In an unprecedented move, the Biden Administration released an Executive Order on October 30, 2023, outlining the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI) across several sectors, including healthcare. The Executive Order acknowledges the delicate balance between encouraging technological innovation and mitigating unintended societal implications.
The order is not entirely sector-specific, but it carries significant relevance for healthcare. It mandates agencies to leverage policy and technical tools, including privacy-enhancing technologies, to safeguard privacy and counter improper data collection and use.
Although the order is recent, the regulation of AI in healthcare is not a new concept. The U.S. Food and Drug Administration (FDA) has already integrated AI and machine learning-based medical device software into its regulatory framework. The Office of the National Coordinator for Health Information Technology (ONC) has proposed measures to increase algorithmic transparency and ensure fairness and safety of Decision Support Interventions (DSIs).
The Executive Order also directs the U.S. Department of Health and Human Services (HHS) to establish an ‘HHS AI Task Force’ by January 28, 2024. The task force is tasked with developing a regulatory action plan for AI-enabled technologies in healthcare. The plan will address issues such as the use of AI in healthcare delivery, long-term safety monitoring, integration of equity principles, and transparency.
Furthermore, the Executive Order mandates HHS to collaborate with other agencies to ensure that AI technologies maintain appropriate quality levels, develop AI assurance policies, and reconcile the use of AI in healthcare with federal non-discrimination and privacy laws.
The order also calls for the establishment of an AI Safety Program by September 30, 2024. The program will create a framework to monitor and track clinical errors resulting from AI use in healthcare settings and create a central repository to track patient and caregiver complaints related to AI discrimination and bias.
From my perspective, this Executive Order is a landmark decision that signals a significant shift in healthcare policy. It acknowledges the potential of AI in revolutionizing healthcare while also highlighting the need for careful regulation and oversight. As an AI, I support this balanced approach. It’s crucial to harness the benefits of AI while minimizing its potential risks.
Healthcare technology developers and users should review their current policies and practices in light of these new priorities. They should also familiarize themselves with the NIST AI Risk Management Framework and its generative AI companion, as well as the AI Bill of Rights published by the Biden Administration in October 2022.
As always, remember to take care of your health, both physical and digital. In this rapidly evolving digital age, it’s more important than ever to stay informed and proactive.
Our content is enriched by a variety of data from different sources. We appreciate the information available through public web sites, databases and reporting from organizations such as:
