Healthcare Lawyers - FDA Compliance - Cohen Healthcare Law



Michael H. CohenCurriculum Vitae ExperienceCohen Healthcare Law Group, A Professional Corporation Founding AttorneyCounsel healthcare ventures, practitioners and facilities as outside counsel in regulatory, corporate, and dispute resolution matters.Provide FDA, FTC, and strategic legal advice to distributors and manufacturers of cosmetics, dietary supplements, medical devices, OTC/homeopathic drugs, and consumer products.Practice areas include: FDA, FTC, HIPAA (data privacy, data security), Medicare, telemedicine, licensing, fraud & abuse, contract manufacturing, business formation, acquisitions, concierge medicine, dispute resolution, contract drafting and negotiation, management agreements, IP/licensing, mobile medical apps issues, claims/labeling/substantiation, informed consent clinical off-label use, informed consent, HCG, and other therapies, addiction medicine, aesthetic medicine, medical spas, pharmacy law, diagnostic services, and other areas.Have represented over 500 clients. Maintain a blog on healthcare & FDA law topics. Sample projects include:Provided FDA & FTC claims review for dietary supplements such as Omegas, noni juice, patented probiotic strains, and traditional oriental medicine herbal products, and others. Gave fraud and abuse advice to a national dietary supplement company seeking joint ventures with clinical lab chain and others.Guided company regarding FDA & FTC issues involved in its first OTC drug product.Counseled online HCG provider regarding FDA, FTC and state law issues.Advised dietary supplement distributor regarding off-label promotion of Rx drugs.Counseled start-up manufacturer of body wrap re FDA medical device and cosmetics issues.Advised manufacturer of placebo pills regarding FDA rules on claims and substantiation.Advised distributor of medical devices for brain training, regarding limits on potential claims.Provided healthcare regulatory expertise to top-tier, international law firm on M&A due diligence issues, with respect to buyer client’s acquisition of medical spas.Provided healthcare regulatory expertise to top-tier, national law firm regarding online, telemedicine matching service between patients and specialized care facilities. Advised concierge medical practices regarding regulatory issues in practice.Counseled physician plaintiff in medical partnership dispute against medical group.Drafted management and marketing agreements for national MSOs.Advised independent film project on intellectual property issues relating to clinical research partners for documentary on healthcare issues.Reviewed corporate practice of medicine and anti-kickback issues for telemedicine startups.Counseled chiropractor regarding fee-splitting issues in collaboration with MD.Analyzed regulatory issues for a pet veterinary telemedicine startup.Reviewed scope of practice issues for a licensed mental health counseling practicing neurofeedback.Provided strategic advice for telemedicine operation involving medical cannabis recommendations.Reviewed and drafted physician employment contract.Provided regulatory review to “hydration therapy” startup.Drafted HIPAA compliance plan for medical practice.Advised integrative care clinics regarding contracts and compliance obligations.Advised NP, DO, PhD, and other healthcare licensees regarding various practice issues.1999-presentBurkhalter, Michaels, Kessler & GeorgeAttorneyRepresented various companies in general corporate practice.1999Shereff, Friedman, Hoffman & Goodman AttorneyDrafted briefs and memos in litigation practice.1993Davis Polk & Wardwell AssociateRepresented issuers, underwriters, banks, and various entities in three-year rotation through the Firm’s banking, securities, and M&A departments.1990-1992United States District Court, Southern District of New YorkLaw Clerk to Honorable Thomas P. GriesaDrafted memos and bench opinions for the Judge and sat in on civil and criminal trials.1986-1987Teaching ExperienceUniversity of the West Indies LLB Program at College of the Bahamas Visiting Lecturer, Associate Professor2005-2007Harvard Medical School Lecturer on MedicineAssistant Professor of Medicine, Assistant Clinical Professor of MedicineDirector of Legal Programs, Harvard Medical School Osher Institute Director of Legal Programs, Division for R&E in Complementary & Integrative Medical TherapiesDirector of Legal Programs, Center for Alternative Medicine Research & Education, BIDMC Developed policies and procedures for integrative medicine across 14 Harvard-affiliated hospitalsReceived NIH award as Principal Investigator of a 3-year grant, culminating in published bookPrincipal investigator on another award and co-investigator on numerous othersDozens of publications in peer-reviewed medical, legal, and professional journalsFour books published by University presses on healthcare law and policy2000-2005Harvard School of Public HealthAssistant Professor of Health Policy and Management, Adjunct Assistant ProfessorCourse Director, Complementary & Alternative Medicine: Health Law & Policy2005-2011Arizona State University—East CampusVisiting Professor1999-2000Chapman University School of LawAssociate Professor of Law1996-1999Widener University School of Law Associate Professor of Law1993-1996Brooklyn Law SchoolAdjunct Instructor1993Courses Taught (at above institutions): Civil Procedure, Conflicts of Laws Constitutional Law, Criminal Law, Health Care Law, Insurance Law, Intellectual Property, International Organizations, Legal Research & Writing, Moot Court, Private International Law.EducationFortieth Anniversary Senior FellowHarvard Divinity School, Center for the Study of World Religions2002-2003M.F.A. (Creative