New AI Executive Order Has Several Implications for Healthcare | ideas

New AI Executive Order Has Several Implications for Healthcare |  ideas

On October 30, 2023, President Joe Biden signed a sweeping Executive Order (EO) and invoked the Defense Production Act to create the first set of standards for the use of artificial intelligence (AI) in healthcare and other industries. The advent of the Internet has fundamentally changed healthcare, and artificial intelligence is poised to do the same. The rapid expansion of AI in healthcare holds the promise of dramatically changing diagnosis, treatment, research, risk assessment, drug development, and even payment systems. This Holland & Knight alert examines the potential of AI in healthcare and timelines for establishing government oversight.

wide range

AI is still in its relatively early stages, but there are many applications that are already poised to disrupt the healthcare status quo. These include wearable devices that can generate real-time biometric data for use in advanced analysis and AI-powered technologies to predict the 3D shape of protein molecules from amino acid sequence data, widely known as the “protein folding problem.” AI approaches are shaped by emerging legislation, regulatory oversight, civil liability law, and industry standards. Accordingly, the need for a more unified approach to AI governance has provided the impetus for the Biden administration to establish principles to guide federal agencies in the development, use, and oversight of AI.

It is worth noting that the EO uses the definition of “artificial intelligence” found at 15 USC 9401(3): “A machine-based system that can, for a specified set of human-determined objectives, make predictions, recommendations, or decisions that affect real or virtual environments. “Therefore, the scope of EO is not limited to generative AI or even machine learning techniques in general. Instead, EO is likely to influence any A machine-based system that makes predictions, recommendations, or decisions.

Employers’ Organization and Department of Health and Human Services

Overall, the EO seeks to balance controlling AI risks while encouraging innovation that may benefit consumers. To ensure the safe and responsible use of AI in the healthcare sector, the Office of Ethics has provided healthcare-specific guidance to the US Department of Health and Human Services (HHS) over the next year.

Within 90 days

Establishment of a Department of Health and Human Services Artificial Intelligence Task Force (Section 8.B). The Secretary of Health and Human Services is directed to work with the U.S. Secretary of Defense and the Secretary of Veterans Affairs to establish a Department of Health and Human Services Artificial Intelligence Task Force and, within one year, develop a strategic plan that includes policies and frameworks, possibly including regulatory actions, 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, health care delivery and financing, and public health).

Within 180 days

Issue a strategy on whether AI technologies in the health and human services sector maintain appropriate levels of quality (Section 8.B.ii). Requires the Secretary of the Department of Health and Human Services 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 includes the development of an AI assurance policy—to assess fundamental aspects of the performance of AI-enabled healthcare tools—and infrastructure needs to enable pre-market assessment and post-market oversight of AI-enabled healthcare technology algorithmic system performance against real-world data.

Ensure that health care providers receiving federal funding comply with nondiscrimination requirements when using AI technology (Section 8.B.iii). The HHS Secretary, in consultation with such relevant agencies as the HHS Secretary deems appropriate, is required to consider appropriate actions to promote prompt understanding of and compliance with Federal nondiscrimination laws by health and human services providers receiving Federal financial assistance, as well as how such laws relate to artificial intelligence.

Within 365 days

Establish an AI safety program (Section 8.B.4). Directs the Secretary of Health and Human Services, in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, to establish an Artificial Intelligence Safety Program that, in partnership with federally listed voluntary patient safety organizations, establishes a framework for methods for identifying clinical errors resulting from artificial intelligence deployed in health care settings, from Among other things.

Develop a strategy to regulate the use of AI or AI-enabled tools in the drug development process (Section 8.Bf). Requires the Secretary of the Department of Health and Human Services (HHS) to develop a strategy to identify the goals, objectives, and principles required for appropriate regulation during each drug development process and to identify areas where future rulemaking authority may be necessary, in addition to existing budget and resources for the new public and private sectors. The partnerships needed for such a regulatory system.

Employers’ Organization and the National Salvation Front

The EO also directs the National Science Foundation (NSF) to take certain steps to promote AI innovation, including the following.

Within 45 days

Coordinate the launch of the National Artificial Intelligence Research Resource (NAIRR) (Section The heads of agencies designated by the NSF Director to coordinate the launch of the NAIRR Pilot Program, consistent with previous recommendations of the NAIRR Task Force, must submit to the NSF Director a report identifying agency resources that can be developed and integrated into these programs. Demo program.

Within 90 days

Launch NAIRR (Section The program should follow infrastructure, governance mechanisms, and user interfaces to pilot the initial integration of distributed computational, data, modeling, and training resources that will be made available to the research community to support AI-related R&D.

Within 120 days

Strengthen existing training programs (Section 5.2.(b)). Establish a pilot program with the US Secretary of Energy to enhance existing successful training programs for scientists, with the goal of training 500 new researchers by 2025 capable of meeting the growing demand for AI talent.

