Summary:
- Digital Healthcare Act (DVG) introduces mobile applications on prescription, online video consultations, electronic health records, e-prescriptions and secondary use of data for scientifical purposes;
- The mobile app, to become reimbursable, must be tested for safety, functionality, quality, data security, and data protection by the Federal Institute for Drugs and Medical Devices (BfArM);
- If it goes successfully through the "fast-track," the statutory health insurance funds can reimburse the application for a period of one year. Then the manufacturer must prove its efficiency;
- The German statutory health insurance system covers 72 million citizens. It is the largest healthcare system in Europe;
- €200 million per year will be invested in the innovation fund until 2024.
Bold and progressive digital law
On 7th November German parliament passed the so-called Digital Healthcare Act – DVG ("Digitale Versorgung Gesetz"). For the national healthcare system, which has stuck in digital stagnation for years, this is a real breakthrough. The new law enables statutory health insurance to invest in VC funds. Patients will get access to the electronic patient record (EHR). Pharmacies (by the end of September 2020) and hospitals (by 1 January 2021) have to connect to the data exchange system – Telematics Infrastructure (TI).
Doctors issuing electronic documents, like electronic sick leave notice or e-prescriptions, will receive financial incentives. The new legislation also opens the door for the secondary use of data. The data available to the health insurance funds will be collected in a pseudonymous format at the research data centre. Research institutes, on request, will get access to these data for Big Data analysis. The Act also lays the foundations for open and standardized software interfaces that will allow for faster and easier exchange of information.
Regulated digital health application (DiGA)
In order to accelerate the market readiness of digital health care innovations, the DVG defines a structured path for digital health care applications (DiGA) to be reimbursed. Following the details published by the Federal Ministry of Health, if the Federal Institute for Drugs and Medical Devices (BfArM) approves the app in terms of safety, functionality, quality, data security, and data protection, it will be accepted to be reimbursed by the statutory health insurance. Within a 1-year trial period, manufacturers must prove to the BfArM that their app improves patients' outcomes and are efficient. In this way, the evaluation of functionality and benefits will be checked in a real-world setting.
A digital health applications (DiGA) is a medical-grade device with the following characteristics:
- the medical device of risk class I or IIa (according to Medical Devices Directive);
- the primary function of DiGA is based on digital technologies;
- the medical objective is achieved through the primary digital function;
- DiGA supports the detection, monitoring, treatment, or alleviation of disease or the detection, treatment, relief of injury or disability.
- DiGA is used by the patient or together by the service provider and patient.
“Digital health is not an end in itself. It is about improving patient care in everyday life through better information and communication. We will be the first country in the world where the statutory health insurance funds will reimburse mobile applications if they prove an added value to care. It is also about better care through better research with better data,” – said the Federal Minister of Health Jens Spahn at the parliament during the approval process of the new law.
With the progressive legislation, Germany wants to make paper and fax in the healthcare system a thing of the past. DiGA providers can apply to BfArM for reimbursement starting from the end of May. The application process includes a three-month examination of the product characteristics declared by the provider.
