The rapid growth of digital devices, software and technologies means that the medical device sector is changing. Many small and independent manufacturers are encountering medical device regulation for the first time. At the same time, responsive and effective regulation of digital devices requires sound understanding of the underlying new technologies and concepts.
Algorithms as medical devices describes how digital health is covered by existing medical device regulation and outlines three critical areas:
The challenges that the digital health sector may pose for regulators and developers
How digital devices can be regulated as medical devices under UK/EU and US law
The specific problems that machine learning could pose to medical device regulation
Meanwhile the market for black box medicine is growing, unless any regulator leaves their continous vacation.
