Regulatory, Policy and Industry Consulting
David A. Simon advises government bodies, companies, investors, hospitals and patient-safety organizations on the regulation of medical devices and prescription drugs, liability for artificial intelligence in healthcare, health data and privacy, and intellectual property.
Advisory areas
- Medical device regulation and safety
- Classification and pathway strategy; what 510(k) clearance does and does not establish; postmarket surveillance, Medical Device Reporting and the limits of the MAUDE database; recalls and safety communications; device transparency and labeling disclosure; how patent filings interact with device oversight. He co-directs the Amy J. Reed Collaborative for Medical Device Safety with Tufts Medical Center and is Principal Investigator of an Arnold Ventures project analyzing device safety data.
- Drug regulation and access
- Evidence standards for approval and the tradeoffs between speed and certainty; off-label use, promotion and reimbursement as a de facto second gate; drug repurposing; how changes to approval standards propagate through liability, reimbursement and innovation incentives.
- Artificial intelligence in healthcare
- Governance frameworks for clinical AI; allocation of responsibility among developers, institutions and clinicians; ambient scribes and automated documentation; validation, monitoring and the duty to detect drift; the regulatory picture for AI-enabled devices after Loper Bright. He is a member of the research team on CLASSICA, a Horizon Europe project on AI-assisted cancer surgery.
- Health data and privacy
- Rights in patient data and who holds them; consent architecture for recording, transcription and secondary use; neural and brain data; consumer health apps and wearables and the rules that reach them; data sharing arrangements between institutions.
- Liability exposure and compliance
- How regulatory posture shapes products liability and malpractice risk; preemption; promotional review; structuring compliance programs around the obligations that actually generate exposure.
- Intellectual property strategy and policy
- Patent, copyright and trademark questions in health and technology; what IP regimes do and do not accomplish; certification marks and standards; IP policy analysis for agencies and organizations.
Forms of engagement
- Written analysis. Memoranda and briefing papers on a defined regulatory or liability question.
- Regulatory advocacy. FDA citizen petitions, comments on proposed rules, and written or oral testimony.
- Advisory roles. Standing advisory board or working group participation.
- Diligence support. Independent assessment of regulatory and liability risk for investors and acquirers evaluating regulated products.
- Briefings and training. Sessions for boards, legal and regulatory teams, and clinical leadership, including CLE- and CME-accredited formats.
- Empirical work. Analysis of FDA datasets, patent records and clinical trial registrations where a question turns on what the data show.