California Anti-Kickback and Fee-Splitting Law for Smarties
California Anti-kickback and Fee-Splitting Law for Smarties is the subject of today’s video.
Fee-Splitting & Anti-Kickback Issues for Healthcare Clinics
In today’s video, we discuss how multidisciplinary clinical healthcare practices can be profitable without running afoul of legal rules prohibiting corporate practice of medicine, and prohibitions against kickbacks and fee-splitting.
FTC Legal Issues Require Nuanced Legal Advice
In today’s video, we return to FTC substantiation rules and talk about the dilemma substantiation causes for dietary supplement and cosmetics companies, as well as how to break through.
Can FTC Substantiation Requirements Take Down Your Healthcare Product?
In today’s video, we describe how FTC substantiation rules can make or break the marketing you can make for your health and wellness product.
Will FDA/FTC Substantiation Rules Blow Your Supplement Company Up?
In today’s video, we discuss how FDA and FTC substantiation rules can ensnare, derail, and detonate dietary supplement and cosmetics companies.
Hiring a Healthcare or FDA Lawyer: How to Get the Most Value
In today’s video, we talk about how to get the most out of your engagement with a healthcare and FDA law firm or lawyer.
Functional Medicine Legal Issues
In today’s video, we discuss how functional medicine practices can navigate some of the legal traps that assail many medical practices and healthcare businesses, especially when they get into somewhat novel or unconventional waters such as functional medicine.
Healthcare Law – Telemedicine Future
Michael H. Cohen was a featured speaker on the panel for legal and compliance threats to Health Care organizations at the Southern California State of Reform Health policy conference.
Dr. Seymour Heart on Telemedicine
Dr. Seymour Heart shares his thoughts on Health Care reform
Cannabis Labeling Legal Issues
Cannabis labeling legal issues are the subject of today’s video. By the end of this video you’ll have some basic familiarity with the way FDA lawyers approach labeling issues for dietary supplements as well as for cannabis products.
Does the FDA Regulate Your Cosmetics as Drugs?
In today’s video, we discuss how FDA regulates cosmetics claims, and the risk that FDA could regulate your cosmetics as a drug.
10 Ways Your Dietary Supplement or Cosmetic is a Drug
In today’s video, we discuss how FDA can find that your dietary supplement or cosmetic deserves to be regulated as a “drug,” which means you can’t sell your product unless you get premarket, New Drug Approval from FDA.
How FDA’s Intended Use Doctrine Shapes Your Nutraceutical Marketing
In today’s video, we discuss how FDA’s Intended Use Doctrine really shapes the potential market for your dietary supplement claims. We’ll also explain how the Intended Use Doctrine affects your marketing of dietary supplement or cosmetics product.
How the FDA Regulates Supplement Claims
In today’s video, we discuss how FDA regulates dietary supplement claims.
Does an App Count as a Medical Device?
In today’s video, we return to the topic of medical devices to address a more specific question: are apps medical devices? If you’ve seen our previous video on medical devices, you’ll recall the definition that medical devices had to be an instrument, apparatus, implement, etc. But a big question from our health and wellness industry clients working in the digital space is how an app fits in to all of this.
Medical Devices 101
In today’s video, we discuss medical devices and the basic information you need to know about them. Many of our clients have asked us how they are supposed to know whether something is considered a medical device or not, and what kind of regulations apply to medical devices.
Oceanic Wishes Health & Wellness Clients
In today’s video, I’m going to talk about the gap between the law and what you want to accomplish as a healthcare startup or a health and wellness practice or a healthcare company.
Dr. Seymour Heart on Keto Diets
In today’s video, we interview world-renowned cardiologist, Dr. Seymour Heart, on what he recommends to his patients for diet and nutrition
Stark vs Anti-Kickback vs Fee-Splitting
In today’s video, I’m going to speak extemporaneously about Stark Law and Anti-Kickback Law. Why? Because Stark and anti-kickback and fee splitting, also known generally as fraud and abuse, these issues come up again and again and again with every single healthcare venture.
