Table of Contents
- Health Coaching and Telemedicine
- Five Steps to Meet HIPAA Obligations and Privacy & Security Compliance
- Liability Protection & the Practice of Medicine for Non-Physicians
- Breaking Away Into Your New Practice and Common Insurance Issues
- Avoiding Malpractice Through Strong Informed Consent Practices
- Safeguarding Your License & Avoiding Malpractice: Standard of Care in Integrative Medicine
- Los Angeles Healthcare FDA Lawyer Regulatory Compliance
- From Wall Street to Awakening: How to Bridge Your Passions & Expertise to Change the World
- Telemedicine and Online Health: Legal & Regulatory Pathways to Future Medicine
- Dietary Supplement Laws and FDA Regulations
- Stark and Anti-kickback (Part 1): Self-Referral and Fee-Splitting
- Stark and Anti-kickback (Part 2): Exceptions and Safe Harbors
- Stark and Anti-Kickback (Part 3): Compliance Tips
- HIPAA in the Real World (Part 1): Why Compliance Matters
- HIPAA in the Real World (Part 2): Breach Notification
- HIPAA in the Real World (Part 3): Telemedicine & HIPAA
- HIPAA in the Real World (Part 4): Culture of Compliance
- Michael H. Cohen Health Care Lawyer for Psychologists
- Complementary and Alternative Medicine Legal Issues
- Fee-Splitting Legal
- Unlicensed Medical Practice
- Anti-Kickback and Fee-Splitting Legal Rules
- Medical Spas – Legal Issues, Medical Board Issues
- Dietary Supplements and Natural Products
- FDA and FTC Legal Issues in Online Ventures
- Online Health Services and Products
- Multi-disciplinary Clinical Practices
- Medical Board Discipline & Integrative Medicine
- Complementary and Alternative Medicine Legal Issues
- Psychology, Life Coaching Legal Issues
- Standard of Care Issues in Healthcare Practice
- Board Investigations
- Healthcare Legal Issues
- Complementary and Alternative Medicine
- Legal and Ethical Perspectives on Healthcare and Human Evolution
- Legal Issues in Complementary Healthcare
- Nutritional Practice – Legal Issues
- Telemedicine Legal Issues
- Life Coaching and Psychology Licensure
- Michael H. Cohen, Business and Healthcare Attorney
- The Practice of Integrative Medicine: A Legal and Operational Guide
- How Can You Transform an Idea into a Business?
- How Is an LLC Different than an Incorporation?
- What Is the Best Way to Choose the Correct Business Structure?
In today’s video, we talk about the relationship between the MSO and the professional medical corporation—or in the case of mental health, it might be a psychological or behavioral health corporation—this is a scenario we know well.
In today’s video, we return to the puzzle of how the MSO brands its enterprise, given that the licensed medical doctor calls the shots for the professional medical corporation in the venture.
Right here, on today’s video, we are going to help unlicensed (or non-licensed) practitioners understand how prohibitions against unlicensed practice of medicine might or might not constrain their services or facilitate them.
This is a California-specific law. And many states already recognize nurses and provide nurses with the authority to practice autonomously. California was one of those holdout states that didn’t for years until now. And I’ll say that with caveats because I’ll explain kind of what the deal is here in California going forward.
In today’s video, we address whether a physician can legally invest in a pharmacy that is owned by a startup that provides online telehealth services, including diagnosis and prescription based on a questionnaire to its customers.
In today’s video, we dive deep into some of the laws governing medical spa and physician supervision of nurses.
In today’s video, we return to physician supervision of nurses within a medical spa.
In today’s video, we talk about a proposed partnership between a licensed medical doctor and a nutritionist, chiropractor, etc.
In today’s video, we’ll talk about a healthcare startup that wants to buy a medical or psychological or chiropractic practice and/or let’s just say partner with an MD, NP or RN, psychologist, or chiropractor.
In today’s video, we give a brief refresher on the difference between Stark and anti-kickback laws.
In today’s video, we describe legal strategies to help your telehealth, tele-counseling practice flourish.
