In Mid-May 2019 the German Federal Health Minister presented a draft law for the “Digital Health Care Act (Digitale Versorgung-Gesetz – DVG)”. By German standards, it contains almost spectacular new regulations, as it provides, among other things, for insured persons to be entitled to digital health applications (“diGA”). Digital health applications might soon be prescribed by doctors and might gain access to the primary healthcare market.
At the request of the provider, the application would be audited by the Federal Institute for Drugs and Medical Devices (BfArM) for compliance with all legal requirements, data protection and data security as well as for positive healthcare effects and then would be included in the directory of reimbursable digital health applications.
To be listed reimbursable, the “diGA” must be a medical device with a low risk class, i.e. risk class I or IIa according to the Medical Devices Regulation. Stand-alone software, which prepares and makes available information to decide on diagnoses or treatments, is in risk class IIa. However, if it can directly or indirectly cause a serious deterioration in health, it is in a higher class. As a result, many applications would be excluded from the new regulation.
Further development of this draft law will be presented in the next eMEN newsletter.