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How to Handle Stark and Anti-Kickback Legal Barriers When Physicians Invest in an MSO

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

Tips for Structuring Healthcare Practice as an Unlicensed Practitioner

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.

5 Ways Cosmetic Product Companies Can Comply with FDA Labeling Requirements & Help Avoid FDA Enforcement.

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.

HIPAA compliance not the end of liability for compromising patient privacy

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.

How to Respond to an FDA Warning Letter about Dietary Supplements or Cosmetics

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.

Do healthcare markups violate fee-splitting laws?

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?

Should physicians, chiropractors, and other healthcare practitioners worry when they offer coupons for discounts to patients?

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: Telemedicine Law Often Requires It, but What does this Mean?

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?

What doctors, users, growers and others should understand about the passage of Prop 64 and Prop 215

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

The Legal Dangers Physicians Face When Working with Third Parties

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.

Do Discounted Vitamin Shots Create Legal Risk of Enforcement?

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.

Can the MSO Legally Brand the name of a Medical Clinic?

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.

Are you a Physician or a Health Coach? Lawyer Up!

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.

An Overview of Legal, Ethical, and Compliance Issues Governing Physician Relationships Doctors Should Know

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.

What Legal Strategies Work for Multi-Disciplinary Healthcare Practices Involving MDs, DCs, and NPs?

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 Gain Legal Traction

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.

Navigate the Weird Legal Twists and Turns of Your State’s Telemedicine’s Laws

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.

MSO Gets Light Enforcement Touch by California Appellate Court Reviewing Management Services Agreement Legal Issues

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.

Is your therapy an FDA-regulated medical device? How would you know?

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.

Corporate Practice of Medicine: Medical Management Organizations and Professional Medical Corporation–Who Controls What?

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 Dietary Supplement Labeling Requirements: Comply or Die

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

Is Clinical Decision-Making (CDS) Software Expanded or More Legally Ambiguous under the CURES Act?

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?

How Do You Navigate Telemedicine Veterinary Legal Issues?

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…

When Is Telemedicine Legally Risky Business?

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

Is Health Coaching Legal aka Can You Function as a “Health Coach” and Avoid Medical Licensing or Board Discipline?

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

Does Healthcare Law Favor or Smash Integrated Healthcare Practices Between Medical Doctors and Chiropractors?

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.

Is Buying a Medical Spa a Smart Move for a Medical Doctor?

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.

Licensed ND Subject to Discipline for Offering “Shots” and Falsely Advertising Professional Services

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.

Prescribing through Telemedicine Raises Legal Challenges: Learn the Regulatory Terrain

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

3 Keys to Managing Legal Risks in Healthcare Ventures with MDs

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.

Should physicians, chiropractors, and other healthcare practitioners worry when they offer coupons for discounts to patients?

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?

Should Integrative Medicine Legal Standards Drive Physicians’ Risk Management Practices?

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…

Exceptions to the Stark Law Prohibition of Medical Referrals

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…

5 Ways Cosmetic Product Companies Can Comply with FDA Labeling Requirements & Help Avoid FDA Enforcement

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 Signals Tough New Regulatory Stance on Homeopathic Drugs

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…

Five Steps to Meet HIPAA Obligations and Privacy & Security Compliance

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

Can HIPAA Compliance Derail your Healthcare Website or Digital Health App?

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.

MedSpa: Physician Supervision of RNs—Do You Need It?

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?

TELEMEDICINE LEGAL SERIES—PART 5: HIPAA

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.”

7-PART TELEMEDICINE LEGAL SERIES—PART 4: STANDARD OF CARE ISSUES

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

TELEMEDICINE LEGAL SERIES—PART 3: E-PRESCRIBING

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

TELEMEDICINE LEGAL SERIES—PART 2: LICENSING ISSUES

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).

TELEMEDICINE LEGAL SERIES—PART 1: PRACTICE ISSUES

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.

Liability Protection & the Practice of Medicine for Non-Physicians

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.

Study: Scientifically Unproven Marketing Claims Very Common on Websites

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

Dental Telemedicine MSO—Is it Legal? “We’re Just a Technology Platform”

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.

