c/sup\u003e. The information provided by the Federal Ministry of Health and the National Association of Statutory Health Insurance Physicians has also improved, but it must be actively sought out, which continues to make access to information difficult.\u003c/p\u003e\n\u003cp\u003eOpportunities for Higher-Level Stakeholders\u003c/p\u003e\n\u003cp\u003eFor higher-level stakeholders, two significant advantages can be identified: first, a significant improvement in the healthcare system for insured individuals, and second, long-term cost reductions through more efficient processes in healthcare, such as by avoiding redundant examinations.\u003c/p\u003e\n\u003cp\u003eThe further expansion of the TI and the successful implementation of digital applications would help the German healthcare system not only keep pace with the digital age but also improve its standing in international comparisons. For the German state, the primary focus is on achieving \u0026quot;\u003cem\u003eimproved and cost-effective public health\u003c/em\u003e\u0026quot;\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e91\u003c/span\u003e\u003c/sup\u003e. In contrast, health insurance companies are primarily interested in \u0026quot;\u003cem\u003eefficient and effective patient care with as low a cost structure as possible\u003c/em\u003e,\u0026quot; as they must operate according to economic principles\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e91\u003c/span\u003e\u003c/sup\u003e. According to Zhang et al., digital access to telemedicine can ensure continuity of care while enabling cost reductions in healthcare\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e95\u003c/span\u003e\u003c/sup\u003e. During the COVID-19 pandemic, telemedicine applications proved particularly effective and cost-efficient, especially in reducing infections, as well as saving on protective clothing, masks, and disinfectants\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e92\u003c/span\u003e\u003c/sup\u003e. M\u0026auml;der et al. also emphasise that the meaningful integration of digital health applications can improve healthcare cost-effectively\u003csup\u003e\u003cspan class=\"CitationRef\"\u003e79\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eText Box 2. Practical Implications\u003c/strong\u003e\u003c/p\u003e\n\u003ctable style=\"width: 100%;\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 100.0000%;\"\u003eThe findings show several areas for improvement in practice. Although growing usage numbers indicate that TI-applications are increasingly being integrated into everyday care\u003csup\u003e53\u003c/sup\u003e, there is still room for optimisation. A key aspect is the development of a unifying element that ensures a comprehensive overview of applications and their usage\u0026ndash;an aim pursued through the BMG\u0026apos;s digitalization strategy with the \u0026apos;ePA for all\u0026apos; initiative\u003csup\u003e7\u003c/sup\u003e. Further progress depends on resolving persisting software issues in practice and hospital management systems\u003csup\u003e84\u003c/sup\u003e and achieving nationwide implementation to reduce regional disparities\u003csup\u003e13\u003c/sup\u003e. This also applies to the differences between privately (~\u0026thinsp;8.7%)\u003csup\u003e103\u003c/sup\u003e and statutory insured persons, as the existing infrastructure currently, with few exceptions, only serves statutory health insurance holders. Since the legal obligations of TI only apply to statutory health insurance companies, private health insurance companies receive no financial support for the expansion of the telematics infrastructure and therefore have little incentive to offer their insured TI applications. However, some private health insurance companies have now begun to provide health applications like the ePA to their insured. Equally important is the comprehensive training and education of medical staff and patients to optimally utilise the TI and its applications. Stakeholders must provide targeted educational resources, and statutory insurers should enhance informational services to reduce the burden on providers. Better-informed users could increase adoption of digital and e-Health applications, improve care quality, and generate time and cost savings \u0026ndash; benefits that could also translate into higher provider reimbursement and greater professional satisfaction. Lastly, data security concerns need to be adequately addressed to increase trust and enhance adoption.\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this review, we have discussed past and planned measures on the German digitalisation strategy and its digital infrastructure for outpatient care. Following a slow start, the political will to integrate digital technologies has become evident in recent years and Germany has seen a wave of new laws and measures aimed at digitising the German healthcare system\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. The BMG has laid out several key initiatives for the upcoming years including removal of the 30% cap on telemedical services, the introduction of assisted telemedicine, Digital Disease Management Programs, research pseudonyms, interoperable nursing documentation, and the transformation of gematik into a digital health agency\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. By 2026, government targets include assisted telemedicine access in 60% of underserved regions, 80% paperless communication across healthcare settings, and the launch or completion of 300 eHealth research projects\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eBut these are future plans and promises \u0026ndash; how successful are the measures implemented so far, and what effects have they had on the German healthcare system? According to the KBV's \"PraxisBarometer