In today’s video, we discuss key legal issues faced by a recent medical spa client.
In today’s video, we discuss legal issues related to health coaching and unlicensed medical practice.
In today’s video, we discuss what you need to know if you’re a healthcare company or coach who need a consent form.
In today’s video, we look again at whether physician prescription by telemedicine is legal. But this time we are going to zoom in on FDA and FTC issues.
In today’s video, we talk about the slippery slope between practicing medicine, on one hand, and hanging up your physician or psychology or other license hat and doing health coaching, on the other. Today we’ll look at a business model that involves interpreting what other doctors or clinicians are saying and then translating that advice into plain English, following that by coaching patients on how to navigate their medical or psychological journey.
In today’s video, we ask: what are some key legal strategies that a multi-disciplinary health and wellness, mobile platform or app can deploy to handle legal risks?
In today’s video, we address a subscription-model healthcare startup that has the RN or Registered Nurse do the heavy lifting when it comes to signing up patients, visiting them at home and getting them to do the paperwork, administering medication and injections, a whole lot more, basically turbo-charging the profitability of that healthcare startup.
In today’s video, we look at a telehealth startup that has physicians prescribing remotely or digitally, and also gets solicited to become investors in the startup.
In today’s scenario, a psychiatrist desires to prescribe ketamine to psychiatric patients for mental health, via telemedicine. The psychiatrist wishes to prescribe across states yet is only licensed in California. What legal risks present, and how should a healthcare attorney guide this kind of a physician client?
In today’s video, we talk about the thorny question of whether bonusing staff on a per-patient business is legal or legally risky.
In today’s video, we discuss whether acupuncture laws allow remote practice or digital practice by telehealth.
At a surface level this is a story of professional development whose roots go deep into my childhood, the fact that I’m I healthcare lawyer.
Each and every week we get at least several new IV hydration, nutritional therapy and weigh management types of clients coming to us for legal advice.
Clients with medical spas, IV hydration clinics, and health and wellness centers often come to us wondering how to structure their venture with a physician. Sometimes it’s the healthcare entrepreneur who comes to us, sometimes a nurse in search of a collaborating physician, or a psychologist, social worker, nutritionist, or health coach.
In today’s video, we talk about disclaimers for a health coaching website. You might think a disclaimer is a disclaimer is a disclaimer, but there are some nuances.
Many medical spa, IV hydration, and health and wellness center clients call us with this question: can you help us with “entity formation”? Which entity should I use?
You have a health and wellness product and you’re wondering whether FDA will likely regulate it as a dietary supplement, a cosmetic, or a prescription drug. So many products out there seem to blur the lines and by the way, they’re sold online with outrageous claims.
We’re awash–pardon the pun–in medical spas, IV hydration centers, nurses opening healthcare practices, multidisciplinary centers, and health and wellness groups of all types. This stuff is exploding around the country.
Can a chiropractor employ a licensed medical doctor? The question reminds me a tee-shirt I once saw which said: “Can I pay my Mastercard with my VISA?”
In today’s video, we revisit a healthcare startup that wants to do telemedicine (but really telehealth) but they want to stay within the coaching model. So, is this possible? Is it okay to have a telemedicine that isn’t really “medicine?”
Nurses today are asking our law firm what are the upcoming big changes to nursing scope of practice in California from AB 890.
To be or NOT to be a Medical Director. That is the question. Recently we advised a physician who had received a terrific offer to become a medical director. The clinic itself was owned by a nonphysician in California.
So many medical spas and IV hydration clinics are opening, everyone wants to know the steps they need to take to launch. What agreements are necessary, what partners do you bring in, what do you do about a lease, where do you start?
In today’s video, we look at some of the convoluted, quirky paths that teletherapy laws and regulations can take.
In today’s video, we return to the legal twists and turns of health coaching.
In today’s video, we talk about how a disclaimer can help with you if you’re doing health coaching, even if you’re a medical doctor doing health coaching, chiropractor, psychologist, nursing professional, or other healthcare provider who wants to style themselves a health coach.
