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. Author manuscript; available in PMC: 2024 Sep 13.
Published in final edited form as: Sci Transl Med. 2023 Sep 13;15(713):eadi0336. doi: 10.1126/scitranslmed.adi0336

Table 1. Recommendations for stronger AI regulation, organized by type of oversight, that protect the principles espoused by the OSTP and are enforceable.

Guiding examples are provided, when available.

Type of Oversight Recommendation Examples
Policy Synthesis and Coordination Convene expert panel to provide recommendations and for the oversight of AI and synthesize existing guidance; update existing National Science Advisory Board for Biosecurity (NSABB) mandate to include biosecurity risks posed by AI NSABB panel on gain-of-function research
Create coordinated framework for regulating AI across diverse agencies Coordinated Framework for Regulation of Biotechnology
Developer Review Mandate certification of organizational excellence FDA’s Software Precertification (Pre-Cert) Pilot Program
Funding Set acceptable risk levels for federally fundable research Risk stratification in the Artificial Intelligence Act (EU)
Tie release of institutional funding to specialized review mechanisms Stanford’s Ethics and Society Review
Research Review Create specialized review mechanism for federally funded research Embryonic Stem Cell Research Oversight Committee
Require independent analytical validation of regulated AI products
Product Review Provide clear guidance about approval processes for regulated AI products, including post-approval oversight The FDA’s Good Machine Learning Practice for Medical Device Development: Guiding Principles
Require independent clinical evaluation of regulated AI products
Clinical Implementation Tie patent clocks to regulated AI products’ approval
Mandate post-approval oversight, including evaluation of real-world performance and impact of continuous learning
Establish reimbursement policies for AI-based medical services that prioritize safety, efficacy, and equity Alternative payment models, value-based care
Establish best practices for hospitals and providers, including accreditation, training requirements, assessment of competency and ongoing monitoring, that are subject to penalties The Joint Commission
Dissemination Mandate proof of specialized review for publication International Committee of Journal Medical Editors requirement for statement about IRB approval