Healthcare Law

If you the buyer of a medical spa in an M&A transaction, what kinds of due diligence questions should you ask regarding regulatory compliance?

Is your data safe? Healthcare hacks and data breaches increasing, even as HIPAA compliance grows. HIPAA training, HIPAA compliance, HIPAA manuals, HIPAA policies & procedures, HIPAA forms matter [...]

Pundits prognosticate, but how do we measure a future for healthcare when every trend morphs asymptotically?

If you want to know where the next healthcare revolution will come from, look inside. Physical medicine becomes virtual medicine, becomes mobile healthcare, becomes wearable health and then [...]

Is practicing hypnotherapy legal in California? That all depends on what the practitioner is doing and claiming.

Learn how to rock concierge medicine laws by answering some key concierge medicine legal questions.

If you've designed a home health kit to test for, say, pregnancy or HIV, can you go ahead and market the product without FDA clearance or state law authorization? FDA regulates some health test [...]

Health care governing boards can look to "Practical Guidance for Health Care Governing Boards on Compliance Oversight" for advice in designing a compliance program.

Once you "friend" your refrigerator on Facebook (because it's that smart, and knows about your dietary and nutritional habits than your doctor), healthcare will be unrecognizable even to fans of [...]

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 [...]

If you're in any business at all, you must read Data Crush: How the Information Tidal Wave Is Driving New Business Opportunities by Christopher Surdak; pay extra attention to Data Crush if you're [...]

The federal Food and Drug Administration (FDA) has been responding to an avalanche of new health technologies in ways that signal less, rather than more enforcement. The first wave of FDA [...]

The federal Office of the Inspector General (OIG) reviewed a laboratory's proposal to enter into agreements with physician practices to provide all laboratory services for the practices' [...]

Can a medical management company or MSO control physicians given corporate of medicine concerns, especially in a strong corporate practice of medicine state? Whether the MSO can control [...]

Expect to see more and more compliance enforcement actions against physician practices - and also more physician awareness of how they can pro-actively manage liability and follow legal [...]

The Supreme Court case of North Carolina Board of Dental Examiners v. FTC is, in some ways, a watershed in terms of judicial resistance to monopolization of health care practices by a licensing board.

Advertising and marketing are two areas that concierge medicine practices frequently neglect when assessing liability risk. But legal jeopardy can arise from advertising and marketing claims on [...]

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 [...]

Unlike California, which provides clear guidance regarding legal and enforcement hot buttons for medical spas and integrative care clinics, Massachusetts law requires more digging.

Whether HIPAA applies to acupuncturists who share a medical record, is one of those arcane questions our healthcare lawyers get. The answer isn't all that easy to obtain. Like many healthcare & [...]

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."

HIPAA sounds like "hippo" for a reason: it's big, clunky, noisy, and unwieldy. Can, and should, a small physician practice implement HIPAA practices? HIPAA Is it worth the effort?

If you're a medical doctor, dentist, acupuncturist, chiropractor, or other licensed healthcare provider, and you offer your patients "9 sessions, get 1 free," have you violated kickback laws?

"I provide medical (or acupuncture, chiropractic, osteopathic, massage) services on an hourly basis and get paid a percentage of revenues in return.” Is that fee-splitting?

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.

How do you wear two licensed hats at the same time - if, for example, you're an medical doctor (MD) and a chiropractor (DC), or a chiropractor and an acupuncturist - or, a naturopathic physician [...]

Even if HIPAA doesn't technically apply to your wearable tech venture, mobile medical app, or telemedicine project, state laws have mirror privacy and security provisions with which your company [...]

Sales of dietary supplements by physicians, acupuncturists, chiropractors, and other licensed professionals raise thorny legal issues.

How can integrative medicine be made "clinically responsible, ethically appropriate, and legally defensible?" I invented the above mantra during my five years on faculty at Harvard Medical School.

Making HIPAA compliance easy is like trying to catch a firefly in your hand. I'm also reminded of those really short video summaries of A Game of Thrones where you get a plot twist a second, and [...]

If you think Obamacare is the most important story in regulation of healthcare, you're missing these key trends that will shape the medicine of 2015 and beyond. Remember that technological [...]

With 2015 right around the corner, here are 5 legal and regulatory issues that integrative health practitioners need to know.

Many online ventures want to know whether Stark, anti-kickback, and fee-splitting laws are violated by business arrangements that offer online coupons or Web-based coupons to customers. Let's [...]

The Federal Trade Commission (FTC) has proposed to settle charges with two marketing companies promoting "shapewear garments" with "slimming claims for caffeine-infused products." FTC vigorously [...]