Concierge or Functional Medicine Practice Legal Issues: An Overview

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

Breaking Away Into Your New Practice and Common Insurance 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.

Off-Label Promotion Has Legal Limits

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.

Rock Your Practice with an MSO—MSO Compliance vs. using Independent Contactor Practitioners

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.

TELEMEDICINE LEGAL SERIES—CONCLUSION: PUTTING IT ALL TOGETHER

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 My Product to be a Medical Device?

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.

Avoiding Malpractice Through Strong Informed Consent Practices

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.

Federal Trade Commission Slams Homeopathic Drugs

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.

Kickbacks, Fee-Splitting, Corporate Practice of Medicine, Stark, MSOs: Guiding Healthcare Ventures through the Maze

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.

FDA and FTC Encourage Public to Report Dietary Supplement Labeling Violations

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

Keynote Speaker: Michael H Cohen at the 2016 AuDacity Convention

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

FDA Personal Importation Policy Is More Limited Than People Think

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.

Corporate Practice of Medicine on Steroids: How Your MSO and Professional Medical Corporation Could Work Together Without Courting Legal Disaster

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.

How Can An MD Set up An Health Education Website Legally (without compliance nightmares)?

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.

Legal Issues In Integrative And Functional Medicine: History, Licensing, And Tele-Medicine

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.

Walking the Medicine Wheel: A Review

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.

Prompt pay, cash discounts, dual fees legal for healthcare providers (physicians, chiropractors, acupuncturists)? (Part 2)

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?

SAFEGUARDING YOUR LICENSE & AVOIDING MALPRACTICE: STANDARD OF CARE IN INTEGRATIVE MEDICINE

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.

Prompt pay, cash discounts, dual fees legal for healthcare providers (physicians, chiropractors, acupuncturists)?

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 – 21st Century Cures Act Changes FDA’s Regulatory Game

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.

Health Coaching and Telemedicine

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?

Physician Advertising of Medical Services: Avoiding 5 Legal Traps

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…

Independent contractor physician – kickback or compensation?

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?

Physicians Fee-splitting & Nurse Fee-Splitting More Common Than You Realize

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.

Avoid These 8 Common Legal Mistakes Before Signing Physician Agreements

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 beware of FDA warning letters

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?

How substance abuse treatment centers navigate anti-kickback rules

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.

Telehealth Legal Issues: A Telemedicine Lawyer’s Practical Guide for Industry

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.

Medical Spa Legal Compliance Issues Get You Down? Try These Legal Remedies

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.

FEE-SPLITTING 101 FOR MDS AND OTHER INTEGRATIVE HEALTH PRACTITIONERS

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?

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.

5 LEGAL TIPS FOR SETTING UP A FUNCTIONAL MEDICINE PRACTICE

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 CONSULTING THE EVOLUTION OF INTEGRATIVE MEDICINE LAW AND WHAT THE FUTURE PORTENDS

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 common FDA mistakes marketing health products

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

WHY I WRITE—AND WHY YOU SHOULD, TOO

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.

Super friendly AI could reform human experience

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

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.

Neurofeedback expert tackles “luminosity” of FTC “brain training” enforcement action

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?

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?

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

OTC drug marketing legal checklist: 5 legal strategy steps

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

Telemedicine Prescription and Distant Diagnosis Allowed? Read Telemedicine Laws Carefully – Interpretation Can Be Tricky

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

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

Transcendence: Is AI Energy Healing Feasible in the age of Superintelligence?

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

“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?

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

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

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?

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

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

Common HIPAA privacy and security violations flagged

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.”

“Terms of Use” to Limit Liability and Contract with Customers

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?

Can chiropractors legally practice functional medicine?

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

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.

Online tracking of personal information disclosures required in website privacy policies

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

Is Your Medical Assistant Practicing Medicine Illegally?

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

Integrative medicine standard of care: an evolving legal rule

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

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.

FDA medical device guidance – substantial equivalence

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: Establishment Registration & Product Listing

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

Understanding FDA tobacco compliance – legal requirements, warnings, advertisements, and other regulatory restrictions

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.

FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act: A brief overview

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

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?

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

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 healthcare services directory a medical referral service?

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

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

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

Legal risks arise in interdisciplinary MD-DC practice, challenging integrative medicine model

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.

How Can A Healthcare Clinical Practice Bonus Its Staff, Employees, & Marketing Personnel Without Trigger Fee-Splitting and Anti-Kickback Issues?

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

An open letter to Superintelligence: AI, Blaze Humanity’s Path to the Cosmos

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

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

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?

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

Dietary supplement legal review could save your company

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

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

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?

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

“The Doctor Weighs In” Features Interview on FDA Mobile Medical App Regulation

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 in New York AG action

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?

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

FTC false advertising legal traps – walk the compliant side of marketing healthcare products

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

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

4 Legal Tips for Setting Up A Functional Medicine Practice

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 Artificial Intelligence Will Usher In Utopia

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

The Internet of Things (IOT) Legal and Regulatory Issues

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

Dietary Supplements, Cosmetics, Medical Devices – Why Substantiating Claims Matters

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

5 Ways to Increase Physician Income Despite Healthcare Reform

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

Corporate practice of medicine & fee-splitting lead medical spa compliance enforcement

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

Alternative Medicine Fraud Remains an FDA Staple, Despite FDA Guidance on Low-Risk, General Wellness

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.

What does Consciousness have planned for us when the Singularity arrives?

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 Healthcare Means Medical Devices Increasingly Important in Healthcare Regulation

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.

Digital health personalizes medicine, revolutionizes healthcare, and makes healthcare law anachronistic

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.

4 Ways to Minimize the Risk of an FDA, FTC or Private Plaintiff, Healthcare Fraud Label When Marketing Healthcare Products

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.

FTC Slams Fat Burning, Calorie-Blocking and Body Slimming Marketing

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…….

Legal Issues Buying or Selling an Urgent Care Center

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

Will Artificial Intelligence Healthcare Lawyers Augment or Replace Human Attorneys

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?

Your Medical Spa Fire Physician or Physician Sue Medspa for Breach of Contract

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?

Medical Spa Due Diligence Questions – M&A due diligence checklist for buyer

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?

Healthcare hacks and data breaches increasing, even as HIPAA compliance grows

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.

Veterinary Telemedicine Legal Issues Similar to Human Telemedicine

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.

Will FDA Act if You Link Dietary Supplement Claims to Testimonials or Scientific References?

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?

Which disruptive healthcare innovations will push medical frontiers in the next 5 years?

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

Advertising health products online? Check FTC endorsement guides for dos and don’ts

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

The Next Healthcare Revolution is Inside You: Wearable Health Tech Legal & Regulatory Issues Will Astound Us

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.

These 3 integrative medicine legal trends can make or break your integrative medicine practice

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?

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

How to Rock Concierge Medicine Laws by Creating a Concierge Medicine Legal Checklist

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?

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?

How are home health kits regulated under FDA and state law?

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.

Dietary Supplements – Strategies to Reduce FDA Risk

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

What healthcare compliance program policies and procedures should be included in healthcare compliance program?

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

Telemedicine laws expand as Arkansas legislates to encourage telemedicine use

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 participates in Leadership Program in Integrative Health

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

CFO Sentenced to Federal Prison for Falsely Attesting to Meaningful Use

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.

How The Internet of Things Will Change Healthcare: Artificial Intelligence & Wellness Harness Information to Augment Your Experience

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.

How will FDA regulate predictive clinical software as predictive analytics pushes medical frontiers?

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.

Superintelligence, Artificial Intelligence, The Singularity, & Life in the Universe

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

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 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.

Medical device advertising: free speech or conspiracy?

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

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.

When marketing healthcare products, review websites and materials for FTC and liability risk

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.

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 Bar Association.

FDA cosmetics regulatory power enhanced by proposed Personal Care Products Safety Act

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

Federal bill to boost health IT innovation by exempting low-risk medical software and mobile apps from FDA regulation

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.”

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 in the health and wellness industry. Why?

