Is personalized medicine future healthcare?

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 [...]

Physician stem cell therapies legally ambiguous, while regenerative clinics prosper

Recent press calls into question widespread “regenerative” and anti-aging medicine, and physician practices that use stem cell therapies.

Michael H Cohen Speaks on MHealth & Wearable Health Technology: Will FDA Legal Compliance Stymie or Promote Innovation

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 [...]

Ride The Information Tidal Wave: Crush or be Crushed

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 [...]

FDA eases regulation of medical device data systems (MDDS), medical image storage devices, and medical image communications devices

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 [...]

Physician-Lab Agreements to Provide Exclusive Lab Services and Waive Patient Fees Could Be Kickback, OIG Advises

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 an MSO control physicians given corporate practice of medicine?

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 [...]

4 Key Compliance Trends for Physician Practices

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 [...]

Dental licensing board’s monopoly power challenged by U.S. Supreme Court

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.

Does your concierge medicine advertising create legal jeopardy and liability?

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 [...]

Herbal Supplements Investigated for Misbranding and Adulteration

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 [...]

How can you organize a Massachusetts medical spa or integrative care center legally without fee-splitting?

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

Is yoga therapy unlicensed practice of medicine?

Yoga therapy brings the art of yoga to therapeutic issues and is a natural extension of yoga for wellness and general health; but when does yoga therapy cross the line into unlicensed practice?

Do acupuncturists have to comply with HIPAA when they share an electronic medical record?

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 & [...]

FDA regulates mobile medical apps, medical device data systems, and medical device software as “connected health”

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."

Does HIPAA scale for a physician practice? Is HIPAA compliance mandatory?

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?

Packaging medical services – is it a legal concierge arrangement, or an illegal kickback?

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?

Is it fee-splitting for medical doctors to share revenues with non-medical business owners?

"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?

Does Wearable Tech Give Away Your Quantifiable Self? FDA Medical Device, HIPAA Privacy and Security, and Legal Issues Over Who Owns Your Data

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.

Are you handling licensing, corporate practice of medicine, fee-splitting, standard of care, informed consent, HIPAA, liability, advertising, contract, FDA issues in your telemedicine venture?

When you launch any virtual, electronic, online, mobile, or other non-physical telemedicine or telehealth venture, you have to navigate several interlocking, overlapping legal issues, from [...]