Digitalisierung\" survey in 2023, digital health applications are indeed increasingly becoming an integral part of everyday healthcare\u003csup\u003e\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e\u003c/sup\u003e. By 2023, the eAU was being utilised by 92% of respondents, and there were also notable increases in the use of the eMP, NFDM, and the ePA\u003csup\u003e\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eA 2023 survey revealed that 45.2% of doctors, psychotherapists, and staff encountered technical problems with practice software several times per week\u003csup\u003e\u003cspan citationid=\"CR84\" class=\"CitationRef\"\u003e84\u003c/span\u003e\u003c/sup\u003e. Instead of streamlining workflows, TI-related issues \u0026ndash; particularly those involving electronic health cards or issuing eAUs \u0026ndash; have increased administrative burdens, disrupted clinical processes, and extended patient waiting times\u003csup\u003e\u003cspan citationid=\"CR84\" class=\"CitationRef\"\u003e84\u003c/span\u003e\u003c/sup\u003e. Issues with practice/hospital management software (PVS/KVS) arise mainly when reading the eGK or when using TI applications like issuing an eAU\u003csup\u003e\u003cspan citationid=\"CR84\" class=\"CitationRef\"\u003e84\u003c/span\u003e\u003c/sup\u003e. Problems also often occur due to software updates\u003csup\u003e\u003cspan citationid=\"CR84\" class=\"CitationRef\"\u003e84\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eSince uninterrupted use of PVS/KVS is essential in daily practice, a framework agreement with new requirements for software manufacturers was published by the KBV in March 2024\u003csup\u003e35\u003c/sup\u003e. However, manufacturers are not required to join this agreement\u003csup\u003e\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e. To improve user-friendliness and more efficient use of ePA content, additional regulations and legal requirements from the government are thus being called for\u003csup\u003e\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eA further barrier to successful implementation is underfunding. Although the BMG allocates a monthly TI allowance, this funding is often insufficient to cover the true cost of integration. Full reimbursement is only granted when all mandated TI applications are installed; otherwise, financial penalties apply\u003csup\u003e\u003cspan citationid=\"CR85\" class=\"CitationRef\"\u003e85\u003c/span\u003e\u003c/sup\u003e. While the BMG claims that the allowances reflect historical costs and aim to ensure financial neutrality, only 18% of practices report full compensation for connector replacements\u003csup\u003e\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e\u003c/sup\u003e. Despite these funding shortfalls, 98% of medical practices are now connected to the TI\u003csup\u003e\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e\u003c/sup\u003e. Still, concerns persist that cost-benefit ratios remain unfavourable, especially in smaller or rural practices.\u003c/p\u003e\u003cp\u003eDigital health applications \u0026ndash; particularly DiGAs \u0026ndash; are gaining traction. In September 2023, 48 DiGAs were officially listed, with 214,000 prescriptions issued that year, marking a 53% increase from 2022\u003csup\u003e103\u003c/sup\u003e. In July 2025, 44 digital health applications were permanently included in the DiGA directory of the Federal Institute for Drugs and Medical Devices, with 13 additional DiGA applications provisionally listed\u003csup\u003e\u003cspan citationid=\"CR78\" class=\"CitationRef\"\u003e78\u003c/span\u003e\u003c/sup\u003e. According to the DiGA report of the National Association of Statutory Health Insurance Funds for 2024, a total of over one million DiGA had been prescribed by doctors or approved by health insurance funds by the end of 2024\u003csup\u003e104\u003c/sup\u003e. According to the report, this also means that usage has risen significantly \u0026ndash; to a total of 85%. The most commonly used DiGA are \u0026ldquo;\u003cem\u003ethose for the treatment of mental illnesses (30%), but also DiGA that address metabolic diseases (28%) and DiGA for diseases of the musculoskeletal system (16%)\u003c/em\u003e\u0026rdquo;\u003csup\u003e104\u003c/sup\u003e. Among users, 58% reported that DiGAs were a meaningful addition to their therapy\u003csup\u003e\u003cspan citationid=\"CR105\" class=\"CitationRef\"\u003e105\u003c/span\u003e\u003c/sup\u003e. Yet, their integration into standard care remains limited, and no DiGAs are currently licensed for disease prevention\u003csup\u003e\u003cspan citationid=\"CR89\" class=\"CitationRef\"\u003e89\u003c/span\u003e\u003c/sup\u003e. This represents a significant gap, considering their potential for early intervention and long-term cost savings. In contrast, telemedicine services, which saw a surge during the COVID-19 pandemic, have stagnated post-pandemic\u003csup\u003e\u003cspan citationid=\"CR86\" class=\"CitationRef\"\u003e86\u003c/span\u003e\u003c/sup\u003e. A key reason may be the low reimbursement rate for video consultations compared to in-person visits, despite an estimated \u0026euro;4.3\u0026nbsp;billion in annual savings through telemonitoring-driven hospital avoidance\u003csup\u003e\u003cspan citationid=\"CR91\" class=\"CitationRef\"\u003e91\u003c/span\u003e,\u003cspan citationid=\"CR106\" class=\"CitationRef\"\u003e106\u003c/span\u003e\u003c/sup\u003e. Usage figures indicate that DiGAs are significantly more popular than telemedicine. This could be due to the different reimbursement rates: video consultations are reimbursed at a much lower rate than in-person visits with a doctor\u003csup\u003e\u003cspan citationid=\"CR91\" class=\"CitationRef\"\u003e91\u003c/span\u003e\u003c/sup\u003e. DiGAs, however, are offered only as a complement to therapy, not as an alternative. They