By David Harlow – The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.
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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 U.S. Food and Drug Administration approved the FoundationOne CDx, the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic test that can detect genetic…
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.
By William Hyman – One form of Clinical Decision Support (CDS) software is that which suggests one or more diagnoses or other important assessments based on some set of patient specific data.
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.
By Kathleen “Cook” Uhl MD – At FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research, 2015 was an important…
By Matt Patterson MD – There is broad agreement that the U.S. healthcare system must focus on improving overall care quality and cost efficiency. The pressures imposed on the system by the Affordable Care Act make this need abundantly clear.
We conclude our Celebrating Women in Healthcare Month by saluting Dr. Margaret Hamburg as she resigns after six years of serving as the Commissioner of…