WASHINGTON, D.C. — In a move hailed as a major step forward for innovation in American health care, Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM) have introduced the Health Tech Investment Act (S. 1399)—a bipartisan bill designed to create a stable reimbursement pathway for FDA-authorized medical devices that utilize artificial intelligence (AI) and machine learning (ML). These technologies, known collectively as Algorithm-Based Healthcare Services (ABHS), are increasingly being used to enhance diagnostic accuracy, accelerate care delivery, and improve patient outcomes.
The legislation responds to growing calls from both industry leaders and patient advocates to close a critical gap in the health tech ecosystem: reimbursement. While AI-driven medical technologies are gaining FDA clearance and demonstrating tangible benefits—particularly in fields like radiology—the lack of a consistent payment structure has hindered their adoption across health systems.
AdvaMed, the Advanced Medical Technology Association, praised the bill’s introduction and called on Congress for its swift passage. “With AI-enabled medical technologies already making remarkable strides in patient care, and with even more incredible strides ahead of us, now is the time to establish a predictable reimbursement pathway,” said Scott Whitaker, President & CEO of AdvaMed. “We thank Senators Rounds and Heinrich for their leadership. This legislation is critical to advancing the medical progress upon which patients depend.”
Industry voices echoed the enthusiasm. Peter J. Arduini, President & CEO of GE HealthCare and Chair of AdvaMed’s Board of Directors, emphasized that a clear reimbursement framework will unlock access to life-changing technologies. “This act would help bring beneficial medical innovation to patient care by ensuring a clear payment pathway for algorithm-based health care services,” Arduini said.
From a clinical perspective, AI is already showing significant promise in diagnosing and managing complex conditions. Tools powered by AI are helping clinicians detect cancers, cardiovascular anomalies, and neurological disorders earlier and with greater accuracy. Advocates argue that wider adoption of these tools could reduce overall health system costs and enhance quality of care.
Dave Pacitti, President of Siemens Medical Solutions USA and Head of the Americas for Siemens Healthineers, stressed the potential impact on underserved communities. “Improved payment pathways for innovative AI software and devices will increase adoption and expand access for all patients,” said Pacitti. “This legislation is a vital step toward making AI solutions more available for screening, diagnosing, and treating a wide range of diseases.”
In prior sessions of Congress, both the Senate and House Appropriations Committees—as well as bipartisan AI task forces—highlighted the need for a reimbursement framework for AI-driven medical devices. The Health Tech Investment Act marks a formal response to these policy recommendations.
Currently, inconsistent or absent reimbursement policies remain one of the largest barriers to integrating FDA-cleared AI technologies into clinical practice. The proposed legislation would establish a much-needed payment pathway that ensures physicians and hospitals are adequately compensated for using AI-enabled tools in patient care.
As lawmakers from both parties consider the bill, supporters are urging rapid progress. If passed, the Health Tech Investment Act could accelerate the deployment of AI across U.S. health care systems, offering more patients access to state-of-the-art tools and giving clinicians new resources to deliver more efficient, accurate, and equitable care.
