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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.

No sooner had the ink dried on my post, Telemedicine: The Medicine of the Future, than some blogger pronounced telemedicine the "medicine of the past." There, by a stroke of the pen, someone [...]

Healthcare & FDA lawyer Michael H Cohen speaks on MHealth & Wearable Health Technology: Will FDA Legal Compliance Stymie or Promote Innovation, at the Health Law Section of the Los Angeles County [...]

FDA would have significantly greater authority over cosmetic products under the Personal Care Products Safety Act. The Personal Care Products Safety Act would increase regulation over many [...]

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 approved marketing for 23and Me's Bloom Syndrome Carrier test, months after halting the company's marketing of direct-to-consumer genetic tests. FDA now classifies genetic carrier screening [...]

New York's Attorney General initiated the investigation against major retailers of herbal supplements, based on DNA testing of plant materials suggesting contaminants, and mislabeling; was the [...]

The Daily Journal published FDA’s General Wellness Guidance is Welcome News by healthcare and FDA lawyer Michael H. Cohen. The article (Cohen.P.0129) goes through FDA's general wellness guidance [...]

If you market your healthcare products, FTC enforcement can stop your sales in their tracks. All it takes is a search - yes, good old keywords - and you're in line for significant penalties for [...]

FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk

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 [...]

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, 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 [...]

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.

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.

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 [...]

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.

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 [...]

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 [...]

The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow [...]