Insights

New York – January 16, 2024: Linda Malek, Jason Johnson and Blaze Waleski are joining Crowell & Moring’s Health Care and Privacy & Cybersecurity groups and will be based in the New York office.

On October 29, 2024, the Department of Justice (DOJ) published a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the E.O.).  The E.O. addresses the national security threat posed by the continued effort of certain countries of concern to access and exploit certain kinds of Americans’ sensitive personal data, which includes health data and genetic data. This builds on DOJ’s Advance Notice of Proposed Rulemaking (ANPRM) published on March 5.  Comments are due on November 29, 2024.

On September 12, 2024, the Department of Health and Human Services’ (“HHS”) Office of Research Integrity (“ORI”) released a final rule updating 42 CFR Section 93, Public Health Service Policies (“PHS”) on Research Misconduct (“Final Rule”). The research misconduct rule was promulgated almost 20 years ago without subsequent revision, until now. It affects all recipients of Public Health Service funding for biomedical or behavioral research, requiring them to update their policies and procedures governing research misconduct to remain in compliance with the regulation.

The Federal Trade Commission (FTC) recently entered into a settlement with Monument, Inc., an alcohol addiction treatment service, for allegedly disclosing users’ personal health data to third-party advertising platforms without consumer consent and violating their own website claims to consumers with respect to the disclosure of such data. The action follows other settlements by the FTC focused on tracking technologies collecting sensitive health information through web pages and web portals. “This action continues the FTC’s work to ensure strict limits on how firms handle sensitive health data, rather than putting the onus on consumers to protect themselves,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “Following on the heels of actions against GoodRx, BetterHelp, and Premom, the market should be getting the message that consumer health data should be handled with extreme caution.”

In this episode, hosts Megan Beaver and Savanna Williams talk to Jason Johnson and Linda Malek about the evolving regulatory landscape related to artificial intelligence (AI) in health care. In particular, Jason and Linda discuss the use of AI by organizations engaged in clinical research including key issues and emerging themes in this field.