Caveman Blogger Has Procedural Win on Appeal of First Amendment Case on Unlawful Nutrition & Dietetics Charge

The 4th Circuit Court of Appeals in Cooksey v. Futrell has weighed in on the fate of the “caveman blogger.”Recall that in this case, the caveman blogger sued the North Carolina Board of Dietetics [...]

OIG Opines that services by LLC owned by podiatrist and wife do not violate anti-kickback laws

In Advisory Opinion 13-02, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued a favorable opinion approving an arrangement whereby a podiatrist and his wife [...]

FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden

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.

Concierge Medicine Today features “LEGAL: Concierge Medicine v. Direct Primary Care: Legal Issues”

Concierge Medicine Today, a leading digital resource for timely, trusted health news and concierge medical information, featured LEGAL: Concierge Medicine v. Direct Primary Care: Legal Issues.

FDA Mobile Medical App Guidance Reads FDA Medical Jurisdiction Expansively

The FDA's Mobile Medical App Guidance contains many nuanced definitions that determine whether your mobile app will likely be regulated by the FDA as a medical device.Recent clients have asked [...]

Michael H. Cohen Speaking on FDA & Related Legal Issues in Online Health Ventures

Attorney Michael H. Cohen speaks on "FDA & Related Legal Issues in Online Health Ventures" at a prominent LA law firm's Restaurant, Food & Beverage Group on July 9.

Memories, Dreams, Reflections – A Horse and the Color Red

I dreamed last night that I was in an apartment building or high tower–the window was high–and I dropped some red jelly on a horse. The strange thing about the dream was that this red jelly [...]