Epic Systems and Oracle Health submitted letters to the Department of Health and Human Services in February outlining policy recommendations related to the adoption and use of AI in clinical care.
The letters respond to HHS’ request for information on accelerating the adoption and use of AI as part of clinical care.
Here are eight things to know:
- In its Feb. 20 letter to the Office of the National Coordinator for Health Information Technology, Epic said its software includes more than 175 generative AI use cases that have been released or are in active development. The company wrote that generative AI differs from prior healthcare innovations because it is probabilistic and requires continuous validation and because compute, storage and model usage costs can be variable and difficult to predict.
- Epic said AI can improve clinician productivity, reduce documentation burden, lower burnout, support more timely clinical decision-making and improve patient engagement. The company recommended the Department consider assembling a vendor-agnostic repository of AI use cases with demonstrated return on investment, supported by independent research.
- Epic also recommended time-based grants that would cover AI infrastructure costs for a fixed period rather than a fixed dollar amount. The company referenced its Jump Start Cloud Infrastructure Package, which it said covers cloud infrastructure costs for approximately 50 AI features through a flat monthly fee based on organization size. According to the letter, customers participating in the program demonstrated median month-over-month AI resource utilization growth of 45%, compared with 18% for nonparticipants, and used 17 times more AI resources than nonparticipants of comparable size.
- Epic further recommended support for “local validation,” in which healthcare organizations evaluate AI performance using their own data and workflows prior to and after deployment. The company said smaller and rural providers may lack resources for post-deployment monitoring and suggested targeted grant support. It also recommended regulators define standard metrics and validation processes for AI performance.
- Oracle Health in a Feb. 23 letter to HHS Secretary Robert F. Kennedy Jr., expressed support for “a forward-leaning, industry-supportive and secure approach” to accelerate AI adoption. The company recommended limiting regulation that could stifle innovation, aligning AI-related policies across federal agencies and clarifying how existing legal frameworks apply to AI in clinical care.
- Oracle cited concerns about federal guidance related to clinical decision support software and said certain interpretations expand oversight beyond the framework established in the 21st Century Cures Act. The company recommended guidance clarifying when software functions fall outside FDA device requirements and when healthcare institutions customizing decision support tools are not subject to device regulation.
- Oracle also encouraged the Department to develop publicly available, privacy-preserving benchmark datasets for AI model evaluation and to update patient data privacy and deidentification standards to incorporate AI-relevant provisions.
- In addition, Oracle recommended the Department align payment and reimbursement models to support clinician time spent testing and implementing AI-enabled technologies and ensure AI-enabled technologies are available and affordable to rural providers.
Both letters state that AI-enabled technologies are intended to support clinical workflows and that clinicians and health systems retain decision-making authority over patient care.
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