The Bundesverband der Pharmazeutischen Industrie e.V. (BPI, German pharmaceutical industry body) has noted the apparent criticism of medical apps and software, and reminded stakeholders of the strict requirements to approve the technologies.
BPI has joined forces with the Spitzenverband Digitale Gesundheitsversorgung e.V. (SVDGV – High Association for Digital Health Care), Bundesverband der Arzneimittelhersteller e.V. (BAH – Federal Association of Drug Manufacturers) and Bundesverband Internetmedizin (BiM – Federal Association of Internet Medicine) to respond to the Association of Statutory Health Insurance Physicians in Bavaria. The Association called for its clinicians to “be careful when using and prescribing digital health applications (DiGA)”.
The joint statement reads:
“Prescription apps shouldn’t be the exception, they should become the rule. This is also intended by law. We understand the concerns of the KVs as a signal for more dialogue and as an incentive to provide more information. Digital health applications rightly have to meet the highest requirements for data protection, data security and quality assurance. This includes, among other things, proof of positive health care effects through evidence-based comparative studies checked by the BfArM. Our member companies work hard every day to meet these regulations in order to develop solutions in Germany as an innovation location.”
The statement acknowledges that regulations for such technologies are continuously developing, and they are confident developers will continue to adhere to the most rigorous measures.
Read the BPI statement for more information.