How to choose a healthcare lawyer or FDA attorney and regulatory consultant

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 [...]

Concierge medicine, direct pay, and employee wellness clinic legal issues

Concierge medicine legal issues require adroit navigation as medical practices continue to move into concierge and hybrid models. Our law firm handles concierge medicine practices, providing [...]

Packaging services raises anti-kickback and fee-splitting issues, even in “concierge” medicine practice

Our concierge medicine lawyers represent physicians and medical practices seeking to develop concierge medicine practices, and so we see many questions about the legality of "packaging" medical [...]

HIPAA Laws Mandate HIPAA Policies & Procedures, HIPAA training, and HIPAA compliance implementation even for small medical practices (and business associates)

HIPAA compliance is mandatory, not optional, with both federal and state governments stepping up HIPAA enforcement.Recently, our Los Angeles HIPAA lawyers have handled HIPAA breaches involving [...]

FTC wins advertisement substantiation case against online marketer of health products

The Federal Trade Commission (FTC) won a $2.2 million judgment against health food marketer Wellness Support Network, Inc. (WSN) in federal court for the “Diabetic Pack” and the “Insulin [...]

If someone asks you to be Medical Director, run….

There's an old quote that says: "If you meet the Buddha on the road, kill him!" And what if your friendly neighborhood chiropractor asks you to be Medical Director, especially in California? [...]

California stem cell regulations guide the emerging stem cell research effort and industry

California stem cell laws boost the stem cell industry by funding stem cell research, but the product side of industry is largely in the hands of the FDA.

FDA rules say a cosmetic is sometimes just a cosmetic – and sometimes a “drug”

To paraphrase Freud, sometimes a cosmetic is just a cosmetic – and sometimes it’s a drug.... Which is it—drug or cosmetic? The answer, FDA says, depends on intended use.

FDA’s evolving regulatory position on stem cell therapies

The federal appellate decision in U.S. v. Regenerative Sciences, LLC (see Court upholds FDA's legal authority to regulate stem cell therapies) also reflects FDA's evolving legal authority over [...]

Court upholds FDA’s legal authority to regulate stem cell therapies

FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative [...]

Stem cell laws and regulations: FDA regulation of stem cell therapies

If you wanted to upgrade the old film, "The Graduate," you'd have Dustin Hoffman's character shouting out "stem cells!" instead of "plastics!" Of course, he would immediate meet his favorite [...]

FDA proposes updates to Nutrition Facts label on food packages

The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information.

The Future of Medicine: From Physical to Online to Mobile to Wearable to Implantable

Just as the silicon "ink" dried on Telemedicine: The Future of Medicine, someone, somewhere, pronounced that there is a future for medicine beyond the future. This was no sweat for me, since I'm [...]

California medical board arrests man for unlicensed practice of medicine

California and other state medical boards still run undercover investigations for unlicensed practice of medicine. California is in the minority of states that have a statute that authorizes [...]

Legalzoom Publishes “Telemedicine: The Future of Health Care” on Telehealth Laws

Legalzoom featured Telemedicine: The Future of Health Care, by Los Angeles healthcare and FDA lawyer Michael H. Cohen, as the lead article in its Insight newsletter.

“From Wall Street to Awakening” Features Interview with Healthcare & FDA Lawyer Michael H. Cohen

Julie Migneault: Your Soul Fully Expressed features a Skype interview with healthcare and FDA lawyer Michael H. Cohen, entitled: "From Wall Street to Awakening: How to Bridge Your Passions & [...]

FDA Mobile Medical App Guidance continues to exert pressure on health-related apps

The FDA's final Guidance for Industry and FDA staff on mobile medical apps continues to constrain industry development of new health apps. Like the draft mobile medical app FDA guidance, the [...]

Telemedicine laws increasing in number and scope

Several important pieces of federal telemedicine legislation, introduced in the past 12-18 months, could affect the way medicine and healthcare are practiced through online, virtual, and mobile means.

FDA exerts authority over medical devices with genomics

FDA flexed its jurisdictional muscle by warning 23andMe that its marketing of the 23andMe saliva test kit and personal genome service without marketing clearance or approval violated that federal [...]

Ancient Wisdom & Modern Technology: Legal Issues in Online Health, Mobile Health, E-Health, and Future Medicine

Healthcare and FDA lawyer Michael H. Cohen spoke on "Ancient Wisdom & Modern Technology" on ExitCoach Radio. Today, there are many healthcare and wellness related businesses popping up