On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI while highlighting many known risks of AI tools and systems. It directs a broad range of actions around new standards for AI that will impact many sectors, and it articulates eight guiding principles and priorities to govern the development and use of AI (outlined below). This summary highlights directives in the EO that impact the use of AI in healthcare.
The timeline below and its accompanying table outline the tasks and deadlines that implicate AI in health as they stand today*.
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All stakeholders across the AI lifecycle (developers, deployers, users, auditors, etc.) should review the directives in the EO. While several directives significantly impact technology companies developing “foundation models,” along with government contractors and others developing advanced AI systems, the EO also directs action, reevaluation and potential changes in existing regulatory and enforcement schemes that could affect a variety of organizations. Additionally, the EO highlights a range of opportunities for formal and informal engagement to shape AI policy and standards, including through new task forces.
EO’S EIGHT GUIDING PRINCIPLES AND PRIORITIES FOR DEVELOPMENT AND USE OF AI
HEALTHCARE-SPECIFIC DIRECTIVES IN THE EO
Section 8. Protecting Consumers, Patients, Passengers and Students
Section 8.b.i. Within 90 days of the EO’s publication, the secretary of the US Department of Health and Human Services (HHS), in consultation with the secretary of defense and the secretary of veterans affairs, is required to establish an HHS AI Task Force. Within one year of establishment, the task force is required to develop a strategic plan that includes policies and frameworks—possibly including regulatory action, as appropriate—on responsible deployment and use of AI and AI-enabled technologies in the health and human services sector (including research and discovery, drug and device safety, healthcare delivery and financing, and public health), and identify appropriate guidance and resources to promote such deployment, including in the following areas:
Section 8.b.ii. Within 180 days of the EO’s publication, the secretary of HHS is required to develop a strategy, in consultation with relevant agencies, to determine whether AI-enabled technologies in the health and human services sector maintain appropriate levels of quality. This work is to include developing AI assurance policy—to evaluate important aspects AI-enabled healthcare tools’ performance—and infrastructure needs for enabling pre-market assessment and post-market oversight of AI-enabled healthcare-technology algorithmic system performance against real-world data.
Section 8.b.iii. Within 180 days of the EO’s publication, the secretary of HHS, in consultation with relevant agencies as the secretary of HHS deems appropriate, is required to consider appropriate actions to advance the prompt understanding of, and compliance with, federal nondiscrimination laws by health and human services providers that receive federal financial assistance, as well as how those laws relate to AI. Such actions may include:
Section 8.b.iv. Within 365 days of the date of this order, the secretary of HHS, in consultation with the secretary of defense and the secretary of veterans affairs, is required to establish an AI safety program that, in partnership with voluntary federally listed patient safety organizations:
Section 8.b.v. Within 365 days of the date of this order, the secretary of HHS is required to develop a strategy for regulating the use of AI or AI-enabled tools in drug-development processes. The strategy must, at a minimum:
Section 5.2 Promoting Innovation
Section 5.2.a.i. Within 90 days of the EO’s publication, in coordination with the heads of agencies that the director of the US National Science Foundation (NSF) deems appropriate, launch a pilot program implementing the National AI Research Resource (NAIRR), consistent with past recommendations of the NAIRR Task Force.
Section 5.2.a.iii. Within 540 days of the EO’s publication, the director of NSF should establish at least four new national AI research institutes, in addition to the 25 that are currently funded.
