Dive Brief:
- A branch of the HHS that funds breakthrough and high-risk research, awarded contracts to six teams to build an FDA-authorized, autonomous artificial intelligence tool to treat patients with heart failure, the agency announced Wednesday.
- The Advanced Research Projects Agency for Health will dish out $33.7 million in the first year of the four-year, $62.7 million contract. Recipients include Kaiser Permanente, Duke University and Stanford University, as well as health AI vendors Atman Health, Tempus AI and Updoc.
- Teams will build a patient-facing AI agent to serve as a “digital member of the clinical care team,” a second supervisory agent that oversees it and a deployment plan to scale the tech in health systems, according to ARPA-H.
Dive Insight:
The Advocate program, first announced in January, aims to address preventable deaths from heart disease — the leading cause of death in the U.S. — and fill cardiac care gaps in rural areas, ARPA-H said.
Nearly half of U.S. counties do not have a practicing cardiologist, and those that don’t often have higher rates of cardiovascular disease.
ARPA-H says it wants to tackle those gaps by funding an AI tool to provide 24/7 autonomous cardiovascular care that patients can use between visits to real clinicians. The AI agent will essentially be part of the patient’s care team, fielding questions independently and only engaging human providers when necessary.
The program is split into three focus areas, with each contract awardee working toward a shared goal of improving cardiac care with AI.
Still, ARPA-H’s programs are fueled by competition — total award amounts are contingent upon meeting aggressive research milestones, and those who don’t reach them can be kicked out. It’s a model ARPA-H got from the Defense Advanced Research Projects Agency, which led to technological breakthroughs like the internet.
Under the first focus area, three health tech companies will compete to create an AI agent that will be submitted for FDA authorization in two years.
Atman Health, a health AI company focused exclusively on cardiovascular care and chronic disease management, plans to use up to $7.7 million in Advocate funding to advance its large language models with a voice-based interface that heart failure patients can talk to.
Telehealth company Updoc will use $9 million to develop its own conversational AI assistant, while precision medicine company Tempus AI will leverage $9.5 million to extend its existing patient health app and add continuous monitoring features to detect changes in a patients’ health.
Under the second focus area, researchers at Stanford University will build a system to identify any unsafe recommendations produced by the patient-facing AI tool.
Teams from Duke University and Kaiser Permanente will use their funds under the third area to map out a deployment strategy.
North Carolina-based Duke, awarded $15.5 million, will create a platform to test the agents across five health systems on electronic health records systems from Epic and Oracle.
Kaiser Permanente will use $16.3 million to deploy the agents into its Epic EHR workflows for heart failure patients across 21 medical centers and more than 260 clinics to test its safety and efficacy.
ARPA-H has also contracted with the Johns Hopkins University Applied Physics Laboratory, which will serve as an independent evaluator of the tech.
Additionally, program leaders said they’ll work alongside the FDA throughout the program to develop a regulatory framework for this class of clinical AI.
The FDA has not yet approved an agentic AI tool for clinical care. If this program is successful, it could create a regulatory pathway for future applications of clinical AI, which the Trump administration has advocated for in recent years.