Stark vs Anti-Kickback: The Key Differences
In today’s video, we return to the topic of Stark Law to discuss the differences between Stark and the Anti-Kickback Statute, because many of our clients have asked us about how these two features of the regulatory landscape relate to one another.
Stark Law Exceptions that Might Apply to You
In today’s video, we discuss some exceptions to Stark Law, which deals with improper referrals by physicians and healthcare practitioners.
Stark Penalties Stink: What to Watch Out For
In today’s video, we return to the topic of Stark Law to discuss what some of the penalties for violating Stark Law are.
Cannabis Legal Highs & Lows: FDA on CBD
In today’s video, we discuss CBD oil claims that are very common on the shelves, yet which the FDA has specifically warned will lead to FDA enforcement action.
CBD: How to Avoid FDA Enforcement
In today’s video, we discuss FDA enforcement against CBD product manufacturers and how to escape the jaws of the FDA.
CBD Oil Claims: The FDA Law Basics
In today’s video, we talk about marketing CBD oil products, and what FDA allows vs. what FDA prohibits.
Cannabis Laws 101
In today’s video, we discuss laws governing the cannabis industry. Many healthcare companies are rushing into the cannabis and CBD oil space, and they’re looking for legal counsel on what they can lawfully market (or not).
Q&A with Dr. Seymour Heart
An interview with world renowned cardiologist, Dr. Seymour Heart.
Key Points You Need to Remember About Fee-Splitting
In today’s video, we discuss fee-splitting, anti-kickback, Stark and anti-markup rules, and how these are all related.
What You Need to Know About Fee-Splitting
In today’s video, we discuss when fee-splitting occurs, specifically medical fee-splitting and including doctor fee-splitting in California.
The First Steps to Understanding Stark Law
In today’s video, we will be introducing you to Stark Law.
Can a Professional Medical Corporation Stop Corporate Practice of Medicine?
In today’s video, we discuss whether having a professional medical corporation can get you out of corporate practice of medicine enforcement.
What Practitioners Can Fit in My Professional Medical Corporation?
In today’s video, we talk about what healthcare practitioners you can mix and match in your professional corporation.
Why Do I Need a Professional Medical Corporation?
In today’s video, we discuss whether you need a professional medical corporation if you’re a licensed medical doctor.
Ways to Avoid False Advertising Pitfalls in Healthcare
Our law firm is getting so many questions related to these kinds of issues that we’re going continue on our series of false advertising including the California Business and Professions Code section 651 as well as federal law and we’re going to delve into more of the legal requirements from these different Codes.
FTC Regulations You Must Know for Healthcare Advertising
Lots of physicians and healthcare companies have had us reviewed their marketing materials, and inevitably, we’ve quickly spotted gaping holes where they’ve left themselves vulnerable to liability or regulatory exposure.
Federal Advertising Laws that Can Ruin Healthcare Businesses
The FTC requires all advertising to be truthful and backed up, meaning that all claims in the advertising must be substantiated. How do they assess this? They have a variety of ways. Just like we discussed with the California regulations before, the FTC will consider whether information omitted from an ad will mislead or deceive consumers.
Your Excellent Healthcare Legal Adventure: Learning and Growing From Your Legal Strategy Session
We love our clients, we appreciate them, and we wish that more people would take advantage of the opportunity to take a deep dive into ways that they can strategically handle the very complex legal and regulatory environment
Why Some Healthcare Startups and Practices Succeed While Others Fail: Legal Intel
We’ve counseled hundreds and hundreds of healthcare companies, ventures and practices over the last 30 years. I’d like to talk to you about the difference between what makes a successful healthcare venture grow versus what leads to an unsuccessful healthcare business venture. I can say this with confidence, because we’ve seen these same patterns, and trends over, and over, and over again amongst our healthcare clients.
