Andrew Jonathan Hillman

Andrew Jonathan Hillman

Healthcare Compliance Expert Witness and Senior Paralegal

Dallas, Texas, United States

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Healthcare compliance should be provable on paper before anyone asks. Andrew Jonathan Hillman is a healthcare compliance expert witness and senior paralegal based in Dallas, Texas. His operating years are closed: three decades running FDA regulated businesses, starting with Hillman Ventures, founded in 1995. His expert practice is open, retained through counsel on FDA biologics pathways (Section 351(a) versus 361 HCT/P), Medicare overpayment rules and federal enforcement patterns. He will not offer legal conclusions or opinions outside his field, and he is not an attorney. He writes The Hillman Letter on Substack and hosts The Hillman Letter Podcast on Spotify and Apple Podcasts.

Area of Expertise

  • Health & Medical
  • Law & Regulation

Topics

  • Healthcare Compliance
  • FDA Regulation
  • Biologics
  • Legal Tech
  • AI Governance
  • Risk Management

351 or 361? How FDA Decides What Counts as a Biologic

How FDA distinguishes Section 351(a) biologics from Section 361 HCT/Ps, and what that means for compliance planning. This is regulatory education, not legal advice.

Duration: 45 minutes.

Six Compliance Patterns Behind Federal Healthcare Enforcement

Six recurring patterns in federal healthcare enforcement actions, and how compliance teams can document against each before anyone asks. This is regulatory education, not legal advice.

Duration: 45 minutes.

AI Governance Rules for Healthcare Teams

Practical governance rules for deploying AI in healthcare organizations: accountability, documentation, risk review and oversight. This is regulatory education, not legal advice.

Duration: 30 minutes.

Andrew Jonathan Hillman

Healthcare Compliance Expert Witness and Senior Paralegal

Dallas, Texas, United States

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