Health Privacy

Earlier this month, WPF attended a joint conference focused on the shifting dynamics of how the Common Rule that governs human subject research in the US will be interpreted amidst new technological shifts such as AI. The department of Health and Human Services is seeking to define what the next steps and new policy frameworks should be to ensure the Common Rule protects individuals in current and future research environments. Details on the presentations, conversations, and key takeaways in the post.

The FTC announced its first enforcement action under its Health Breach Notification Rule. This rule applies to entities that are not covered under HIPAA. The announcement of the proposed order was filed by the U.S. Department of Justice on behalf of the FTC against the “…telehealth and prescription drug discount provider GoodRx Holdings, Inc. for

The World Privacy Forum (WPF) submitted comments on an important Notice of Proposed Rulemaking that proposes modifications of the protection requirements for substance use disorder (SUD) treatment records. Currently, health records regarding treatment for Substance Use Disorders receive special protections under what is called Part 2 regulations, or,  42 CFR Part 2. The changes proposed

Thank you Chair and Commissioners. The profusion of health apps, websites and digital tools that provide consumers with assistance and insights about their health is a positive development. However, it has come at the cost of increasing privacy risks. One of these risks is that consumers are confused about when and where federal health privacy protections apply to their health information.

WPF recently reviewed and provided recommendations regarding a proposed AI Framework meant to apply to medical research involving human subjects. The issue of human subject research is a critically important one. In the US, The Common Rule (45 CFR subpart A) is a key regulation that protects people from unethical medical research. As research utilizing tools such as AI and SaMD — software as a medical device — grows in use, there is an urgent need to determine the proper ethical, legal, and regulatory framework for the use of these tools in the human subject research context. For this reason, WPF was pleased to review and provide recommendations to the Secretary’s Advisory Committee on Human Research Protections, SACHRP, on its proposed AI Framework.