Within 150 days

Support regional innovation (Section 5.2.a.ii.). Fund and launch at least one regional NSF innovation engine that prioritizes AI-related work, such as AI-related research, societal needs, or workforce needs.

Within 540 days

New National Research Institutes for AI (Section 5.2.A.iii). Establishes at least four new national institutes for artificial intelligence research, in addition to the 25 institutes currently funded as of the date of this order.

Employers’ Organization, US Patent and Trademark Office, and Library of Congress

The EO recognizes that 1) the level of protection that AI systems can receive under US patent law and 2) that the processing of the output of an AI system under intellectual property law will have a significant impact on the development of this technology. The Employers’ Organization seems to implicitly understand that many people think so Alice Corp Pty. Ltd.. v. CLS Bank Intern., 573 US 208 (2014), and subsequent patentability jurisprudence have created potential headwinds and uncertainty regarding the development of artificial intelligence. The EO also shows an awareness of precedent, which precludes copyright protection for AI-generated content. Therefore, to encourage innovation and clarify issues related to artificial intelligence and the invention of patentable subject matter, the Under Secretary of Commerce for Intellectual Property and the Director of the USPTO (Director of the USPTO) are directed to take certain actions. These action items will have a tremendous impact on the development and ownership of key AI technologies and deliverables in the healthcare context, among many other issues.

Within 120 days

Publication of guidance for patent examiners and applicants (Section Publish guidance for USPTO patent examiners and applicants on invention and the use of artificial intelligence, including generative artificial intelligence, in the inventive process, including illustrative examples of where artificial intelligence systems play different roles in inventive processes and how invention issues should be addressed in Every example. Analyzed.

Within 270 days

Issue additional and updated guidance (Section 5.2.c.ii). Issue additional guidance to USPTO patent examiners and applicants to address other considerations at the intersection of AI and intellectual property, which could include, as the USPTO Director deems necessary, updated guidance on patentability to address innovation in AI and emerging and biotechnologies.

Issue recommendations to the President regarding potential executive actions (Section 5.2.c.iii). Within 270 days or 180 days after the Library of Congress’s U.S. Copyright Office publishes its next study on artificial intelligence, the Director of the U.S. Copyright Office must consult and issue recommendations to the President regarding potential executive actions related to copyright and artificial intelligence. The recommendations should address any copyright and related issues discussed in the US Copyright Office study, including the scope of protection for works produced using AI and the treatment of copyrighted works in AI training.


Implementation of many employer directives depends heavily on the agencies and companies called into action. As noted above—in a summary that captures only a subset of the overall scope of the stakeholder organization—many of these elements involve interactions among multiple stakeholders, adding to the complexity of what is about to unfold, especially for the healthcare industry. Accordingly, the White House and agencies are likely to begin activating and engaging industry and seeking input to deploy AI systems and processes.

Following the CEOs decision, the White House Office of Budget Management (OMB) issued a draft memorandum to the heads of executive agencies stating that each agency must appoint a chief artificial intelligence chief executive (CAIO) within 60 days. The appointed CAIO will be tasked with “promoting responsible innovation in AI” and “managing risks arising from the use of AI.” The draft memorandum is subject to public comment until December 5, 2023, through the Office of Management and Budget website.

At the same time, as issues of executive deference appear to be top of mind for the US Supreme Court, litigation challenges may also play an important role in determining how the executive order is actually implemented. See, for example, Luber Brite Enterprises v. Raymundo, 45 F.4th 359 (D.C. Cir. 2022), Cirt. Granted, 216 l. Mr. Dr. 2d 414 (May 1, 2023) (No. 22-451). This is especially true for labor law provisions, which create new obligations, for example, the Section 4.2(a) requirement that certain AI activities be reported to the federal government.

The Ethics Office is also following increased scrutiny of AI by Congress. In the 118th Congress, at least 40 bills were introduced that either focused on AI or contained AI-focused provisions. There have also been numerous roundtables and congressional hearings to help inform lawmakers of potential legislative and regulatory needs around the use of AI. Congress is considering whether the federal government’s current mechanisms for AI oversight and policymaking are adequate, the federal government’s role in supporting AI research and development, the potential impact of AI technologies on the workforce, and detection, testing, and validation of AI use. Artificial intelligence systems. For the Biden administration, there is an acknowledgment that Congress may be slow to act, and significant action by the federal agency is needed in the meantime.

The information in this alert is intended for the general education and knowledge of our readers. It is not designed to be, and should not be used, as the sole source of information when analyzing and resolving a legal problem, nor should it be a substitute for legal advice based on specific factual analysis. Furthermore, the laws of each jurisdiction are different and constantly changing. This information is not intended to create an attorney-client relationship, and its receipt does not constitute one. If you have specific questions regarding a particular factual situation, we encourage you to consult the authors of this publication, a Holland & Knight representative, or other competent legal counsel.

    (tags for translation) AI Executive Order AI

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