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

FDA Approves 23andMe’s DNA Personal Genome Test for Bloom Syndrome Carrier

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.

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’ 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 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 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.

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 compliance obligations.

Concierge medical practice vs. retail medicine clinic: which one competes more successfully?

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.

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 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.

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 investigation premature?

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.

Daily Journal Publishes “FDA’s General Wellness Guidance is Welcome News”

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.

9 Keys to Managing Risk of FTC enforcement (especially with anti-aging and weight loss claims)

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.

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?

Does anyone remember Hammurabi? Concierge Medicine Today Features “Does Concierge Medicine Advertising Create Liability”

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 is hands-off Low Risk General Wellness Products

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 deepen our access to Spirit

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.

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

Weight Loss Products FTC Weighs In

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.

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?

Joint Commission Includes Complementary Therapy Approaches in Pain Management Standard

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.

Navigating spirituality in medical situations – what doctors and patients need to know

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 raise a monster of FDA and state legal concerns

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?

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?

Michael H Cohen quoted in USA Today on Healthcare Legal Issues

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

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 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.

Will You Get Rx Drugs from a Shopping Mall Kiosk? Telemedicine and Internet Prescribing:

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

Daily Journal publishes “Future of Medicine is Just a Tap Away” as lead front-page article

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.

Do HCG Weight Loss Products Work? FTC Cracks Down on Homeopathic HCG Drops

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.

Who owns neurofeedback (or any therapy)? Psychologists, psychiatrists, non-licensed NF practitioners, or everyone?

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?

How to Piss Off the FTC After Offending the FDA

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 does a dual-licensed healthcare provider wear two hats and satisfy both professionals boards?

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?

Are your privacy and security practices HIPAA compliant?

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.

Can you get Medicare reimbursement for telehealth as an originate site?

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.

Key Points for Physicians and other Healthcare Licensees to Consider When Selling Dietary Supplements to Patients

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

Can Integrative Medicine Be Made Clinically Responsible, Ethically Appropriate, and Legally Defensible?

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.

Can you make HIPAA Privacy & Security easy for a small doctor’s office or other practice?

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 prescribing position softened by North Carolina Medical Board to allow virtual examination and evaluation

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?

Key Legal & Regulatory Trends in the Trillion-Dollar Healthcare Market for the New Year

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.

5 Legal Issues for Integrative Health Practitioners in the new year

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

Do online coupons for discounts to physician and other clinician services violates Stark, anti-kickback and fee-splitting laws?

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.

Michael H Cohen Speaks on Telemedicine, Mobile Medical App (M-Health) and Wearable Health Tech Legal Issues

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.

Marketing “wearable caffeine” can get you in trouble with FTC, the regulatory watchdog over advertising

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.

Wearable Health Technology: Health Care Dream or Privacy Nightmare? (published by LegalZoom)

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

FON Therapeutics (Integrative Medicine Consulting) Features Fee-Splitting 101

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 on Neurofeedback legal and regulatory issues

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

FTC requires mobile apps to include disclosures, adding to FDA mobile medical app regulatory requirements

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.

Physicians are shifting to concierge medicine and direct pay, or joining health networks

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.

How to resolve wearable tech legal and regulatory issues without wearing out your legal budget

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.

“From Physical to Mobile to Wearable Healthcare: How Government Regulation of User-Generated Health Data Affects Ventures and Consumers”

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

Wearable technology is tracking You, raising legal issues

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

Telemedicine Rocks, AMA Says – Licensure & Standard of Care Still Thorny

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.

Tweet Your Medical Device Ad But Watch the FDA Hammer

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.

Corporate Practice of Medicine & Anti-Kickback / Fee-Splitting Rules: Deep Down the Regulatory Rabbit Hole

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.

Quick Summary of Federal “Stark” Self-Referral & Anti-Kickback Law and California Self-Referral and Fee-Splitting Prohibitions

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.

California Reimbursement for Telehealth

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.

The Medicare originating site fee incentivizes telemedicine

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.

