President Joe Biden signed an executive order Oct. 30 establishing new standards for the safe and secure use of artificial intelligence (AI) via federal oversight across different sectors, including health care.
The order – which will require congressional action for full implementation – creates an early set of guardrails for health care settings to protect patients and consumers from potential risks posed by AI. The move comes as Congress takes up AI policy considerations in health care with the U.S. Senate Committee on Health, Education, Labor, and Pensions holding a hearing on Nov. 8.
The Texas Medical Association’s House of Delegates adopted artificial and augmented intelligence policy last year. TMA policy supports the use of AI when “used appropriately to support physician decision-making, enhance patient care, and improve public health.”
Utilizing the Defense Production Act, the executive order requires leading AI developers to share safety test results and other information with the government. From there, the National Institute of Standards and Technology will create guidelines – used by the Department of Homeland Security, which also will establish the AI Safety and Security Board – to ensure AI tools are safe and secure before public release.
These measures will ensure AI systems are “safe, secure, and trustworthy” before companies make them public, per the White House.
The executive order also requires the U.S. Department of Health and Human Services (HHS), in collaboration with the secretary of Defense and the secretary of Veterans Affairs, to establish an HHS AI Task Force by Jan. 28, 2024.
Once created, the task force has one year to develop a regulatory action plan for AI technology used in health care settings that includes:
- Human oversight where appropriate;
- Safety and performance monitoring of AI technology;
- Equity principles in AI systems, including monitoring for discrimination and bias;
- Collaboration with state, local, tribal, and territorial health and human services agencies to communicate successful AI use cases and best practices; and
- Use of AI to make workplaces more efficient and reduce administrative burden where applicable.
HHS has 180 days following the executive order to take the following steps:
- Consult with other relevant agencies to determine if AI technology in health care maintains appropriate levels of quality;
- Develop policies to evaluate the performance of AI-integrated health care tools and algorithm performance against real-world data; and
- Provide clarity to health care professionals and payers about their obligations under federal nondiscrimination and privacy laws related to AI and the potential consequences of noncompliance.
Additionally, HHS has one year to implement an AI Safety Program that will create a framework organizations can use to monitor clinical errors resulting from AI usage. The program will track complaints from patients and health care professionals who report discrimination stemming from the use of AI.
HHS also must develop a strategy to regulate the use of AI technology or AI-integrated tools during phases of drug development, including determining opportunities for future regulation, rulemaking, guidance, and the use of additional authority.
“As AI’s capabilities grow, so do its implications for Americans’ safety and security. With this executive order, the president directs the most sweeping actions ever taken to protect Americans from the potential risks of AI systems,” the order’s fact sheet states.