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This is a story about how Harry, a healthcare entrepreneur, worked through a proposed arrangement that was raising Stark and Anti-Kickback issues.

Harry met Sally because Harry had migraines, sinusitis, chronic fatigue or tiredness of unknown origin, depression or just an emotional heaviness, or maybe because he needed help with relationships, finances or his sex life.

Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are two laws, however, that regulate the entry of cosmetic products into interstate commerce. Since most cosmetic companies sell their products through the Internet and through regional, national, or international distributors; companies that make, pack, distribute or market cosmetic commodities need to understand these laws and how to comply with them.

You think you’ve got HIPAA compliance handled, in order to try to stay ahead of steep federal penalties, and then learn that is just the beginning of the story. HIPAA compliance itself is thorny. The statute isn’t written in English—aliens landed from another planet onto the Capitol and wrote it according to their customs and culture. Seriously.

The United States Food and Drug Administration (FDA) regulates much more than food and drugs. It regulates dietary supplements, cosmetics, medical devices, tobacco products, animal food, vaccines, and many other health related items.

A telemedicine healthcare startup wants to create a profitable healthcare venture by connecting patients with medical doctors, and also getting a markup off of goods and services sold to patients. What’s wrong with this picture?

Naturally, like any other business model, augmenting one’s clientele may be a priority for medical and other healthcare practitioners. Is it legal to offer coupons and discounts?

Establishing the physician-patient relationship is often a requirement of state telemedicine law, but what does it mean that the physician has in fact “established” the physician-patient relationship?

Thinking of Smoking a Marijuana Joint or Growing Your Own Cannabis in California? Learn How California’s Adult Marijuana Recreational Use and Medical Use Laws Apply to You from an Experienced California Cannabis Lawyer

Physicians regularly work with businesses who want the doctors to use their products. To encourage physicians to choose their practice over competitor practices, vendors often offer incentives. Doctors need to know which incentives are legitimate, which relationships create a conflict of interest, and which business relationships can result in state or federal charges that the doctor violated civil or criminal law.

Anti-aging and longevity medicine is everywhere these days. From California to Florida and everywhere in between, the health, wellness and beauty industry beckons people toward the promise of greater youth, vitality, and greatness in the body.

If you have a medical management company (MSO), you might be wondering, can your MSO brand itself with the same name as the medical clinic, and even license the name to the physician that owns and operates the medical clinic.

Whether you’re a health coach or a physician trying to be a health coach, understanding these key legal issues can help you manage liability risks.

Doctors need to understand the laws and regulations that apply to the way they bill for services, work with insurance companies, submit claims to the government, enter into business relationships with other doctors and vendors, provide documentation, and other parts of their medical practice.

Hello, this is Michael H. Cohen – I am a healthcare and FDA attorney and the founder of the Cohen Healthcare Law Group. I am going to talk today about multi-disciplinary clinical healthcare practices. This comes up again and again among my own clients.

Functional medicine wellness practices must answer to similar legal rules as medical practices in general – only we tailor our legal consults to the needs of the particular functional medicine practice.

Telemedicine offers a lot of promise for both physicians and patients. For doctors, it offers another source of revenue – new patients. Telemedicine can mean lower expenses as well because distant patients don’t require an office or an examination room.

MSOs (medical services organizations), or physician management and marketing companies, routinely come to us for legal advice about how to create and run an MSO profitably, in a compliant way, without running afoul of corporate practice of medicine, and Stark, fee-splitting, & anti-kickback prohibitions.

Today’s legal strategy sessions involved a healthcare business that is really a healthcare practice in disguise. Let’s look at what legal strategy lessons we can learn here.

The Corporate Practice of Medicine (CPM) doctrine continues to befuddle, beleaguer, and bewilder healthcare companies seeking to venture with physicians and non-physician entrepreneurs.

FDA labeling is one of the most important regulatory requirements for dietary supplements in that it provides the consumer the necessary information on the product. Indeed, ensuring that all information concerning that particular dietary supplement is in compliance with FDA labeling requirements, may be difficult and often very onerous

The CURES Act codifies the way FDA has regulated clinical decision-making software, but is this better or worse for healthcare startups that are trying to position their software within the CDS model?

The first step in evaluating how laws impact veterinary medicine is to understand what telemedicine means.
Telemedicine during veterinary practice (also known as tele-veterinary practice) can include…

Telemedicine laws are increasingly permissive, as more and more states understand the value of providing healthcare services online instead of through brick-and-mortar.

Physicians, chiropractors, and other healthcare licensees often want to function as “health coaches” and avoid thorny laws. Can they?

Many aspects of healthcare are now becoming integrated. Medical practices that used to specialize are now trying to broaden their services by contracting with other medical providers who provide related services. So are chiropractors.

You’re a licensed medical doctor, happy in your aesthetic medicine or plastic surgery practice, and you’re working part-time with a medical spa in a way that is increasing your income without upping your stress.

A California investigation and disciplinary action against a California naturopathic doctors suggests how physicians can incur legal jeopardy when operating a medical spa, holistic healthcare practice, or integrative medicine clinic.

As prescribing through telemedicine raises legal challenges, understanding where telemedicine laws are tough can help you design your telemedicine startup.

Healthcare ventures between entrepreneurs and medical risks create legal risks of corporate practice of medicine and fee-splitting. In this article, learn 3 keys to navigating these healthcare legal risks.

Naturally, like any other business model, augmenting one’s clientele may be a priority for medical and other healthcare practitioners. Is it legal to offer coupons and discounts?

Physicians who incorporate complementary and alternative medical (CAM) modalities into their practice, or brand themselves as using integrative medicine, functional medicine, or similar approaches, often consult with our integrative medicine lawyers as to the best way to manage liability and regulatory risks…

The Stark Law governs what types of referrals doctors can make if they bill for Medicare and Medicaid. The presumption is that that referrals made by a doctor to a designated health service are not legal if the doctor has a financial interest in a designated health service…

Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are two laws, however, that regulate the entry of cosmetic products into interstate commerce. Since most…

FDA is changing the playing field by withdrawing its earlier Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on Drug Products Labeled as Homeopathic…

Is HIPAA compliance a mystery to you? What do you have to do for HIPAA, and when?

Worried about HIPAA compliance for your healthcare website or digital health app?

Consider a class action privacy lawsuit that came—and went—against MDLive.
MDLive received a class-action lawsuit alleging the MDLive did not protect patients’ protected health information. The lawsuit sought $5 million in damages.

THERE CAN BE A LOT OF CONFUSION IN THE INDUSTRY—AND MEDICAL SPA TREATMENT BY RNS UNDER PHYSICIAN SUPERVISION IS AN ENFORCEMENT HOT BOTTOM.
How Much Treatment Can RNs Do in a Medical Spa?

