The Office of the National Coordinator for Health Information Technology may have overstepped its statutory authority provided under the HITECH Act, and in the process encroached on the regulatory functions of other federal agencies, such as the Food and Drug Administration.
That’s the contention of Health IT Now, a coalition of providers, patient advocates, consumers and payers. In particular, the group is concerned about a final rule released by ONC last October that codified modifications and new requirements under the agency’s Health IT Certification Program designed to protect public health and safety as well strengthen the accountability and transparency of certified HIT.
ONC’s Enhanced Oversight and Accountability Rule could have potentially negative consequences for the healthcare industry, according to Health IT Now Executive Director Robert Horne.
In a March 13 letter to Health and Human Services Secretary Tom Price, MD, Horne charged that ONC may be overstepping its statutory authority by moving forward with direct review of uncertified functionalities and products, in addition to certified products.
“We believe such actions 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,” writes Horne in his letter to Price.
Horne says the question remains “what the appropriate role for ONC should be in the marketplace?” At the same time, he emphasizes that Health IT Now is “not asking that ONC be done away with—we’re asking for a top-down conversation about what its regulatory footprint should be for health IT.”
Consequently, Horne has requested that “Congress and the administration 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.” Specifically, the group is asking Price to conduct a “thorough review” of the current ONC Health IT Certification Program.
“Through this review, we urge the administration to better align the Certification Program with the needs of providers and patients under future CMS programs, such as the Quality Payment Program,” states Horne’s letter. “It is worrisome that vendors are spending an increasing amount of time on conforming to certification requirements and, in turn, have less time to focus on the needs of their customers in meeting the needs of their patients.”
An ONC spokesman declined to comment on HITN’s letter to Secretary Price, deferring to his counterpart at HHS. However, an HHS spokesman was not immediately available for comment.
Horne believes the start of the new Trump administration is the right time for Price at HHS to review and clarify the role of ONC vis-à-vis the FDA, whose statutory requirement is to ensure health products are safe and effective.
“The statute that established ONC had a very defined role for the agency,” he says. “Where in the HITECH Act was ONC’s role as a regulator defined? Nowhere in the statute is ONC given the authority to regulate health IT products. Safety and effectiveness is what the FDA is charged with. If federal agencies are going to regulate health IT, they should have clear direction from statute and be able to support it.”
Leigh Burchell, past chair of the EHR Association and vice president of government affairs at Allscripts, says EHRA shares many of HITN’s concerns about ONC’s Enhanced Oversight and Accountability Rule.
“We look forward to working with the new administration to evaluate opportunities to address that example of regulatory overreach,” adds Burchell. “At the same time, we appreciate that ONC has indicated that they are receptive to suggested improvements to the certification program. We also recognize that ONC has been given an important job by Congress in executing on their refocused priorities outlined in the 21st Century Cures Act.”
Lee Barrett, executive director of the Electronic Healthcare Network Accreditation Commission (EHNAC), agrees that a review by HHS might help to further clarify the role of ONC and that of the private sector.
While ONC has been an excellent resource and facilitator to guide and provide a roadmap and framework for the industry, Barrett contends that this review “would assure the highest level of collaboration and leveraging of existing standards and best practices to be used to promulgate interoperability, EHR certification, future roadmap and more.”
He points out that ONC has been involved in supporting initiatives such as the Direct protocol, interoperability roadmap, as well as facilitating and providing a framework for electronic health records.
EHNAC is a voluntary self-governing standards development organization created to develop standard criteria and accredit organizations that electronically exchange health data that “looks forward to continuing our collaboration with ONC as we further align and obtain our industry goals of interoperability, trusted data exchange by providing the highest levels of ‘stakeholder trust’ in privacy/security of networks, implementation of MIPS/MACRA, The Cures Act, and other federal and state inter/intra-connectivity initiatives,” adds Barrett.
For its part, EHRA believes that ONC should continue its important role in coordinating health IT work by federal and state government agencies.
“We look forward to working closely with ONC to ensure that policy initiatives and regulations are focused and responsive to market needs without being overly prescriptive or duplicative of other efforts,” concludes Burchell.
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