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.
The law recognizes a difference between:
- Health education and information
- Clinical practice (medicine, chiropractic, acupuncture, psychology and mental health care counseling, dentistry, nursing, and so on)
Legal and regulatory issues come into play as we further develop longevity medicine and anti-aging through the combination of technological approaches, such as:
- Nanotechnology
- Robotics (and nanobots for health)
- Genomics and nutritional genomics
- Scientific study of epigenomic effects
- Neurotech, including wireless medical device technologies and wetware
- Other scientific methods based on technological breakthroughs
- Personalized, DNA-based medicine
- Medical spa, anti-aging and longevity therapies that involve stem cells
And high-touch, compassion-based, humanistic, and complementary therapies, such as:
- Manual therapies (including chiropractic, osteopathic medicine and massage therapy)
- Biofield therapies (such as Reiki, polarity therapy, and other forms of energy healing and energy medicine)
- Color and light therapies, sound therapy, music therapy, art therapy
- Spiritual and mind-body therapy
- Alternative approaches to health, wellness, and lifestyle
- Risk reduction through lifestyle choices
- Targeted nutritional products
For example, multidisciplinary clinical approaches require legal vetting for such regulatory issues as:
- The corporate practice of medicine doctrine (prohibition against non-physicians hiring doctors)
- Anti-kickback, self-referral and fee-splitting laws
- FDA rules governing dietary supplements, medical devices, cosmetics, and claims / indication for use
- Legal rules governing management agreements, marketing arrangements, cross-referrals between practitioners, and ownership of entities
- Insurance and third-party reimbursement issues; billing and coding
It is important to address these legal issues when addressing, for example, such emerging diagnoses as metabolic syndrome, which emerge from clusters of symptoms as well as cultural developments (i.e., the obesity epidemic, standard American diet, etc.), or when diagnosing and treating lifestyle-related illnesses such as diabetes and cardiovascular disease.
Also it is critical to address issues such as:
- Overcoming legal obstacles to concierge medicine, boutique medicine, or retail medicine
- Understanding legal rules that can affect packaging services and offering patients discounts on services
- Legal rules governing the business of insurance, and definition of health care plans
Our law firm has been at the forefront of legal and regulatory developments governing multidisciplinary clinical practices and entrepreneurial ventures in emerging healthcare spaces. We understand laws governing anti-aging clinics and longevity practices, and the wide variety of legal rules applicable to new healthcare ventures. Contact our healthcare attorneys today for a legal consultation.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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