FDA is hands-off Low Risk General Wellness Products
FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk
Weight Loss Products FTC Weighs In
You could burn 50 calories just by reading this blog post. Or not. But if you sell a weight loss product with false, deceptive, and misleading claims, you'll burn a lot more calories when the [...]
FDA regulates mobile medical apps, medical device data systems, and medical device software as “connected health”
What do we call our emerging futurist healthcare-- digital health, e-health, m-health, mobile medicine, tele-health, or old-fashioned "medicine?" FDA is "hip" with its terms, "connected health."
Energy drinks raise a monster of FDA and state legal concerns
Energy drinks, like dietary supplements promising energy boosts, weight loss, and other benefits, raise significant FDA legal challenges; how can manufacturers avoid the barrage of FDA and state [...]
Does Wearable Tech Give Away Your Quantifiable Self? FDA Medical Device, HIPAA Privacy and Security, and Legal Issues Over Who Owns Your Data
Wearable health technology is here, creating new legal and regulatory questions about who owns the data, whether HIPAA applies and protects the privacy of your quantifiable self.
Daily Journal publishes “Future of Medicine is Just a Tap Away” as lead front-page article
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.
Do HCG Weight Loss Products Work? FTC Cracks Down on Homeopathic HCG Drops
Recently a physician called me, raving about HCG for weight loss, letting me know he recommends HCG to all his obese patients, because he lost over 150 pounds on HCG. "The scientific evidence is [...]
How to Piss Off the FTC After Offending the FDA
If you want to know how not to offend the FDA and FTC sequentially, here's an instructive lesson about a company that has gotten a big regulatory bruise.
Wearable Health Technology: Health Care Dream or Privacy Nightmare? (published by LegalZoom)
LegalZoom published Wearable Health Technology: Health Care Dream or Privacy Nightmare, on the heels of Apple's announcement of the Apple Watch. The article makes the point that the Apple Watch [...]
How to resolve wearable tech legal and regulatory issues without wearing out your legal budget
Wearable technology legal and regulatory issues can sidetrack your wearable tech venture, unless you're savvy about navigating the legal landscape. Wear your wearable tech on your sleeve - not [...]