PRIVACY, CONFIDENTIALITY, AND SECURITY ISSUES ARISE WHEN PRACTICING TELEHEALTH OR TELEMEDICINE JUST AS THEY DO IN A BRICK-AND-MORTAR PRACTICE. IT’S ESPECIALLY IMPORTANT TO UNDERSTAND THESE ISSUES, SINCE MANY CLINICIANS ADVERTISE ON THEIR WEBSITE THAT THEY ARE “HIPAA COMPLIANT.”

HOW DO HEALTHCARE PRACTITIONERS HANDLE STANDARD OF CARE ISSUES WHEN DIAGNOSING AND TREATING FROM A DISTANCE?

THE LAW HANDLES TELEMEDICINE PRESCRIPTION DIFFERENTLY THAN DIAGNOSING AND TREATING REMOTELY. HOW CAN YOU BEST COMPLY?
PRESCRIBING IS DIFFERENT THAN OTHER TREATMENT

BECAUSE TELEHEALTH AND TELEMEDICINE OFTEN INVOLVE PRACTICE ACROSS STATE LINES, HEALTHCARE PRACTITIONERS MUST UNDERSTAND THE STATE LAWS WHICH ALLOW PRACTICE IN SITUATIONS WHERE THE HEALTHCARE PROVIDER IS LICENSED IN HIS OR HER OWN STATE (BUT NOT THE PATIENT’S).

Healthcare providers who move beyond a brick-and-mortar physical practice often find themselves in a legal gray zone, wondering whether they are compliant, or even what rules might apply.

This confusion is understandable. The laws governing medicine were first framed in the late 19th century and were slowly adapted to advancing medicine and treatments; technological progress has always moved faster than laws can evolve.

Are you a non-physician who wants to “partner” with physicians? Learn how the Medical Services Organization (MSO) model can help buffer you against regulatory risk. Understand the basics of fee-splitting, Stark, anti-kickback, corporate practice of medicine, and related prohibitions.

Michael H Cohen has been interviewed by the Medical Ethics Advisor, a well established publication that focuses on current healthcare issues.

As telemedicine has exploded into many forms – tele-dermatology, tele-gerontology, tele-counseling, tele-psychiatry, and other areas of medicine and healthcare – we’re also seeing tele-dentistry.

So far, no one can clean your teeth using a remote tool, but with advances in robotics and artificial intelligence, the day will surely come.

Many physicians, chiropractors, and other healthcare practitioners are wanting to start a cash-based, concierge or functional medicine practice yet not run afoul of legal and regulatory issues

Are you planning to break away from your current employment to form your own medical or healthcare practice? Be sure to understand some of the insurance legal basics.

While recent legal developments have loosened legal strictures around truthful, non-misleading, off-label promotion of drugs, there are legal limits to an off-label promotion strategy.

Here are several key limits to off-label drug promotion.

Growing Pains in Your Healthcare Practice or Healthcare Venture?

We’ve had many clinical practices and healthcare ventures come to us asking how to mitigate risk of anti-kickback and fee-splitting enforcement as their healthcare clinic, medical group, or health and wellness venture grows.

A FEW YEARS AGO, TELEMEDICINE AND TELEHEALTH BURST ON THE SCENE, IMMEDIATELY CHALLENGING ESTABLISHED LEGAL FRAMEWORKS BUILT AROUND BRICK-AND-MORTAR PRACTICES.
The novelty forced healthcare practitioners and companies—and the lawyers who represent them—to work through the holes in the law, in an effort to bring new practices and products to market.

Does FDA deem your product to be a medical device, or is it just a consumer product that would not be regulated by FDA?

Here are basic steps you can take to work through the puzzle.

Informed consent is critical in all areas of medicine; it takes on added importance with integrative medicine, functional medicine, anti-aging and aesthetic medicine, and non-mainstream approaches. Follow these guidelines to develop strong informed consent practices.

The Federal Trade Commission (FTC) has slammed homeopathic drugs with a guidance document on substantiation. This is perhaps the biggest regulatory backlash against homeopathic medicine since the homeopaths were labeled “cultists” during the war by allopathic medicine.

Fundamentally, you’re worried about legal rules prohibiting kickbacks, fee-splitting, corporate practice of medicine, as well as Stark law; you don’t know whether the MSO or management structure will work; you’d like to be as aggressive as possible yet not incur the huge civil (and sometimes criminal) penalties.

If you’re a dietary supplement manufacturer or distributor, know that FDA and FTC now encourage the public to report dietary supplement labeling violations.

Michael H. Cohen speaks at the AuDACITY 2016 Convention “Dares to Succeed” in Era of Disruptive Change

Many healthcare companies, practitioners, and patients, think that they can get away with bringing unapproved drugs into the U.S. and that the FDA Personal Importation Policy will cover them.

That is far from the truth. FDA’s personal importation policy for drugs is very limited.

You, MSO is my own variation on I Claudius.

Poor Uncle Claudius, everyone said. Ended up becoming Emperor of Rome. Through craft and careful strategy.

So you have an MSO and want to operate successfully and profitably. The legal rules can be scary.

An MD, DO, or chiropractor wants to set up a health education website legally—without running undue compliance risk.

The MD, DO, ND, chiropractor, or other licensed healthcare professional wants to devote themselves entirely to integrative medicine, functional medicine, or to their own branded form of healthcare.

Michael H. Cohen has pioneered the field of legal issues in integrative health. He served as Assistant Professor of Medicine at Harvard Medical School and Adjunct faculty at Harvard School of Public Health. He’s the Author of 6 leading books on Health and Wellness Law, and has counseled over 250 healthcare clients, including functional and integrative medicine practitioners and clinics.

Can indigenous healing systems resolve complex, modern clinical problems such as trauma and PTSD?

Answering this question, as part of a larger inquiry into integrative medicine, psychiatrist and integrative physician David Kopacz, and Native American visionary Joseph Rael (Beautiful Painted Arrow), have written Walking the Medicine Wheel: Healing Trauma & PTSD.

Are prompt pay, cash discounts, dual fees legal? In this Part 2, let’s focus on differential payment schemes. When physicians, chiropractors, acupuncturists, and other healthcare providers provide prompt pay discounts to patients, or cash pay discounts to non-insured patients, are these legal?

When you practice integrative medicine, do you worry about standard of care?
Perhaps you’re developing the latest and most beneficial approach. How do you handle liability risk mitigation?
Especially when your practice is on the line.

Are prompt pay, cash discounts, dual fees legal?

There are lots of questions and many different variations. Let’s explore a few, focusing on the idea of providing differential services to a population of patients.

Regulation of Clinical Decision Support Software is much clearer now, thanks to the 21st Century Cures Act.

Section 3060, entitled Clarifying Medical Software Regulation, amends Section 520 of the federal Food, Drug, & Cosmetic Act (FDCA) by adding language about Regulation of Medical and Certain Decisions Support Software.

Are you wanting to move your medical practice or other clinical healthcare practice into more of an coaching service? Worried about telemedicine laws and unlicensed practice rules? Wanting to expand but concerned about jeopardizing your licensure?

When medical doctors advertise their professional medical services (including online advertising) they can easily run afoul of legal and regulatory traps.

