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Artificial Intelligence:

Learn How President Biden’s AI Executive Order Affects Healthcare

Published on Fri Dec 01, 2023

Will new regulations hinder innovation?

On Oct. 30, 2023, President Joseph Biden signed an Executive Order (EO) and invoked the Defense Production Act to establish standards for safe and responsible artificial intelligence (AI) use in healthcare and other industries.

Tech and Innovation in Healthcare examined the presidential action to ascertain how it will affect AI development in healthcare.

Know What Technology Falls Under the EO

Most of the AI technologies grabbing headlines over the past year involve generative AI or machine learning technologies, but the EO’s focus expands beyond those models. The EO uses the AI definition according to 15 U.S. Code 9401(3), which outlines AI as “a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments.”

“Instead, the EO potentially impacts any machine-based system that makes predictions, recommendations, or decisions,” writes Robert S. Hill, partner attorney, Isaac F. Fuhrman, associate attorney, and Miranda A. Franco, senior policy advisor, with law firm Holland & Knight LLP in online analysis of the order.

The Biden-Harris administration lays out several goals in the EO, which include, but are not limited to:

  • Establishing new standards for AI safety and security.
  • Protecting Americans’ privacy.
  • Promoting responsible AI use.
  • Advancing innovation.
  • Improving equity and civil rights.

The directives laid out apply to all industries, including healthcare.

Prioritize Citizens’ Safety and Security

The White House is directing the U.S. Department of Health and Human Services (HHS) to take on healthcare-specific initiatives over the next year. Each of the initiatives have timetables of 90, 180, and 365 days. “With this Executive Order, the President directs the most sweeping actions ever taken to protect Americans from the potential risks of AI systems,” the administration writes in a fact sheet on the order.

A collaboration of the HHS Secretary, U.S. Secretary of Defense, and the Secretary of Veterans Affairs will work together to establish an HHS AI Task Force within 90 days of the EO’s signing. The task force will also put together a strategic plan for responsible AI and AI-enabled technology implementation and use in the health and human services sector. The plan’s policies and frameworks will cover AI use in several healthcare-related industries, such as:

  • Healthcare delivery and financing
  • Drug and device safety
  • Research and discovery
  • Public health

Within 180 days, the HHS Secretary will consult “relevant agencies” to “determine whether AI-enabled technologies in the health and human services sector maintain appropriate levels of quality,” wrote the White House in the EO. In the same 180 days, the EO directs the HHS Secretary to work with relevant agencies to ensure healthcare providers who are using AI and receiving federal dollars are complying with nondiscrimination requirements.

By one year after the EO takes effect, the HHS Secretary, U.S. Secretary of Defense, and the Secretary of Veterans Affairs are required to construct an AI safety program that “establishes a common framework for approaches to identifying and capturing clinical errors resulting from AI deployed in healthcare settings,” as well as determine regulations for using AI and related tools in developing drugs.

Foster AI Innovation and Competition

President Biden’s EO also seeks to foster growth and competition as organizations develop AI technologies. In Section 5, “Promoting Innovation and Competition,” the administration aims to:

  • Attract AI developers to the United States.
  • Advance growth in the technology.
  • Encourage competition.

The EO enlists the National Science Foundation (NSF) director to take crucial steps toward promoting AI innovation. These steps include:

  • National AI Research Resource (NAIRR) launch: The NSF director and other agencies will create the NAIRR tool, which will “provide AI researchers and students access to key AI resources and data,” according to the White House. Plus, industries like healthcare will have access to grants for AI research.
  • Improve training programs: The EO aims to enhance existing training programs for scientists to handle the demand for skilled AI talent. The administration listed a goal of “training 500 new researchers by 2025” in the EO.
  • Support regional innovation: Within 150 days, the NSF director will fund and launch at least one NSF Regional Innovation Engine. The engine(s) will be focused on prioritizing AI-related work like research, workforce, or societal needs.
  • Establish national AI research institutes: As of the date of the order, there were 25 funded National AI Research Institutes. The EO instructs the NSF director to establish at least four new institutes within 540 days of the EO taking effect.

Preliminary Reactions to the President’s Action

The administration’s order has been deemed “ambitious” and a “good start,” but tech and healthcare industry experts are interested to see how the order will take shape.

“The execution of many of the EO directives depends heavily on the agencies and companies that have been called to action … many of these items involve the interactions of multiple stakeholders, adding to the complexity of what is about to unfold, especially for the healthcare industry,” Holland & Knight authors wrote.

Stay tuned to Tech & Innovation in Healthcare for more information as AI continues to evolve in healthcare.

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