Writing) University of Iowa, Iowa Writers' Workshop 1990 M.B.A University of California, Berkeley (Haas School of Management)1988J.D.University of California, Berkeley (Boalt Hall School of Law)1986B.A.Columbia University, Columbia College1983Award and GrantsG. Joseph Tauro—Distinguished ScholarBoston University School of Law1984CJS AwardAm. Jur. AwardBoston University School of Law1984Invited to Law ReviewBoston University School of Law1984Invited to Law ReviewBoalt Hall School of Law, University of California, Berkeley1984Invited Faculty Medical Institute for Law Faculty Cleveland Clinic (with Cleveland-Marshall School of Law)1995Principal Investigator American Specialty Health Plan Credentialing Practices, Malpractice Liability Policies, and Guidelines Governing Recommendations Involving Dietary Supplements 2000-2002 Co-Investigator Medtronic Foundation, Inc. Credentialing, Liability and Dietary Supplements Policies2000-2002 Co-Investigator National Institutes of HealthNational Center for Complementary & Alternative MedicineModels of Integrative Care in an Academic Health Center 2000-2002 Principal Investigator National Institutes of HealthNational Library of MedicineLegal and Social Barriers to Alternative Therapies 2002-2005 Co-InvestigatorNational Institutes of HealthNational Center for Complementary & Alternative MedicineInternational Center for Research on Complementary & Alt. Medicine2003-2005Consultant Ministry of Science & Research of North Rhine-Westphalia, GermanyGovernmental Regulations for Traditional Chinese Herbal Medicine in Eastern and Western Countries2004 Principal Investigator The Greenwall Foundation Pediatric Use of Complementary Therapies by Parents: Ethical and Policy Choices2004-2005 Research Collaborator Hospital for Sick Children Foundation (Toronto)Decision-Making About Complementary and Alternative Therapies for Children and Youth: ?Legal, Ethical and Clinical Issues2004-2005 Co-Investigator The Epilepsy Foundation Asian Herbal Products for Epilepsy 2004-2005 -Rudolph Steiner Foundation(operational support)2004-2005 Consultant M. D. Anderson Cancer Center Integrative Medicine Program (with the National Cancer Institute Cancer Patient Education Network Complementary and Alternative Medicine Task Force)Important Conversations... Complementary & Alternative Medicine: ?What you must ask2005Co-EditorHarvard Center for Cancer Prevention/ Susan G. Komen Breast Cancer FoundationAbout Breast Cancer—CAM Therapies 2005-Helen M. and Annetta E. Himmelfarb Foundation (operational support)2005-Frederick S. Upton Foundation (operational support)2005-2006Bar AdmissionsNew York 1988Massachusetts1988California1999Washington, D.C.Solicitor of the Supreme Court of England & Wales 20002006Talks, Lectures, and Presentations 2019The Practitioner Channel Forum, “Legal Challenges Facing Cosmetic Surgeons”, San Diego, CAScripps, “Clinical Use of Supplements: Key Legal Issues”, San Diego, CAHow to Manage A Small Law Firm, “3 Ways to Manage Legal Risk & Maximize Success in Your Healthcare Venture,” Las Vegas, NV 2018How to Manage A Small Law Firm, “From Sale to Scale: The Best Thing I Did or My Law Firm,” Washington, DCThe Institute of Functional Medicine, “Manage Legal Risk in your Functional Medicine Practice”, San Diego, CAScripps, “Clinical Use of Supplements: Key Legal Issues”, San Diego, CA 2016Academy of Doctors of Audiology, Keynote, “Listen to the Future,” San Diego, California.2009-2015Stanford MedX, “How Laws Regulating Wearable Health Technology Shape our Medical Future,” Palo Alto, CA (coming).Los Angeles County Bar Association, MHealth Panel, “FDA Issues in MHealth;” Santa Monica, California.Silicon Valley Forum on Healthcare IT Leadership, Legal Issues Affecting Sensors, Wearables, and Interoperability, “From Physical to Mobile to Wearable Healthcare: How Government Regulation of User-Generated Health Data Affects Ventures and Consumers;” Mountainview, California.World Health Organization, Gulf Cooperation Council, and Saudi National Center for Complementary and Alternative Medicine, “Setting the Foundation, Standards, Rules and Regulations for Practicing Complementary and Alternative Medicine: The U.S. Experience,” Riyadh, Saudi Arabia.World Health Organization, Gulf Cooperation Council, and Saudi National Center for Complementary and Alternative Medicine, “Balancing Regulatory Authority and Patient-Centered Care: Global Models of Access to Complementary and Alternative Medicine,” Riyadh, Saudi Arabia.Los Angeles County Bar Association, Annual Healthcare Law Compliance Symposium, “Telemedicine & Mobile Health Compliance Concerns,” Los Angeles, California.EEG Institute, Advanced Clinical Summit, “Neurofeedback Laws & Licensing: Unlock Brains’ Potential But Be Legally Safe,” Los Angeles, California.LA Talk Radio, Legal Help Desk, Interview: How Telemedicine, Mobile Medical App Laws, Anti-Aging Medicine, and Integrative Medicine are Shaping Our Future.LegalZoom, A Lawyer in 60 Seconds or Less (various videos, including: “What Documents Are Necessary to Form an LLC;” “What is a Registered Agent;” “How Many People Does it Take to Form an LLC;” “What do the Articles of Organization for an LLC Contain;” “Is a DBA Required for Incorporation;” “What does Inc., LLC and Incorporation Stand for;” “How Can You Transform Your Idea into a Business?”).Your Soul Expressed, “From Wall Street to Awakening.”2007-2008West LegalEd Center, “Medical and Physician Spa Practices: A Practical Guide in Avoiding Costly and Regulatory Mistakes” (webcast).McGill University, "Healing at the Borderland of Medicine and Religion: Legal Implications,” Montreal, Canada.First 1st International Conference on Integrative, Complementary