Biden Administration Introduces Groundbreaking AI Regulations in Healthcare
The Biden Administration has taken a significant step towards regulating the use of artificial intelligence (AI) in healthcare. On October 30, 2023, President Biden signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, outlining the administration’s priorities and policies regarding AI across various sectors, including healthcare.
Recognizing the need to balance technological innovation with potential societal consequences, the Executive Order emphasizes the importance of protecting privacy and combatting the improper collection and use of individuals’ data. It also highlights the existing efforts of regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC) in incorporating AI into their regulatory frameworks.
To ensure the safe and effective use of AI in healthcare, the Executive Order mandates the establishment of an HHS AI Task Force by January 28, 2024. This task force, in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, has been given 365 days to develop a regulatory action plan for predictive and generative AI-enabled technologies in healthcare. The plan will address issues such as algorithmic transparency, fairness, and patient safety.
In addition to the AI Task Force, the Executive Order also directs the Department of Health and Human Services (HHS) to organize and implement an AI Safety Program by September 30, 2024. This program, in collaboration with Patient Safety Organizations, will create a framework for monitoring and tracking clinical errors resulting from the use of AI in healthcare settings. It will also establish a central tracking repository to address complaints related to discrimination and bias in AI usage.
Moreover, HHS will utilize its existing grant and award programs to support ethical AI development by healthcare technology developers. These programs aim to promote the responsible use of AI in improving the quality of patient care. Additionally, the Secretary of Veterans Affairs will host nationwide AI Tech Sprint competitions to further enhance AI systems for the benefit of veterans’ healthcare.
The Executive Order provides valuable insights into the future regulation of AI in healthcare. It highlights key areas of focus, including drug development, non-discrimination, data privacy, and security. Healthcare technology developers are advised to review their policies and practices to align with the Biden Administration’s priorities.
As the development and use of AI continue to evolve, the National Institute of Standards and Technology (NIST) has released the voluntary AI Risk Management Framework to help organizations analyze and manage risks associated with AI systems. NIST is also tasked with developing a companion resource for generative AI in response to the Executive Order.
This groundbreaking move by the Biden Administration sets the stage for the development of AI-focused working groups, policies, and possible future regulations within the healthcare sector. Stakeholders in healthcare should familiarize themselves with the NIST AI Risk Management Framework, the AI Bill of Rights, and other relevant resources to ensure the responsible deployment and use of AI systems in their organizations.
In conclusion, the Biden Administration’s Executive Order on AI regulations in healthcare marks a pivotal moment in shaping the future of AI development and usage. By prioritizing safety, ethics, and fairness, this initiative aims to harness the potential of AI while safeguarding individuals’ rights and well-being.
