Market access regulations for mHealth applications in Germany, Austria and Switzerland: A Review

Market access regulations for mobile health applications are divergent across countries. A uniform legal framework for mobile health applications is currently lacking, therefore, this review compares the requirements and processes for mobile health applications in Germany, Austria, and Switzerland. The review used a combined search in domestic law databases, PubMed and institutional websites to synthesise the available information for market access. The investigated countries have similar ongoing digital health projects; therefore, mandatory enforcement procedures to encourage the use of mobile health applications are implemented. Mobile health applications must meet different additional domestic requirements including increased data security and interoperability with existing telematic structures which are common in all countries. A formal process of certification for mobile health applications must be completed in Germany. In Austria, there are no formal processes, and in Switzerland, healthcare facilities must provide certification. However, in all three countries regulatory steps involve: the Ministry of Health, a Medical Device agency and telemedicine/digital health expert center. Manufacturers need to familiarise themselves with diverse regulatory and legal requirements early in the product development process. In the future, new cooperation approaches between industry, policymakers and MedTech associations can help to fulfil requirements on time and thus advance market entry for digitalised health products in the healthcare sector. Public interest summary: Rules for placing mobile health applications on the market differ in Germany, Austria, and Switzerland. Hence, manufacturers of such products must understand the requirements in each of the country separately. The study has examined these rules and compared them. Mobile health applications in these countries must meet extra requirements like better data security to protect users privacy and the ability of those products to “communicate” and exchange information with existing IT systems. In Germany, there is a formal process for approval of these products. In Austria, there is not a formal process but mobile health applications need to be evaluated according to set criteria, and in Switzerland, healthcare facilities must provide approval themselves. In all three countries, the government's Ministry of Health, a Medical Device agency, and a center of experts in digital health play a role in the regulations. Manufacturers need to understand these different rules early on when they are developing their products.