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May 02, 2024

Race Against the Clock: Federal Agencies Issue Their Six-Month Updates on AI Activities in Accordance With President Biden’s Executive Order on AI

Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and expectations outlined therein. As was the case for the deadlines that have already passed, we saw a flurry of activity and agency announcements earlier this week as we hit the 180-day mark since the EO was issued, and President Biden’s office published an overview of those actions on the White House website. While many of these actions are generally applicable, below, we focus on a few of the updates of interest to those operating in the health and life sciences industry. 

The U.S. Department of Commerce Issues Draft Guidance and Seeks Public Comment on AI 

The U.S. Department of Commerce issued several announcements relating to its 180-day initiatives outlined in the EO, including announcements from the National Institute of Standards and Technology (NIST) and the U.S. Patent and Trademark Office (USPTO), two offices the Department of Commerce oversees:

The U.S. Department of Health and Human Services Pre-Announces a New AI-Related Rule

The U.S. Department of Health and Human Service’s Office of Civil Rights issued a statement on April 26 preannouncing issuance of the final version of a new rule under Section 1557 of the Patient Protection and Affordable Care Act. The rule, which is expected to be officially issued sometime next week, is designed to strengthen nondiscrimination protections and advance civil rights in health care, including through the application of technology.  The rule clarifies that the requirement for nondiscrimination in health programs and activities “continues to apply to the use of AI, clinical algorithms, predictive analytics, and other tools,” a clarification that the HHS considers a “key pillar[]” of its response to the EO. One main focus of the new rule is the application of Section 1557’s nondiscrimination principles to the use of patient care decision support tools in clinical care, including how covered entities will identify and mitigate discrimination in the context of that use

With numerous additional forthcoming deadlines outlined in the EO, the health and life sciences industry can expect the next 180 days (and beyond) to be just as busy as these last 180 days. Faegre Drinker’s AI-X team is keeping a close eye on those updates — stay tuned for more! 

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