support early detection, treatment, and follow-up, but are not yet completely adopted in routine care\u003csup\u003e\u003cspan citationid=\"CR89\" class=\"CitationRef\"\u003e89\u003c/span\u003e,\u003cspan citationid=\"CR107\" class=\"CitationRef\"\u003e107\u003c/span\u003e\u003c/sup\u003e. From a policy perspective, Germany, along with the UK, remains a leader in digital health application governance\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Germany is particularly advanced in comparison, especially in approval and reimbursement processes (DiGA Fast-Track) and offers legal evidence standards\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. France has already adopted the German model, and other European countries are monitoring the rollout with interest\u003csup\u003e\u003cspan citationid=\"CR75\" class=\"CitationRef\"\u003e75\u003c/span\u003e,\u003cspan citationid=\"CR79\" class=\"CitationRef\"\u003e79\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eA key structural limitation of Germany\u0026rsquo;s digital infrastructure is the insufficient interoperability between systems. Many providers cite the lack of integrated health data as the greatest barrier to meaningful use\u003csup\u003e\u003cspan citationid=\"CR87\" class=\"CitationRef\"\u003e87\u003c/span\u003e\u003c/sup\u003e. The ePA is central to overcoming this issue. The \u0026ldquo;ePA for all\u0026rdquo; initiative introduces a default enrolment (opt-out) model, shifting away from the previous opt-in procedure that led to slow uptake\u003csup\u003e\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e. While Estonia has demonstrated the effectiveness of the opt-out model, public support in Germany remains low\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. Although 70\u0026nbsp;million ePAs have now been issued, only a fraction of these are actively used\u003csup\u003e\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u003c/sup\u003e. Germany's largest statutory health insurer, Techniker Krankenkasse, stated that it had created 11\u0026nbsp;million ePAs, but only 750,000 of these are actively used. Barmer, another big statutory health insurer, reports similar figures: of the 7.8\u0026nbsp;million ePAs created, only around 250,000 are actively used\u003csup\u003e\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u003c/sup\u003e. Nevertheless, the new ePA version offers significant advances, including the integration of e-prescriptions, new vaccination records, diagnostic reports, imaging data, emergency information, and digital health application data\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e. G\u0026ouml;tz et al. emphasise that this could position the ePA as the \u0026ldquo;\u003cem\u003ecentrepiece of digital healthcare and a catalyst for further e-health applications\u003c/em\u003e\u0026rdquo; \u0026ndash; but only if it is routinely used in clinical practice\u003csup\u003e\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e. Persistent criticism remains, however, that the ePA functions as a passive document archive rather than a dynamic, interoperable system. Concerns about data leakage and system intelligence continue to undermine user trust and slow adoption.\u003c/p\u003e\u003cp\u003eWith \u0026ldquo;TI 2.0,\u0026rdquo; the government has laid out a more ambitious and future-oriented vision for the telematics infrastructure. Planned expansions include the integration of additional healthcare stakeholders \u0026ndash; such as outpatient care providers, therapists, rehabilitation centres, and long-term care facilities \u0026ndash; and the deployment of a mobile-accessible digital health ID\u003csup\u003e\u003cspan citationid=\"CR108\" class=\"CitationRef\"\u003e108\u003c/span\u003e\u003c/sup\u003e. This is expected to simplify access to services such as the ePA and video consultations, while physical health cards remain available as an alternative. At the technical level, TI 2.0 proposes a shift to cloud-based access via standard internet connections, replacing the costly and maintenance-heavy connector infrastructure. A unified digital identity will also replace current SMC-B and eHBA cards, allowing secure mobile login, especially in ambulatory care.\u003c/p\u003e\u003cp\u003eHowever, cybersecurity remains a key concern and is to be addressed through a \u0026ldquo;zero-trust\u0026rdquo; architecture designed to improve system resilience. The Federal Ministry of Health has aligned these plans with its Digitalisation Strategy for Healthcare and Nursing, which outlines goals through 2030\u003csup\u003e7\u003c/sup\u003e. Priorities include ePA expansion, assisted telemedicine via pharmacies and health kiosks, and the promotion of equitable, affordable access across all regions. Yet, implementation remains slow. Fragmented infrastructures, complex governance, limited digital literacy, and continued scepticism among both providers and patients hamper progress. Many elements of TI 2.0 are still in pilot phases or face long lead times before nationwide rollout. In this context, TI 2.0 appears less a technological reinvention and more a necessary course correction. While the foundations for a modern digital health ecosystem are being laid, success will depend on political continuity, pragmatic implementation, sustainable funding, and improved coordination across all levels of the healthcare system. As emphasised by the recent McKinsey report, Germany must focus on three priorities: scalability, integration of TI applications, and the structured exchange and use of health data\u003csup\u003e\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis narrative review showed that the telematics infrastructure in German outpatient care is progressing but must accelerate to realise its full potential. Various digital health components have already been implemented, including the electronic health card, insurance master data management, emergency data management, medication plan, patient record, KIM communication, electronic doctor's letter, sick note, and e-prescription. Telemedicine and DiGAs have further expanded digital care. These developments bring both challenges and opportunities for providers, patients, and stakeholders.