Neurofeedback Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe–Part 5: Marketing Your Neurofeedback Practice—Legal Issues in Case Studies

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 Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe–Part 4: Malpractice Liability, Informed Consent, and Other Issues

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 Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe–Part 3: Proposed New York Legislation

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 Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe –Part 2: Legal Scope of Practice

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

Neurofeedback Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe–Part 1: Unlicensed Practice

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

Neurofeedback Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe

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.

What anti-kickback and fee-splitting legal issues arise when physicians or other healthcare providers lease space?

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.

Telemedicine & telehealth accelerates with American Medical Association’s New Telemedicine Principles

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 to avoid legal pitfalls of physician (MD) collaboration with chiropractors (DC)

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 Telemedicine and Telemedicine Prescribing Standards Effective

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

Can a medical doctor operate a separate online health and wellness business?

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.

How Telemedicine, Mobile Medical App Laws, Anti-Aging Medicine, and Integrative Medicine are Shaping Our Future

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.

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

The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow this four-step process.

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

Concierge medicine legal issues require adroit navigation as medical practices continue to move into concierge and hybrid models. Our law firm handles concierge medicine practices, providing legal,regulatory, transactional, and strategic advice to physicians seeking to deploy concierge medical or wellness models.

Legalzoom features video feed of Michael H Cohen discussing how to form an LLC

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

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

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

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

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

FTC wins advertisement substantiation case against online marketer of health products

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

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

There’s an old quote that says: “If you meet the Buddha on the road, kill him!” And what if your friendly neighborhood chiropractor asks you to be Medical Director, especially in California? Remember, we’re lawyers who counsel companies and practices involved in holistic healing.

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

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

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

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

FDA’s evolving regulatory position on stem cell therapies

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

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

FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative Sciences, a Colorado-based company, in a 2008 warning letter, for violating FDA’s human cell, tissue and tissue-products (HCT/P regulation)

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

If you wanted to upgrade the old film, “The Graduate,” you’d have Dustin Hoffman’s character shouting out “stem cells!” instead of “plastics!” Of course, he would immediate meet his favorite regulatory attorney to understand FDA regulation of stem cell therapies.

FDA proposes updates to Nutrition Facts label on food packages

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

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

Just as the silicon “ink” dried on Telemedicine: The Future of Medicine, someone, somewhere, pronounced that there is a future for medicine beyond the future. This was no sweat for me, since I’m into the future of the future, especially when it comes to medicine and healthcare.

California medical board arrests man for unlicensed practice of medicine

California and other state medical boards still run undercover investigations for unlicensed practice of medicine. California is in the minority of states that have a statute that authorizes non-licensed practitioners of the healing arts to offer healing services.

Daily Journal Publishes “What’s Behind FDA’s Sudden Soda Interest?”

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

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

“A human birth is rare, and time is precious”

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.

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

Julie Migneault: Your Soul Fully Expressed features a Skype interview with healthcare and FDA lawyer Michael H. Cohen, entitled: “From Wall Street to Awakening: How to Bridge Your Passions & Expertise to Change the World.”

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

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

Telemedicine laws increasing in number and scope

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

Energy healing: honoring the initiation

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 exerts authority over medical devices with genomics

FDA flexed its jurisdictional muscle by warning 23andMe that its marketing of the 23andMe saliva test kit and personal genome service without marketing clearance or approval violated that federal Food, Drug & Cosmetic Act.

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

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

Fee-splitting 101 for medical doctors, chiropractors, acupuncturists, and others

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 in healing into 2014

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

Michael H Cohen Speaks on FDA Legal Issues to SoCal IP

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.”

Health & Wellness Lawyer Michael H Cohen Speaks in Saudi Arabia on U.S. Regulation of Complementary and Integrative Medicine

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.

LegalZoom Publishes “Health Apps as Medical Devices: What It Means for Consumers”

“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.

Bringing the priestly blessing through

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.

Online HIPAA training developed by Cohen Healthcare Law Group

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.

How Medicare.gov helps with legal review of concierge medicine services

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

Medico-Legal Issues in Cardiology published by Cardiology in Review

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.

Principles for a Conscious Law Practice

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.

California Privacy and Security Requirements for Protected Health Information Add to HIPAA Burden

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 Speaking on FDA Legal Issues at the Ventura BioScience Incubator

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.

