Introduction
On October 30, 2023 [1] [3], a significant executive order was enacted to guide federal agencies in the responsible integration and regulation of artificial intelligence (AI) across various sectors, with a particular focus on health care. This initiative is set to reshape compliance and regulatory landscapes, prompting stakeholders to prepare for new federal guidelines.
Description
On October 30, 2023 [1] [3], an executive order was signed to establish guidelines for federal agencies on the responsible integration of artificial intelligence (AI) into their operations and the regulation of AI across various industries [1] [3], with significant implications for the health care sector [1]. This initiative prompts industry stakeholders to assess compliance and prepare for forthcoming federal regulations governing AI use in health care [1] [3].
In conjunction with this effort, the Department of Health and Human Services (HHS) has launched an AI Safety Program designed to monitor harmful incidents related to AI in health care and evaluate mitigation strategies [2]. HHS has also outlined specific objectives and principles for the use of AI in drug development and AI-enabled devices [2], emphasizing the importance of transparency in AI and predictive algorithms within certified health information technology [2].
Legal experts discuss the evolving landscape of health care AI, highlighting the necessity for industry stakeholders to understand compliance requirements and the associated legal [3], policy [1], and regulatory challenges that may arise from the executive order [1]. Furthermore, a finalized civil rights regulation mandates that health care entities identify and address discrimination when utilizing AI and decision support tools in patient care [2], underscoring the critical need for ethical considerations in AI deployment.
Conclusion
The executive order and accompanying initiatives by HHS are poised to significantly impact the health care sector by establishing a framework for AI integration that prioritizes safety, transparency [2], and ethical considerations. Stakeholders must navigate the evolving regulatory environment to ensure compliance and address potential legal and ethical challenges, ultimately fostering a more responsible and equitable use of AI in health care.
References
[1] https://www.ebglaw.com/insights/podcasts/advancements-of-artificial-intelligence-in-health-care-one-year-after-white-house-executive-order
[2] https://www.whitehouse.gov/briefing-room/statements-releases/2024/10/30/fact-sheet-key-ai-accomplishments-in-the-year-since-the-biden-harris-administrations-landmark-executive-order/
[3] https://www.jdsupra.com/legalnews/advancements-of-artificial-intelligence-66628/
