President Biden’s Executive Order on Artificial Intelligence seeks to address emerging risks and harness innovation in health care and life sciences.

The Biden administration’s EO works to strike a balance between promoting AI’s potential to transform technological innovation and protecting against the risk of unintended consequences. This view is consistent with the approach the FDA is already taking. This has prioritized the development of specific policies for AI.² Additionally, the Office of the National Coordinator for Health Information Technology (ONC) offers a comprehensive health IT certification program for predictive decision support interventions.³ that we write about here

Like many other sectors, AI adoption in the healthcare sector is still progressing well. And development is outpacing federal efforts to regulate its use. For example, in 2021 AI/machine learning (ML) was included in one or more development steps for drugs and biologics. More than 100 species submitted to FDA⁴ And as of October 19, 2023, the FDA has inspected 171 AI/ML-based medical devices.⁵ The FDA has expressed the need for long-term safety and monitoring of real-world efficacy of AI-enabled technologies; Integration of the principle of equality in AI-based technologies, integration of safety standards. privacy and integrating security into the software development lifecycle. and tailored guidance to review the role of AI/ML in drug development, and the EO issues orders addressing all of these considerations.

In addition to FDA, HHS is likely to call on various agencies and offices. Implements various aspects of EOs including ONC, Office of Civil Rights, Centers for Medicare and Medicaid Services, National Institutes of Health. and office for Protecting Human Research The EO also calls for broad coordination among agencies. This is in addition to the HHS-led action items.

EO Order for HHS

The EO calls on HHS to support AI development while protecting patients, consumers, and employees by issuing the following orders:

Other EO directives and policies affecting the health sector

The EO also includes recommendations used in various sectors. that will have a special impact on health care, such as a directive that federal agencies use privacy-enhanced technology (PET) where appropriate Directives aimed at tackling AI in critical infrastructure and cybersecurity will also affect the health sector. Additionally, some provisions directly apply to private companies. This includes companies in the healthcare sector, such as the requirement that developers of dual-use baseline models submit a report to the Commerce Department outlining the training and testing process.

Additionally, many of the commonly used guiding principles listed in the EO are of particular relevance to healthcare. For example, the first guiding principle is that AI must be safe. This resonates deeply in the health sector. The EO further explains that in order to achieve this goal Robust and standardized AI system evaluation is required to test, understand, and mitigate AI system risks before they are deployed. The EO also emphasizes that testing and evaluation Including checking performance after use It is necessary to help ensure that AI systems work as intended. It is resilient to misuse or malicious modification. Ethically developed Do so in a safe and compliant manner. with applicable law

The overarching Guiding Principles also address privacy concerns and are a reminder that relevant privacy requirements remain applicable in the AI ​​context. The EO declares that the federal government will enforce existing laws and enact safeguards. violation of privacy Noting that one important field of importance is health care. Mistakes or misuse of AI can harm patients. Indeed, privacy regimes operating under HIPAA, HITECH, and the FTC Act may remain in effect once they are created, implemented, and maintained. Send or process data by the AI ​​system⁶

The EO also includes statements related to synthetic nucleic acids. Including supervision of the Director of the Office of Science and Technology Policy. In consultation with the Secretary of HHS (and others), to develop a framework to encourage adoption by synthetic nucleic acid sequencing providers. A comprehensive, scalable, and verifiable synthetic nucleic acid supply screening mechanism. Including recommended standards and incentives within 180 days, the EO also charges the Secretary of Commerce within 180 days and, in consultation with the Secretary of HHS (among others), to initiate industry engagement efforts. and relevant stakeholders To develop and improve for possible use the specifications of synthetic nucleic acid sequencers for Effective nucleic acid synthesis procurement screening and best practices for managing concern sequence databases to support such screening. The EO also stipulates that within 180 days of the arrangement Do this framework. All agencies funding research in the life sciences must determine: The procurement of synthetic nucleic acids is carried out through service providers or manufacturers that comply with the funding regulatory framework.

Next steps

EO provides an opportunity for stakeholders to engage with AI issues related to healthcare and life sciences. As one example, the EO calls for collaboration with appropriate private sector actors through HHS programs that may support the advancement of AI-based tools that develop personalized immune response profiles for patients.

The Akin Health Care & Life Sciences team regularly advises clients on the development and deployment of AI/ML technology and will continue to monitor federal efforts to regulate the use of AI, including the implementation of this EO.

^{1 The administration also publishes a fact sheet highlighting key points of the EO, which is available at https://www.whitehouse.gov/briefing-room/statements-releases/2023/10/30/fact-sheet-president-biden -Problems-Executive-Order-Safe-Safe-and-Reliable-Artificial Intelligence/.}

^{2 FDA releases action plan for software used AI/machine learning (ML) as a medical device in January 2021 and two discussion papers on the use of AI and ML in drug development and manufacturing in May 2021. 2023 FDA, artificial intelligence /Action Plan for Using Software Using Machine Learning (AI/ML) as a Medical Device (SaMD) (January 2021), https://www.fda.gov/media/145022/download; FDA, Use Artificial intelligence and machine learning in drug and biological product development (May 2023), https://www.fda.gov/media/167973/download; FDA, Artificial intelligence in drug manufacturing (May 2023), https http://www.fda.gov/media/165743/download The FDA also announced a new Digital Health Advisory Committee to help the agency explore issues related to digital health technologies (DHT), including AI. /ML FDA, Digital Health Advisory Committee, https://www.fda.gov/medical-devices/digital-health-center-excellence/fda-digital-health-advisory-committee (Last updated on October 13, 2023)}

^{3 Health Information, Technology, and Interoperability: Updating Certification Programs Algorithmic transparency and Information Sharing 88 Fed Reg. 23746 (Proposed April 18, 2023) (To be processed at 45 CFR pts. 170, 171)}

^{4 FDA, FDA releases two discussion papers to stimulate conversation about artificial intelligence and machine learning in drug development and manufacturing (May 10, 2023), https://www.fda.gov/news-events /fda-voices/fda-releases – Two debates – documents – stimulate – discussion – about – artificial intelligence – and – machines.}

^{5 FDA, Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence -and-machine-learning- aml-enabled medical devices (last updated 19 Oct 2023)}

^{6 especially These privacy systems are implemented under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Economic and Clinical Health Information Technology Act of 2009 (HITECH), and Section 5 of the Federal Trade Commission Act (the Health Insurance Portability and Accountability Act of 1996 (HIPAA). FTC ).}