Watch out for these 7 legal traps in physician advertising…

If you’re a successful physician, chiropractor, acupuncturist, or other licensed healthcare provider, and you want to provide overflow patients to another practitioner you hire, is it a kickback if you pay that second practitioner as an independent contractor?

An RN who is working on getting her NP recently called our law firm, asking whether he was engaging in illegal “fee-splitting” in her compensation arrangement with a physician.

Physician fee-splitting, and fee-splitting with other licensed healthcare professionals (such as nurses) is very common, not only in medical spas, but also in other healthcare ventures.

Medical school teaches you a lot of science and clinical skills, but it doesn’t prepare you for the “streets” of legal documentation when you sign your physician contract.

Even sophisticated physicians can make mistakes in signing physician employment or independent contractor agreements. Whether the physician is reviewing a physician…

Animal dietary supplement manufacturers and distributors can run afoul of FDA prohibitions against “drug” claims and receive an FDA warning letter, unless they understand how FDA regulates animal dietary supplements.

Does FDA regulate dietary supplements for animals?

Substance abuse treatment centers must steer carefully when sending patients for labs. Self-referral, anti-kickback, and fee-splitting rules can create legal enforcement issues and must be considered in any healthcare referral arrangement.

A few years ago, telemedicine and telehealth burst on the scene, immediately challenging established legal frameworks built around brick-and-mortar practices.

The novelty forced healthcare practitioners and companies—and the lawyers who represent them—to work through the holes in the law, in an effort to bring new practices and products to market.

If you have a medi-spa where the physician is never there but serves as “Medical Director,” think again.

A lot of people misunderstand the concept of “medical director.” A medical director is supposed to direct a medical operation – other doctors, as well as nurses or physician assistants. Not a general corporation or LLC.

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, “Stark,” self-referral, and anti-kickback issues concern many health care practitioners who seek legal counsel from our law firm.

Is it illegal for audiologists to dispense PSAPs? More broadly – are disruptive technologies also exploding healthcare professionals’ ability to prescribe or recommend to their patients?
I addressed these questions in my keynote, Listen to the Future at the Audacity conference for the Academy of Doctors of Audiology.

WHEN ESTABLISHING YOUR FUNCTIONAL MEDICINE PRACTICE, YOU’LL BE WADING INTO CLINICAL WATERS THAT ARE OFTEN NAVIGATED BY MANY MEDICAL COLLEAGUES, YET NOT NECESSARILY ADOPTED WITHIN THE MAINSTREAM MEDICAL COMMUNITY.
HERE ARE 5 LEGAL TIPS THAT ADDRESS SOME CORE LEGAL FUNDAMENTALS WHEN SETTING UP A FUNCTIONAL MEDICINE PRACTICE.

FON: When you aren’t managing your practice and giving lectures, you’re practicing yoga. How did you discover integrative medicine and what impact has it had on your early law career and personal health?

Michael H. Cohen: I started my legal career as a Wall Street lawyer. The demands of a nonstop professional life led me to transcendental meditation ™

Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.

In my previous career—publisher of a consumer magazine—I contributed a whopping two articles over 25 years; and they needed a lot of cleaning up. But that was okay, I didn’t fancy myself a writer. I remained comfortable on the operations side, focusing on business writing.

Could we get a “super-friendly AI”—one that exceeds our musings of light, not our darker imagination?

The strange world of the California medical board Fictitious Name Permit inhabits one of those arcane places in healthcare law that many physician clients wonder about. Here’s everything you wanted to know about the California medical board Fictitious Name Permit, and weren’t afraid to ask.

Our guest post this month is from Siegfried Othmer, Chief Scientist of the EEG Institute and President of the Brian Othmer Foundation, challenging this year’s FTC “brain training” enforcement.

Do retrospective physician bonuses violate anti-kickback laws? Well they are problematic.

Are online call centers illegally practicing medicine or engaging in kickbacks and fee-splitting?

For an OTC drug marketing legal checklist, 5 legal strategy steps can propel you to market.

We know telemedicine is expanding, but are telemedicine prescription and distant diagnosis allowed under any given state legislative scheme? Sometimes the art of lawyering is the art of careful reading; and at other times it helps to get a regulator’s input, even informally.

When Chiropractors work with Medical Doctors, fee-splitting issues arise. This is like Harry met Sally without the New Year’s scene.

While I can’t claim Marvin Minsky as a mentor I knew personally, his work did influence me–particularly his suggestion that the us v. them version of humans and robots (or AI) in the movies is wrong: what’s coming is the merger of humans and machine.

“Medical director” creates enforcement red flags particularly when medical spas or health care ventures award the title willy-nilly. In this post, we discuss legal pitfalls and offer some legal strategy for healthcare companies wanting to capture the derived glory from “medical director” affiliation.

When leaving a medical practice, can you take patient records?

Integrative medicine advertising legal review: does a flyer need legal review or just “wordsmithing?”

Is there a Moore’s law for law? Can healthcare and FDA laws regulate convergent, exponential technologies?

Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products.

Common HIPAA violations are flagged by HIPAA Helper, a publication of ProPublica,an “independent, non-profit newsroom that produces investigative journalism in the public interest.”

Can healthcare and other startups creatively use Terms of Use to limit liability and Contract with Customers, creating clear expectations that manage their relationship with the end user?

Functional medicine is rapidly gaining traction (pardon the pun) among chiropractors, but can chiropractors legally practice functional medicine? Let’s look at definitions of functional medicine as well as scope of practice issues faced by non-MD healthcare practitioners.

False and misleading educational products incur FTC wrath, particularly when it comes to claims about training pr protecting or improving the brain, treating ADD and ADHD, and marketing to children.

California, like other states, makes online tracking of personal information disclosures required in website privacy policies.

Is your medical assistant practicing medicine illegally? Understand the difference between medical assistance and medical practice.

Kudos to integrative medicine consultant Glenn Sabin for his bold post on integrative medicine standard of care – suggesting that integrative health should be the standard against which healthcare practices are judged.

Onsite corporate wellness programs raise corporate practice of medicine issues, requiring separation between the medical, clinical side and the management and marketing operations, in strong corporate practice of medicine states.

According to FDA medical device guidance – substantial equivalence in the 510(k) premarket notification process can be clearly determined if you know the underlying legal rules. One of the things I can appreciate about FDA is the clarity of its website and some of its guidance documents.

FDA’s tobacco products Deeming rule imposes many regulatory requirements on tobacco products retailers, manufacturers, distributors, importers,including establishment registration and product listing.

FDA’s tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products “deemed” to be subject to FDA jurisdiction. This is a brief compliance guide.

If you are a retailer, manufacturer, distributor, or importer of tobacco products, become familiar with the final rule by FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (also known as the “Deeming rule”). Here is a brief overview.

Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.

Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA’s view, diagnoses and treats disease.

Legal review of concierge medicine contracts is needed to handle regulatory issues & liability risks, as otherwise medical doctors opening concierge practices risk triggering all sorts of enforcement tripwires.

