The new Digital Care Act (Digitale-Versorgung-Gesetz) is part of Germany’s efforts to expand the digitization of the healthcare system in Germany. Germany has already been pursuing this path since the so-called ‘E Health Act’ from 2016. The aim of the ‘E-Health Act’ was to establish information and communication technology in healthcare. It focuses in particular on the development of the ‘electronic health card’ and the corresponding ‘electronic patient file’ for statutory health-insured people (see below for more information on such applications), the protection of the data stored in such files against unauthorised use, the creation of a secure ‘telematics infrastructure’, the improvement of the interoperability of healthcare IT systems, and the provision of telemedical services. The ‘telematics infrastructure’ will be an interoperable and compatible information, communication and security infrastructure for the use of the ‘electronic health card’ and the corresponding ‘electronic patient file’, its applications and other electronic applications in healthcare and health research.
The new Digital Care Act builds upon the ‘E-Health Act’ by focusing on the following: medical doctors will not only be allowed to prescribe traditional medicines and treatment methods to their patients, but also health apps. Such health apps may, for example, remind chronically ill people to take their medicine regularly, or provide a diary function where users can note their daily well-being. In the future, German statutory health insurances funds have to reimburse the costs of health apps under certain conditions. Initially, the health app shall be tested for data security, data protection and functionality by the German Federal Institute for Drugs and Medical Devices (‘BfArM’). After the successful test and launch, statutory health insurances will reimburse the costs provisionally for one year. During this period, the manufacturer of the health app must prove to the BfArM that its health app improves patient care. The reimbursement amount will be negotiated with the German Association of Health Insurance Funds (GKV-Spitzenverband).
The new Digital Care Act also aims to expand the ‘telematics infrastructure’ within the health sector. According to the new act, patients should be able to use digital services such as the ‘electronic patient file’ throughout the country as soon as possible. Therefore, the new act obliges pharmacies (by the end of September 2020) and hospitals (by 1 January 2021) to connect to the ‘telematics infrastructure’. Midwives and physiotherapists as well as nursing and rehabilitation facilities may voluntarily join the ‘telematics infrastructure’ and will be reimbursed for that voluntary connection.
Moreover, the new Digital Care Act strengthens the use of remote/video consultations by patients which have been legally used in Germany since 2017. To achieve this, the German Act on Advertising for Therapeutic Products that currently prohibits advertising for such remote consultations will be amended. This amendment will allow patients to find medical doctors that offer such remote/video consultation more easily.
Lastly, the new Digital Care Act has removed any planned regulations of the introduction of the ‘electronic patient file’. In order not to jeopardise the start date of the introduction of the ‘electronic patient file’ at the turn of the year 2020/2021, on a separate law shall be agreed upon in that regard as soon as possible. To provide further background information: under the German Social Insurance Code V, the ‘electronic patient file’ is supported by the so-called ‘electronic health card’. The ‘electronic health card’ serves as an insurance card (in chip card format) for people with statutory health insurance and serves as proof of entitlement to benefits from the statutory health insurance. Statutory health-insured people may voluntarily store other data on the ‘electronic health card’, such as emergency treatment data. The sovereignty over the data rests here with the insured person.
The ‘electronic patient file’ ‑ which has yet to be built ‑ can be described as further development of the ‘electronic health card’ and will provide further applications. It will support the statutory health-insured person in making information available about findings, diagnoses, therapy measures, treatment reports, vaccinations received and other medical data to the care providers (‘Leistungserbringer’). In the German healthcare system, Leistungserbringer are all those groups of service providers who provide services for the insured persons of the health insurance funds, such as medical doctors, dentists, pharmacies, psychotherapists and hospitals). Critics did not see the data protection aspect sufficiently addressed in the recent draft of the new act, so the German Government decided to agree on the ‘electronic patient file’ in a separate act.