\u003c/p\u003e\u003cp\u003eA key hurdle is making the use of digital solutions more efficient and appealing. Providers and patients must better adapt to digital workflows and improve their digital literacy. Higher-level stakeholders must create frameworks that promote acceptance, offer training, and provide incentives or opt-out options to support implementation. TI applications offer clear benefits, including improved care with time and cost savings. Statutorily insured individuals may benefit from shorter waiting times and broader service access, while providers could gain relief in daily practice. In the long term, improved care may reduce healthcare costs and enhance population health, benefiting political and insurance stakeholders. Digital health also supports research by enabling the use of aggregated health data\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eThe 'ePA for all' could play a central role through its opt-out design and integration with DiGAs, offering users greater transparency and better health data use \u0026ndash; if its full potential is rolled out\u003csup\u003e\u003cspan citationid=\"CR87\" class=\"CitationRef\"\u003e87\u003c/span\u003e\u003c/sup\u003e. Although further integration steps are needed, acceptance and utilisation of digital solutions are increasing. Still, improvements in cybersecurity remain essential to build trust among sceptical users. In conclusion, the expansion of the TI will hopefully \"\u003cem\u003egain significant speed after a slow start [...] with new laws and measures surrounding TI\u003c/em\u003e\"\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAbbreviation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGerman Term\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEnglish Term\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eB\u0026Auml;K\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eBundes\u0026auml;rztekammer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eGerman Medical Association\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eBZ\u0026Auml;K\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eBundeszahn\u0026auml;rztekammer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eGerman Dental Association\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eBMG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eBundesministerium f\u0026uuml;r Gesundheit\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eFederal Ministry of Health\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eBSI\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eBundesamt f\u0026uuml;r Sicherheit in der Informationstechnik\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eFederal Office for Information Security\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eCCC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eChaos Computer Club\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eChaos Computer Club\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eDAV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eDeutscher Apothekerverband\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eGerman Pharmacists\u0026apos; Association\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eDiGA(s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eDigitale Gesundheitsanwendungen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eDigital Health Application(s)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eDiPA(s)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eDigitale Pflegeanwendungen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eDigital Care Application(s)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eDigiG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eDigital-Gesetz\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eDigital Law\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eDKG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eDeutschen Krankenhausgesellschaft\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eGerman Hospital Federation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eDVG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eDigitale-Versorgung-Gesetz\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eAct for Better Care through Digitalisation and Innovation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eGKV-Spitzenverband\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eSpitzenverband Bund der Krankenkassen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eNational Association of Statutory Health Insurance Funds\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eeArztbrief\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eElektronischer Arztbrief\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eElectronic doctor\u0026rsquo;s letter\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eeAU\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eElektronische Arbeitsunf\u0026auml;higkeitsbescheinigung\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eElectronic sick note\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eeGK\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eElektronische Gesundheitskarte\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eElectronic health card\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eE-Health\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eElektronische Gesundheit\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eElectronic