Smart Healthcare Venture, Smart Legal Choices
We have great passion for what you’re doing for your business. We want to see you make smart choices and we’re there with you every step of the way.
Evangelizing your Health and Wellness Venture with your Angel Attorney
Healthcare Law is a Labyrinth. It’s a maze. It’s a regulatory maze. What makes us different? People come to us for legal strategies and solutions. We provide legal strategies and solutions to businesses and practices that accelerate health and wellness. And I’m excited about it.
Why Compliance is not a Secret Healthcare Lawyer’s Word
If you’re a healthcare company, whether you’re a healthcare start up or a mature healthcare company. You probably know that compliance is not a boring word. Compliance is something that you think about, it’s part and parcel of being in the health and wellness industry. It’s just what you do. It’s what you do as a company, you pay attention to compliance.
Political and Legal Shifts Harken Archetypical Health and Wellness Energetic and Spiritual Reversals
Hello. This is Michael H. Cohen, president and founder of Cohen Healthcare Law Group. And as you can see, I’m in my car. It’s just me talking to you, not exactly Jimmy Carter and his fireside chat but I am wearing a sweater, though not a sweater vest and albeit with a bit of neon underneath. It’s myself and my organic natural gluten-free state, here to report to you my latest thoughts on health and wellness and our evolution as a species and the evolution of law toward empowering health and wellness.
How to Empower the Arts of Healing through Law
Hello, this is Michael H. Cohen, President, and Founder of Cohen Healthcare Law Group. I have ditched the suit and tie for a more California look, here in lovely Carlsbad, overlooking some beautiful trees, and one of my corporate offices.
I’d like to talk to you about healing and healthcare, and health and wellness, why it’s such an amazing industry, and why we’re right there with you, passionately committed to improving health and wellness in this world.
Our Coaching Culture Helps You Navigate through Legal Compliance
Hello, this is Michael H. Cohen. Healthcare and FDA attorney and founder and president of the Cohen Healthcare Law Group. I was just sitting in my car driving on the way of Veggie Grill, when I’m sitting outside the lovely Veggie Grill here in this beautiful San Diego, with its sunny weather, and I was thinking about, how do we compete with the large law firms? Because I’ve been doing some SEO for my website, and I noticed that a lot of niche areas that I had successfully penetrated and thought I was pioneering…
Work Through the Thorny Knots of Healthcare Law
Hello, this is Michael H. Cohen, founder and president of Cohen Healthcare Law Group. I’d like to tell you why we are so passionate about the health and wellness industry, and why our team is dedicated to helping people, like you.
You see, we’re not just lawyers on the other side using our brains, and our heads, to help you think through weighty legal issues, thorny regulatory issues, enforcement hazards, liability challenges, and the thorny knots of the law sometimes imposes in the way of health and wellness businesses and practices.
How can MDs practice functional medicine without undue fear of legal risk?
Hello. Good morning. Good day. Good afternoon. Buenos Dias. Shalom. Wherever you are. I’m Michael H. Cohen, a healthcare and FDA lawyer. Today’s topic is how can functional and integrative medicine doctors practice without undue fear of legal jeopardy?
Functional Medicine & Multidisciplinary Clinic Legal Issues
Hello, this is Michael H. Cohen, I’m a healthcare and FDA attorney and the founder of and Michael H. Cohen Law Group. I’m going to talk today about multidisciplinary clinical healthcare practice. This is an issue that comes up again and again among my own clients. Typically you’ll have an MD or DL, a physician, collaborating with let’s say a chiropractor, an NP or some other kind of healthcare professional.
Health Coaching and Telemedicine
I’m spending an increasingly large percentage of my time counseling physicians who want to distance themselves from medical practice and move into more of a coaching world. Now, some physicians want to stay on the medical side. Others want to expand their practice and their role into more of an educator, assisting people with lifestyle changes and nutrition, but not serving in a clinical capacity.