In today’s video, we’ll talk about how anti-kickback and fee splitting concerns permeate healthcare arrangements, and some ways to spot arrangements that potentially violate these laws, vs. those that are more likely to survive enforcement.
In today’s video, we are going to discuss patient brokering, fee-splitting and kickbacks.
In today’s video, we turn back to the question of physician prescription online, but this time, we will focus on comparing some of the telemedicine laws across different states.
In today’s video, we take a different tack on the question as to whether physician prescription by telemedicine is legal, illegal, or something in the middle. Let’s focus in on controlled substances. The prescription might involve, say, ketamine, testosterone, estrogen, or any controlled substance.
In today’s video, we return to the question as to whether physician prescription by telemedicine is legal or not.
Let’s say that you’re a telehealth company and you’ve got some complicated healthcare, regulatory, legal, and compliance questions. You’ve got HIPAA you’re concerned about, but maybe you have a vendor taking care of some of that, but still, you might be using the data in unusual ways. You’ve got some corporate practice of medicine concerns in states that have really sticklers about CPM and fee-splitting.
What’s the difference between using the MSO model on one hand or the Moscone-Knox Professional Corporation Act on the other? People sometimes get these two confused. So I’m going to give you a very quick overview.
In today’s video, we talk about whether and how an MSO can operate a medical practice. The key here is, what do we mean by the term, “operate?” Are we talking about the business side, the clinical side, something in-between?
What’s your story? Why are you doing what you’re doing? Why are you devoting so much of your time and energy and breath and resources and late nights thinking about your health and wellness venture? Sometimes people ask me, what’s your story, Michael, how did you get into being a healthcare lawyer?
In today’s video, we address legal issues and legal risk mitigation for clinical practices that prescribe bioidentical hormones or have a functional medicine or integrative medicine approach.
In today’s video, we talk about even more common labeling mistakes that dietary supplement manufacturers and distributors make when making marketing claims for their products.
In today’s video, we return to one of my favorite subjects, common labeling mistakes that dietary supplement manufacturers and distributors make when creating marketing claims for their products.
Here’s today’s scenario. Joe is someone who took biology, chemistry, thought about going to medical school, but didn’t do so. Didn’t get a license although he’s got cousins that are nurses and doctors and psychologists, maybe Joe’s ABD with a psychology PhD.
Today, I’d like to talk about some key questions related to telehealth. Does telehealth use the MSO model, and are telemedicine companies and platforms essentially MSOs, and who cares? why does this matter?
In today’s video, we talk about whether a healthcare startup that connects doctors and patients can charge patients a software access fee.
In today’s video, we discuss more basics of federal and state anti-kickback and fee-splitting prohibitions.
In today’s video, we talk about how a health coaching disclaimer is different from a medical consent, and when you should use one versus the other.
In today’s video, we discuss the basics of federal and state anti-kickback and fee-splitting prohibitions.
In today’s video, we talk about legal risks and risk mitigation related to provision (once again) of IV therapies—and we focus on Federal Trade Commission (FTC) enforcement around false advertising charges.
In today’s video, we return to legal risks and risk mitigation for a healthcare startup deploying IV therapies.
In today’s video, we return to legal issues in functional medicine and anti-aging practices, including IV therapies.
In today’s video, we talk about laws governing mobile patient services such as IV hydration, vitamins, and concierge medical spa services like Botox.
In today’s video, we discuss how Telemedicine Startup Kickback & Fee-Splitting Laws are going to shape your healthcare venture.
In today’s video, we discuss how the MSO model can support a healthcare startup, let’s say for Women’s Health or Men’s Health or any other kind of specific medical concept.
In today’s video, we shed more light on the substantive legal issues in a per-click or software fee for telemedicine patients.
In today’s video, we’ll talk about some more not so obvious ways that FDA can classify your dietary supplement as a drug.
In today’s video, we’ll talk about some not so obvious ways that FDA can classify your dietary supplement as a drug.