Health\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eeHBA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eElektronischer Heilberufsausweis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eElectronic health professional card\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eeMP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eElektronischer Medikationsplan\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eElectronic medication plan\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eePA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eElektronische Patientenakte\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eElectronic health record\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eeRezept\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eElektronisches Rezept\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eElectronic prescription\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003egematik GmbH\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eGesellschaft f\u0026uuml;r Telematikanwendungen der Gesundheitskarte mit beschr\u0026auml;nkter Haftung\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eCompany for Telematics Applications of the Health Insurance Card, limited liability\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eKBV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eKassen\u0026auml;rztlichen Bundesvereinigung\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eNational Association of Statutory Health Insurance Physicians\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eKIM\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eKommunikation im Medizinwesen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eCommunication in the Medical Field\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eKVS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eKrankenhausverwaltungssoftware\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eHospital management software\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eKZBV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eKassenzahn\u0026auml;rztlichen Bundesvereinigung\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eNational Association of Statutory Health Insurance Dentists\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eMVZ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eMedizinisches Versorgungszentrum\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eMedical care centres\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eNFDM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eNotfalldatenmanagement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eEmergency data management\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003ePKV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eVerband der Privaten Krankenversicherungen e.V.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eAssociation of German Private Healthcare Insurers\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003ePVS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003ePraxisverwaltungssoftware\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003ePractice management software\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eSGB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eSozialgesetzbuch\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eSocial Security Code\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eSMC-B\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eSecurity Module Card\u0026ndash;Betriebsst\u0026auml;tte\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eSecurity Mobile Card \u0026ldquo;Work\u0026rdquo;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eTI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eTelematikinfrastruktur\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eTelematic Infrastructure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eTIM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eTI-Messenger\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eTI-Messenger\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eVPN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eVirtuelles Privates Netzwerk\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eVirtual Private Network\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17.8037%;\"\u003e\n \u003cp\u003eVSDM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 51.2479%;\"\u003e\n \u003cp\u003eVersichertenstammdatenmanagement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.9484%;\"\u003e\n \u003cp\u003eInsured person master data management\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eThe \u003cstrong\u003eABK\u003c/strong\u003e and \u003cstrong\u003eAMB\u003c/strong\u003e declare that they have no competing interests related to this work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMS\u003c/strong\u003e declares the following potential conflicts of interest in the past five years (2021\u0026ndash;2025). \u003cstrong\u003eAcademic roles:\u003c/strong\u003e Member of the Board of Directors, \u003cem\u003eSociety of Light, Rhythms, and Circadian Health (SLRCH)\u003c/em\u003e; Chair of \u003cem\u003eJoint Technical Committee 20 (JTC20)\u003c/em\u003e of the \u003cem\u003eInternational Commission on Illumination (CIE)\u003c/em\u003e; Member of the \u003cem\u003eDaylight Academy\u003c/em\u003e; Chair of \u003cem\u003eResearch Data Alliance Working Group Optical Radiation and Visual Experience Data\u003c/em\u003e. \u003cstrong\u003eRemunerated roles:\u003c/strong\u003e Speaker of the Steering Committee of the \u003cem\u003eDaylight Academy\u003c/em\u003e; Ad-hoc reviewer for the \u003cem\u003eHealth and Digital Executive Agency\u003c/em\u003e of the \u003cem\u003eEuropean Commission\u003c/em\u003e; Ad-hoc reviewer for the \u003cem\u003eSwedish