Healthcare Law

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 [...]

The Federal Trade Commission (FTC) reports that mobile apps need to provide consumers with more disclosures, and also protect the privacy and security of consumer data--thus adding to the [...]

The private practice of medicine increasingly is disappearing or morphing into concierge medicine, direct pay, or practice through giant health systems, reports the Los Angeles Times.

The AMA now supports telemedicine, but insists on "safeguards" to help ensure the best patient care. While the AMA Policy on Telemedicine does not focus on legal issues, the telemedicine policy [...]

Here is a quick summary of federal self-referral ("Stark law") and anti-kickback law, and California self-referral and anti-kickback / fee-splitting rules. Each state has its own laws, of course.

How do you market an emerging healthcare practice, without running afoul of regulatory walls, from federal and state advertising law to licensing laws, and the law governing unfair business practices?

Neurofeedback, biofeedback, EEG, hypnosis, Reiki, energy healing ... how do practitioners evaluate, and handle, malpractice liability risk? Do they have obligations of informed consent? What [...]

Neurofeedback, biofeedback, EEG, hypnosis, Reiki, energy healing ... how do practitioners evaluate, and handle, malpractice liability risk? Do they have obligations of informed consent? What [...]

Who can legally practice neurofeedback—only licensed professionals—and what laws govern neurofeedback practice?

Many physicians, chiropractors, acupuncturists, and other healthcare practitioners want to know whether they are fee-splitting when they rent a room hourly from a medical practice or other [...]

How can integrative medicine physicians collaborate with chiropractors, without triggering unnecessary patient liability, medical board discipline, or other legal exposure for fee-splitting, [...]

Many physicians are dissatisfied with their medical practice and wonder whether they can legally open a side online health and wellness business--be it online health and wellness coaching, [...]

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 [...]

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 [...]

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? [...]

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 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 [...]

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

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 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 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.

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 & [...]

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 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 [...]

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

Is it fee-splitting to hire another medical doctor, chiropractor, acupuncturist, or other health care practitioner in your office and give them a "cut" of patient revenues? Fee-splitting, [...]

Healthcare & FDA attorney Michael H Cohen spoke in Woodland Hills, California to the SoCal IP Law Group on "Our Designer Future: How FDA Legal Issues Shape Human Health–From Medical Devices to [...]

Healthcare & FDA attorney Michael H Cohen spoke in Riyadh, Saudi Arabia, at the invitation of the World Health Organization, the Gulf Cooperation Council, and the Saudi National Center for [...]

"Health Apps as Medical Devices: What It Means for Consumers" by healthcare, FDA & business lawyer Michael H Cohen was published by LegalZooom in its online legal headlines on Technology. The [...]

Register for online HIPAA compliance training. HIPAA mandates HIPAA training for those required to comply. All members of the workforce (including employees, volunteers, trainees, and others [...]

The government's Medicare website is useful in performing a legal and regulatory review of what healthcare services a concierge medical practice might offer.

FDA Attorney Michael H. Cohen speaks on FDA Legal Issues at the Ventura BioScience Incubator on October 17, 2013.The talk will focus on FDA regulation of cosmetics, dietary supplements, and [...]

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

FDA now requires a cyber security plan in your medical device submission. On June 14, 2013, FDA issued Draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in [...]

The Federal Trade Commission (FTC) requires that advertising be truthful and not misleading, and will take enforcement action if mobile app developers make deceptive claims about their apps.