In today’s video, we discuss what’s involved in an FDA label review. Typically, a client comes to us with a proposed dietary supplement product and asks us something like, “can you please tell me what it would take to review our labels?”
In today’s video, we’ll help you further understand some of the important FDA rules around medical devices.
In today’s video, we help you further understand potential exposure to the legal and regulatory quagmire of FDA and FTC liability.
In today’s video, I’ll help you understand potential exposure to the legal and regulatory quagmire of FDA and FTC false advertising liability.
In today’s video, we talk about some of the legal lines between the practice of medicine and psychology, and health coaching.
In today’s video, we help you further understand some of the important FDA rules around labeling your product.
In today’s video, we help you further understand some of the important FDA rules around labeling your cosmetics product.
In today’s video, we discuss key legal issues facing a multidisciplinary healthcare center that includes a medical doctor, a chiropractor, a health coach, a nurse, psychologist, behavioral health counselor, nutritionist, physical therapist, and other practitioners.
In today’s video, we discuss some key questions that clients bring to us when they have a new dietary supplement or cosmetic.
In today’s video, we discuss the “friendly PC” model and how PCs and PLLCs, or Professional Corporations and Professional Limited Liability Companies, can work with MSOs without getting shredded by regulators.
In today’s video, we talk about how we helped one telehealth practice navigate a range of legal issues including Stark and anti-kickback, fee-splitting, consents, and business structure questions.
In today’s video, we talk about the free legal consult that is a hook for many healthcare ventures. Go fish.
If you’re someone who is publishing a book or e-book on health and wellness and you’re looking at a lot of media opportunities, and you’re concerned about your potential liability, then this video is for you.
In today’s video, we discuss how investors can profit from businesses that deliver clinical services—and where they get themselves in trouble.
Dietary supplement claims are the focus of today’s video: when you want to market a dietary supplement product, what are the basic FDA rules that you need to follow?
In today’s video, we discuss health coaching and whether health coaches can carve out a professional niche that doesn’t create undue risk of enforcement for unlicensed practice of medicine, psychology, or nutrition.
In today’s video, we talk about the question healthcare startups and mature healthcare companies routinely ask us: How do we know if we’re a good fit?
In today’s video, we talk about the regulatory issues that healthcare startups can face, and why it’s important to understand that these regulatory risks can trip up the healthcare venture.
After some preliminary material in the physician employment agreement we’ve talked about elsewhere, there’s an all-important section describing the medical doctor’s compensation.
In today’s video, we tell you about key legal challenges associated with a multidisciplinary, integrative healthcare practice that has an MD (medical doctor), and a DC (chiropractic doctor), and other practitioners like nurses, psychotherapists, behavioral health counselors, acupuncturists, naturopathic doctors, and other healthcare licensees.
In today’s video, we talk about more common labeling mistakes that dietary supplement manufacturers and distributors make when creating marketing claims for their products.
In today’s video, we discuss the basics of federal Stark law, and the anti-kickback and fee-splitting prohibitions.
In today’s video, we discuss how corporate practice of medicine fears still shape healthcare startup decisions about how to structure their digital health business, and we talk about the MSO model as a tried and tested option.
In today’s video, we talk about how a physician can have a dual role, one is treating the patient and the other is providing online education.
In today’s video, we talk about how physicians can tackle the legal and regulatory issues that often arise with health coaching.
In today’s video, we talk more about legal risk mitigation for physicians, chiropractors, and other clinicians who want to do health coaching.
So you’d like to create an MSO for a telemedicine company, so what’s the best way to do this?
In today’s video, we discuss some of the legal perils involving IV hydration therapy and potential legal strategies and solutions.
In today’s video, we discuss how one client handled the legal uncertainty regarding the claims he could make for his new dietary supplement, which happened to involve the arena of brain health.
In today’s video, we talk about legal issues raised by IV hydration therapy, in particular in the area of COVID-19 aka coronavirus.
In today’s video, we talk about how to choose a healthcare and FDA law attorney. How do you choose your healthcare or FDA law attorney?
In today’s video, we discuss how a behavioral health therapist might do telehealth across states.