Five Steps to Meet HIPAA Obligations and Privacy & Security Compliance
If you’re submitting claims electronically for reimbursement, you are under HIPAA. This subjects you to all the privacy and security obligations of HIPAA. Simply having an electronic medical record system that says, HIPAA Compliant, is not going to be enough.
Liability Protection & the Practice of Medicine for Non-Physicians
What’s the difference between a professional corporation and a general corporation, and why do you need each?
In most states clinical practice can only be provided through the professional corporation or PC. In this case a professional medical corporation. Using a professional corporation has several advantages:
Breaking Away Into Your New Practice and Common Insurance Issues
Let me talk for a moment about clarifying insurance issues.
If you are already employed within a hospital or medical group or within another medical setting and planning to breakaway, be sure to understand the existing arrangements that you may have with third party reimbursement carriers.
Avoiding Malpractice Through Strong Informed Consent Practices
Informed consent is critical in all areas of healthcare and medicine. It takes on even added importance when you’re suggesting a non-mainstream approach.
Safeguarding Your License & Avoiding Malpractice: Standard of Care in Integrative Medicine
Whether you’re practicing conventional medicine or integrative anti-aging or functional medicine, if there’s ever a hint of trouble medical boards will look to see whether you’ve covered the bases of standard of care. You may be using therapies or modalities that are not 100% mainstream. If so, you’ll want to follow these best practices.
Los Angeles Healthcare FDA Lawyer Regulatory Compliance
Los Angeles Healthcare & FDA Lawyer Michael H. Cohen speaks to nursing students about his interest in complementary, alternative, and integrative medicine and why he became a healthcare lawyer following his career as a Wall Street corporate lawyer and then professor at law schools and Harvard Medical School.
From Wall Street to Awakening: How to Bridge Your Passions & Expertise to Change the World
Julie Migneault, Energy Healer | Intuitive Coach, conducted this interview. Julie writes: “Have you ever wondered what you would do if you could bring your true talents and passions into your field of expertise? Do you have hidden passions that are asking to be expressed more fully? Michael H. Cohen journeyed from corporate Wall Street lawyer into a deep exploration of consciousness, meditation, yoga and healing. Bringing his passions and expertise together, he is now the leading expert on health care law, serving as a bridge between integrative and alternative medicine and the legal system.”
Telemedicine and Online Health: Legal & Regulatory Pathways to Future Medicine
Telemedicine legal expert Michael H. Cohen guides you through legal and regulatory pathways to future medicine, by describing legal barriers and opportunities facing online health and wellness ventures, including mobile health, e-health, e-wellness, and remote medical applications. Both U.S. and international start-up entrepreneurs must understand telemedicine, telehealth, and telepsychology legal issues when opening or operating Internet-based health companies.
Dietary Supplement Laws and FDA Regulations
Michael H Cohen, President of the Cohen Healthcare Law Group in Beverly Hills, California, discusses Dietary Supplement Laws and FDA Regulations. Michael H. Cohen is a healthcare and FDA lawyer who has taught at Harvard Medical School and written several books on legal rules governing integrative and complementary medicine.
Stark and Anti-kickback (Part 1): Self-Referral and Fee-Splitting
Stark and federal anti-kickback laws, and state self-referral, anti-kickback, and fee-splitting laws, continue to challenge healthcare providers and entities with their complex safe harbors and exceptions. Attorney, author, and speaker Michael H. Cohen explains the basics and how state self-referral and fee-splitting laws also have to be factored into any Stark and anti-kickback analysis. Not only physicians, but also medical spas and other entities in the health and wellness arena need to understand this nuanced area of healthcare regulation.
Stark and Anti-kickback (Part 2): Exceptions and Safe Harbors
Attorney, author, and speaker Michael H. Cohen explains exceptions and safe harbors for employment relationships, personal management contracts, space and equipment leases, and fair market value, under Stark and federal anti-kickback laws, and state self-referral, anti-kickback, and fee-splitting laws. These legal rules continue to challenge healthcare providers and entities with their complex safe harbors and exceptions. Not only physicians, but also medical spas and other entities in the health and wellness arena need to understand this nuanced area of healthcare regulation.
