Amazon and Google are pushing back against ONC proposals to regulate predictive artificial intelligence in healthcare.
The federal health IT agency has proposed transparency requirements for predictive models or algorithms used for so-called "decision support interventions." Both Big Tech companies say the drafted rules are too broad and would hurt AI innovation and, ultimately, consumers.
In a June public comment, Amazon Web Services said the rules should focus only on technologies that could "present a meaningful risk to patients."
"For example, the use of DSIs for back-end processes that help healthcare organizations operate efficiently on behalf of patients should not be within the scope of the Regulations," the company wrote.
Amazon said "high-risk uses include leveraging AI/ML technology to make final decisions affecting medical diagnosis and treatment without human intervention" while "lower-risk use cases could include applications to support the documentation of care for review by the clinician."
Both Big Tech companies said the rules are so broad as to possibly loop in developers of general AI and machine learning tools, such as large language models, that don't focus specifically on healthcare.
Amazon also expressed fears that the rules could reveal intellectual property and trade secrets and slow research and development by classifying predictive decision support software as a medical device, opening it up to FDA regulation as well.
Google, meanwhile, wrote that the definitions as written are too vague. "For example, the developer of an [large language model]-powered [EHR] application for patient billing and administrative recordkeeping would be unable to determine whether the software is a predictive DSI," the company said.
It also said ONC should exclude "low-risk use cases for consumers, such as general wellness (e.g., nutrition, sleep, activity, and fitness)" and "predictive DSI tools used for non-clinical purposes (e.g., EHR integrations for administrative notes and billing)."
Google said overburdensome regulations would increase costs for developers, "which may be passed on to customers and result in less affordable or widely available health AI applications."
Epic, the nation's largest EHR vendor, also opposes the new AI transparency rules.