HHS today released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication.
The Congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.
The report was developed by the U.S. Food and Drug Administration (FDA) in consultation with two other federal agencies that oversee health IT: HHS’ Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC). The FDA seeks public comment on the draft document.
“The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” said HHS Secretary Kathleen Sebelius. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety.”
Innovative health IT products present tremendous potential benefits, including: greater prevention of medical errors; reductions in unnecessary tests; increased patient engagement; and faster identifications of and response to public health threats and emergencies.
However, if health IT products are not designed, implemented or maintained properly, they can pose varying degrees of risk to the patients who use them. The safety of health IT relies not only on how a product is designed and developed, but on how it is customized, implemented, integrated and used.
As proposed in the draft report, posted on the ONC, FDA and FCC websites, there would be three health IT categories, based on function and level of risk, that focus on what the product does, not on the platform on which it operates (mobile medical device, PC, or cloud-based, for example).
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Via Chuck Sherwood, Senior Associate, TeleDimensions, Inc