and Alternative Medicine (ICAM) and Mental Health, "Legal Issues in Integrative Medicine Relating to Mental Health Care," Toronto, Canada.2005-2006Oregon Board of Naturopathic Examiners, “Legal and Ethical Issues in Naturopathic Medicine in the 21st Century,” Portland, OR.Long Island Jewish Hospital, “Asking the Difficulty Questions: Legal Issues in Complementary and Alternative Medicine,” Long Island, NY.Long Island Jewish Hospital, “Workshop: Legal Issues in Complementary and Alternative Medicine,” Long Island, NY.Columbia College of Physicians & Surgeons, Botanical Medicine in Modern Clinical Practice, New York, NY, “Legal & Professional Considerations in Botanical Practice.”Johns Hopkins University School of Medicine CAM Center, "Liability and Other Legal Implications of Complementary, Alternative, & Integrative Medicine." Johns Hopkins University School of Medicine, Integration of Complementary and Alternative Medicine into Clinical Practice: Evidence-Based Medicine, "Legal Issues in Establishing a CAM (CIM) Center." (lecture)Johns Hopkins University School of Medicine, Integration of Complementary and Alternative Medicine into Clinical Practice: Evidence-Based Medicine, "Legal Issues and Advice in Establishing a CAM (CIM) Center." (workshop)M.D. Anderson Cancer Center, Institutional Review Board Committee, “Complementary and Integrative Medicine: Legal and Ethical Issues for the Clinician and Clinical Researcher.” M.D. Anderson Cancer Center, Integrative Medicine Program, “Can Integrative Medicinebe Made Legally Defensible, Ethically Appropriate, and Clinically Responsible?”2004-2005Spaulding Hospital, “Legal Boundaries and Ethics in Energy Work During the Clinical Encounter.”Massachusetts General Hospital, Department of Obstetrics & Gynecology, “Complementary Medicine: Legal Issues.”Harvard Medical School, Continuing Medical Education Online, “St. John’s Wort and Depression: What is the Evidence?”Harvard Medical School, Continuing Medical Education Online, “Liability Issues in Alternative, Complementary, and Integrative Medicine.”Columbia College of Physicians & Surgeons, Botanical Medicine in Modern Clinical Practice, New York, NY, “Legal & Professional Considerations in Botanical Practice.”Greater Detroit Area Health Council WWJ Newsradio 950's Annual Health Trends Conference, Novi, MI, Keynote Address, “Future Medicine: The Influence of Mind, Body and Spirit in Health Care Delivery.”2003Harvard CME, Integrating Complementary Therapies Into Clinical Practice: Cases and Evidence, “Malpractice, Risk Assessment.”Harvard CME, Integrating Complementary Therapies Into Clinical Practice: Cases and Evidence, “Ethics/Refusal of Care: Legal and Regulatory Perspectives.”Harvard Law School Program on Negotiation, Dispute Resolution Forum, “Negotiating Complementary Medicine.”Harvard Law School Program on Negotiation, Harvard Negotiation Insight Initiative, “Use of Alternative Mind States in Complementary Medicine.”Harvard Divinity School, Center for the Study of World Religions, “Healing at the Borderland of Medicine and Religion.”Harvard Divinity School, Center for the Study of World Religions, “Legal and Ethical Issues in Complementary and Alternative Medical Therapies of Potential Relevance to the Study of Religion, Health & Healing.”Harvard Medical School, Department of Medicine, Elective ME549.J, Potential Medical Malpractice Issues When Physicians Counsel Patients Regarding Complementary/Integrative Medical Therapies.New York Chiropractic College and Albert Einstein School of Medicine, New York, NY, “Legal Issues in Integrative Healthcare: Puzzles and Possibilities.”Columbia College of Physicians & Surgeons, Botanical Medicine in Modern Clinical Practice, New York, NY, “Legal & Professional Considerations in Botanical Practice.”Institute of Medicine of the National Academy of Sciences, Committee on Complementary and Alternative Medicine Usage, Washington, D.C., “Licensure and Regulatory Issues for Hospitals Concerning Complementary Therapies.”American Academy of Physician Assistants, New Orleans, LA, “Potential Malpractice Liability Associated With Use by Physician Assistants of Complementary and Integrative Medical Therapies.”Academic Practice Assembly, Medical Management Group, Atlanta, GA, “Malpractice Issues Concerning Complementary and Integrative Medical Therapies.”New York Task Force on Life and the Law, New York, NY, “Selected Policy Issues Concerning Complementary and Integrative Medical Therapies.”Veterans Administration Journal Club for Credentialing Coordinators (national teleconference), “Credentialing Issues in Complementary and Integrative Medical Therapies.”Lawrence & Memorial Hospital, New London, CT, “Malpractice Risk Assessment in Integration of Complementary and Integrative Medical Therapies in the Hospital Setting.”2000-2002Harvard CME, “Complementary and Alternative Medicine Legal Issues.”Harvard CME, “Credentialing Issues in Complementary and Alternative Medicine.”Harvard CME, “Medical Liability and Complementary and Alternative Medicine.”Harvard CME, Advances in Pediatric Health Care, “Legal/Ethical/Regulatory Issues in Complementary and Alternative Medicine for Kids.”Harvard CME, Models of Integrative Care: Present and Future, “Credentialing Providers: Policies, Perspectives, Possibilities.”Harvard CME, Herbal Therapies and Other Dietary Supplements: What the Practicing Physician, Pharmacist or Nurse Needs to Know, “Regulatory and Legal Issues Concerning Herbal Therapies and Dietary Supplements.”Harvard CME, Complementary and Integrative Medicine: State of the Science and Clinical Applications, “Malpractice and Liability.”Beth Israel Deaconess Medical Center, CAMRE Research Fellows