In today’s video, we discuss whether in a post-COVID world, telemedicine licensing laws will be easier.
In today’s video, we discuss three top legal strategies for medical spa compliance. We have three tips for you today, legal strategies that potentially can pay off in terms of lowering your overall compliance risk.
In today’s video, we discuss whether COVID relaxed telemedicine laws.
In today’s video, we discuss one of the big traps that a healthcare provider in the U.S. can run into when trying to expand its clientele by positioning itself to take advantage of the growing trend of medical tourism and seeing patients from abroad.
In today’s video, we discuss key mistake medical spas are making in their legal compliance, and how medical spas can thrive instead of floundering in the complicated legal maze.
Hello, this is Michael H. Cohen, founding attorney of Cohen Healthcare Law Group. I’d like to take this opportunity to express my appreciation and gratitude to you, to all of our clients who have been with us during the past year.
In today’s video, we discuss some legal foundations for your integrative and functional medicine telehealth practice.
In today’s video, we’ll talk about how FDA can classify your dietary supplement as a drug, subjecting you to enforcement that might require you to stop selling your product, and at a minimum will require significant rebranding.
In today’s video, we discuss the dangers of marketing products without proper legal review—in this case, not just FDA enforcement, but even more significantly, FTC (Federal Trade Commission) action. We talk also about ways to manage FTC enforcement risk when you have your FDA and FTC attorneys review your Web, your online and digital marketing copy.
In today’s video, let’s talk some more about FDA and FTC issues in consumer products that focus on health, wellness, lifestyle or fitness.
In today’s video, we discuss how FDA regulates direct-to-consumer tests, tests that are marketed directly to consumers without the involvement of a health care professional, like the patient’s medical doctor.
In today’s video, we discuss whether physicians something that many of our physician clients have asked us about, namely, whether they can operate and open their own pharmacies or even have ownership interest in a pharmacy.
In today’s video, we discuss how a distributor of a health and wellness consumer product (it could be you) bought themselves a lawsuit, when they purchased an FDA-registered, Class 1 medical device and promote it on their website.
In today’s video, we talk about some secret that health coaches must know before launching on the market and getting in trouble with the law for health coaching.
In today’s video, we return to the topic of a medical doctor who does health coaching.
In today’s video, we discuss healthcare legal compliance challenges that an online health and wellness company might face.
In today’s video, we return to the question of health coaching and whether licensed medical doctors, psychologists, marriage and family therapists, behavioral health specialists and counselors, can call themselves “health coaches” and provide mental and behavioral health services online.
In today’s video, we discuss healthcare legal compliance challenges that a healthcare startup might face when it ventures into digital healthcare, and advises its customers on healthcare and lifestyle choices, using health coaches or life coaches.
Dr. Bob Smith came to our law firm, he was a hospital physician with 15 years’ experience. The hospital let go a lot of its staff, and Dr. Bob decided to open a telemedicine practice focusing on functional medicine, emphasizing nutrition, dietary supplement, and lifestyle.
In today’s video, we discuss what are the minimum number of times per year and that a physician must see a patient, in-person, prior to treating the patient via telehealth?
Is it a crime to give people information about alternative complementary integrated therapies that could potentially be a benefit to them? Is it against the law? Is it a statutory violation?
In today’s video, we discuss disease claims for dietary supplements, and the major enforcement risk that would get raised if you made them for your supplement product.
In today’s video, we discuss whether you need a specific type of consent form to offer patients telemedicine or telehealth services.
Any health and wellness company not strong or tough enough to take the FTC pain, should have its marketing materials reviewed by legal counsel before putting them up on the Web.
In today’s video, we talk to those of you who want to make functional medicine work in a virtual healthcare, telehealth, telemedicine platform, that means without seeing the patient in person.
In today’s video, I’ll give you three legal tips for physicians forming a business.
In today’s video, we discuss healthcare law issues in a digital, telehealth functional medicine practice or business.
In today’s video, we’ll talk about how the FTC handles weight loss claims—and we’re not referring to “love” handles, either. We’ll also give you some legal risk mitigation ideas.