Is an online directory of healthcare centers a medical referral service? We’ve had several online directories of healthcare services ask us what legal rules govern their operation. Below we discuss some legal requirements relevant to an online healthcare services directory.

FTC Big Data regulation tells companies how to use big data legally and responsibly, in FTC’s report, Big Data: A Tool for Inclusion or Exclusion? Understanding the Issues,

A concierge medicine legal issues checklist is handy for physicians contemplating a concierge medicine practice and concerned about legal questions.

When medical doctors collaborate with other licensed healthcare providers (such as chiropractors) in a multidisciplinary, clinical care or integrative medicine setting, legal risks can arise that require careful navigation.

Healthcare bonuses raise fee-splitting and anti-kickback issues; is there a workaround?

In this, an open letter to Superintelligence, my algorithm for AI is simple: to blaze humanity’s path to the cosmos by delving into the part of the human data stream known as spirituality.

Physician health coaching raises telemedicine issues, as it’s challenging (but not impossible) for medical doctors (like any professional) to remove the professional hat. Below.

FTC tackles native advertising and sponsored content in an Enforcement Policy Statement on Deceptively Formatted Advertisements.

Are physician online dietary supplement sales, kickbacks or fee-splitting?

If you want to sell healthcare products online, the legal hurdles can be steep. 

If it a kickback when a medical center offers insurance agent services to its patients?

Are medical tourism legal questions variations on MSO-Physician arrangements?

Blogger Patricia Salber, MD MBA featured Understanding whether a medical app needs FDA regulation can be tricky on The Doctor Weighs In. In this videotaped interview, held at the 2015 Stanford MedX, Dr. Salber probed into when healthcare entrepreneurs, particularly those developing mobile apps, require FDA guidance.

Corporate practice challenges medical management (MSO) organizations, especially in New York AG, as shown by recent enforcement action.

Can the non-licensed healer practice legally, including giving nutritional and weight loss advice?

FTC false advertising legal traps can hurt any business, small or established. Here’s how to walk the compliant side of marketing healthcare products.

Where healthcare policy & the future of humanity meet is at the intersection of technology and consciousness.

Here are 4 legal tips for setting up a functional medicine practice. When establishing your functional medicine practice, you’ll be wading into clinical waters that are perhaps navigated by many medical colleagues, yet not necessarily adopted within the mainstream medical community.

A benevolent AI (artificial intelligence) could usher in utopia… but will augmented intelligence destroy it?

The Internet of Things (IOT) raises legal and regulatory challenges, mainly in the area of privacy and security.

Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market – why?

Healthcare reform and declining Medicare reimbursement have thrown physicians for a financial loop; how can medical doctors increase physician income despite healthcare reform?

California, New York, Massachusetts, and other states that emphasize corporate practice of medicine & fee-splitting lead medical spa compliance enforcement.

Healthcare fraud remains a broad regulatory category that enforcement authorities can use against the manufacturer or distributor of a healthcare product that raises questions in the minds of officials.

Two trends are colliding: artificial intelligence (AI) is becoming more pervasive with machine intelligence outpacing human intelligence, and consciousness is waking up. Which one will trump–or are they in any way coordinated? This is a question I ponder every day.

P4 medicine takes healthcare to a whole level, requiring deeper understanding of how healthcare & FDA law shape the path to market for your healthcare service or product.

By putting healthcare in the hands of patients, healthcare technology is not only revolutionizing the way we think about medicine, but also the way laws shape personal health.

Whenever you market a healthcare product, beware of potential FDA and FTC enforcement as well as private plaintiffs who can sue for false advertising, unfair competition, deceptive and misleading business practices , or some variation.

Would you like to lose weight without diet or exercise, by a magical fat-burning, calorie-busting, body-slimming dietary supplement or cream? Here’s how…….

When buying, selling, or starting an urgent care center, be sure to handle legal and regulatory pitfalls adroitly.

Will artificial intelligence (AI) replace or augment professional human functions such as the analytical prowess and advisory skill of a talented attorney, as machine intelligence evolves, and traditional healthcare morphs into telemedicine, mobile health, and fitness self-tracking devices?

A physician called our law firm, complaining that the management company had “embezzled” funds from the account for the medical doctor’s clinic. What should he do?

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 – if you’re in the healthcare space, eat, drink, think, and dream HIPAA.

Are pets like humans under telemedicine laws and regulations? As telehealth laws continue to expand to accommodate telemedicine practices, more and more practitioners are jumping on the telehealth bandwagon.

Can a dietary supplement company link to scientific references that show that that the dietary supplement product is effective in treating a disease such as cancer, diabetes, or hypertension?

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

Advertising health products online? Check FTC endorsements guides on testimonials and endorsements, as FTC enforcement action can come with huge penalties.

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 digestible, implantable nanotech health care.

Integrative medicine is morphing from an extension of complementary medicine and/or intrusion into conventional care, into everyday prevention and wellness. Find out how three integrative medicine legal trends can make or break you.

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 your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?Many clients have asked us: do we have a medical device? Do we need to submit a 510k? What happens if we don’t file a 510k submission? Can we fly under the FDA radar?

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 kits as over-the-counter tests.

Because marketing and distributing dietary supplements carries FDA risk, we offer sample strategies to reduce FDA risk when selling dietary supplements.

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

Arkansas has a enacted statute encouraging telemedicine use. In Arkansas, SB 133, designed to “encourage the use of telemedicine,” advises all state agencies to evaluate and amend their policies and rules to remove regulatory barriers prohibiting the use of telemedicine.

Michael H Cohen will be presenting Legal Issues In Integrative Healthcare for The Leadership Program in Integrative Healthcare at Duke University.

The U.S. Attorney for the Eastern District of Texas pleaded guilty to making a false statement, in attesting to his hospital’s compliance with “meaningful use” requirements.

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 the tricorder.

Predictive analytics will push the frontiers of clinical care; the question is whether FDA regulation will promote or stifle innovation in the name of consumer protection.

Today a client asked me, “are you worried about the drought?” I said, “No, I’m worried about AI eating the world.”

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 purported to nullify my prescient writing on healthcare law and relegate to, as Ronald Reagan used to say about communism, the ash-heap of history.

If you think medical device advertising is immune from criminal prosecution, look to the current charges against the CEO of Vascular Solutions.

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

FTC’s aggressive enforcement of federal law prohibitions against false and deceptive advertising have hit marketers of healthcare products hard, while class action lawsuits are reaching the digital health market. FTC actions regarding health, wellness and beauty (cosmetics) products, showcase FTC’s activity in this arena and suggest key pitfalls that makers of health and wellness products should seek legal review to avoid.

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 Bar Association.

FDA would have significantly greater authority over cosmetic products under the Personal Care Products Safety Act. The Personal Care Products Safety Act would increase regulation over many aspects of the cosmetics industry

Senators Bennet and Hatch reintroduced the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, to “cut red tape at the Food and Drug Administration (FDA) and help boost innovation in health IT.”