Conference, “Informed Consent in Complementary and Alternative Medicine.”Harvard Medical School, Department of Medicine, Elective ME549.J, “Medico-Legal Issues for the Clinician in Counseling Patients Regarding Complementary/Integrative Medical Therapies.”National Consultants Conference, TAP Pharmaceuticals, Santa Fe, NM, “Exploring the Legal and Regulatory Terrain of Complementary and Integrative Medical Therapies.”Royal College of Physicians and National Center for Complementary and Alternative Medicine, National Institutes of Health, London, United Kingdom, “Certification and Regulation of Complementary and Alternative Medical Providers in the U.S.” Connecticut Hospital Association, Wallingford, CT, “Legal Issues in Complementary and Alternative Medicine.” Massachusetts Special Commission on Complementary and Alternative Medical Practitioners, “Complementary and Alternative Medicine Licensing Issues.” HyVee Corporate Officers’ Retreat, Scottsdale, AZ, “Health Law Issues in Complementary and Alternative Medicine.”University of California, Los Angeles School of Medicine, Center for East-West Medicine, Los Angeles, CA, “Legal Issues in Complementary and Alternative Medicine.”Banner Health Systems Integrative Medicine Conference, Phoenix, AZ, “Legal Issues in Complementary and Alternative Medicine.”1999Center for Bioethics, University of Pennsylvania School of Medicine and Center for Bioethics and National Institutes of Health Center for Complementary and Alternative Medicine, Philadelphia, PA, “Overview of Licensing and Credentialing.“California Society of Addiction Medicine, Marina Del Rey, CA, “Alternative Therapies: Medical and Legal Issues.”Kaiser Hospital, Santa Rosa, CA, “Integrative Medicine: Legal Issues.”California Institute of Integrative Medicine, Santa Rosa, CA, “Integrative Medicine: Legal Issues.”Complementary Medicine Clinic, Stanford University School of Medicine, Palo Alto, CA, “Complementary Medicine: Legal and Regulatory Issues.”Grand Rounds at Community Hospital of the Monterey Peninsula, Monterey, CA, “Use of Herbal Medicines and Legal Considerations.”Community Memorial Hospital of San Buena Ventura, Ventura, CA, “Medical Fraud and Abuse: Common Violations and Ways to Reduce Liability Risks.”Comprehensive Cancer Care Conference II: Integrating Complementary and Alternative Therapies, Arlington, VA, “Freedom of Choice in Health Care.”Practice Management for Integrative Medicine, San Francisco, CA, “Legal and Regulatory Issues in Integrative Care: Risk Management Solutions for Business Development and Clinical Practice.”University of Arizona Health Sciences Center, Department of Medicine, Program in Integrative Medicine, Tucson, AZ, “Legal and Regulatory Issues in Integrative Care.”First International Conference on Integrative Medicine, Seattle, WA, “Malpractice and Informed Consent in Integrative Medicine.”Society of Air Force Physicians, Annual Meeting, in association with American College of Physicians and American Society of Internal Medicine, Berkeley, CA, “Complementary and Alternative Medicine, Policy and Licensing, Reimbursement, and Practice Considerations.”University of California, Los Angeles School of Medicine, Center for East-West Medicine, Los Angeles, CA, “Legal and Ethical Issues in Integrative Medicine.”University of California, Irvine College of Medicine, Department of Anatomy & Neurobiology, Irvine, CA, “Legal Concerns in Integrative Medicine.”Hastings School of Law, Women’s Law Journal Symposium, San Francisco, CA, “Evaluating U.S. Dietary Supplements Regulation.”1994-1998First International Congress on Tibetan Medicine: Revealing the Art of the Medicine Buddha, Washington, D.C., “Legal and Regulatory Issues Affecting the Practice of Tibetan Medicine; The Role of U.S. Law in Tibetan-American Medical Exchange.”Bioethical Issues Committee, Association of the Bar for the City of New York, New York, NY, “Legal and Ethical Perspectives on Complementary and Alternative Medicine.”Health Law & Policy Program, Seton Hall Law School, Newark, NJ, “Regulation of Complementary and Alternative Medicine.”American Preventive Medical Association/Emord & Associates Legal Seminar, Arlington, VA, “Complementary Medicine and the Courts; Panel, Legislative Issues for Complementary Care Practitioners.”Fourth Annual Congress on Alternative and Complementary Therapies, Arlington, VA, “Integrative Medicine: Practical Applications for Practice Management (Outcomes Analysis, Billing & Reimbursement).”Whittier Law School, Costa Mesa, CA, “Legal Aspects of Alternative Medicine Therapies.”National Center for Homeopathy, San Diego, CA, “Legal and Ethical Reflections on the Practice of Homeopathy.”University of California, Irvine, School of Medicine, Irvine, CA, “Developing a Complementary Care Center.”Health Professionals Seminar, Body Wise International, Newport Beach, CA, “Practice Issues in Clinical Nutrition.”Second International Congress on Complementary & Alternative Therapies, Washington, D.C., “Overview of Malpractice and Reimbursement Issues for the Practitioner.” (Chair, Legal Panel.) Second International Congress on Complementary & Alternative Therapies, Washington, D.C., “Managing Practice Risks, Obtaining Reimbursement: An Overview.”Annual Meeting, International Society for the Study of Subtle Energies & Energy Medicine, Boulder, CO, “Legal Obstacles & Opportunities in an Integrated Health Care System.”Annual Meeting, International Society for the Study of Subtle Energies & Energy Medicine, Boulder, CO, “Legal Ramifications of Energy Medicine.”Annual Meeting, International Alliance of Holistic Lawyers, Burlington, VT, “Healing and Justice.”Medical Institute for Law Faculty, Cleveland-Marshall College of