The Trump administration is seeking proposals to advance the use of artificial intelligence in health care from predictive to generative. The Advanced Research Projects Agency for Health (ARPA-H), an agency within HHS, hopes to set a regulatory precedent for the use of generative AI in high-risk settings.
The objective of the Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) is to develop technology that could schedule appointments, adjust medications and support diet and exercise. Developers selected for the program will create a patient-facing AI agent for cardiovascular disease that can perform clinical tasks, such as determining whether a patient is in heart failure or increasing a medication, that a cardiologist could do over the phone.
“We are focused on heart failure,” said Dr. Haider Warraich, program manager at ARPA-H, according to Fierce Healthcare. “Part of it is that the idea is that you need an intended use for your technology. The FDA cannot authorize an AI doctor, but they can authorize a technology that improves outcomes for patients with heart failure.”
The entire project, including FDA approval, is expected to last just over three years. After the agents for cardiovascular disease are codeveloped with health systems, they will be tested locally for their impact on the system and gather data. Warraich expects the most challenging part of the project to be developing the supervisory agent that provides ongoing monitoring for continuously learning AI systems.
“Even though we haven't mandated it, it would be really nice for this also to be open source, as opposed to the cardiovascular disease agent technology, which is almost certainly going to be proprietary technology that's been designed for FDA authorization,” he said.
The American Heart Association, which has its own AI evaluation center for cardiovascular solutions, told Fierce Healthcare that it supports the initiative. “The American Heart Association is supportive of the ADVOCATE funding opportunity from ARPA-H and all funding opportunities that rigorously design and test different approaches for how AI can improve heart and stroke health for all individuals,” a spokesperson said.
John Whyte, CEO of the American Medical Association, said AI can help physicians reach more patients, and physicians support efforts to improve access to cardiovascular disease treatment. “At the same time,’ he said in a statement, “using autonomous AI to deliver cardiovascular care without clear physician oversight raises serious concerns about patient safety. Heart care is complex, and mistakes in diagnosis or treatment can be life-threatening.”
ARPA-H will select teams of innovators in June and then eliminate some research groups and select the most promising technologies after a year of testing.
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