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FTC Amends Health Breach Notification Rule to Regulate Health Apps and Expand Breach Notification Requirements

On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a complement and counterpart to the breach notification requirements...more

Ten Takeaways From Long-Awaited Section 1557 Nondiscrimination Protections

On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the...more

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

New Year, New Laws: California Healthcare Providers Subject to New Requirements in 2024

The California legislature has created a lot of holiday homework for California healthcare providers, passing more than 50 new laws regulating a wide range of healthcare providers and healthcare business operations that apply...more

California’s New Reproductive Privacy Laws AB 352 and AB 254 Create Complexities For Health Information Sharing

In the wake of the Supreme Court of the United States’s decision in Dobbs v. Jackson Women’s Health Organization and the adoption of laws outside California that criminalize most abortions as well as gender affirming care,...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

For the General Counsel’s Desk: Managing Enforcement Risks Involving Cookies, Pixels, and Other Tracking Technologies

Data governance is a mission-critical issue for every company and institution in the United States. GCs face a host of pressing cybersecurity concerns. Triaging them requires time, attention, and a well-rounded strategy...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

Washington Legislature Passes My Health My Data Act

Washington State’s My Health My Data Act (the Act), which is working its way through the reconciliation process after the Washington Senate and House passed different versions of the Act, is ultimately expected to be signed...more

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