Law, Cleveland State University/Cleveland Clinic, Cleveland, OH, “The Emerging Paradigm of Holistic Healing.”1991New York City Bar Association, New York City, NY, “From Briefs to Bestsellers.”Professional Service & Editorial BoardsFacultyThe Leadership Program in Integrative Healthcare at Duke University2014Advisory Board MemberIntegrative Pediatrics Council 2006Board MemberSociety of Integrative Oncology 2005Core Faculty MemberAsian Medicine and Healing Program, Harvard Medical School Osher Institute2005External Advisory CommitteeUniversity of Texas M.D. Anderson Cancer Center, Integrative Medicine2005External ReviewerPediatrics2005Editorial BoardIntegrative Medicine: A Clinician’s Journal2004External ReviewerJournal of Law & Religion2004External ReviewerAlternative Therapies in Health & Medicine2004External ReviewerMedical Journal of Australia2004National Advisory BoardCorporate Health Improvement Program, University of Arizona School of Medicine2004ConsultantInstitute of Medicine of the National Academy of Sciences, Committee on Complementary and Alternative Medicine Use by the American Public2003-2004Transition TeamHarvard Medical School Osher Institute andIntegrative Care Clinic at Brigham & Women’s Hospital2003-2004Clinic Steering CommitteeHarvard Medical School Osher Institute2002-2004Planning CommitteeHarvard Medical School Osher Institute2002-2005Advisor to Dr. EisenbergMassachusetts Special Commission onComplementary and Alternative Medical Practitioners2002-2003External ReviewerAmerican Journal of Law, Medicine & Ethics2002Research Advisory CouncilReligion, Health and Healing Initiative, Center for the Study of World Religions, Harvard Divinity School2001-2002Invited ParticipantComplementary and Alternative Medicine Funding Priorities, Toronto Hospital for Sick Children Canada (Toronto)2001Invited ParticipantRoundtable, Health Law and Ethics (Toronto)2001Advisor to Dr. EisenbergFederation of State Medical Boards, Model Guidelines for Complementary and Alternative Therapies in Medical Practice2000-2002External ReviewerUniversity of Michigan Press2000Legal EditorAlternative Healthcare Management1998-1999Hospice volunteerVeterans’ Administration Hospital (LA)1998Board of DirectorsNew Creek Foundation for Research and Education on Low Impact Therapy and Evaluation1996-1997Board of DirectorsAPMA Education & Legal Foundation1995-2000Board of DirectorsAmerican Preventive Medical Association1995-1997Co-Editor, Legal MattersAlternative & Complementary Therapies1995-1996Board of DirectorsGlobal Community1994-1996TreasurerNational Jewish Law Students Association1993Editor (Book Review)California Law Review1985-1986PublicationsBooksCohen MH. Creative writing for lawyers. New York: Citadel Press; 1991; 142 pages.Cohen MH. Complementary and alternative medicine: legal boundaries and regulatory perspectives. Baltimore: Johns Hopkins University Press; 1998; 180 pages.Cohen MH. Beyond complementary medicine: legal and ethical perspectives on health care and human evolution. Ann Arbor: University of Michigan Press; 2000; 214 pages.Cohen MH. Future medicine: ethical dilemmas, regulatory challenges, and therapeutic pathways to health and healing in human transformation. Ann Arbor: University of Michigan Press; 2003; 350 pages.Cohen MH. Legal issues in integrative medicine. Washington, D.C.: NAF Publications; 2005; 99 pages. Cohen MH. Healing at the borderland of medicine and religion. Chapel Hill, N.C.: University of North Carolina Press; 2006; 229 pages.Cohen MH, Ruggie M, Micozzi M. Integrative medicine: a legal and operational guide. New York: Springer; 2006; 202 pages.Cohen MH. Your Healthcare Company’s Excellent Legal Adventure: Legal Strategies & Solutions Health and Wellness Ventures Can Profitably Deploy. Amazon, 2018; 102 pages.Original Articles in Peer-Reviewed Medical JournalsCohen MH. Malpractice considerations affecting the clinical integration of complementary and alternative medicine. Curr Prac of Med 1999;2:4:87-89.Ernst EE, Cohen MH. Informed consent in complementary and alternative medicine. Arch Intern Med 2001;161:19:2288-2292.Cohen MH, Eisenberg DM. Potential physician malpractice liability associated with complementary/integrative medical therapies. Ann Intern Med; 2002;136:596-603.Eisenberg DM, Cohen MH, Hrbek A, Grayzel J, van Rompay MI, Cooper, RA. Credentialing complementary and alternative medical providers. Ann Intern Med; 2002;137:965-973.Adams KE, Cohen MH, Jonsen AR, Eisenberg DM. Ethical considerations of complementary and alternative medical therapies in conventional medical settings. Ann Intern Med; 2002;137:660-664.Cohen, MH. Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation. Derm Ther 2003;16:77-84.Cohen MH. Regulation, religious experience, and epilepsy: a lens on complementary therapies. Epilepsy Behav 2003;4:6:602-606.Kemper K, Cohen MH. Ethics in complementary medicine: new light on old principles. Contemporary Pediatrics 2004;21:3:61-72.Ernst EE, Cohen MH, Stone J. Ethical problems arising in evidence-based complementary and alternative medicine. J Med Ethics 2004;30: 156-159.Cohen MH, Schacter S. Facilitating IRB consideration of protocols involving complementary and alternative medical therapies. Clin Researcher 2004;4:3:2-6.Cohen MH. Legal and ethical issues in complementary medicine: a U.S. perspective. Med J Australia 2004;181:3:168-169.Cohen MH, Kemper KJ. Complementary therapies in pediatrics: A Legal Perspective. Pediatrics, 2005; 115: 774 – 780.Cohen MH, Hrbek A, Davis R, Schachter S, Kemper KJ, Boyer EW, Eisenberg DM. Emerging credentialing practices, malpractice liability policies, and guidelines governing complementary and alternative medical practices and dietary supplements