BODY OF WORK
Books, publications, and ideas shaping
healthcare law, policy, and AI governance.
FEATURED BOOK
Digital Diagnosis: The AI Revolution in
Healthcare and the Future of Regulation
Artificial intelligence is transforming medicine faster than regulation can keep up. The promise is extraordinary. So is the risk.
Digital Diagnosis is a guide for healthcare attorneys, compliance officers, hospital executives, and physicians navigating the legal and regulatory landscape of AI in medicine. Written by two seasoned healthcare attorneys and compliance professionals, it maps the full sweep of AI risk in healthcare.
More Books
Explore more of Harry Nelson’s books on healthcare law, regulation and policy.
Publications & Articles
Ideas. Analysis. Insight.
Thought leadership on healthcare law, regulation, compliance, and the business of medicine.
How Much ER Data Does Product Safety Require?
The federal Consumer Product Safety Commission (CPSC) has a challenge. For over 50 years (since 1972), its National Electronic Injury Surveillance System – NEISS has…
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Where Is California Heading on the Corporate Practice of Medicine? A Call for Standards, Not Ambushes
July 24, 2026 By: Harry J. Nelson, Esq. For several years, we watched California make a series of false starts at “reining in” the corporate…
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Thinking About This Moment in Medicare Enforcement: The Politics and Collateral Damage of Fighting Fraud
For much of my career as a healthcare lawyer, government enforcement at both the federal and state levels has moved through long, relatively stable stretches.…
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Is the Window Closing on GLP-1 Compounding? Opening on Peptides? My Latest Thoughts
Many people are unaware that GLP-1 compounding predates the FDA-approved GLP-1s, semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound). For over two decades before Novo Nordisk and Eli…
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Reimagining Informed Consent in the Digital Era: Closing the Gap Between Legal Standards and Clinical Reality
Informed consent remains one of the most foundational—and most persistently misunderstood—obligations in healthcare. While the doctrine is rooted in patient autonomy, its real-world implementation has…
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DEA Places State-Licensed Medical Marijuana in Schedule III of the Controlled Substances Act: What It Means and What It Does Not
The Drug Enforcement Administration (DEA) took a significant step in federal marijuana policy, announcing on April 23, 2026 that FDA‑approved marijuana products and marijuana products…
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California AG Signals Harder Line on CPOM in PC-MSO Succession Agreements
The California Attorney General’s (“AG”) recent amicus filing is another clear signal that California is intensifying its scrutiny of the corporate practice of medicine (“CPOM”)…
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A Win for Providers in No Surprises Act IDR Litigation
On April 9, 2026, the U.S. District Court for the Central District of California handed providers an important win under the No Surprises Act. In Anthem…
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False Claims Act Risk and the 340B Program: What the Ninth Circuit’s Recent Decision Means for Industry Stakeholders
On March 17, 2026, the Ninth Circuit revived a whistleblower complaint by Adventist Health System against four major drug companies alleging that the manufacturers violated…
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CMS Updates Medicare ABN Form: What It Means for Your Practice
On March 13, 2026, the Centers for Medicare & Medicaid Services (CMS) released an updated version of the Advance Beneficiary Notice of Non-Coverage, Form CMS-R-131,…
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Stark Law Enforcement: Lessons from the Community Health Network Settlement for Physician Compensation and Recruitment
A recent $345 million Stark Law settlement involving Community Health Network highlights the continuing enforcement focus on physician recruitment and compensation arrangements. The case underscores a recurring…
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Anti-Kickback Statute Enforcement: Lessons from the $202 Million Gilead Speaker Program Settlement
A recent $202 million settlement involving Gilead Sciences serves as another reminder that physician speaker programs remain a continuing focus of federal healthcare enforcement. While speaker programs…
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Entire Opioid Supply Chain Faces First Test in New York Case
The first lawsuit putting the entire opioid supply chain on trial will begin pretrial hearings Friday in New York State Supreme Court in Suffolk County.…
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“Purely Cosmetic?”: Aesthetic Medicine and Wellness Care During COVID-19
While the majority of U.S. healthcare infrastructure reopens, California providers of aesthetic and various wellness services – including plastic surgeons, cosmetic dermatology, medspas, and providers…
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The Recovery Executive Podcast: The Legal Ins and Outs of Addiction Treatment with Harry Nelson
Healthcare laws are complex to say the least. Regular attorneys just don’t know enough, which is why I’m having Harry Nelson, Managing Partner of Nelson-Hardiman…
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