Three key legislations will have a significant impact on electronic patient records, telemedicine, e-prescription, and digital application approval and reimbursement in Germany.
By Remy Denzler, Ph.D. (Consultant, Health Advances GmbH)
Since the formation of Germany’s coalition government in March 2018, the Ministry of Health has been very active in drafting three new laws that together will constitute a great leap in digitalisation:
(1) Service Supply Act: Introduces a statutory electronic patient record that includes medical records and grants access to patients, makes telemedicine mandatory in rural areas, and promotes electronic appointment services
(2) Drug Safety and Supply Act: Will expand the possibilities of telemedical applications by implementing electronic prescriptions
(3) Digital Provision Act: Still in the process of being drafted, this law not only signifies ground-breaking changes in the access, prescription, and reimbursement of digital applications but also aims to introduce financial incentives and interoperability standards for EPR as well as to advance telemedicine and the interconnection of healthcare stakeholders
Four years have passed since Germany instituted its first E-Health law in history (E-Health Act, 2015). Although considered visionary at the time, many of its provisions were not extensive enough to have a significant impact. For example, the law resulted in an electronic patient record (EPR) lacking historic medical data as well as a telematics data exchange infrastructure for healthcare professionals, neglecting hospitals and pharmacies. In addition, the E-Health Act did not cover important topics such as electronic prescriptions (e-prescriptions) and telemedicine. Nevertheless, it prompted a political debate and laid the foundation to three key new legislations that will accelerate digitalisation in Germany in the years to come: (1) Service Supply Act, (2) Drug Safety and Supply Act, and (3) Digital Provision Act.
Service Supply Act
After only four months in operation, the newly appointed Ministry of Health drafted the Service Supply Act, which was ratified in May 2019. Although this legislation primarily focuses on improving patient access to medical services, many of its directives lay a foundation for several areas central to digitalisation including EPRs, telemedicine, and physician appointment services.
Electronic Patient Records
Health insurances are required to offer EPRs to patients by 2021. In contrast to the rudimentary EPR introduced by the E-Health Act, the EPR will now contain medical records, will be accessible to patients, and can be amended with additional health insurance service offerings. This holistic approach will finally solve the diverging developments of recent years, in which the government and health insurances were offering two separate, non-compatible electronic record systems that differed substantially in the extent data were recorded and accessible (see our previous blog, “E-Health in Germany: Rapid Progression of Digitalisation?”).
To ensure high-quality medical services across the country, health insurances are required to establish telemedicine consultation services in rural areas lacking adequate medical provider coverage. This goes as far as providing incapacity-to-work certificates electronically without in-person consultation. These changes together reflect important steps toward fully remote teleconsultation services.
Booking of physician appointments will be facilitated by implementing the infrastructure and standards for electronic appointment as well as a national 24-7 telephone service.
Figure 1: Impact of key national laws on digitalisation in Germany
Note: EPR = Electronic Patient Record, TSVG = Terminservice- und Versorgungsgesetz, GSAV = Gesetz für mehr Sicherheit in der Arzneimittelversorgung, DVG = Digitale Versorgung-Gesetz.
Source: Health Advances analysis, German Ministry of Health.
Drug Safety and Supply Act
Effective in July 2019, the new Drug Safety and Supply Act introduces several new regulations around drug safety and supply. From a digitalisation perspective, the most important change is the introduction of electronic prescriptions. Planned to launch in June 2020, e-prescriptions will play a vital role in unlocking the full potential of telemedical services.
Digital Provision Act
The Digital Provision Act was presented in May 2019 and is the successor of the initial E-Health Act. Although subjected to several rounds of refinement, the current version entails both advancements in telemedicine, EPR adoption and connection to the telematics infrastructure as well as exciting reforms around the approval and reimbursement of digital applications and telemedicine.
Digital applications with risk class I and IIa will be eligible for a fast access pathway, in which only data protection, data security, transparency as well as ease of use are assessed. Initial admission grants one year access to the German market, in which applications have free pricing, are reimbursed and can be prescribed by physicians. After this year, manufacturers need to provide clinical data that show the benefit of their application and negotiate prices with the National Association of Statutory Health Insurance Funds (GKV).
Telemedicine will be made available on a larger scale and reimbursed in addition to current provider fee structures.
Electronic Patient Records
Adoption of EPR will be promoted by financially incentivizing physicians to populate and manage medical records, and by commissioning health insurances to establish interoperability by January 2022.
Connection to the telematics infrastructure will become mandatory for pharmacies by March 2020 and for hospitals by March 2021. In addition, professional fees of non-connected physicians’ offices and hospitals will be penalized by cuts of 2.5% and 1% starting in March 2020 and January 2022, respectively.
Collectively, all three key legislations will have a significant impact on several aspects of the German healthcare system. The reforms in EPRs, telemedicine, e-prescription, and digital application approval and reimbursement will unlock many possibilities for companies who intend to access the German market with innovative, digital health solutions.
(1) Ministry of Health – Bundesministerium für Gesundheit (BMG).
|About the Author|
Remy Denzler, Ph.D. is a member of Health Advances European Practice, which helps clients navigate through the diversity of European healthcare systems to optimize commercialization strategies of pipeline and in-market products.