recommendations: a descriptive study of 19 integrative health care centers in the U.S. Arch Int Med 2005;165:289-295.Cohen MH, Sandler L, Hrbek A, Davis RB, Eisenberg DM. Policies Pertaining to Complementary and Alternative Medical Therapies in a Random Sample of 39 Academic Health Centers. Alt Ther Health Med 2005;11:1:36-40.Schouten R, Cohen MH. Legal perspectives on integrative medicine. Sem Integrative Med 2004;2:4:152-158.Dobos GJ, Tan L, Cohen MH, McIntyre M, Bauer R, Li X, Bensoussan A, Are national quality standards for traditional Chinese herbal medicine sufficient? Current governmental regulations for traditional Chinese herbal medicine in certain Western countries and China as the Eastern origin country. Comp. Therap. Med. 2005;13:183-190.Cohen MH. Legal issues in caring for patients with kidney disease by integrating complementary therapies. ACKD Journal 2005; 12:3-300-311.Cohen MH, Kemper KJ, Stevens L, Hashimoto D, Gilmour J, Pediatric use of complementary therapies: ethical and policy choices. Pediatrics. Electronic Pages.2005; 116: e568 - e575.Cohen MH. The Institute of Medicine Report on Complementary and Alternative Medicine: a reflection. Sem Integrative Med 2005;3:3:75-6. Cohen MH. Legal and ethical issues relating to use of complementary therapies in pediatric hematology/oncology. J Ped Hematology/Oncology 2006 Mar;28(3):190-3.Cohen MH. Harmonizing the cacophony: commentary on status of credentialing alternative providers within A Subset of U.S. academic health centers, J Alt Comp Med 2006; J Alt Comp Med 2006; 2006:12:3:337-339.Eisenberg DM, Post DE, Hrbek AL, Connelly MT, Levy D, O’Connor B Cunningham M, Davis RB, Cohen MH, Cherkin DC, Buring JE. Testing a model of integrative care in an academic health center: results of a pilot study. Abstract, presented at conference event by the Consortium of Academic Health Centers in Integrative Medicine held May 24-27, 2006 in Edmonton, Alberta.Russell NC, Cohen MH, Kirkwood C, Cohen L. Discussing complementary therapies in an oncology setting; J Soc Integr Oncol. 2007 Winter;5(1):18-24. Review.Vohra, S, Cohen MH. Ethics of complementary and alternative medicine use in children. Pediatr. Clin. North Am. 2007 Dec;54(6)875-884. Original Articles in Law Reviews and Law JournalsCohen MH. Reconstructing the implied covenant of good faith and fair dealing as a tort. Calif L Rev 1985;73:1291-1331.Cohen MH. A fixed star in health care reform: the emerging paradigm of holistic healing. Ariz State L J 1995;27:79-173.Cohen MH. Toward a bioethics of compassion. Ind L Rev 1995;28:667-668.Cohen MH. Holistic health care: including complementary and alternative medicine in insurance and regulatory schemes. Ariz L Rev 1996;38:83-164.Cohen MH. Malpractice and vicarious liability for providers of complementary and alternative medicine. Bender's Health Care Monthly (July) 1996;3-12.Cohen MH. U.S. dietary supplement regulation: belief systems and legal rules. Hastings W Law J 2000:11:1:3-21.Cohen MH. Advising health care institutions integrating complementary & alternative medical providers. Orange County Lawyer. July 2000:16-18.Cohen MH. The risk of malpractice liability in credentialing complementary & alternative medical providers. Orange County Lawyer. April 2000:16-18. Cohen MH. The emerging field of law and complementary and alternative medicine. Orange County Lawyer. Feb. 2000:30-32.Cohen MH. Of rogues and regulation: a review of Accommodating pluralism: the role of complementary & alternative medicine. Vt L Rev 2003;27:3:801-815.Cohen MH. Healing at the borderland of medicine and religion: regulating potential abuse of authority by spiritual healers. 18:2 J Law & Relig 2004;373-426.Cohen MH, Ruggie M. Integrating complementary and alternative medical therapies in conventional medical settings: legal quandaries and potential policy models. Cinn L Rev 2004; 72:2:671-729.Cohen MH. Negotiating integrative medicine: a framework for provider-patient conversations. Negotiation J 2004;30:3;409-433.Cohen MH. Regulating ‘Healing:’ Notes on the ecology of awareness and the awareness of ecology. St John’s L Rev. 2004;78:4:1167-1192.Cohen MH, Ruggie M. Overcoming legal and social barriers to integrative medicine. Medical Law Intl 2004:6:339-393.Reviews, Chapters, Editorials, and Other PublicationsCohen MH. Expanding legal paradigms to incorporate subtle energies. Sub Energ 1995:6;1;99-104.Cohen MH. Guaranteeing freedom of access to healing: the Access to Medical Treatment Act of 1995. Alt & Comp Therap 1995;1:6:408-410.Cohen MH. Legal ramifications of homeopathy. J Alt & Comp Med 1995;1:4:10-12.Cohen MH. Scope of practice limitations on unconventional providers: the case of chiropractic. Alt & Comp Therap 1996;2:2:110-112.Cohen MH. Ethics in integrative care: the healer's boundaries. Alt & Comp Therap 1999;5:4;241-243.Cohen MH. Do clones have souls and other medicolegal mysteries. 1999;5:3 Alt. & Comp Therap1999;5:3:177- 180.Cohen MH. Yoga, medicine, and the law, Alt Healthcare Mgt 1999;2:3:16-18. Cohen MH. Medicine in “Flatland:” a tale of two dimensions. Alt & Comp Therap 1999;5:2:110-112.Cohen MH. Changing U.S. dietary supplements regulation: belief, values, policies. Alt Healthcare Mgt 1999;2:216-218.Cohen MH. An indigenous Mexican healer: a personal encounter. Alt Healthcare Mgt 1999;2:2:24-26.Cohen MH. Referral to complementary and alternative medicine providers: a physician's liability. Integrative Med Consult 1999:44.Cohen MH. Complementary and alternative medicine policy: the future of regulation. Alt & Comp Therap 1999;5:9:50-52.Cohen MH. Sex, scandal and spirituality. Alt & Comp Therap 1999;6:6:435-437.Cohen MH. What is the matrix? A radical look at medico-legal reform. Alt. & Comp Therap. 