Harry J. Nelson is arguably the leading healthcare and life science lawyer in America. Over the past three decades, he has built a record of respected authority on a broad range of healthcare compliance issues. Harry serves as outside general counsel to numerous healthcare organizations – including hospitals, behavioral health facilities, physician organizations, telemedicine companies, labs, pharmacies, and others – advising on healthcare licensing, business structuring, regulatory matters, and reimbursement compliance and strategy. Harry leads clients through risk identification, provides strategies and practical solutions for compliance, and regularly assists clients in managing crises in healthcare settings. He has delivered critical victories for providers, investor groups, and public companies in a series of hotly contested enforcement actions initiated by the Medical Board of California and the Board of Chiropractic Examiners related to corporate practice of medicine. Many crises have been averted by Harry’s able management and guidance.
- Oversaw the organization of a national addiction treatment center, including compliance program design, implementation, and extensive state-level certification and licensure, following a number of patient harm incidents.
- Oversaw development of standards and guidelines for providers and health plans on fraud and abuse issues, including waivers and discounts of patient financial responsibility and marketing activities.
- Developed a regulatory and reimbursement model for addiction treatment provider integration of medical and mental health professional services.
- Advised a telehealth provider on compliance and risk management strategies in servicing Medicare beneficiaries and contracting with Medicare and in-network healthcare providers.
- Advised a telehealth company on regulatory strategy for roll-out of an asynchronous telehealth model, including development of relationships with state regulators, self-funded employer plans, and venture investors.
- Defended a national clinical laboratory in an FDA investigation and persuaded the FDA to refrain from enforcement action, based on corrective action plan and compliance program.
- Advised a clinical research organization (CRO) on compliance in handling research related to cannabis and CBD.
- Prepared white papers on emerging issues in FDA regulatory pathways for stem cell therapeutics and other biologics.
- Served as an expert witness in the successful defense of corporate practice of medicine investigation of a national chain of retail healthcare, subsequently overseeing redesign and implementation of their compliance program.
- Advised national physician specialty organization in developing a HIPAA-compliant patient data registry, providing outcomes measurement and quality improvement.
- Served as an expert witness on cases involving allegations of data breaches; advised multiple covered entities and business associates on HIPAA privacy and data security compliance, as well as a post-brief response strategy.
- Represented medical group in a $3.1 million reduction in Medicare overpayment determination via a contested hearing against the recovery audit contractor.
- Developed and implemented regulatory compliance programs for over 100 skilled nursing facilities.
- Oversaw the implementation of a corporate integrity agreement on behalf of a skilled nursing facility chain, following the federal investigation of Stark Law and Anti-Kickback Statute violations.
- Resolved disputes with five cities across California regarding complaints concerning behavioral health housing.
- Successfully defended a sober living home against criminal charges brought by the City of Los Angeles, based on the mischaracterization of the home as an unlicensed community care facility and misapplication of the Los Angeles City Municipal Code. All licensing and occupancy charges were dropped, the case against the sober loving home was dismissed, and the property owner was thereby able to continue housing individuals recovering from addiction.
California
Hawaii
Illinois
J.D., cum laude, University of Michigan
A.B. with high distinction, University of Michigan
- National Behavioral Health Association of Providers (Founder and Chair)
- Keck School of Medicine of USC (Adjunct Clinical Assistant Professor of Anesthesiology)
- Los Angeles County Bar Association (LACBA) (Member, Healthcare Section)
- California Society of Healthcare Attorneys
- California Academy of Attorneys for Healthcare Professionals
For-Profit Board Memberships
- Compliagent (Board Member)
- Adaptive Health Capital (Board Member)
Non-Profit Board Memberships
- CLARE/Matrix (Former Board Member, 2017-2019)
- Project Opioid (Former Board Member, 2019-2023)
- Hillel Hebrew Academy (Former Board Chair and President, 2012-16; Board Member, 2005-2024)
- Kahal Chasidim (President, 2018-present)
- American Bar Foundation (Fellow, 2019-present)
Appointments
- Keck USC School of Medicine, Voluntary Adjunct Clinical Assistant Professor (2022-present)
- Wavemaker 360 Council of Strategic Advisors, 2022-2023
- National Behavioral Health Association of Providers, Co-Founder and Board Chair (2015-present)
- California Department of Consumer Affairs, Taskforce on Aesthetic Medical Devices (2015-2017)
- Medical Board of California, Volunteer Instructor (2017-2019)
Martindale-Hubbell
Martindale-Hubbell Rating, AV® Preeminent
Best Lawyers
Best Lawyer, Healthcare Law, Best Lawyers Magazine (2010-2025)
Best Lawyer, Administrative/Regulatory Law, Best Lawyers Magazine (2010-2025)
Super Lawyers
Super Lawyer, Southern California Super Lawyers Magazine (2010-2025)
Additional Accolades
Behavioral Health Network Resources, Addiction Treatment Advocate of the Year Award (2018)
Top Healthcare Lawyer in California, The Daily Journal (2019)
Davis Direct Foundation, Writer of the Yea (2019)
CLARE | MATRIX Spirit Award for Mental Health and Addiction Advocacy Award (2019)
United States of Opiods: A Prescription for Liberating a Nation in Pain (2019)
ObamaCare to TrumpCare: Why You Should Care (co-author) (2017)
Public Health Law: Concepts and Case Studies, Contributor (Springer 2021).
Patient Financial Responsibility Toolkit, Co-author (BHAP 2018).
Developer of C-ATM Certification Program for Behavioral Health Marketing Compliance
American College of Healthcare Executives (ACHE)
American Health Lawyers Association (AHLA)
California Society of Healthcare Attorneys (CSHA)
Los Angeles County Bar Association Health Section (CSHA)
California Consortium of Addiction Programs and Professionals (CCAPP)
CCSAD; WCSAD; TCIV; Autism Investors Summit; Health Dimensions Group
Media Appearances/Quoted By:
CNN
Fox News
KNX
KTLA
NewsNation