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 strategy and safety. Classification and pathway decisions, postmarket obligations, recalls, and what clearance does and does not protect you from.
• Drug regulation and access. Evidence standards, labeling, off-label use and promotion, and reimbursement.
• Artificial intelligence in healthcare. Governance, validation, and who bears responsibility when a clinical AI tool gets it wrong.
• Health data and privacy. Data rights, consent, recording and transcription, and secondary use.
• Liability and risk. Products liability, preemption, malpractice exposure, and the compliance choices that drive them.
• Intellectual property. Patents, copyright and trademarks in health and technology, and the policy questions behind them.
• Regulatory policy. How a proposed rule or statute will behave once regulated parties respond to it.

Forms of engagement

• Written analysis. Memoranda and briefing papers on a defined regulatory or liability question.
• Regulatory advocacy. 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.
• Briefings and training. Sessions for boards, legal and regulatory teams, and clinical leadership, including CLE- and CME-accredited formats.
• Empirical work. Analysis of the underlying records where a question turns on what the data show.