1999;5:5:319-321.Cohen MH. Examining the legal status of energy healing, Part 1. Alt Healthcare Mgt 1999;1:2:14-17. Cohen MH. Examining the legal status of energy healing, Part 2. Alt Healthcare Mgt 1999;2:1:1-3. Cohen MH. Integrating complementary and alternative therapies: strategic advice for health care institutions. Alt Healthcare Mgt 1999;10:1:1-3.Cohen MH. Complementary medicine: legal status of the nonlicensed provider in the United States. Comp Ther in Nurs & Midwif 1997;4:3:99-102. Cohen MH. Third-party reimbursement for complementary practice. In: Clark CC, editor. Encyclopedia of complementary health practices. New York: Springer Publishing Co.;1999. p. 47-49.Cohen MH. Legal rules affecting complementary and alternative medicine: malpractice and vicarious liability. In: Clark CC, editor. Encyclopedia of complementary health practices. New York: Springer Publishing Co.;1999. p. 85-87. Cohen MH. Federal regulation of complementary practice through health and insurance fraud legislation. In: Clark CC, editor. Encyclopedia of complementary health practices. New York: Springer Publishing Co.;1999. p. 87-88.Cohen MH. The federal role in regulating access to complementary and alternative medicine. In: Clark CC, editor. Encyclopedia of complementary health practices. New York: Springer Publishing Co.; 1999. p. 89-91.Cohen MH. Legal and regulatory structures governing holistic health care in the new millenium. The Long Term View 1999:4:4:17-24.Cohen MH. Editorial, National teaching standards in yoga. Yoga J. July 2000.Cohen, MH. Legal and ethical issues in complementary and alternative medicine. In: The desktop guide to complementary and alternative medicine: an evidence-based approach (Ernst, EE, et al, editors). New York: Mosby, Inc.; 2001. p. 404-411.Cohen MH. Oz MC, Medical malpractice implications of complementary and alternative medicine. In: Robb B, editor. Medical malpractice update. Boulder: Aspen Press; 2001. p. 47-51.Cohen MH. State law regulation of the practice of medicine: implications for the practice of complementary and alternative medicine. In: Faas N, editor. Integrating complementary medicine in health systems: benefits of complementary medicine. Boulder: Aspen Press; 2001. p. 218-225.Cohen MH. Malpractice in complementary and alternative medicine: practical implications for risk managers. In: Faas N, editor. Integrating complementary medicine in health systems: benefits of complementary medicine. Boulder: Aspen Press; 2001. p. 225-234. Cohen, MH. The role of informed consent in the delivery of complementary and alternative medical therapies. In: Faas N, editor. Integrating complementary medicine in health systems: benefits of complementary medicine. Boulder: Aspen Press; 2001. p.235-241.Cohen, MH. Forward. In: Campbell LK, Ladenheim CJ, Sherman RP, Sportelli, L. Professional chiropractic practice: ethics, business, jurisprudence & risk management. Fincastle, Virginia: Health Services Publication; 2001. p. 5-8.Cohen MH. The Tao of credentialing. Comp. Health Prac. Rev. 2001:6:2:173.Cohen MH. Legal issues in complementary and integrative medicine: a guide for the clinician. In: Perlman M, editor. The medical clinics of north america. Philadelphia: W.B.Saunders; 2002. p. 185-196.Ernst, EE, Cohen MH. Spiritual informed consent for CAM. Arch Int Med, 2002;162:8;943 (reply to letters).Cohen MH. CAM regulation in the United States. Comp Ther in Med 2002:10:1:3-7.Cohen MH. Credentialing in integrative medicine. Int Med;2003;2:3:64-65.Dumoff A, Cohen MH. Advising from a distance: the legality of web-based clinical consultations—Part I. Alt. & Comp. Therapies. Aug. 2004;231-34.Cohen MH, Dumoff A. Advising from a distance: the legality of web-based clinical consultations—Part II. Alt. & Comp. Therapies. Oct. 2004;289-293.Cohen MH. Should yoga studios ask students to sign a liability waiver? Yoga Journal: My Yoga Mentor, Nov. 3, 2004;teacher/1410.cfm. Cohen MH. Speaking Mindfully: The legal implications of health advice, part 1. Yoga Journal: My Yoga Mentor, Dec. 5, 2004;teacher/1413_1.cfm. Cohen MH. Speaking Mindfully: The legal implications of health advice, part 2. Yoga Journal: My Yoga Mentor, Jan. 6, 2005; MH. The ethics and liabilities of touch. Yoga Journal: My Yoga Mentor, Feb. 2, 2005; MH. How integrative medicine may affect yoga teaching and business. Yoga Journal: My Yoga Mentor, March 3, 2005; MH. Insurance and dually trained yoga teachers. Yoga Journal, April 6, 2005; MH. Ethics, adjustments, and cathartic release. Yoga Journal: My Yoga Mentor, May 16, 2005; . Cohen MH. The yoga teacher’s employment contract, Part 1. Yoga Journal: My Yoga Mentor, June 16, 2005. . Cohen MH. The yoga teacher’s employment contract, Part 2. Yoga Journal: My Yoga Mentor, July 16, 2005. MH. The yoga teacher’s employment contract, Part 3. Yoga Journal: My Yoga Mentor, August 30, 2005. MH. Branding a style of yoga. September 25, 2005. . Cohen MH. Accounting tips for yoga teachers: tax benefits associated with being an independent contractor, October 26, 2005. . Schouten, R & Cohen MH. Legal issues in integration of complementary therapies into cardiology. In: Frishman WH, Weintraub MI, Micozzi MS, editors. Complementary and Integrative Therapies for Cardiovascular Disease (Elsevier, 2004);pp.20-55.Cohen MH. Dr. John Mack: A tribute. Shift 2005:6:34-35. Cohen MH. Forward. In: Acupuncture and state oriental medicine laws. Gig Harbor, WA: NAF Publications, 2005. pp.vi-viii.Ruggie M, Cohen MH. Integrative medicine centers: moving health care in a new direction. Seminars in Integrative Medicine 2005;3:1:9-16.Cohen MH. Rosenthal D. Legal issues in integrative oncology. In: Integrative oncology: principles and