Research Council\u003c/em\u003e; Associate Editor for \u003cem\u003eLEUKOS\u003c/em\u003e, journal of the \u003cem\u003eIlluminating Engineering Society\u003c/em\u003e; Examiner, \u003cem\u003eUniversity of Manchester\u003c/em\u003e; Examiner, \u003cem\u003eFlinders University\u003c/em\u003e; Examiner, \u003cem\u003eUniversity of Southern Norway\u003c/em\u003e. \u0026nbsp;\u003cstrong\u003eFunding:\u003c/strong\u003e Received research funding and support from the \u003cem\u003eMax Planck Society\u003c/em\u003e, \u003cem\u003eMax Planck Foundation\u003c/em\u003e, \u003cem\u003eMax Planck Innovation\u003c/em\u003e, \u003cem\u003eTechnical University of Munich\u003c/em\u003e, \u003cem\u003eWellcome Trust\u003c/em\u003e, \u003cem\u003eNational Research Foundation Singapore\u003c/em\u003e, \u003cem\u003eEuropean Partnership on Metrology\u003c/em\u003e, \u003cem\u003eVELUX Foundation\u003c/em\u003e, \u003cem\u003eBayerisch-Tschechische Hochschulagentur (BTHA)\u003c/em\u003e, \u003cem\u003eBayFrance (Bayerisch-Franz\u0026ouml;sisches Hochschulzentrum)\u003c/em\u003e, \u003cem\u003eBayFOR (Bayerische Forschungsallianz)\u003c/em\u003e, and \u003cem\u003eReality Labs Research\u003c/em\u003e. \u003cstrong\u003eHonoraria for talks:\u003c/strong\u003e Received honoraria from the \u003cem\u003eISGlobal\u003c/em\u003e, \u003cem\u003eResearch Foundation of the City University of New York\u003c/em\u003e and the \u003cem\u003eStadt Ebersberg, Museum Wald und Umwelt\u003c/em\u003e. \u003cstrong\u003eTravel reimbursements\u003c/strong\u003e: \u003cem\u003eDaimler und Benz Stiftung\u003c/em\u003e. \u003cstrong\u003ePatents:\u003c/strong\u003e Named on European Patent Application EP23159999.4A (\u0026ldquo;\u003cem\u003eSystem and method for corneal-plane physiologically-relevant light logging with an application to personalized light interventions related to health and well-being\u003c/em\u003e\u0026rdquo;). With the exception of the funding source supporting this work, MS declares no influence of the disclosed roles or relationships on the work presented herein. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eAuthors\u0026apos; contributions (CRediT roles)\u003c/h2\u003e\n\u003cp\u003eConceptualization: ABK, AMB\u003c/p\u003e\n\u003cp\u003eData curation: not applicable\u003c/p\u003e\n\u003cp\u003eFormal analysis: ABK, AMB\u003c/p\u003e\n\u003cp\u003eFunding acquisition: not applicable\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eInvestigation: ABK, AMB\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMethodology: ABK, AMB\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eProject administration: AMB\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResources: MS\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSoftware: not applicable\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSupervision: MS, AMB\u003c/p\u003e\n\u003cp\u003eValidation: AMB\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eVisualization: ABK, AMB\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWriting \u0026ndash; original draft: AMB\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWriting \u0026ndash; review \u0026amp; editing: ABK, MS, AMB\u003c/p\u003e\n\u003ch2\u003eAcknowledgements\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eNiedermann, F. \u0026amp; Deetjen, U. Future-proofing German healthcare: Three catalysts to accelerate change. \u003cem\u003eMcKinsey \u0026amp; Company\u003c/em\u003e https://www.mckinsey.de/publikationen/2025-04-02-future-proofing-german-healthcare (2025).\u003c/li\u003e\n\u003cli\u003eD\u0026rsquo;Onofrio, S. Der digitale Wandel im Gesundheitswesen: Grundlagen, Nutzungspotenziale und Herausforderungen von e-Health. \u003cem\u003eHMD\u003c/em\u003e \u003cstrong\u003e59\u003c/strong\u003e, 1448\u0026ndash;1460 (2022). doi:10.1365/s40702-022-00930-4.\u003c/li\u003e\n\u003cli\u003eNordmann, K. \u003cem\u003eet al.\u003c/em\u003e Challenges and conditions for successfully implementing and adopting the telematics infrastructure in German outpatient healthcare: A qualitative study applying the NASSS framework. \u003cem\u003eDIGITAL HEALTH\u003c/em\u003e \u003cstrong\u003e10\u003c/strong\u003e, 1\u0026ndash;10 (2024). doi:10.1177/20552076241259855.\u003c/li\u003e\n\u003cli\u003eStachwitz, P. \u0026amp; Debatin, J. F. Digitalisierung im Gesundheitswesen: heute und in Zukunft. \u003cem\u003eBundesgesundheitsbl.\u003c/em\u003e \u003cstrong\u003e66\u003c/strong\u003e, 105\u0026ndash;113 (2023). doi:10.1007/s00103-022-03642-8.\u003c/li\u003e\n\u003cli\u003eBl\u0026uuml;mel, M., Spranger, A., Achstetter, K., Maresso, A. \u0026amp; Busse, R. \u003cem\u003eGermany Health System Review\u003c/em\u003e. https://iris.who.int/bitstream/handle/10665/341674/HiT-22-6-2020-eng.pdf (2020).\u003c/li\u003e\n\u003cli\u003eGematik GmbH. Arena f\u0026uuml;r die digitale Medizin: Whitepaper Telematikinfrastruktur 2.0 f\u0026uuml;r ein f\u0026ouml;deralistisch vernetztes Gesundheitssystem. https://www.gematik.de/media/gematik/Medien/Telematikinfrastruktur/Dokumente/gematik_Whitepaper_Arena_digitale_Medizin_TI_2.0_Web.pdf (2020).\u003c/li\u003e\n\u003cli\u003eBundesministerium f\u0026uuml;r Gesundheit. Gemeinsam digital. Digitalisierungsstrategie f\u0026uuml;r das Gesundheitswesen und die Pflege. https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/D/Digitalisierungsstrategie/BMG_Broschuere_Digitalisierungsstrategie_bf.pdf (2023).\u003c/li\u003e\n\u003cli\u003eFederal Office for Information Security. Corona-Warn-App. https://www.bsi.bund.de/EN/Themen/Unternehmen-und-Organisationen/Standards-und-Zertifizierung/E-Health/CWA/Corona-Warn-App.html?nn=910506 (n. d.).\u003c/li\u003e\n\u003cli\u003eKn\u0026ouml;rr, V. \u003cem\u003eet al.