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 in the health and wellness industry. Why?

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 guidance came with FDA tackling mobile medical apps — smart-phone applications that address health.

FDA approved marketing for 23and Me’s Bloom Syndrome Carrier test, months after halting the company’s marketing of direct-to-consumer genetic tests. FDA now classifies genetic carrier screening tests as Class 2 medical devices but intends to exempt these devices from premarket review.

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’ patients, and waive all fees for those practices’ patients who are enrollees of certain insurance plans that require patients to use a different laboratory. In Advisory Opinion No. 15-05 (posted 3/25/15), OIG concluded that this proposed arrangement could constitute an illegal kickback under federal anti-kickback law.

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 physicians given corporate practice of medicine concerns is a question many of our law firm clients ask, when they have a telemedicine company, medical spa, or another health and wellness venture where non-physicians seek to enter into business with medical doctors.

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 compliance obligations.

In the showdown at the commercial coral between concierge medical practices and retail medicine, which one will trump? With these two behemoths taking such a chunk out of traditional medical practices, I’m reminded of Godzilla v. Mothra.

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 your website or in your brochures, patient handouts, and other marketing materials–whether you have an integrative medicine clinic, functional medicine practice, anti-aging medicine group, concierge or retail medicine practice, or even a conventional medical or surgical practice.

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 investigation premature?

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

The Daily Journal published FDA’s General Wellness Guidance is Welcome News by healthcare and FDA lawyer Michael H. Cohen. The article (Cohen.P.0129) goes through FDA’s general wellness guidance for low-risk devices that promote a health lifestyle.

If you market your healthcare products, FTC enforcement can stop your sales in their tracks. All it takes is a search – yes, good old keywords – and you’re in line for significant penalties for false, deceptive and misleading advertising.

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?

Concierge Medicine Today featured “Does Concierge Medicine Advertising Create Liability” by healthcare and FDA Michael H. Cohen. The article analyzes the recent verdict against MDVIP based on principles of advertising law and vicarious liability.

FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk

Virtual reality in medicine and health will augment and expand our sense of reality – yet it’s only a harbinger of deeper access to consciousness.

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 legal issues, this HIPAA question is a fun treasure hunt through the legal rules.

You could burn 50 calories just by reading this blog post. Or not. But if you sell a weight loss product with false, deceptive, and misleading claims, you’ll burn a lot more calories when the Federal Trade Commission (FTC) comes after you, or if you get sued by a consumer plaintiff’s lawyer.

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?

The Joint Commission, which accredits and certifies more than 20,500 health care organizations and programs in the United States, has revised its pain management standard to include complementary therapies such as acupuncture therapy, massage therapy, chiropractic therapy, osteopathic manipulative treatment, physical therapy, and relaxation therapy.

Michael H Cohen was quoted in A Sacred Space: Navigating Religion and Spirituality in Medical Situations, in The New Physician, for comments on spirituality in medicine and health care

Energy drinks, like dietary supplements promising energy boosts, weight loss, and other benefits, raise significant FDA legal challenges; how can manufacturers avoid the barrage of FDA and state enforcement actions?

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?

Bay Area / San Francisco and Los Angeles lawyer Michael H Cohen was quoted by CNBC in USA Today on healthcare issues.

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.

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 licensure to corporate practice of medicine and fee-splitting, to basic state law rules that govern any medical endeavor. If this seems daunting, have your robot call our robot.

Internet prescribing has been the bad boy of telemedicine, lagging behind telemedicine rules for medical practices generally; is this about to change?

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 there,” the medical doctor insisted.

Neurofeedback has been shown effective for treating of a variety of physical and mental disorders, but can or should neurofeedback (or any promising therapy that can be self-administered, or administered by non-licensee) be regulated and rEEG Infoelegated to a licensed monopoly?

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 and a shaman?

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 must comply.To comply with state law privacy and security requirements, you’ll need mirror HIPAA policies, procedures, and forms.

The Medicare Originating Site Fee is a perk for provision of telemedicine services. State law also may provide its own rules. Let’s look below at federal law and then California law.

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 the commentator describes the whole season in a rapid-fire monologue.

Telemedicine laws continue to push forward to keep pace with telehealth market practices. Telehealth legal requirements for prescribing have long been at issue across states. In many cases, medical board rules or applicable telemedicine statutes simply state that an “appropriate” or “good faith” exam must first be given, or that there must be an “established physician-patient relationship.” But what is an appropriate good faith exam — can it be virtual?

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 progress is ever-accelerating and that today’s office physical may seem like ancient history tomorrow.

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 break this question down a bit for analysis.

Healthcare and FDA lawyer Michael H. Cohen spoke on telemedicine, mobile medical app (M-health) and wearable health tech legal issues at the Los Angeles County Bar Association’s Healthcare Law Compliance Symposium in Los Angeles.

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 enforces federal laws against deceptive advertising where it finds that claims for health care products are false and unsubstantiated by scientific evidence.

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 is just a stepping stone to future medicine

ON Therapeutics, a consulting firm focused on integrative medicine branding, marketing and strategy, featured Fee-Splitting 101 and related articles on legal and regulatory issues. FON is dedicated to positioning integrative health organizations for long term growth while advancing evidence-based integrative medicine as the standard of care.

Michael H Cohen spoke at the Advanced Clinical Summit of the EEG Institute on Neurofeedback Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe.

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 regulatory burden already imposed for health apps by the FDA’s mobile medical app regulation.

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.

Wearable technology legal and regulatory issues can sidetrack your wearable tech venture, unless you’re savvy about navigating the legal landscape. Wear your wearable tech on your sleeve – not your legal issues.

Healthcare & FDA lawyer Michael H Cohen speaks at the Silicon Valley Forum on Healthcare IT Leadership on legal issues affecting Sensors, Wearables, and Interoperability.

As medicine moves from Physical, to Virtual, to Mobile, to Wearable, to Implantable, new privacy legal issues arise, bringing legislative attention.

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 provides a window into increasing institutional and public policy support for the migration of medicine from physical to virtual, online and mobile.

The FDA provides guidance for pharmaceutical and medical device manufacturers as to how to present risk and benefit information for their medical devices and products on social media.

Many healthcare ventures seek to avoid corporate practice of medicine (or psychology) and fee-splitting violations, but they need to first understand how deeply down the rabbit hole these prohibitions go.

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.

While Medicare reimbursement for telemedicine has garnered a lot of attention, many states also have extensive laws about telehealth reimbursement. For example, California laws provide for significant telehealth reimbursement.

Medicare pays an originating site fee, spurring telemedicine for Medicare recipients, but many facilities do not know how to find the rules or whether they are eligible. Medicare rules are complicated, and sometimes they are laid out in a variety of places – statutes, regulations, guidance documents, and Medicare benefit policy manuals.

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 about the FDA? Let’s focus for now on neurofeedback.