Section 5.2.e. To advance responsible AI innovation by a wide range of healthcare technology developers that promotes the welfare of patients and workers in the healthcare sector, the EO requires the secretary of HHS to identify and prioritize grantmaking and other awards, as well as undertake related efforts, to support responsible AI development and use, including:
NON-HEALTHCARE-SPECIFIC DIRECTIVES IN THE EO
Section 4. Ensuring the Safety and Security of AI Technology
Section 4.1.a. Within 270 days of the EO’s publication, the secretary of commerce is required to develop guidelines, standards and best practices for AI safety and security. Specifically, the secretary of commerce is required to work through the director of the National Institute of Standards and Technology (NIST), and in coordination with the secretary of energy, the secretary of homeland security and the heads of other relevant agencies as the secretary of commerce may deem appropriate, to:
Section 4.2.a. Within 90 days of the EO’s publication, to ensure and verify the continuous availability of safe, reliable and effective AI in accordance with the Defense Production Act, the secretary of commerce will require:
Section 4.5.a. Within 240 days of the date of this order, the secretary of commerce, in consultation with the heads of other relevant agencies as the secretary of commerce may deem appropriate, is required to submit a report to the director of the Office of Management and Budget (OMB) and the assistant to the president for National Security Affairs identifying the existing standards, tools, methods and practices, as well as the potential development of further science-backed standards and techniques, for:
Section 4.5.b. Within 180 days of submitting the abovementioned report, the secretary of commerce, in coordination with the director of OMB, will develop guidance regarding the existing tools and practices for digital content authentication and synthetic content detection measures.
Section 4.6.a. Within 270 days, the secretary of commerce, in consultation with the secretary of state, is required to solicit input from the private sector, academia, civil society and other stakeholders through a public consultation process on potential risks, benefits, other implications, and appropriate policy and regulatory approaches related to dual-use foundation models for which the model weights are widely available.
Section 6. Supporting Workers
Section 6.b.i. Within 180 day of the EO’s publication s, the secretary of labor, in consultation with other agencies and with outside entities (including labor unions and workers) as the secretary of labor deems appropriate, is required to develop and publish principles and best practices for employers that could be used to mitigate AI’s potential harms to employees’ well-being and maximize its potential benefits. The principles and best practices shall include specific steps for employers to take with regard to AI, and shall cover, at a minimum:
Section 12. Implementation
Section 12.a. The EO creates the White House Artificial Intelligence Council, which will coordinate the activities of agencies across the Federal Government to ensure the effective formulation, development, communication, industry engagement related to, and timely implementation of AI-related policies, including policies set forth in this EO.
IMPORTANT DEFINITIONS IN THE EO
CONCLUSION
The order is a consequential landmark document that sets the stage for the responsible governance of AI in the United States. By laying down guiding principles and a broad range of policy directives, the administration has created a roadmap for a coordinated, multi-stakeholder approach to AI across numerous industry sectors. This is a pivotal moment for AI governance, and while this EO is historic in its approach, the execution of its many directives depends heavily on the agencies and companies that have been called to action. Many of the key, material details and AI governance standards will be developed during the next six months to one year. For organizations interested in developing or using AI or machine learning tools in healthcare, there will be far-reaching implications as new standards, compliance expectations and other guidelines emerge.
Notably, this EO comes on the heels of increased attention on AI by senior lawmakers in the House and Senate. Senate Majority Leader Chuck Schumer (D-NY) is leading a bipartisan group in holding a series of roundtables and listening sessions to help educate members and staff on the benefits and risks of AI across various sectors. Similarly, a primary committee of jurisdiction on the House side, the Energy and Commerce Committee, has begun a series of hearings on AI to help inform policymakers of potential legislative and regulatory needs around the use of AI. For the administration’s part, there is a recognition that Congress may be slow to act and meaningful federal agency action is needed in the meantime. There is also an eagerness to make progress heading into an election year.
We will continue to unpack and provide analysis on the directives in the EO, including as federal agencies work to implement the policies described in the EO. Note that the administration also published a fact sheet about the EO. If you have questions about the EO or other AI regulatory, legal or policy developments, reach out to one of the authors below or your regular McDermott lawyer.
Visit our AI in Healthcare Resource Center for more health AI updates, listen to our Breakroom podcast on the EO and watch our recorded webinar, “AI and the Next Frontier: Understanding What’s Ahead in Health Policy, Regulatory Oversight and Market Access.”
For more information, please contact Kristen O’Brien, Rachel Stauffer, Jiayan Chen (Partner-McDermott Will & Emery), Jennifer S. Geetter (Partner-McDermott Will & Emery), Alya Sulaiman (Partner-McDermott Will & Emery), Dale C. Van Demark (Partner-McDermott Will & Emery), Purnima Boominathan (Counsel-McDermott Will & Emery), Sam Siegfried (Associate-McDermott Will & Emery).