\u003c/em\u003e Use of telemedicine in the outpatient sector during the COVID-19 pandemic: a cross-sectional survey of German physicians. \u003cem\u003eBMC Prim. Care\u003c/em\u003e \u003cstrong\u003e23\u003c/strong\u003e, 92 (2022). doi:10.1186/s12875-022-01699-7.\u003c/li\u003e\n\u003cli\u003eEuropean Health Observatory on Health Systems and Policies. 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Was Deutschland von seinen europ\u0026auml;ischen Nachbarn lernen kann. https://web-assets.bcg.com/7d/f3/8c7722cd4309b2c121f645a1db39/bcg-digital-health-vergleich-eu-mar2023.pdf (2023).\u003c/li\u003e\n\u003cli\u003egematik GmbH. TI-Atlas. https://www.gematik.de/telematikinfrastruktur/ti-atlas (2025).\u003c/li\u003e\n\u003cli\u003eKeshav, S. How to read a paper. \u003cem\u003eSIGCOMM Comput. Commun. Rev.\u003c/em\u003e \u003cstrong\u003e37\u003c/strong\u003e, 83\u0026ndash;84 (2007). doi:10.1145/1273445.1273458.\u003c/li\u003e\n\u003cli\u003eKassen\u0026auml;rztliche Bundesvereinigung. Telematikinfrastruktur (TI): Datenautobahn f\u0026uuml;r das Gesundheitswesen. https://www.kbv.de/html/telematikinfrastruktur.php (2024).\u003c/li\u003e\n\u003cli\u003egesund.bund.de. Telematikinfrastruktur: das sichere Netz im Gesundheitssystem. https://gesund.bund.de/telematikinfrastruktur (2022).\u003c/li\u003e\n\u003cli\u003eBundesamt f\u0026uuml;r Sicherheit in der Informationstechnik. Telematikinfrastruktur \u0026ndash; sichere Vernetzung medizinischer Versorgung. https://www.bsi.bund.de/DE/Themen/Unternehmen-und-Organisationen/Standards-und-Zertifizierung/E-Health/Telematikinfrastruktur/telematikinfrastruktur.html?nn=127024 (n. d.).\u003c/li\u003e\n\u003cli\u003eTelematikinfrastruktur: Bedeutung, Anwendungen, Zukunft. https://www.bundesdruckerei.de/de/innovation-hub/telematikinfrastruktur (2023).\u003c/li\u003e\n\u003cli\u003eTeam digitales-gesundheitswesen.de. Chronik der Telematikinfrastruktur. \u003cem\u003eMagazin\u003c/em\u003e https://magazin.digitales-gesundheitswesen.de/telematikinfrastruktur-chronik/ (2024).\u003c/li\u003e\n\u003cli\u003eKohnert, J. TI-Messenger \u0026ndash; Advancing Secure Healthcare Communication within Germany \u0026ndash; Matrix Conference 2024. \u003cem\u003eMatrix.org\u003c/em\u003e https://2024.matrix.org/documents/talk_slides/LAB4%202024-09-20%2013_30%20Jan%20Kohnert%20-%20The%20TI-Messenger_%20Advancing%20Secure%20Healthcare%20Communication%20within%20Germany.pdf (2024).\u003c/li\u003e\n\u003cli\u003eKassen\u0026auml;rztliche Bundesvereinigung. Technische Ausstattung. https://www.kbv.de/html/30722.php (2024).\u003c/li\u003e\n\u003cli\u003eBundesamt f\u0026uuml;r Sicherheit in der Informationstechnik. Wie funktioniert ein Virtual Private Network (VPN)? https://www.bsi.bund.de/DE/Themen/Verbraucherinnen-und-Verbraucher/Informationen-und-Empfehlungen/Cyber-Sicherheitsempfehlungen/Router-WLAN-VPN/Virtual-Private-Networks-VPN/virtual-private-networks-vpn.html?nn=131120 (n. d.).\u003c/li\u003e\n\u003cli\u003egematik GmbH. 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Digitale\u0026ndash;Versorgung\u0026ndash;und\u0026ndash;Pflege\u0026ndash;Modernisierungs\u0026ndash;Gesetz. https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/guv-19-lp/dvpmg (2021).\u003c/li\u003e\n\u003cli\u003eBundesministerium f\u0026uuml;r Gesundheit. Digital-Gesetz (DigiG). https://www.bundesgesundheitsministerium.de/ministerium/gesetze-und-verordnungen/guv-20-lp/digig (2023).\u003c/li\u003e\n\u003cli\u003eBundesministerium f\u0026uuml;r Gesundheit. Gesundheitsdatennutzungsgesetz (GDNG). \u003cem\u003eBMG\u003c/em\u003e https://www.bundesgesundheitsministerium.de/ministerium/gesetze-und-verordnungen/guv-20-lp/gesundheitsdatennutzungsgesetz (2023).\u003c/li\u003e\n\u003cli\u003eintersoft consulting. Art. 9 DSGVO \u0026ndash; Verarbeitung besonderer Kategorien personenbezogener Daten. \u003cem\u003eDatenschutz-Grundverordnung (DSGVO)\u003c/em\u003e https://dsgvo-gesetz.de/art-9-dsgvo/.\u003c/li\u003e\n\u003cli\u003eBirkert, Dr. C., Rehmann, Dr. W. A., Tillmanns, Dr. C., \u003cem\u003eet al.\u003c/em\u003e \u003cem\u003eE-Health/Digital Health\u003c/em\u003e. (C. H. Beck Verlag, M\u0026uuml;nchen, 2022).\u003c/li\u003e\n\u003cli\u003eKassen\u0026auml;rztliche Bundesvereinigung. Versichertenstammdatenmanagement. Was Praxen f\u0026uuml;r den Datenabgleich auf der eGK wissen sollten. https://www.kbv.de/documents/infothek/publikationen/praxisinfo/praxisinfo-vsdm.pdf (2024).\u003c/li\u003e\n\u003cli\u003eDeutsches \u0026Auml;rzteblatt. Praxisinfo zum Versichertenstammdatenmanagement. https://www.aerzteblatt.de/nachrichten/81882/Praxisinfo-zum-Versichertenstammdatenmanagement (2017).\u003c/li\u003e\n\u003cli\u003eHaser\u0026uuml;ck, A., Kurz, C. \u0026amp; Lau, T. Digitalisierung: Versorgung digital unterst\u0026uuml;tzen. \u003cem\u003eDeutsches \u0026Auml;rzteblatt, Issue 9/2024\u003c/em\u003e https://www.aerzteblatt.de/archiv/238703/Digitalisierung-Versorgung-digital-unterstuetzen (2024).\u003c/li\u003e\n\u003cli\u003eKassen\u0026auml;rztliche Bundesvereinigung. TI-Anwendungen. \u003cem\u003eKassen\u0026auml;rztliche Bundesvereinigung Infothek\u003c/em\u003e https://www.kbv.de/infothek/zahlen-und-fakten/gesundheitsdaten/statistik-ti-anwendungen (2024).\u003c/li\u003e\n\u003cli\u003eG\u0026ouml;tz, A. \u003cem\u003eet al.\u003c/em\u003e Entwicklung der Rahmenbedingungen f\u0026uuml;r E-Health. in \u003cem\u003eE-Health Monitor 2023/24. Deutschlands Weg in die digitale Gesundheitsversorgung \u0026ndash; Status quo und Perspektiven (Eds. McKinsey \u0026amp; Company, Padmanabhan, P., Redlich, M., Richter, L., Silberzahn, T.)\u003c/em\u003e 3\u0026ndash;14 (Medizinisch Wissenschaftliche Verlagsgesellschaft, 2024).\u003c/li\u003e\n\u003cli\u003eTagesschau. Millionen Patienten nutzen E-Akte noch nicht aktiv. \u003cem\u003etagesschau.de\u003c/em\u003e https://www.tagesschau.de/inland/gesellschaft/digitalisierung-krankenakte-100.html (2025).