Neurofeedback, biofeedback, EEG, hypnosis, Reiki, energy healing … how do practitioners evaluate, and handle, malpractice liability risk? Do they have obligations of informed consent? What about the FDA? Let’s focus for now on neurofeedback.

Is the practice of neurofeedback legally safe as part of another professional practice such as clinical psychology?

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

Neurofeedback, EEG, biofeedback entrain your brain, but are they legally safe practice? What do consumers and practitioners need to know? This 5-part series examines neurofeedback laws, including licensing, scope of practice, malpractice liability, FDA regulatory questions, and other legal issues.

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 healthcare facility or practitioner. The answer, of course, depends on the arrangement, including whether other aspects of it raise fee-splitting, Stark, or anti-kickback considerations.

The American Medical Association (AMA) approved guiding principles to ensure appropriate coverage of and payment for telemedicine services. During its 2014 Annual Meeting, the AMA voted to approve these telemedicine principles to encourage use of telemedicine “to deliver care to patients could greatly improve access and quality of care, while maintaining patient safety,” according to the press release.

How can integrative medicine physicians collaborate with chiropractors, without triggering unnecessary patient liability, medical board discipline, or other legal exposure for fee-splitting, anti-kickback violations and other legal pitfalls?

Florida’s Standards for Telemedicine Practice and Standards for Telemedicine Prescribing Practice are now effective. There are four new Florida regulations

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, dietary supplement sales, Skype second medical opinions, or another health venture.

Attorney Michael H. Cohen, President of the Michael H. Cohen Law Group, was interviewed on LA Talk Radio’s Legal Help Desk by cyber-lawyer Salar Atrizadeh on the future of health care.

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 this four-step process.

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 legal,regulatory, transactional, and strategic advice to physicians seeking to deploy concierge medical or wellness models.

Legalzoom’s newsletter featured its video on LLC formation by Los Angeles telemedicine, concierge medicine, healthcare, & FDA lawyer Michael H. Cohen

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 services.

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 the following scenarios

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 Resistance Pack.”

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? Remember, we’re lawyers who counsel companies and practices involved in holistic healing.

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.

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.

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 stem cell services and products

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 Sciences, a Colorado-based company, in a 2008 warning letter, for violating FDA’s human cell, tissue and tissue-products (HCT/P regulation)

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 regulatory attorney to understand FDA regulation of stem cell therapies.

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 into the future of the future, especially when it comes to medicine and healthcare.

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 non-licensed practitioners of the healing arts to offer healing services.

The Daily Journal published an article by Peter A. Arhangelsky and Michael H. Cohen on FDA’s decision to review caramel coloring of several soft drinks.

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.

Birthdays, I believe, are really for the world – we celebrate what we give to others. It seems to me the best way for me to celebrate this birthday is to celebrate the meaning my life can have in this accelerating world, and to discover the joy, bliss and transcendence that lie pristine below the waves of changing circumstances.

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 & Expertise to Change the World.”

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 final FDA Guidance reads FDA jurisdiction expansively.

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.

I had a dream last night about one of the most significant teachers in my life, who has been a pioneer in the field of energy healing. All I remember of the dream is that my teacher was very close, and telling me that I should always honor and love myself, because I am doing worthy work in the world.

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 Food, Drug & Cosmetic Act.

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, “Stark,” self-referral, and anti-kickback issues concern many health care practitioners who seek legal counsel from our law firm.

Integrating body, mind and spirit and accelerating healing has been my passion since studying energy healing after leaving Wall Street.

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 Mobile Apps.”

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 Complementary and Alternative Medicine (NCCAM), Ministry of Health, on healthcare law and regulation.

“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 article analyzes legal issues, including FDA regulation, related to use of smartphones for healthcare technology.

One of the most unusual mystical experiences occurred two nights ago when I could not sleep, and received guidance to put my hands in the air in the shape of a V. I was then led to move the fingers apart in twos in the shape–popularized by Spock as “live long & prosper”–which comes from the priestly blessing of the Israelite tribe of cohanim.

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 under the control of the organization) must be trained on HIPAA privacy policies and procedures.

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

Healthcare & FDA attorney Michael H. Cohen is co-author of “Medico-Legal Issues in Cardiology,” published by Cardiology in Review 2013;21:222-228. The article aims to educate physicians about the current litigation climate in cardiology and cardiac surgery, with a focus on the most frequently litigated areas of practice, including failure to diagnose and treat.

Returning from a talk I gave on Conscious Business Leadership for Start-ups: Legal Issues From the Perspective of a “Conscious Lawyer,” I went way back and found the mission and guiding principles for my practice around its opening.

State privacy and confidentiality laws (such as California’s) can add to the HIPAA compliance burden when handling protected health information (PHI).Data breaches are becoming increasingly common. Recently, our HIPAA attorneys handled two data breaches, one electronic and the other involving a mix-up of paper medical records of several patients.

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 medical devices, including mobile medical apps with telemedicine applications.

Michael H. Cohen spoke at SpaceMonkey Creative in Ojai today on Conscious Business Leadership for Startups: Manifest Your Edge & Leverage Your Intuitive Superpowers.

“Complementary & Alternative Medicine in Alternative Medicine in Child and Adolescent Psychiatry” by Michael H. Cohen, Suzanne R. Natbony, and Ryan B. Abbott was published by Child and Adolescent Psychiatric Clinics of North America.

Thanks to Joshua Grossman, MD for a review of Healing at the Borderland of Medicine and Religion in the Journal of the National Medical Association.

We appreciate a new review on Yelp for the Cohen Healthcare Law Group.

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 and Nutrition, alleging that the board violated his First Amendment rights by causing him to self-censor certain speech on his Internet website wherein he offered both free and fee-based dietary advice to website visitors.

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 would operate an LLC that would contract to provide orthotics to various entities.

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.

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 about the legal status of their mobile health apps, requiring in-depth analysis of the FDA’s position.

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.

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 injured the horse.

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 Medical Devices (“Draft Cybersecurity Guidance”).

I received a most amazing pet psychic reading which I’ll post later….

Healthcare attorney Michael H Cohen was quoted in The New Physician for insights into informed consent issues, and medicine and spirituality.

This full moon’s meditation at Meditation Mount in Ojai brought a surprising message.

This is written in honor of Castor, Eternal friend. Castor made his transition on the Summer Solstice 2013. He chose his time, I believe.

The concierge medicine news source, Concierge Medicine Today, featured LEGAL: Concierge Medicine Raises Legal Issues by Michael H. Cohen.

Healthcare lawyer Michael H Cohen was quoted in the Tan Sheet on an article about FDA Preemption Lawsuits involving Monster beverages.

Michael H Cohen was quoted in the Los Angeles Bar Journal in the Legal Forum: Malpractice Malaise, an appendix to Attorney, Heal Thyself.

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.

American Telemedicine Association President-Elect Ed Brown, M.D., founder and CEO of the Ontario Telemedicine Network, coined this phrase at the American Telemedicine Association annual meeting.

