Regulation of Medical Digital Technologies

Abstract

M-Health applications may be subject to regulation. Regulatory requirements depend on the geographical area where the application is available, the intended use, and the type of data collected. This chapter discusses medical device and privacy regulation in the US and EU. Most apps will not be regulated. However, if the publisher claims a medical purpose, regulation will apply. The applicable regulations have historically been developed for pharmaceuticals; then adapted to medical devices; and these have been applied to software. As a result, regulatory approaches and software development best practices often clash. Developers should have a strategy to cope with regulatory affairs from the start. This article discusses the most important requirements, gives suggestions for the best way to handle these, and illustrates the approach with practical examples from the Dutch SME SilverFit.