Overview: HHS Aligns on AI Adoption
The U.S. Department of Health and Human Services is moving fast on artificial intelligence. Department leaders say they are now aligned on a shared path forward, anchored by the HHS AI Strategy released in December 2025 and sustained dialogue with healthcare stakeholders.
“Our goal is to improve access, affordability and the impact of healthcare through technology, including AI,” said Thomas Keane, National Coordinator for Health IT, during a recent HHS-hosted webinar.
The webinar reviewed findings from a December 2025 Request for Information, which asked how HHS could use its regulatory, reimbursement, and research-and-development strengths to drive AI adoption in clinical care. By its late-February deadline, HHS received more than 7,300 comments — a sign of the industry’s urgent interest.
What Stakeholders Are Asking For
Three Recurring Themes from 7,300+ Comments
HHS leaders distilled the massive comment volume into three clear themes:
- Coordination: Stakeholders want better alignment across HHS departments, not siloed efforts.
- Support and Governance: Healthcare organizations need practical frameworks for responsible AI adoption.
- Benchmarking and Evaluation: Stakeholders want clear metrics to assess AI tools in clinical settings.
“We at HHS understand that AI is a new and heterogeneous field and that our approach has to be nuanced,” Keane noted.
These three themes now guide how HHS departments are designing and launching AI programs. Importantly, the webinar spotlighted three departments leading by example.
ARPA-H Tackles Cardiovascular Disease with Agentic AI
How ADVOCATE Works
The Advanced Research Projects Agency for Health (ARPA-H) launched the ADVOCATE program — Agentic AI-EnableD CardioVascular CAre TransfOrmation — to address one of the country’s most urgent health crises.
Cardiovascular disease remains the leading cause of death in the United States. Yet access to cardiology care is severely limited. Haider Warraich, M.D., cardiologist and program manager at ARPA-H, shared a striking finding: nearly half of all U.S. counties lack a single cardiologist.
“Even when people do have access to cardiologists, the quality of care they receive is often not what you would want for your patients or loved ones,” Warraich said. “There is certainly an opportunity for AI to scale clinical knowledge into action broadly.”
ADVOCATE’s vision centers on AI clinical agents that work around the clock. These agents handle tasks like scheduling appointments, offering diet and exercise guidance, and serving as a first point of contact for patients with heart failure.
“The vision was to support teams that develop a technology that can essentially do everything a clinician can do over the phone,” Warraich explained.
High-Risk AI Functions on the Horizon
Beyond administrative tasks, ARPA-H envisions the AI agents taking on higher-risk clinical functions over time. These include:
- Coordinating patient triage
- Prescribing new medications
- Providing diagnoses
To build these tools responsibly, ARPA-H opened ADVOCATE to a wide coalition. Technology leaders, academic researchers, and nonprofit organizations submitted proposals covering three areas: a patient-facing clinical AI agent, a supervisory agent to monitor safety and efficacy, and a scalable integration plan for clinical workflows.
The program’s ultimate goal is to produce an FDA-approved clinical agentic AI system that serves as a genuine extension of the care team. ARPA-H is actively reviewing proposals.
“I think many of us see the potential of AI, and the more you study it, the more you realize this could well be the defining technology of our age,” Warraich said.
He also acknowledged the gap between potential and reality: patients have not yet seen AI change their health outcomes. Regulatory uncertainty and high development risk remain the primary barriers. Still, Warraich is optimistic — and so is the program’s scope.
“The focus is on patients with heart failure, but the idea is that we are building a template applicable to any patient with chronic disease,” he added. “The impact could be quite broad.”
ACL Uses AI to Help Americans Age in Place
The Administration for Community Living funds community-based services and research to help older adults live independently. Now, it is deploying AI to make that mission more effective and scalable.
Mary Lazare, Principal Deputy Administrator for the ACL, described a broad range of AI applications the department is actively exploring. These include wearables that monitor safety, smart home features such as automated door locks and lighting, and scheduling tools tailored to people with disabilities.
“We’re beginning to look at AI in terms of wearables and modifying homes so that people can remain in their homes — safety features, ease features, all of that,” Lazare said. “AI makes this manageable for people with disabilities and those who want to continue living at home into older age.”
Beyond home safety, the ACL also explores using AI to help people with disabilities find employment, detect scam calls, and prevent financial abuse.
Caregiver AI Prize Challenge
Kelly Cronin, Deputy Administrator for Innovation and Partnership at the ACL, highlighted two active programs. The first is the Caregiver AI Prize Challenge, currently in Phase One.
This challenge seeks practical AI tools that support and extend the caregiver workforce. The goals are to reduce caregiver burden and improve the quality of care — without replacing human connection.
“Importantly, we want to supplement, not replace, human connection,” Cronin said. “We also want AI tools to be user-centered, informed by the voices and experiences of caregivers.”
Health at Home Challenge
The second initiative is the Health at Home Challenge, a multi-phase program supporting dually eligible Medicare and Medicaid beneficiaries. Participants must show how advanced community care networks can improve affordability and independence for these beneficiaries at home.
“Technology infrastructure and tools are going to be an important enabler of this work,” Cronin said. “We want to reward the use of AI — particularly AI that enables clinical and community integration and supports care coordination across the continuum.”
Phase Two of the Health at Home Challenge launches in August 2026. Up to $2 million will go to a maximum of five winning teams from Phase One to accelerate tool implementation.
FDA Focuses on AI Policy Development
The FDA also weighed in during the webinar, though with less operational detail than the other departments. Rick Abramson, M.D., newly appointed Director of the FDA’s Digital Health Center of Excellence, explained that ongoing policy development limited how specifically he could speak.
After public workshops and listening sessions, the FDA identified a clear need: greater regulatory clarity for AI developers and healthcare organizations.
“This has always been important,” Abramson said, “and it will be even more important as we move toward AI systems of greater functional complexity and greater autonomy.”
The FDA is working to define what it regulates, how it regulates it, and what role it will play in both pre-market and post-market settings. Abramson further stressed the need for coordinated policy across federal agencies, state oversight bodies, and international regulators.
“The public should be expecting us to release some ideas for stakeholder comment in very short order,” he said.
Like other HHS departments, the FDA is pressing toward faster clinical AI adoption — while keeping risk management at the center.
Key Takeaways
What HHS’s AI Push Means for Healthcare Leaders
HHS’s coordinated AI effort signals a significant shift in how the federal government approaches health technology. Here is what healthcare organizations should watch:
- Governance frameworks are coming. HHS heard clearly that the industry needs practical, responsibility-centered guidance. Formal frameworks are in development.
- Agentic AI is moving toward clinical settings. ADVOCATE represents a new frontier where AI agents may soon handle triage, prescriptions, and diagnoses.
- Aging-in-place technology is getting federal support. ACL programs create new opportunities for technology developers focused on elder care and disability services.
- FDA clarity is imminent. Stakeholder comment periods on AI regulatory guidelines are expected soon.
“AI is a technology that could well be the defining technology of our age,” Warraich said. HHS, across its departments, appears to agree — and is acting accordingly.