In today’s video, we talk about how medical spas and medical practices handle some of the legal issues with regenerative medicine, and stem cell therapies.
Joe, not the plumber, but the app developer, has an app that combines virtual reality health coaching, personal fitness training and nutritional advice. Joe has come to us for legal advice because of our expertise in health and wellness businesses. What does Joe need?
In this video, we’ll discuss an app that combines virtual reality health coaching, together with personal fitness and nutritional advice and much more. What are the regulatory pitfalls and possible workarounds?
How can a functional medicine doctor create a concierge medicine model for their patients?
There are two important legal tools here: (1) your informed consent form, and (2) your membership agreement with the patient.
In the last video, we were talking about Dr. Bob who got a two-million-dollar contract with a hospital to provide telemedicine services. Unfortunately, Dr. Bob didn’t get the last bit of legal advice he needed. He skimped on the small retainer and found the hospital later exacting a million-dollar penalty. How did this all play out, and what can we learn from this unfortunate scenario?
What can an MSO, a Management Services Organization, do to augment your healthcare compliance?
In this video, we talk to our physician clients about key protections that you’ll want to include in your employment agreement. Now, if you’re a medical practice or medical group, you’ll also want to know what provisions to include on your side of employment agreement.
In today’s video, we discuss whether being “Medical Director” is a Legal Trap for your Medical Spa. By the end of today’s video, you’ll get a sense as to whether it’s a good or bad idea to have a “medical director” in your medical spa, or to be a physician who acts as a medical director for a medspa.
By the end of today’s video, you’ll learn about a super-sneaky trick that was played on somebody who had a contract partly reviewed, but didn’t get the potion of legal advice all the way, so there was not enough.
In today’s video, we’ll talk about how to inoculate yourself against Corporate Practice of Medicine kryptonite, using some sound legal risk mitigation tools and tips.
In this video, we walk you through how we worked with a recent client, a physician who has a telemedicine practice and a management services organization, also known as an MSO.
Why do you need, or want to hire a healthcare lawyer? Why get someone who understands health and wellness law, FDA law? Not just let your business lawyer handle your healthcare practice issues or your health and wellness venture, whether it’s telehealth, mobile medical app, digital platform, or some kind of idea that mediates healthcare and the consumer through technology?
These days, everybody’s into public health. It’s obviously a topic of concern. Everybody wants to know about virology and how we can get healthier. So, being a healthcare lawyer is very occurrent right now. Why is it that we practice healthcare law, and what does this mean to you?
In today’s video, we discuss certain healthcare business models incorporating medical devices that might have to deal with FDA rules on those devices.
2:12 AM here and I had this dream. I went to an islander retreat site, the captain of the bus was telling me about the pandemic conditions. My son was there, but then the dream was about me. I found myself alone at the site. It was deserted out there and a woman’s face was dissolving into the sand. The sea was rushing in, the captain was saying, “This is all about fear.”
In today’s video, we discuss the subject of corporate practice of medicine. Plenty of clients come to us having heard this very anachronistic term and ask us to help them understand what it means for them. Corporate practice of medicine, right? So it has something to do with the big healthcare companies, maybe the giants in healthcare industry? Not quite – but we’re going to unpack it together, make it very digestible.
In this video, we talk about some of the foundational legal documents you will need when you decide to implement a membership model for your medical practice or other healthcare clinical operation.
In today’s video, we discuss the difference between “Healthcare Lawyer” and “FDA Lawyer” and what the distinction means in terms of your potential needs. Many of our clients upon watching our videos or reading our website take notice when we say “Healthcare and FDA lawyers” and they ask us whether these are the same thing, whether they cover totally different areas, or something in between.
In today’s video, we talk more about what to do and what to do and NOT to do, if you’re a physician who is leaving someone else’s medical group, or medical practice, where you’ve been happily employed until you decide to no longer be employed there.
Can a Physician Assistant run your medical practice? By the end of today’s video, you’ll know whether this wish corresponds with reality. We’ll walk through some of the legal compliance fine points, and, danger zones.
