A health IT industry group is reiterating its call for federal officials to reevaluate the role of the Office of the National Coordinator for Health IT (ONC) and making a specific appeal to strip the agency of a recent oversight rule that allows it to conduct targeted reviews of health IT systems with patient safety concerns.
In a letter (PDF) to Department of Health and Human Services Secretary Tom Price on Wednesday, Health IT Now Executive Director Joel White argued that the ONC needs to “refocus” its role “as a coordinator and facilitator of information technology, rather than a heavy-handed regulator.”
White urged Price to shift the ONC’s regulatory approach away from burdensome regulations associated with Meaningful Use and invest the bulk of its energy on improving interoperability and giving health IT innovators the flexibility to focus on outcomes.
In March, Health IT Now’s former executive director, Robert Horne sent a letter to Price arguing the ONC has “overstepped original authorities provided under the HITECH Act” and urged HHS to “clarify the role of ONC in the marketplace.”
Wednesday’s letter made a specific plea for HHS to rescind the ONC Enhanced Oversight and Accountability final rule which allows the agency to directly review certified health information technology where there are public health and safety risks or when multiple functionalities or products have been certified by several authorized certification bodies.
White argued that the ONC’s rule is duplicative since the Food and Drug Administration has the regulatory authority to take actions against products that pose a risk to patient safety.
“Recent actions taken by ONC not only overstep statutory authority, but show dedication to mission creep rather than the core directive from Congress: achieve interoperability and do so quickly,” he wrote.
Price has emphasized the need for a more hands-off approach to health IT regulation, telling audience members at Datapalooza in April that the government should adopt a “60,000 foot” regulatory view and focus on achieving interoperability.
Trump’s proposed budget would cut ONC funding by more than one-third, forcing the agency to eliminate several programs focusing health IT adoption and realign its priorities to focus on policy, governance and standards.