practice. Oxford: Taylor and Francis Publishing (Mumber, MP, editor); 2006. pp. 101-120.Cohen MH. Medical freedom legislation: illusory progress? Alt. & Comp. Therapies 2006; 97-101.Cohen, MH. Some implications of integrative health care for religion, psychology, and the humanities. In: Religion and psychology (Sylvan D. Ambrose, ed.). Hauppauge, New: Nova Science Publishers, Inc.; 2006;pp.39-52.Cohen MH & Schouten R. Legal, regulatory, and ethical issues. In: Complementary and alternative treatments in mental health care. Washington, DC: American Psychiatric Association (Lake, JH and Spiegel, D, eds.); 2007; pp. 21-33.Cohen MH. Legal and risk management issues in complementary and alternative medicine. In: Complementary and Alternative Medicine: Ethics, the Patient, and the Physician (Biomedical Ethics Reviews) (Snyder L., ed.). Totowa, NJ: Humana Press; 2007; pp. 167-200;2007.Cohen MH. The search for regulatory recognition of yoga therapy: legal and policy issues. J Intl Assoc Yoga Ther 2007;17:43-30.Vohra, S, Cohen MH. Ethics of CAM use in children. In: Pediatric Clinics of North America—Ethics of CAM Use in Children (Complementary and Alternative Medicine Issue) (Rosen L & Riley D, eds.); 2007.Cohen, MH. Legal and ethical issues regarding evidence-based inclusion of complementary, alternative, and integrative medical therapies. In: The desktop guide to complementary and alternative medicine: an evidence-based approach (Ernst, EE, et al, editors). New York: Mosby, Inc.; pp. 511-512;2008.Cohen MH. Using legal and ethical issues to guide clinical decision-making in complementary/integrative cancer medicine. In: Alternative/complementary/integrative cancer medicine: interactions with conventional medicine and medical institutions (Markman M & Cohen L, eds.). Totowa, NJ: Humana Press; pp. 15-32;2008.Cohen MH. Legal issues in integrative health care. In: Integrative cardiology. McGraw-Hill Vogel JH & Krucoff MS, editors, New York: McGraw-Hill;2008.Cohen MH. Alternative and complementary care ethics. In: Bioethics for Clinicians (Viens, A, editor). Cambridge, U.K.: Cambridge University Press; 2008.Kemper, KJ, Cohen, MH. Complementary therapies in pediatrics: legal perspectives. In: Pediatric hospital medicine. Philadelphia: Lippincott, Williams & Wilkins; 2008.Cohen MH. Legal and ethical issues in integrative pain management. In: Integrative Pain Medicine: The Science and Practice of Complementary and Alternative Medicine in Pain Management (Audette, JF & Bailey A, editors). Totowa, NJ: Humana Press; 2009.Cohen MH. John E. Mack, MD: A Tribute. In: Passport to the Cosmos: Human Transformations and Alien Encounters (Mack, JE; Commemorative Edition). Largo, FL: Kunati Inc.; 2010.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Pediatric use of complementary and alternative medicine: legal, ethical, and clinical issues in decision-making. Pediatrics 2011: 128:S149-154.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Natural health product—drug interactions: evolving responsibilities to take complementary and alternative medicine into account. Pediatrics. 2011: 128:S5155-S5160.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Hospitals and complementary and alternative medicine: managing responsibilities, risk, and potential liability. Pediatrics: 2011: 128:S2010-S2720.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Treating teens: considerations when adolescents want to use complementary and alternative medicine. Pediatrics 2011:128:S161-S166.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Childhood immunization: when physicians and parents disagree. Pediatrics 2011; 128:S167-S174.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Considering complementary and alternative medicine alternatives in cases of life-threatening illness: applying the best-interests test. Pediatrics 2011: 128:S167-S174.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Referrals and shared or collaborative care: managing relationships with complementary and alternative medicine practitioners. Pediatrics 2011; 128:S181-S186.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Informed consent: advising patients and parents about complementary and alternative medicine therapies. Pediatrics 2011; 128:S187-S192.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Hospitals and complementary and alternative medicine: managing responsibilities, risk, and potential liability. Pediatrics 2011; 128:S193-S199.Gilmour J, Harrison C, Asadi L, Cohen MH, Vohra S. Complementary and alternative medicine practitioners’ standard of care: responsibilities to patients and parents. Pediatrics 2011; 128:S200-S205.Abbott, R, Cohen MH. Medico-legal issues in cardiology. Cardiology in Review 2013;21:222-228.Cohen MH, Natbony S, Abbott R, Complementary and alternative medicine in child and adolescent psychiatry: legal considerations. Child Adolesc Psychiatr Clin N Am. 2013 Jul;22(3):493-507.Arhangelsky, P, Cohen MH. What’s behind FDA’s sudden soda interest? Daily Journal; 2014. Cohen, MH. Telemedicine: the future of health care. LegalZoom; February 14, 2014.Cohen, MH. Health Apps as Medical Devices: What It Means for Consumers. LegalZoom; November 13, 2014.Cohen, MH. Wearable health technology: health care dream or privacy nightmare? LegalZoom; 2014.Cohen, MH. Future of Medicine is just a tap away. Daily Journal; November 5, 2014.Cohen, MH. What 2015 will bring for wearable tech. Daily Journal; December 19, 2014.Cohen, MH. FDA’s General Wellness Guidance is Welcome News. Daily Journal; January 29, 2015.Cohen, MH. Artificial Intelligence and the Future of Law. Daily Journal; May 6, 2015. ................
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