Happy New Year, Happy New Decade! As someone dedicated to health and wellness, to really making a difference in the world, we join you in saluting this new energy of transformation that is coming our way in the healthcare industry.
In today’s video, we discuss a few of the ways a medical practice can be affected by choosing to opt out of Medicare.
In today’s video, we talk to the physician or chiropractor some more about what to do and NOT to do when you are leaving someone else’s medical group, medical practice, integrative medicine center, functional medicine center, health and wellness group, whatever it’s called, where you’ve been, up until now, gainfully employed.
Doctors and nurses and standardized procedures, oh my! Well it doesn’t quite have the same resonance as Dorothy’s chant in Wizard of Oz, but doctors and nurses and standardized procedures really do go together well, and, they lurk out there in the wild woods of compliance land, especially for medical spas and similar healthcare ventures. By the end of today’s video, you’ll know some key compliance pointers that help keep medical spas out of enforcement jujitsu.
In today’s video, we discuss healthcare legal compliance challenges that an online health and wellness, telemedicine company might face.
In today’s video, we discuss medical spa compliance and legal tips and strategies to help you get over the medspa compliance blues. By the end of today’s video, you’ll learn top enforcement hot buttons and how to mitigate legal and regulatory risk for your medical spa.
In today’s video, we talk about laws governing nonsurgical medical cosmetic procedures. Let’s break that down: these are procedures that are nonsurgical, so they don’t involve surgery.
Delegating in your medical spa can be a money-maker; it can also create compliance woes and legal exposure. In today’s video, we talk about some of the compliance do’s and don’ts, especially under California law.
Business Associate Agreements, or BAAs, are all the rage these days. As in rage against the machine, the giant multi-tentacled gleaming metallic horror that is popularly known as the Health Insurance Portability and Accountability Act, or HIPAA.
Who could legally own a medical spa? That’s the question we address in today’s video. By the end of today’s video, you’ll understand how medical doctors and healthcare entrepreneurs use the MSO (or management services organization) model to mitigate the considerable enforcement attention to medical spa operations.
In today’s video, we provide general guidance to medical doctors and medical spas about handling laws and regulations governing regenerative medicine and stem cell practice.
California Anti-kickback and Fee-Splitting Law for Smarties is the subject of today’s video.
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.
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.
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.
In today’s video, we discuss how FDA and FTC substantiation rules can ensnare, derail, and detonate dietary supplement and cosmetics companies.
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.
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.
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 shares his thoughts on Health Care reform
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.
In today’s video, we discuss how FDA regulates cosmetics claims, and the risk that FDA could regulate your cosmetics as 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.
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.
In today’s video, we discuss how FDA regulates dietary supplement claims.
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.
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.
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.
In today’s video, we interview world-renowned cardiologist, Dr. Seymour Heart, on what he recommends to his patients for diet and nutrition
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.
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.
In today’s video, we discuss some exceptions to Stark Law, which deals with improper referrals by physicians and healthcare practitioners.
In today’s video, we return to the topic of Stark Law to discuss what some of the penalties for violating Stark Law are.
In today’s video, we discuss FDA enforcement against CBD product manufacturers and how to escape the jaws of the FDA.
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.
In today’s video, we talk about marketing CBD oil products, and what FDA allows vs. what FDA prohibits.
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).
An interview with world renowned cardiologist, Dr. Seymour Heart.
In today’s video, we discuss fee-splitting, anti-kickback, Stark and anti-markup rules, and how these are all related.
In today’s video, we will be introducing you to Stark Law.
In today’s video, we discuss when fee-splitting occurs, specifically medical fee-splitting and including doctor fee-splitting in California.
In today’s video, we discuss whether having a professional medical corporation can get you out of corporate practice of medicine enforcement.
In today’s video, we talk about what healthcare practitioners you can mix and match in your professional corporation.
In today’s video, we discuss whether you need a professional medical corporation if you’re a licensed medical doctor.
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.
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.
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.