The U.S. Department of Health and Human Services (HHS) is actively formulating new guidance aimed at expediting the integration of artificial intelligence (AI) technologies within the healthcare sector. Federal officials have emphasized that among the primary objectives of this initiative are the establishment of governance frameworks, support for implementation, and innovative strategies for evaluating clinical AI tools.
Officials from various HHS agencies—including the Office of the National Coordinator for Health Information Technology (ONC), the Food and Drug Administration (FDA), and the Advanced Research Projects Agency for Health (ARPA-H)—recently convened to elaborate on a coordinated strategy known as “OneHHS.” This initiative, first unveiled in December, is designed to promote a wider acceptance and utilization of AI technologies in healthcare while simultaneously crafting policies that aim to foster trust among healthcare providers and patients alike.
The OneHHS effort seeks to harmonize the deployment of AI technologies across the healthcare landscape, building upon insights gathered from a public request for information issued by HHS two years prior. This request aimed to attract public input on how the government could effectively encourage the responsible adoption of AI through regulation, development, and reimbursement policies. The department received over 7,000 comments on this request, reflecting a significant level of public engagement.
Mark Atalla, the deputy national coordinator for health information technology, articulated the common themes emerging from this input, stressing the demand for adoption support and governance frameworks that prioritize responsible integration into healthcare workflows. “We heard the need for adoption support, governance frameworks, responsible adoption, with trust at the center,” Atalla remarked, indicating that further developments would be forthcoming.
A chorus of stakeholders, including healthcare organizations, technology developers, and industry thought leaders, expressed a consistent desire for improved coordination among HHS agencies, more robust guidance for implementation, and refined methods for evaluating and benchmarking AI systems within clinical settings. Arman Sharma, the deputy chief AI officer at HHS, highlighted the community’s demand for clarity in how they can best engage with the department regarding AI initiatives. “People want consistency,” Sharma noted.
One of the critical driving forces behind the OneHHS initiative is the increasing demand for healthcare services spurred by an aging population, ongoing shortages of medical specialists, and the mounting pressures faced by family caregivers. The aim is not only to enhance administrative efficiencies but also to extend AI applications to direct patient care. AI technologies are currently making strides in various aspects of healthcare—such as helping clinicians identify stroke patients, facilitating the creation of clinical documentation, streamlining participant recruitment for clinical trials, accelerating drug discovery, and enhancing public health surveillance.
In an assertion of the initiative’s broader goals, Dr. Thomas Keane, the national coordinator for health IT, stated, “Our objective is to enhance access, affordability, and overall impact on healthcare through technology, including AI.” He underscored the proactive drive to place AI at the forefront of healthcare innovation, focusing not just on administrative processes but also on clinical outcomes.
Various ongoing projects within HHS are poised to maximize AI’s potential in this context. For instance, ARPA-H’s Advocate program is spearheading the development of AI-powered cardiovascular care agents. These innovative agents will be designed to engage directly with patients, integrate seamlessly with electronic health records, and connect with wearable devices to help manage chronic heart diseases. Dr. Haider Warraich, an ARPA-H program manager and practicing cardiologist, elaborated on the project, explaining that real-time patient data will be combined with various physiological inputs. He noted that this integration could allow for a more proactive healthcare approach, rather than merely reactive measures, marking a significant shift in patient management.
Collaborative efforts are also underway involving different healthcare systems that will assist in co-developing and eventually deploying this technology within randomized clinical trials. Warraich asserted, “Our goal is to build a comprehensive framework to make this clinical agentic AI accessible to every American.”
The Administration for Community Living (ACL) is concurrently pursuing its own AI-driven initiatives aimed at supporting family caregivers, enhancing the home healthcare workforce, and improving care coordination through advanced digital tools. Kelly Cronin, the ACL’s deputy administrator, expressed the commitment to boost care quality at home, alleviate caregiver fatigue, and fortify the future healthcare infrastructure without supplanting human connection.
On another front, the FDA is strategizing new policy proposals to oversee increasingly autonomous AI-enabled medical technologies while adhering to a risk-based regulatory framework. Rick Abramson, director of the FDA’s Digital Health Center of Excellence, indicated that clarity regarding regulatory expectations and sponsors’ responsibilities would be among the agency’s priorities. “We aim to release initial ideas for public comment soon,” Abramson stated, indicating an expedited timeline for stakeholder engagement.
As the landscape of healthcare evolves with the integration of AI, it remains clear that the HHS’s OneHHS initiative aligns with the broader goal of improving healthcare outcomes while maintaining patient trust and safety as the guiding principles.