The challenges that present in parallel to the acceleration of GenAI are complex and affect a range of stakeholders, including federal agencies, state- and local-level organizations, professional societies, and ultimately the individuals whose data provide the basis of the AI models and may be subject to their output. In response, multiple efforts to address the risks associated with GenAI have been initiated by regulatory bodies.
On a global scale, the World Health Organization (WHO) released guidance around six principles on AI governance for health, and the European Union’s (EU’s) AI Act served as a comprehensive regulatory framework for AI systems across the EU (European Union, 2023; World Health Organization, 2021). From a domestic federal perspective, the Biden administration pulled a variety of policy levers to advance responsible AI in health-related fields. In 2022, the White House Office of Science and Technology Policy developed the AI Bill of Rights, which identifies five principles that guide the design, use, and deployment of automated systems to protect the American public in the age of AI (The White House, 2022). Additionally, President Biden signed the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence Executive Order on generative AI (The White House, 2023). In response, several cities have issued guidelines on generative AI use that seek to recognize the opportunities of AI while mitigating bias, privacy, and cybersecurity risks (City of San Jose, n.d.). At a local and community level, companies are deploying a range of strategies for developing and using GenAI, including pursuing partnerships and direct investments with AI developers for access to key technologies and inputs needed for AI development. As GenAI rapidly expands to include more applications in health care, it is expected that broad governance and guidance will include increasingly detailed aspects specifically for GenAI.
It will be necessary to engage the diverse array of stakeholders influencing the governance and responsible use of GenAI in health care for the public good. The
need for alignment among technology developers, health systems, government agencies, research and advocacy organizations, and patients in future GenAI regulation is crucial to ensure ethical and safe practices. The current applications of GenAI in medicine represent a transformative shift in health care. From aiding clinical decision making, to reducing administrative burden, expediting drug discovery, and enhancing patient education, the integration of GenAI is poised to revolutionize various aspects of the health care continuum, ultimately leading to improved patient outcomes and more efficient health care delivery.
This implementation guide provides a structured approach to effectively disseminate the insights and innovations from our work. Tailored messaging helps to address the specific needs and interests of different stakeholders, enhancing engagement and facilitating broader adoption. This guide serves as a strategic tool to organize key interests for diverse stakeholder groups and align them with tailored messaging strategies.
| Project Background | The National Academy of Medicine’s Digital Health Action Collaborative convened a workshop on October 25, 2023, and a subsequent meeting with federal agency representatives on October 26, 2023, to enhance common understanding among health professionals and health system leaders, technology developers, and government agencies of the nature and health care implications of LLMs and GenAI. Workshop sessions focused on the possible GenAI benefits, risks and necessary guideposts, and guardrails in health care. This publication builds on those discussions and key takeaways. |
| Paper Overview and Takeaways | The integration of LLMs and GenAI in health care holds the potential to transform the practice of medicine, the work and experiences of health care providers, and the health and well-being of patients. GenAI can support clinical decision making and streamline workflows, promote patients’ and their support networks’ engagement in care processes, address health equity issues, and support clinical research. However, successful, ethical, and equitable implementation of GenAI requires careful consideration of the associated risks, particularly those concerning data privacy, bias, transparency, and infrastructure limitations. Collaboration among stakeholders, including health care providers, patients, policy makers, ethicists, and researchers, along with a cross-sector commitment to maximizing the benefit of GenAI while minimizing the risks, is important for navigating the complexities associated with GenAI in health care. Federal and organizational oversight; standardized guidelines for GenAI development, implementation, and responsible and ethical use; and continuous practitioner and patient education can facilitate the ethical and effective application of LLMs in health and medicine to improve patient outcomes, increase equitable access to care, and revolutionize medicine, research, and health care. |
| Stakeholder Group | Applications | Strategies |
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| Providers/provider associations (specialty societies) |
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| Payers |
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| Regulators |
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| Public health |
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| Tech industry |
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| Stakeholder Group | Applications | Strategies |
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| Patients and patient advocates |
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| Medical education |
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