Digital health applications that meet certain requirements will be covered by the German state health insurance schemes from 2020. This is one of the elements of the Digital Healthcare Act 2019 (Digitale Versorgung-Gesetz), which we discussed in an earlier post this year and which was approved by the German Parliament in November and published on December 18th, 2019.
To qualify for coverage, an app must be a low-risk medical device. In addition, the manufacturer must apply for registration with a new registry which will be kept by the Federal Institute for Medicinal Products and Medical Devices. The detailed requirements for registration will be set out in a regulation which is currently being drafted, but will include proof of privacy law compliance, a high level of data security and a concept for evaluation of the medical benefit of the app by an independent expert. Patients will need to obtain a prescription by a physician or psychotherapist or their health scheme’s prior approval.
Independently of this, the Act also contains amendments to the Social Code that will authorize state health insurance schemes to work with device manufacturers, IT companies and others to improve healthcare services through digital innovations. They will also be authorized to invest up to 2% of their financial reserves in investment funds with the aim of furthering the development of digital innovations.