Attorney Michael H. Cohen was quoted in The Tan Sheet (2/25/13) in “Turning Blogger Relationships Into Gold Takes Careful Management,” by Lisa Gillepsie

California law now lowers the threshold of supervision of nurses and other appropriate licensed healthcare practitioners in medical spas.In recent rule-making the Medical Board of California adopted new Section 1364.50 into title 16 of the California Code of Regulations (CCR).

The practice of medicine outside traditional healthcare settings is expanding through retail settings such as Walgreens.

The FTC’s guidance for digital (online) advertising applies to all business advertising on websites, mobile phone applications, or anywhere online (i.e., including on Facebook, smartphones, etc.).

Does health care reform discuss wellness and prevention?Yes, among other things, the Affordable Care Act (“ACA”) provides incentives for individuals to focus on wellness.

Concierge medicine and direct primary care both raise legal issues, though they present different models in terms of how they handle insurance.

Telemedicine legal and regulatory issues are complicated by the fact that there are numerous legal definitions of telemedicine.

Health and wellness mobile apps and online programs raise a variety of legal and regulatory issues that require legal expertise in structuring a health education or healthcare products or services business.

Michael H. Cohen participated in the LARTA Commercialization Assistance Program in Los Angeles (April 2013), sponsored by the National Institutes of Health, as a mentor to provide guidance to early-stage technology companies.

The FDA issued a warning letter citing a dietary supplement company for its online content.In its warning letter to dietary supplement manufacturer M.D.R. Fitness Corp., the FDA warned that “Artery Factors, Cardio Tone, Cranberry Concentrate, Fitness Tabs for Men and Longevit-E are promoted for conditions which cause the products to be drugs.”

The FDA has taken an aggressive stance on dietary supplement promotion and labeling in recent warning letters involving dietary supplement manufacturers’ and distributors’ response to consumer statements online.

Healthcare reform is creating incentives for even more legislative scrambles by different practitioner lobbying groups for favorable legislation that will protect, preserve, and expand their own scope of practice.

A Maryland legislative Committee has called for require state licensing of medical staffing companies after a radiographer was accused of exposing hundreds of Maryland citizens to hepatitis C.

Michael H Cohen joins the advisory Board of the Information System Security Association – Los Angeles Chapter – bringing expertise in HIPAA / patient privacy, confidentiality and security.

The California Medical Board, on its page for proposed regulations, has proposed to amend California law to provide regarding physician supervision of elective cosmetic procedures.

A federal court in Indiana rules that patient’s HIPAA and state privacy claims could stand, based on the allegation that a physician shared information about the patient’s medical condition with his employer.

The FTC put out a press release on a settlement regarding data breaches on mobile smartphones and cellphones.

HHS has issued a sample business associate agreement under the Omnibus Rule, with caveats.

The Federal Trade Commission issued a final order prohibiting POM Wonderful, maker of POM pomegranate juice products, from claiming that any of its products is effective in diagnosing, treating, or preventing any disease unless such claims are supported by at least two randomized and controlled human clinical trials (RCTs).

The HIPAA Omnibus rule makes a number of additional important changes to breach analysis in case of a breach of unsecured PHI.

The Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act, 78 Fed. Reg. 5566 (Jan. 25, 2013), makes a number of additional important changes to existing privacy and security law.

The new HIPAA Omnibus Rule requires that some changes to the rules about business associate agreements must be made.

The HIPAA / HITECH Privacy Rule has been changed.Under the Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act, 78 Fed. Reg. 5566 (Jan. 25, 2013)

The Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act, 78 Fed. Reg. 5566 (Jan. 25, 2013), make some changes to the Security Rule.

The Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act, 78 Fed. Reg. 5566 (Jan. 25, 2013), stiffen the penalties for HIPAA and HITECH violations.

Business Associates and subcontractors have expanded obligations under the Omnibus Rule.

The Department of Health and Human Services Office for Civil Rights (OCR) released its final rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act;

The FTC blasted POM Wonderful for making deceptive and unsupported advertising claims regarding their pomegranate products.

California Attorney General has released Privacy On the Go: Recommendations for the Mobile Ecosystem

Los Angeles healthcare lawyer Michael H. Cohen will speak at the 2013 American Telemedicine Association conference on Legal Issues in Telemedicine: Overcoming Regulatory Obstacles to a Multi-State Telehealth Business. The conference is May 6, 2013 in Austin.

The Hospice of Northern Idaho (HONI) has agreed to pay the U.S. Department of Health and Human Services (HHS) $50,000 to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.

Much-anticipated regulation protects patient privacy under HIPAA and HITECH

An acupuncture student from Northern California wrote in asking the following question about fee-splitting, kickbacks, Stark / self-referral, and group practices.

Some states restrict the markup a physician can have on sales of dietary supplements. For example, New Jersey law has some relevant law.

Whether you are a physician, psychologist, or other clinical healthcare provider, it is a good idea to have a HIPAA and HITECH compliant privacy and security plan for your office or practice.

The FTC Statement to Congress on Deceptive Marketing of Dietary Supplements is a good place to begin to understand legal compliance issues regarding marketing

The U.S. Department of Health & Human Services has a webpage entitled, Your Mobile & Health Information Privacy and Security.

The Federal Trade Commission (FTC) settled a $2 million complain against “an operation that allegedly used fake news websites to deceptively market acai berry weight-loss products.”

Misbranding can also occur when a product is “held for sale after shipment in interstate commerce.

Off-label drug use is not illegal, but off-label drug promotion and marketing can result in significant legal penalties.

The 1-800-GET-THIN ad campaign is embroiled in a criminal investigation for healthcare fraud and other violationsThe FDA and FBI are investigating.

The Department of Health and Human Services Office of Inspector General issued two reports lambasting dietary supplement companies, particularly over structure-function claims related to weight loss and immune support.

Cleveland Clinic is marketing an online second opinion service for patients who live outside Ohio but want medical input.There are many ways to take advantage of telemedicine laws to provide online medical services.

Telemedicine laws will change if the U.S. Congress enacts the “Healthcare Innovation and Marketplace Technologies Act” (“HIMTA”), a bill which seeks to establish the “Office of Mobile Health” within FDA, the federal Food and Drug Administration.

Attorney Michael H. Cohen was quoted as a legal authority in FDA and FTC law in an article in the popular industry weekly “The Tan Sheet” (vol. 20, no. 39) about anticarcinogenic effect claims in the article “FDA to Study Consumer Perceptions of Selenium Health Claims”.

California is an early adopter once again, this time with respect to regulating medical volunteers.

The federal Food and Drug Administration (FDA) announced a draft compliance policy guide (CPG) entitled, “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.”

