Decentralized digital health services caught between the pressure for innovation and the burden of regulations

Abstract

Multiple challenges await third-party digital health services when trying to enter the health market. Prominent examples of such services are clinical decision support systems provided as external software. Uncertainty about their challenges, technical as well as legal, pose serious hurdles for many innovations to be adopted early on. There are many options and trade-offs to provide digital healthcare solutions as a third-party service. This paper discusses them by referring to a pharmacogenetic decision support service. By providing best-practices, scenario descriptions and templates designed for third-party services with respect to legal and technical issues, obstacles and uncertainties can be reduced, which will have an impact on better diagnoses and treatments in the healthcare system. © 2021 European Federation for Medical Informatics (EFMI) and IOS Press.