Blogger Patricia Salber, MD MBA featured Understanding whether a medical app needs FDA regulation can be tricky on The Doctor Weighs In. In this videotaped interview, held at the 2015 Stanford [...]
Digital health personalizes medicine, revolutionizes healthcare, and makes healthcare law anachronistic
By putting healthcare in the hands of patients, healthcare technology is not only revolutionizing the way we think about medicine, but also the way laws shape personal health.
How will FDA regulate predictive clinical software as predictive analytics pushes medical frontiers?
Predictive analytics will push the frontiers of clinical care; the question is whether FDA regulation will promote or stifle innovation in the name of consumer protection.
Federal bill to boost health IT innovation by exempting low-risk medical software and mobile apps from FDA regulation
Senators Bennet and Hatch reintroduced the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, to "cut red tape at the Food and Drug Administration (FDA) and help [...]
FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk
The Daily Journal, California's largest legal news provider, published Future of Medicine is Just a Tap Away, by healthcare & FDA attorney Michael H. Cohen.
The FDA now requires that mobile app developers create a cyber security plan and submit it to the FDA along with their mobile medical app / medical device submission.