Conscious Business Leadership for Start-ups: Legal Issues from the perspective of a “conscious lawyer”

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”

“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.

Healing at the Borderland of Medicine and Religion – Review

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.

Cohen Healthcare Law Group Yelp attorney review

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

Caveman Blogger Has Procedural Win on Appeal of First Amendment Case on Unlawful Nutrition & Dietetics Charge

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.

OIG Opines that services by LLC owned by podiatrist and wife do not violate anti-kickback laws

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.

FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden

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 features “LEGAL: Concierge Medicine v. Direct Primary Care: Legal Issues”

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

FDA Mobile Medical App Guidance Reads FDA Medical Jurisdiction Expansively

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.

Michael H. Cohen Speaking on FDA & Related Legal Issues in Online Health Ventures

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.

Memories, Dreams, Reflections – A Horse and the Color Red

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 Requires Cyber Security Plan Submission for Medical Devices

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”).

A Portrait of the Yogi as a Young Cat

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

Healthcare Lawyer Michael H. Cohen Quoted in The New Physician on Medicine and Spirituality

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

Group Liberation, Ojai Full Moon Meditation & the Collective Consciousness

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

He was more than a cat; he was a yogi (Castor 1993-2013)

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

Concierge Medicine Today Features Post on Concierge Medicine Legal by Michael H. Cohen

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

Healthcare lawyer Michael H Cohen quoted in the Tan Sheet on FDA Preemption Lawsuits

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

Michael H Cohen quoted in Los Angeles Bar Journal

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

Mobile App Developers Can Be Slammed by FTC or FDA

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.

From Telemedicine Everywhere to Telemedicine Anywhere: Legal & Regulatory Issues

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.

Bloggers must take care to not provide clinical health advice

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 Medical Board lowers supervision threshold for medspa and cosmetics affiliated physicians

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).

Retail medicine spreads through Walgreens

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

FTC Releases “.com Disclosures: How to Make Effective Disclosures in Digital Advertising”

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.).

Wellness Programs Under the Affordable Care Act (“ACA”) and Related Federal Laws

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 v. Direct Primary Care: Legal Issues

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

Telemedicine legal definitions and informed consent requirements vary by state

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

Does the FDA Regulate Mobile Apps Designed for Health and Wellness?

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.

LARTA Commercialization Assistance Program

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.

FDA issues warning letter to dietary supplement company for including cancer or diabetes in search field

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.”

FDA takes aggressive stance on dietary supplement promotion and labeling

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.

Affordable Care Act creates scope of practice legislative scramble for healthcare practitioners

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.

Licensing proposed for medical staffing agencies

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 ISSALA

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.

California Medical Board proposes changes to physician supervision rules for elective cosmetic procedures

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.

HIPAA and state law privacy claims stand while medical malpractice claim falls

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.

FTC settles charges based on mobile device data breach

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

Sample Business Associate Agreement Under HIPAA Omnibus Rule for HIPAA Compliance

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

FTC Prohibits pomegrenate juice disease claims

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).

HIPAA Omnibus Rule: Part 8 (Breach Analysis)

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

HIPAA Omnibus Rule: Part 7 (Notice of Privacy Practices & Other Provisions)

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.

HIPAA Omnibus Rule: Part 6 (Business Associate Agreements)

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

HIPAA Omnibus Rule: Part 5 (Privacy Rule Changes)

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)

HIPAA Omnibus Rule: Part 4 (Security Rule Changes)

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.

HIPAA Omnibus Rule: Part 3 (Enforcement & Penalties)

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.

HIPAA Omnibus Rule: Part 2 (Business Associates & Subcontractors)

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

HIPAA Omibus Rule: Part 1 (Overview)

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;

FTC Blasts POM for Disease Claims, Highlighting Substantation Issues

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

California Publishes Mobile Ecosystem Privacy Legal Recommendations

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

Healthcare Attorney Michael H. Cohen Speaks in Austin, Texas on Telemedicine Legal Issues

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.

HIPAA Breach Settlement by HHS Involves Less than 500 Patients

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.