Stark and Anti-Kickback (Part 3): Compliance Tips
Attorney, author, and speaker Michael H. Cohen provides compliance tips relating to Stark and federal anti-kickback laws, and state self-referral, anti-kickback, and fee-splitting laws. These legal rules continue to challenge healthcare providers and entities with their complex safe harbors and exceptions. Not only physicians, but also medical spas and other entities in the health and wellness arena need to understand this nuanced area of healthcare regulation.
HIPAA in the Real World (Part 1): Why Compliance Matters
Healthcare & FDA lawyer Michael H. Cohen explains how HIPAA violations occur in the real world, and what HIPAA attorneys review to counsel clients in case of a data breach. Healthcare compliance is complex and demanding. HIPAA penalties have increased – so have HIPAA audits. Education is the best defense against expensive regulatory enforcement. Whether you’re a healthcare provider or someone who contracts with healthcare service providers (i.e., a business associate) and handles protected health information, learn about your HIPAA obligations and responsibilities.
HIPAA in the Real World (Part 2): Breach Notification
Michael H. Cohen, an attorney representing clients on legal issues in healthcare, wellness & lifestyle industries, describes breach notification and mitigation obligations relating to a HIPAA data breach. Organizations increasingly find themselves with compromised privacy and security of their protected health information (PHI). Knowing HIPAA regulations is a key to minimizing regulatory enforcement and organizational catastrophes.
HIPAA in the Real World (Part 3): Telemedicine & HIPAA
Focusing on telemedicine and HIPAA, healthcare lawyer Michael H. Cohen addresses the HIPAA compliance obligations of business associates and subcontractors. Under HIPAA, one who creates, receives, maintains, or transmits protected health information on behalf of another business associate is also a business associate and has HIPAA compliance obligations. In our growing telemedicine and mobile e-health economy, compliance liabilities increasingly fall on the IT vendors, consultants, billing companies, and even attorneys through whom electronic PHI flows.
HIPAA in the Real World (Part 4): Culture of Compliance
Healthcare & FDA lawyer Michael H. Cohen describes how training staff on HIPAA policies and procedures creates a culture of compliance to help minimize the potential for liability exposure.
Michael H. Cohen Health Care Lawyer for Psychologists
Healthcare attorney Michael H. Cohen explains how the psychology board, like the medical board, can discipline healthcare providers and expose them to liabilities at the boundaries of mental healthcare practice.
Complementary and Alternative Medicine Legal Issues
“Complementary and Alternative Medicine Legal Issues”, Presented by Michael H. Cohen at the Harvard Medical School Department of Continuing Education
Michael H. Cohen, a lawyer, returns to the theme of how federal (Medicare) and state law rules prohibit self-referral (Stark), fee-splitting, patient brokering by clinicians.
Unlicensed Medical Practice
Michael H. Cohen discusses legal issues related to unlicensed medical practice, fee-splitting, professional corporations, corporate practice of medicine, and the need for healthcare and business legal advice when structuring a medical spa or other clinical entity.
Anti-Kickback and Fee-Splitting Legal Rules
Michael H. Cohen, a lawyer, advises clients to get legal counsel before they run afoul of anti-kickback, self-referral (Stark), and fee-splitting legal rules.
Medical Spas – Legal Issues, Medical Board Issues
Michael H. Cohen discusses corporate practice of medicine laws, fee splitting and anti-kickback rules, legal rules relating to professional corporations, and whether laypersons can “hire” medical doctors.
Dietary Supplements and Natural Products
Michael H. Cohen, Attorney, describes legal rules for dietary supplements and natural products, including DSHEA compliant labeling, substantiation, and FDA and FTC rules applicable to claims in marketing materials.
