CAMLAW: Complementary and Alternative Medicine Law Blog

Round Up The Usual Disclaimers

I have modified one of the famous closing lines from Casablanca, "round up the usual suspects," to "round up the usual disclaimers."

Basically, one of the essential skills of any health care law attorney or business lawyer is breaking down a business problem into the relevant legal issues, and then tackling the legal issues one by one in a thorough analysis that is clear and helps the client make a critical business judgment.

Not everything can be answered at once.  Sometimes it is useful to say what a legal analysis has not addressed.  

Below is a fairly comprehensive list of issues that can be incorporated in a disclaimer.  In other words, these issues are disclaimed to the extent not explicitly discussed in the memo.

 

·         Issues relating to direct or vicarious liability for the specific practices and therapies of other practitioners working with or within the entities described in this memo.

·         Issues relating to scope of practice, unauthorized medical practice, or aiding and abetting unauthorized medical practice by any practitioner affiliated with the described entities other than as already discussed in this memo.

·         Insurance issues including billing, coding, and special issues pertaining to Medicare patients.

·         Potential liability relating to negligent credentialing other than as already discussed in this memo.

·         Employment law issues including whether clinicians and staff should be hired as independent contractors or employees under relevant state law.

·         HIPAA and other State and federal privacy and confidentiality concerns.

·         Compliance with FDA and FTC health claims regulations and other potential concerns, such as language that guarantees a result or other common legal pitfalls, associated with website and marketing materials.

·         Tax issues.[1] 

·         Permits, permission or registration required for the facility.

·         OSHA and relevant state law rules with respect to safety matters (such as, but not limited to, the disposal of acupuncture needles).

·         Securities law issues (federal and state) relating to equity investment in any of the described entities.

·         Franchise law or seller-assisted marketing issues (federal and state) relating to duplicating the clinic in other locations.

·         Any other matters specifically disclaimed elsewhere in this memo.

Of course, we try to keep our legal memos concise, clear, and to the point.  No client wants a bunch of excess verbiage; the whole point is to be effective and cost-effective.  Part of being clear involves mentioning what's on the table and what is not.

This may seem like a long list, but it also helps us chunk a project into parts so that we establish a fee structure that works within clients' resources and helps target our work to exactly what they need.


[1] Regarding the proposed entities and compensation arrangements, we recommend review by an accountant for tax consequences, and we make no assertion or claim regarding tax benefits or liabilities.

See also Does my outpatient clinic need a facility license?

 


If you have legal questions concerning telemedicine and telehealth practices in New York, California, Massachusetts, Washington DC, and other states, contact a lawyer who knows the rules.

Consult an experienced health care law attorney who knows complementary medicine and integrative medicine for legal advice pertaining to any project involving allied health or CAM professionals.

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Our law office has attorneys with legal experience  in FDA matters, including guiding  clients involved in health care  delivery, group medical and private  medical practice, who are concerned  about issues at the interface of  federal and state law, concerned  about medical board discipline or  medical malpractice liability  issues.  We also review and draft informed  consent forms and guide  clients concerning a variety of health care law  issues.

If you  have legal questions concerning telemedicine and telehealth practices, HIPAA legal issues, health care reform questions, or        other health law matters in New York, California, Massachusetts, Washington DC, and other states, contact a lawyer who     knows the rules.

Consult an experienced  health care law attorney who                  knows     complementary medicine and  integrative    medicine     for       legal     advice     pertaining to any project     involving     allied    health    or CAM     professionals.

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Healthcare & FDA attorney Michael H. Cohen is a thought leader in healthcare law & FDA law, pioneering legal strategies in healthcare. wellness, and lifestyle markets. As a corporate and transactional lawyer, FDA regulatory attorney who also handles healthcare litigation, healthcare mediation and healthcare arbitration, and international healthcare & wellness law speaker, Los Angeles / Bay Area healthcare & FDA lawyer Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek healthcare & FDA attorney Michael H. Cohen's legal savvy on all aspects of business law, healthcare law, and FDA law, including:

Whether advising start-ups or established companies, Los Angeles / San Francisco / Bay Area healthcare & FDA attorney Michael H. Cohen brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges.  The Michael H. Cohen Law Group counsels healthcare practices, entities, and companies, such as clinical laboratories, physicians, psychologists, chiropractors, acupuncturists, naturopaths, nurses, healers, medical spas, sleep centers, addiction treatment centers, surgery centers, anti-aging centers, integrative medicine clinics, anti-aging practices, mental and behavioral health counselors, medical service organizations, telemedicine and mobile (m-health) companies, online health ventures, stem cell and cord blood entities; and other health and wellness enterprises.  Healthcare and FDA lawyer Michael H. Cohen is admitted to practice in California, Massachusetts, New York, and Washington, D.C. Our clientele is national and international, and we also counsel healthcare and FDA clients in Los Angeles, San Diego, Ventura, San Francisco Bay Area, San Jose, Santa Barbara, Sacramento, San Bernadino, Alameda, Contra Costa County, and other California cities and counties.  Contact our Los Angeles, Ventura County, & San Francisco Bay Area FDA & healthcare attorneys today if you need a telemedicine lawyer, concierge medicine lawyer, HIPAA lawyer, FDA lawyer or FDA regulatory consultant (dietary supplements, medical devices, cosmetics, OTC drugs), advertising compliance lawyer, healthcare mediator or arbitrator, concierge medicine attorney, management services organization attorney, or other specialized healthcare legal advice or FDA regulatory consulting.

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