Medical researchers are growing spare parts from stem cells inside the human body.Another practice, called bioprinting, builds body parts much like an inkjet printer:

The FDA believes that ear candles are dangerous and should be regulated as medical devices.In Don’t Get Burned: Stay Away From Ear Candles, FDA warns consumers against using ear candles, and expands its asserted legal authority over yet another holistic healthcare practice

The Board of Chiropractic Examiners in California has adopted new regulations for the use of lasers in chiropractic

The California Medical Board has adopted regulations pursuant to California law, allowing healthcare practitioners who are licensed in states outside California, to offer healthcare services in California, on a volunteer basis

Dietary supplement manufacturers, medical device manufacturers and distributors, and makers of cosmetics should have legal review of their website advertising and marketing claims for Federal Trade Commission (FTC) issues

Now I’ve heard it all – two dogs in a pet therapy program with hi-tech names. Want to guess? They are called “Twitter” and “Blackberry.”

The California Medical Board has announced another physician arrest for regulatory violations involving prescribing.

Attorney Michael H. Cohen was quoted as a legal authority in FDA and FTC law in an article in the popular industry weekly “The Tan Sheet” (vol. 20, no. 35) about European herbal regulation entitled “UK Regulator’s Echinacea Action Sends Chills Through US Industry”.

New California law enhances penalties for medical spa owners and operators that violate the prohibition against unlicensed medical practice, raising visibility and adding deterrence. In Part 1 (Increased Enforcement, Penalties) we talked a little about the new bill.

California law now includes increased penalties for medical spa owners who violate the corporate practice of medicine and engage in unlicensed medical practice.

Telemedicine laws continue to define online health ventures, but meanwhile industry expands robotic telemedicine options.

Medical doctors as well as non-physician clients frequently ask our healthcare legal team about including non-medical personnel, such as licensed estheticians, in a practice that combines medicine, aesthetic or weight loss medicine, and cosmetics.

Branding your medical spa, longevity center, or anti-aging clinic raises legal and regulatory challenges that a skilled healthcare attorney can help you navigate

Our healthcare attorneys recently advised a business venture that wanted to brand a medical spa or anti-aging clinic in California, as the first of a nationwide series of medical clinics.

Entrepreneurs who fail to properly take into account legal and regulatory issues before opening a longevity and anti-aging medical clinic or health education (or telehealth / telemedicine) venture can find that regulatory enforcement puts a damper on their dreams.

Healthcare reform—aka “Obamacare”—changes much of the financial, tax, and insurance landscape for healthcare. However, it leaves huge swathes of healthcare law untouched.

Health care reform will continue with a myriad of legal and regulatory changes over the next few years.

In National Federation of Independent Business, et al. v. Kathleen Sebelius, Secretary of Health and Human Services, et al., the U.S. Supreme Court upheld the so-called “individual mandate” in the federal health care reform bill, a/k/a the Patient Protection and Affordable Care Act (PPACA), a/k/a Obamacare

Attorney Michael H. Cohen presented a new lecture, “Cloud Computing – Legal Considerations” at the Provisors IT Affinity Group in Los Angeles on June 26 2012.

If you have a dietary supplement or any product for that matter, be sure you have substantiation for your claims. Complying with substantiation legal rules is part of dietary supplement / FDA and FTC legal compliance.

With HIPAA compliance enforcement on the rise, it’s no wonder medical practices are wondering what they can do to help protect the privacy and confidentiality of their patients.

What if everyone wore mobile wireless devices, but some nefarious parties could somehow send signals and interfere with them? This dark scenario was brought to my attention in an article distributing during yesterday’s seminar on cyber-security.

The U.S. Immigration and Naturalization Service, in a fascinating decision, rejected an employment-based immigrant visa petition by a Russian energy healer. The decision, File No. EAC 98 023 51854, stated: The petitioner is a medical clinic. It seeks to classify the beneficiary as an employment-based immigrant pursuant to section 203(b)(1)(A) of the Immigration and Nationality [...]

Off-label marketing by Merck of its pain-killer, Vioxx, resulted in a $950 million settlement for violation of marketing laws

HIPAA legal and regulatory compliance can help healthcare entities, such as doctors’ office, mitigate liability risk. However, compliance must include strong HIPAA policies, procedures, and forms that are legally compliant, as well as a culture of compliance.

The California Medical Board, in its recent newsletter, provides an explanation of language it uses in disciplinary investigations and enforcement actions against physicians

The U.S. Department of Health and Human Services (HHS) has announced a $100,000 settlement and plan take corrective action to implement policies and procedures to safeguard the protected health information of patients by Phoenix Cardiac Surgery, P.C., of Phoenix and Prescott, Arizona

The Times of India reports a new law which brings more compassion into scientific research

The Texas Medical Board approved new stem cell therapy rules

Utah’s recent Medicaid information breach has left the health information of approximately 780,000 Utah residents compromised, including potentially 255,000 Social Security numbers.

2011 Michael H. Cohen is featured as a legal expert in videos by LegalZoom (also see LegalZoom Channel on YouTube). The Michael H. Cohen Law Group has new offices. Visits are by appointment. November 2011 Michael H. Cohen, Esq. speaks at the 12th Annual Science & Clinical Application of Integrative Holistic Medicine conference taking place [...]

2010 The firm moves into new offices. Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.

2009 Laws.com highlights Michael Cohen in its "Famous Lawyers" law blog (2009.10.27). Read the entry. Tenth anniversary of the Michael H. Cohen Law Group, established in 1999. Michael H. Cohen publishes the first in a planned series of affordable “legal toolkits” designed to bring entrepreneurs up to speed on essential legal concepts that they need [...]

2008 Michael H. Cohen is featured in City Line 's article, "Expert on Health & Wellness Legal issues Returns to O.C. From Harvard Medical School" (November 2008, p. 14). Michael H. Cohen gives keynote speech at BNI chapter. Topic: "Don't roll the dice, get legal advice." Michael H. Cohen Law Group opens its Southern California [...]

2007 The Department of Health Policy & Management at Harvard School of Public Health has approved a three-year, renewal of appointment for Michael H. Cohen as Adjunct Assistant Professor of Health Policy & Management. Michael H. Cohen will serve on the advisory board of Integrative Practitioner, an innovative, online community of healthcare professionals. Healing at [...]

2006 November/December 2006 Michael H. Cohen, Esq. is admitted to the Bar of England and Wales as a Solicitor (non-practicing), adding the U.K. law credential to existing membership in the Bar of California, New York, Massachusetts, and Washington, D.C. Donna Eden's Energy Medicine Program is added to the list of selected recent clients. Michael H. [...]

2005 December 2005 December 2, 2005: Michael H. Cohen speaks on Legal and Ethical Issues in CAM at North Shore Long Island Jewish Health System, conference on Complementary and Alternative Medicine: An Evidence-Based Overview September/October 2005 Sept 24-Oct 5, 2005: Michael H. Cohen in meetings in Dubai and Bahrain regarding interest in complementary medicine, health [...]

2004 December 2004 Medical Law International published Overcoming Legal and Social Barriers to Integrative Medicine by Michael H. Cohen and Mary Ruggie, PhD, Professor of Public Policy at the Kennedy School of Government, Harvard University. This is the second of two articles in a study funded by the National Library of Medicine at the National [...]