The Health IT Now Coalition has written a letter to U.S. Department of Health and Human Services (HHS) Tom Price, M.D., calling out concerns the organization has with the Office of the National Coordinator for Health Information Technology (ONC).
The Coalition, whose members include patient groups, provider organizations, vendors and payers, wrote to Price that the ONC, the health IT branch of the federal government, did well in pushing forward electronic health record (EHR) adoption, but recent actions taken by the agency “have the possibility to negatively impact product investment and development in the coming years, which would increase costs and potentially slow the deployment of new tools for providers and patients.”
As such, the Coalition is calling on Congress and the administration to work with stakeholders to “clarify what role and to what extent ONC should play in the overall regulation of health information technology, and how such a role would interact with other regulatory agencies.”
The letter notes, that since the development of the Meaningful Use program, the implementation of EHRs and the construction of health information exchanges (HIEs), new actions taken by ONC may have overstepped the original authorities given to them under federal law. The Coalition is particularly concerned with the potential impact of the ONC Enhanced Oversight and Accountability final rule, specifically:
- Direct Review of Certified and Non-Certified Capabilities for Safety Concerns. ONC’s proposal to directly review products if there are patient safety concerns encroaches on the statutorily required regulatory authority of other federal agencies, specifically the Food and Drug Administration (FDA). Subjecting vendors to duplicate regulatory oversight is overly burdensome and should be addressed, the letter states.
- Regulatory Clarity. Additionally, in setting standards for direct review, ONC has seemingly adopted a “we’ll know it when we see it” approach for reviewing products for non-conformities. This lack of clarity could lead to vendors hesitating to volunteer products for ONC certification, according to the letter. As such, the Coalition also calls for better alignment of the Certification Program with other federal programs such as the Quality Payment Program, under MACRA. It adds that vendors are spending more time worrying about meeting certification requirements than they are in meeting the needs of the customers.
This is not the first time that the Health IT Now Coalition has taken issue with ONC’s level of oversight on the industry. Last fall, when ONC issued a final rule that updated the ONC Health IT Certification Program by setting up a regulatory framework for the agency to directly review certified health IT products and giving itself more direct oversight of health IT testing labs, Health IT Now Coalition executive director Robert Horne said in a statement, ONC “is clearly overstepping its statutory authority by moving forward with direct review of uncertified functionalities and products, in addition to certified products.”
And, regarding ONC’s role going forward, Horne told Healthcare Informatics’ Senior Editor David Raths last fall that he believes a public discussion needs to happen with Congress and stakeholders about ONC’s role in its entirety. “As part of that, people should consider whether ONC has fulfilled its purpose. I am not suggesting it has. But there should be a re-evaluation of its role.” He added that Health IT Now does not see ONC’s role as being a regulator. “Developers looking to bring products to market don’t need another regulator,” he said at the time.