Untangling the Intricate World of Digital Health Regulation-The HSB Blog 6/28/21
Our Take: The current regulatory landscape for digital health tools is complex and doesn’t lend itself to easily determining where digital health tools belong or how they should be regulated. As a result it is not clear how to design these tools within regulatory guidelines and what process they should or may need to follow for approval. This can risk the health and safety of patients as well as slow the pace of development of innovative products to market. Furthermore, it ri