\u003c/li\u003e\n\u003cli\u003eData4Life. Die elektronische Patientenakte (ePA) verstehen. https://www.data4life.care/de/bibliothek/journal/elektronische-patientenakte-epa/ (2024).\u003c/li\u003e\n\u003cli\u003eApotheke Adhoc. Start der ePA \u0026bdquo;niederschmetternd\u0026ldquo;. https://www.apotheke-adhoc.de/nachrichten/detail/politik/start-der-elektronischen-patientenakte-niederschmetternd/# (2025).\u003c/li\u003e\n\u003cli\u003eKrammer, S. 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Hat Deutschland alle Bausteine f\u0026uuml;r ein zukunftsf\u0026auml;higes digitales Gesundheits\u0026ouml;kosystem? in \u003cem\u003eE-Health Monitor 2023/24. Deutschlands Weg in die digitale Gesundheitsversorgung \u0026ndash; Status quo und Perspektiven (Eds. McKinsey \u0026amp; Company, Padmanabhan, P., Redlich, M., Richter, L., Silberzahn, T.)\u003c/em\u003e 37\u0026ndash;52 (Medizinisch Wissenschaftliche Verlagsgesellschaft, 2024).\u003c/li\u003e\n\u003cli\u003eGKV-Spitzenverband. \u003cem\u003eDiGA-Bericht Des GKV-Spitzenverbandes - 2024 - Bericht \u0026Uuml;ber Inaspruchnahme Und Entwicklung Der Versorgung Mit Digitalen Gesundheitsanwendungen\u003c/em\u003e. https://www.gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/telematik/digitales/2024_DiGA-Bericht_final.pdf (2025).\u003c/li\u003e\n\u003cli\u003eMaier, L. \u003cem\u003eet al.\u003c/em\u003e Akzeptanz und Nutzung digitaler L\u0026ouml;sungen. in \u003cem\u003eE-Health Monitor 2023/24. 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Chancen und Herausforderungen aus Sicht der Leistungserbringer. \u003cem\u003eBundesgesundheitsbl.\u003c/em\u003e \u003cstrong\u003e64\u003c/strong\u003e, 1213\u0026ndash;1219 (2021). doi:10.1007/s00103-021-03408-8.\u003c/li\u003e\n\u003cli\u003eGematik GmbH. TI 2.0. https://www.gematik.de/telematikinfrastruktur/ti-2-0 (2025).\u003cbr\u003e \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"eHealth, telematics, German healthcare infrastructure, digital health, telemedicine, electronic patient records, digital adoption, health apps","lastPublishedDoi":"10.21203/rs.3.rs-7409565/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7409565/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eThe introduction of the electronic health card in 2015 marked the start of the German Telematic Infrastructure (TI), a nation-wide e-health infrastructure aimed at digitally connecting healthcare providers, insurers, and patients within the statutory health insurance system. The expansion of the TI within the German healthcare system is progressing but still slow by international comparison. The German government seeks to incrementally enhance this infrastructure to align with the demands of the digital age, thus creating new opportunities for patients and service providers. In this literature review, we critically examined the current status of the TI in Germany, focusing on the implemented and planned measures, challenges encountered, and opportunities available for providers and insured individuals to help inform stakeholders in the field.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eA comprehensive literature search was conducted across PubMed, Journal of Medical Internet Research, relevant governmental websites, and the library catalogues of the Technical University of Munich and Ludwig-Maximilian-University Munich. The review included both qualitative and quantitative studies, as well as governmental publications and internet sources from gematik GmbH and other providers.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eThe analysis indicates that TI elements are increasingly integrated into routine care within medical facilities, but Germany lags behind in international comparisons. Despite Germany's leading role in certifying and distributing digital health applications, their utilisation remains far from optimal especially for prevention purposes for which they are currently not licensed. The deployment of new digital health services and national-wide rollout of TI applications is particularly hindered by technical, financial, and organisational challenges affecting service providers, patients, and key stakeholders such as statutory health insurance companies. Nevertheless, the digital health infrastructure offers clear benefits, including improved healthcare delivery, as well as time and cost savings.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eGermany remains significantly behind other nations in developing a comprehensive digital health infrastructure. To address this lag and the associated challenges, further initiatives, such as the 2025 introduced nationwide implementation of the electronic patient record with an opt-out option, are crucial. However, significant work remains, particularly in enhancing training and education for both healthcare professionals and patients, overcoming technical challenges and addressing the unfavourable cost-benefit ratio.\u003c/p\u003e","manuscriptTitle":"How digital is the German outpatient healthcare system? A review on past and future measures, challenges and opportunities","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-27 07:09:11","doi":"10.21203/rs.3.rs-7409565/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fac8561b-5bcd-438f-87db-88811c478a26","owner":[],"postedDate":"August 27th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":53578060,"name":"Scientific community and society/Business and industry"},{"id":53578061,"name":"Health sciences/Health care"},{"id":53578062,"name":"Health sciences/Medical research"}],"tags":[],"updatedAt":"2025-09-03T05:08:56+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-27 07:09:11","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7409565","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7409565","identity":"rs-7409565","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}