Policy Synthesis and Coordination
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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 |
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Create coordinated framework for regulating AI across diverse agencies |
Coordinated Framework for Regulation of Biotechnology |
Developer Review
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Mandate certification of organizational excellence |
FDA’s Software Precertification (Pre-Cert) Pilot Program |
Funding
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Set acceptable risk levels for federally fundable research |
Risk stratification in the Artificial Intelligence Act (EU) |
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Tie release of institutional funding to specialized review mechanisms |
Stanford’s Ethics and Society Review |
Research Review
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Create specialized review mechanism for federally funded research |
Embryonic Stem Cell Research Oversight Committee |
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Require independent analytical validation of regulated AI products |
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Product Review
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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 |
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Require independent clinical evaluation of regulated AI products |
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Clinical Implementation
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Tie patent clocks to regulated AI products’ approval |
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Mandate post-approval oversight, including evaluation of real-world performance and impact of continuous learning |
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Establish reimbursement policies for AI-based medical services that prioritize safety, efficacy, and equity |
Alternative payment models, value-based care |
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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
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Mandate proof of specialized review for publication |
International Committee of Journal Medical Editors requirement for statement about IRB approval |