Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

The California Attorney General’s Office (AG) unsurprisingly takes an expansive view of how the development, sale, and use of artificial intelligence technology (AI) in healthcare could lead to potential violations of existing California laws. In a recent legal advisory the AG highlights specific areas healthcare organizations should focus on as they develop, train, improve, and

The U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights (“OCR”), recently issued a “Dear Colleague” letter, Ensuring Nondiscrimination Through the Use of Artificial Intelligence (“AI”) and Other Emerging Technologies, which emphasizes the importance of fairness and equity in AI use in patient care decision support tools (e.g., clinical

California’s new law, SB 1120, set to take effect on January 1, 2025, regulates how health care service plans (HCSPs) and disability insurers use automated decision-making tools, such as artificial intelligence, to analyze medical necessity in utilization reviews affecting California enrollees. Compared to federal guidelines, this law is more prescriptive, requiring HCSPs and disability

The U.S. Department of Health and Human Services (HHS) has published its Plan for Promoting Responsible Use of Artificial Intelligence in Automated and Algorithmic Systems by State, Local, Tribal, and Territorial Governments in the Administration of Public Benefits (AI Plan for State and Local Governments). It shows the agency’s current thinking on managing risk from

The use of artificial intelligence (AI) in research and development and the research and development of AI solutions themselves create far reaching legal and policy questions in the clinical research context.

In one of the latest installments of Reed Smith’s video series “AI explained”, Reed Smith attorneys Nancy Bonifant Halstead and Sarah Thompson Schick

Colorado recently passed a law creating consumer protections for interactions with artificial intelligence systems. The law specifically identifies high-risk systems, including in those that impact health care. The law requires risk mitigation, documentation and robust governance.

Monique N. Bhargava has written an in-depth article on the law and what it means for AI regulation in

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) has published its first final rule on Health Data, Technology and Interoperability. The rule, known as the HTI-1 rule, takes effect on February 8, and governs updates to the ONC’s Health IT Certification Program, as well as regulations