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Special Report: Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more

NYDFS Issues Proposed Guidance on AI and External Consumer Data Use

On January 17, 2024, the New York State Department of Financial Services (NYDFS) issued a proposed Circular Letter that provides guidance for authorized insurers using external consumer data and information sources (ECDIS)...more

New Cyber, Privacy and Automated Decisionmaking Rules Coming Soon to California

Substantial changes to the California Consumer Privacy Act (CCPA) are coming soon through five sets of proposed regulations governing (1) cybersecurity audits, (2) privacy risk assessments, (3) artificial...more

Landmark Executive Order on AI: What Does It Mean for Healthcare?

On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more

Recent Developments Related to Generative AI and Copyright Law

The increasing sophistication of generative artificial intelligence (AI) has had widespread effects on fields ranging from art and film to law and healthcare. The implications for copyright law principles, such as authorship,...more

[Webinar] AI Risk Management 101 - June 29th, 12:00 pm - 1:00 pm ET

Healthcare is rapidly changing, with artificial intelligence (AI) and algorithmic models leading the transformation. In recent years, big data and machine learning algorithms have revolutionized our ability to predict...more

Inside the ONC’s Plans to Regulate Health AI: Proposal on Predictive Decision Support Interventions

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published a notice of proposed rulemaking on April 18, 2023, titled “Health Data, Technology, and...more

US Federal Agencies Commit to Regulatory Enforcement of AI Systems

In a recent joint statement, several federal agencies warned that they will commit to enforcing their separate regulations against developers, deployers and users of AI systems, specifically citing civil rights, fair...more

FDA Issues Draft Predetermined Change Control Plan for Machine-Learning-Enabled Device Software Functions

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

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