New HHS Rule Protects Patient Privacy Under HIPAA and HITECH

Much-anticipated regulation protects patient privacy under HIPAA and HITECH

Is it fee-splitting to share profits in an acupuncture, chiropractic, osteopathic, or MD physician group?

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

Physician Sale of Dietary Supplements – Legal and Regulatory Restrictions

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

HIPAA and HITECH Medical Privacy and Security Plans Necessary for Small to Medium Clinical Offices

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.

FTC Statement to Congress on Deceptive Marketing of Dietary Supplements

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

HHS Mobile Device Privacy and Security Website

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

FTC Charges Settled on Fake Endorsements and Deceptive Acai Berry Weight Loss Claims

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.”

Off-label drug promotion and marketing yields significant penalties: Part 2 (Misbranding in interstate commerce)

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

Off-label drug promotion and marketing yields significant penalties: Part 1 (Amgen settlement)

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

Weight Loss Advertisements Found Deceptive and Misleading – Conspiracy and Healthcare Fraud Violations

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

HHS Lambasts Dietary Supplement Companies and Weight Loss & Immune Support Dietary Supplements

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 promotes second medical opinion – telemedicine consults can fit legal exception

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.

Proposed legislation for mobile applications would change telemedicine legal landscape

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.

Michael H. Cohen again quoted in The Tan Sheet

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 medical board regulates medical volunteers who are licensed in other states

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

FDA Announces Draft Compliance Policy Guide on Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats

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 grow spare parts from stem cells inside the body

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:

Are Ear Candles Medical Devices? FDA Thinks So.

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

California Chiropractic Board Adopts New Regulations for the Use of Laser in Chiropractic

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

Health Care Practitioners Who Are Licensed in Other States, But Not California, Can Offer Services in California

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

Misleading advertising of health products triggers FTC Complaint and Penalties

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

Healing Methods 101 – Pet Therapy

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.”

California Medical Board

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

Michael H. Cohen quoted in The Tan Report

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”.

California Steps Up Enforcement with New Law Targeting Medical Spa Treatments: Part 2 (Corporate Practice of Medicine Issues; Legal Strategies)

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 Steps Up Enforcement with New Law Targeting Medical Spa Treatments: Part 1 (Increased Enforcement, Penalties)

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

Robocare Expands with IRobot’s Telemedicine Practice

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

Case Study: Branding Your Medical Spa or Anti-Aging Clinic—Legal Considerations—Part 3 (Physicians & Estheticians)

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.

Case Study: Branding Your Medical Spa or Anti-Aging Clinic—Legal Considerations—Part 2 (Branding & Marketing)

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

Case Study: Branding Your Medical Spa or Anti-Aging Clinic—Legal Considerations—Part 1 (Board Investigations; Structure)

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.

Longevity and Anti-Aging Medicine Legal & Regulatory Issues

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.

Health Care Reform – Legal – Part 3: Longevity & Anti-Aging Medicine, Genomics, Robotics, Nanotechnology, and The New Healthcare Legal Landscape

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 – Legal – Part 2: The New Regulatory Landscape

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

Health Care Reform – Legal & Regulatory – Part 1: The Supreme Court Opinion

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

Michael Cohen presents at Provisors IT Affinity Group

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.

FDA reports $40 million settlement with Skechers over unfounded health claims

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.

Cellphone use in Medical Practice Areas

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.

FDA Regulation of Wireless Devices

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.

Energy Healing’s Validity Tested by Legal Claim in Immigation Petition

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 of Vioxx results in a $950 million settlement for violation of marketing laws

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

AMA Warns “Don’t Let Business Associates Create HIPAA Mess”

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.

California Medical Board details language used in disciplinary investigations of physicians

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

Patient Privacy Case Settled by US Dept of Health and Human Services

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

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

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

Texas Medical Board approves new stem cell therapy rules

The Texas Medical Board approved new stem cell therapy rules

Medicaid Information Breach

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 Archived News

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 Archived News

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

2009 Archived News

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 Archived News

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 Archived News

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 Archived News

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 Archived News

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 Archived News

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 [...]

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