FDA and FTC Legal Issues in Online Ventures
Michael H. Cohen discusses legal issues that Internet businesses face, including potential liability for false advertising, unfair and deceptive practices, and regulatory investigation.
Online Health Services and Products
Michael H. Cohen discusses legal issues arising with telemedicine and online health, including ventures involving dietary supplements, cosmetics, medical devices, and medical claims.
Multi-disciplinary Clinical Practices
Michael H. Cohen, a lawyer, discusses legal risks and liabilities in multidisciplinary clinical practices, such as collaborations between medical doctors, chiropractors, naturopathic physicians, and other integrative care professionals.
Medical Board Discipline & Integrative Medicine
Michael H. Cohen, healthcare attorney, discusses informed consent forms and legal strategy to minimize risk of medical board discipline based on allegations of standard of care violations.
Complementary and Alternative Medicine Legal Issues
Michael H. Cohen, a lawyer, talks about legal issues surrounding complementary and integrative medicine, such as nutritional therapies, homeopathy, functional medicine, and mind-body medicine.
Psychology, Life Coaching Legal Issues
Attorney Michael H. Cohen discusses the legal borderland between psychology and life coaching and legal issues pertaining to unlicensed practice.
Standard of Care Issues in Healthcare Practice
Michael H. Cohen, Attorney-at-Law, describes how standard of care, licensing, and related legal rules affect professional healthcare practice.
Michael H. Cohen recommends seeking experienced legal advice when confronting a Board investigation, to negotiate difficult legal situations with the help of counsel.
Healthcare Legal Issues
California healthcare lawyer Michael H. Cohen describes a day in the life representing conventional medical practitioners as well as complementary and alternative healthcare providers.
Complementary and Alternative Medicine
Michael H. Cohen talks about his first book, Complementary and Alternative Medicine: Legal Boundaries & Regulatory Perspectives, which puts together key laws concerning integrative healthcare.
Legal and Ethical Perspectives on Healthcare and Human Evolution
Business and healthcare attorney Michael H. Cohen points the way to the future of healthcare and the legal parameters of a paradigm shift to energy medicine.
Legal Issues in Complementary Healthcare
Healthcare lawyer Michael H. Cohen discusses “Beyond Complementary Medicine,” his book about legal issues affecting the integration of complementary and alternative medical therapies into hospitals and mainstream healthcare systems, even as healthcare reform transforms the medical system.
Nutritional Practice – Legal Issues
Attorney Michael H. Cohen discuses legal issues relating to the practice of nutrition (and nutritional advice) by licensing nutritionists, other licensed healthcare providers, and non-licensed practitioners.
Telemedicine Legal Issues
Michael Cohen, healthcare lawyer, speaks about telemedicine – “the medicine of the future” – and associated legal and regulatory issues.
Life Coaching and Psychology Licensure
Michael Cohen, healthcare attorney, speaks about life coaching and psychology, and legal gray areas affecting licensed clinical practice and non-licensed therapies.
Michael H. Cohen, Business and Healthcare Attorney
Michael Cohen, Los Angeles, California healthcare and business lawyer, provides clear legal advice to grow your business.
The Practice of Integrative Medicine: A Legal and Operational Guide
Michael H. Cohen, former Harvard faculty and lead author of “The Practice of Integrative Medicine: A Legal and Operational Guide, talks about legal issues in integrative medicine.
How Can You Transform an Idea into a Business?
Attorney Michael H. Cohen describes how to turn your great idea into a successful business in this video from LegalZoom’s Lawyer in 60 Seconds series.
How Is an LLC Different than an Incorporation?
Attorney Michael H. Cohen explains the differences between an LLC and corporation, so you can choose the right structure for your business.
What Is the Best Way to Choose the Correct Business Structure?
Attorney Michael Cohen explains the differences between LLCs, corporations, and DBAs so you can choose the legal business structure that’s right for you. The Lawyer in 60 Seconds series is brought to you by LegalZoom.