FDA

FDA Acts on Radiological CDS

By William A. Hyman – The FDA took two recent actions in the domain of CDS for radiological image interpretation. One was to permit the marketing under the De Novo program of software for the interpretation of fractures of the wrist.

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FDA and Digital Health Regulation

By David Harlow – The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Collectively, these guidances cover a range of digital health issues.


CDS, PDS and FDA

By William Hyman – The 21st Century Cures Act addressed what kinds of medical software are medical devices (and therefore subject to regulation by the FDA), and what kinds are not medical devices (and therefore not regulated by the FDA, but subject to CPSC and FTC).



The Great Digital Hope or Just Hype

By Matt Fisher – Healthcare has become the proverbial shiny object to many technology companies, both within and without of Silicon Valley. The technology companies seem to view healthcare as a great, untapped wilderness that is flush with potential profits.



Mobile Health Apps: Much to Consider

By Matt Fisher – Mobile apps are a topic of frequent discussion in the healthcare field these days. Questions include what regulatory requirements apply, are the apps trustworthy, is information kept safe and secure, and others. The question of what regulations apply in particular leaves many confused and uncertain as to what needs to be done.