Germany Is Going To Specify Safety Expectations For Reimbursable Digital Health Applications

Author:Mr Jean-François Mayoraz
Profession:Baer & Karrer
 
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Last month, Germany introduced the Digital Health Service Act, which grants German patients access to reimbursable digital health applications. In order to establish the procedural formalities as well as material aspects of such health applications the German Federal Ministry of Health is working on an Ordinance concerning the procedure and the requirements for the assessment of reimbursability of digital health applications in the statutory health insurance.

Last month, Germany introduced the Digital Health Service Act, which grants German patients access to reimbursable digital health applications. (Digitale-Versorgungs-Gesetz – DVG; see also Dr. Jörg Schickert et. al. in: Hogan Lovells Newsflash of 15 November 2019, Digital health solutions to become reimbursable in Germany – milestone for patients and providers). In order to establish the procedural formalities as well as material aspects of such health applications the German Federal Ministry of Health is working on an Ordinance concerning the procedure and the requirements for the assessment of reimbursability of digital health applications in the statutory health insurance (Verordnung über das Verfahren und die Anforderungen der Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung – Digitale-Gesundheitsanwendungen-Verordnung – DiGAV ).

The ordinance aims explicitly at specifying expectations on functionality, safety, quality, and data privacy. Manufacturers of digital health applications that want their products to be reimbursable under the Digital Health Service Act must meet the criteria specified in the ordinance and apply for inclusion of the product in the register for digital health applications which is still to be established. Patients using digital health applications that are listed in the register for digital health applications will expect that the products meet these safety criteria.

Under the ordinance as currently drafted, manufacturers are, among other aspects, required to meet specified criteria on

Safety and functionality. The manufacturer must provide proof of safety and functionality. These aspects are assessed in the conformity assessment of the product. The CE marking will usually be an indication that the product meets the criteria and the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) will generally not assess these aspects again for...

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