ARPA-H launches $63M effort to build FDA-authorized AI agents for heart failure care

The Advanced Research Projects Agency for Health (ARPA-H) launched a $62.7 million effort to develop a patient-facing agentic clinical AI system for cardiovascular care, specifically to treat heart failure.

The program, called Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE), aims to create an autonomous digital member of the care team that can continuously monitor heart failure patients, provide certain aspects of care between visits and escalate issues to clinicians when needed. The selected teams will build patient-facing AI, a supervisory agentic AI and a scalable deployment plan to produce a clinical AI system for cardiovascular care.

A key aspect of the initiative is close collaboration with the FDA to establish a regulatory framework for a new class of autonomous clinical AI. The teams working on patient-facing agents are expected to submit an FDA authorization package within two years, ARPA-H said in a press release.

Teams participating in the program will work with ARPA-H to establish shared evaluation standards, interoperability requirements and reimbursement pathways. 

Johns Hopkins University Applied Physics Laboratory (JHU/APL) was tapped as an external evaluation partner. JHU/APL will independently validate the program's performance and safety.