AI Regulations Resource Center

The purpose of this resource center is to identify key federal, state, and international AI policy activity. The resources and articles below include legislative and regulatory activity that is current as of October 2nd, 2024. Relevant updates will be made from time to time, when needed, in addition to regular blog posts explaining important policy updates.
________________________________________
As artificial intelligence continues to transform various sectors, including healthcare, law, and consumer protection, navigating the evolving regulatory landscape is crucial for stakeholders. Ogden Murphy Wallace’s AI Resource Center is designed to provide our clients, legal professionals, policymakers, and industry leaders with comprehensive insights into current and emerging regulations, guidance, and best practices related to artificial intelligence.

Here, you will find curated resources from federal, state, and international sources, including executive orders, agency guidelines, proposed legislation, and significant court cases. Our goal at OMW is to facilitate informed decision-making and compliance in an increasingly complex environment surrounding AI technologies.

Resource Categories

1. Federal Rules & Regulations
   1. Executive Orders and Associated Agency Actions
      1. Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Oct. 2023): Fact Sheet on the First 270 Days
      2. OMB Policy (Mar. 2024): Advancing Governance, Innovation, and Risk Management in AI
      3. BIS Notice of Proposed Rule Making (Sept. 2024): Establishing Reporting Requirements for the Development of Advanced AI
   2. Health Data and Interoperability Regulations
      1. HTI-1 Final Rule (Feb. 2024): Health IT Certification Updates, Algorithm Transparency, and Information Sharing
      2. HTI-2 Proposed Rule (Aug. 2024): Patient Engagement, Information Sharing, and Public Health Interoperability
   3. Federal Trade Commission Actions
      1. Compulsory Process for AI Products and Services (Nov. 2023): Key takeaways
      2. Proposed Rule against AI Impersonation (Feb. 2024): Summary of proposals
   4. Patient Rights and Protections Regulations
      1. CMS Final Rule on Medicare Advantage Plans (Apr. 2024): AI Use for Prior Authorization Determinations
      2. OCR Final Rule on Nondiscrimination in Health Programs (May 2024): Preventing AI Discrimination in Healthcare
2. Administrative Guidance and Publications
   1. AI Bill of Rights (Oct. 2022): Blueprint & Guidance for applications
   2. Joint Statement on Enforcement (Apr. 2024): Overview of collaborative enforcement approaches toward automated systems across agencies
   3. FDA Guidelines: See below for insights into the current state of AI regulations and approaches for medical devices and pharmaceuticals
      1. Artificial Intelligence and Machine Learning in Software as a Medical Device (Sept. 2024)
      2. Artificial Intelligence and Machine Learning for Drug Development (Mar. 2024)
      3. List of AI/ML- Enabled Medical Devices posted by FDA (current as of Aug. 2024)
      4. FDA created the FDA Digital Health Advisory Committee (current as of Sept. 2024)
         1. Digital health Advisory Committee page
      5. Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (Mar. 2024)
      6. Artificial Intelligence Program: Research on AI/ML-Based Medical Devices (Sept. 2024)
      7. Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER (Mar. 2024)
      8. Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles (June 2024)
      9. FDA/CDER Readying Draft Guidance on AI to Support Regulatory Decision-Making (June 2024)
3. State Legislation
   1. California AI Legislation: See below for breakdown of significant bills and legislation trackers
      1. California SB-1047 Safe and Secure Innovation for Frontier Artificial Intelligence Models Act
      2. California SB-942 California AI Transparency Act
      3. California SB-896 Generative Artificial Intelligence Accountability Act
      4. California SB-892 Public Contracts: Automated Decision Systems: Procurement Standards
      5. California AB-1831 Crimes: Child Pornography (re AI use)
      6. California SB-976 Protecting Our Kids from Social Media Addiction Act
      7. California AB-2839 Elections: Deceptive Media in Advertisements
      8. California AB-2655 Defending Democracy from Deepfake Deception Act of 2024
      9. California AB-2355 Political Reform Act of 1974: Political Advertisements: Artificial Intelligence
      10. California AB-2885 Artificial Intelligence
      11. California AB-2013 Artificial Intelligence: training data transparency
      12. Consumer Privacy Protection Agency Board Proposed Automated Decision-making Technology Regulations (Dec. 2023)
      13. Civil Rights Council Proposed Modifications to Employment Regulations Regarding Automated-Decision Systems (May 2024)
   2. Enacted and Pending Legislation in Other States: State tracker with overviews of legislation in Utah, Colorado, Illinois, and more
4. International Developments
   1. Council of Europe’s Framework Convention on AI (Sept. 2024): First legally binding international treaty on AI
   2. European Union AI Act (Aug. 2024): Summary of regulations and implications for global compliance
   3. UN Governance Report (Sept. 2024): Governing AI for Humanity
5. Cases and Controversies
   1. Lawsuits Involving AI: discussion of significant cases regarding UnitedHealth & Cigna over automated claims denials
   2. FTC Crackdown on Deceptive AI (Sept. 2024): Discussion of current cases and settlements
   3. DOJ Interest in Fair Housing and AI (Jan. 2023): Statement of interest alleging unlawful algorithm-based tenant screening practices
6. Additional Resources
   1. Coalition for Health AI Publications: Assurance standards & guidelines for trustworthy AI

The OMW AI Resource Center aims to be a comprehensive hub for professionals navigating the legal intricacies of artificial intelligence. As the landscape evolves, we will continuously update our resources to reflect the latest developments, ensuring you stay informed and compliant.

For further inquiries or specific legal advice regarding AI regulations, please contact our digital health legal team.