- The coalition comprising patient groups, provider organizations, and payers has called on the Department of Health & Human Services and Congress to clarify the role of the Office of the National Coordinator for Health Information Technology (ONC) in regulating health IT systems and services.
“We respectfully request 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,” wrote Health IT Now Executive Director Robert Home in a letter to HHS Secretary Tom Price, MD.
The coalition — whose membership includes healthcare companies such as athenahealth, Aetna, McKesson, and Teladoc — claims the Enhanced Oversight and Accountability final rule could have a negative impact on providers by discouraging health IT product development and the integration of new, innovative technologies into the industry.
While Health IT Now acknowledged the contributions of ONC in supporting EHR adoption, the coalition believes the Enhanced Oversight and Accountability final rule is a step backwards in the work toward technological advancement.
Furthermore, the coalition questions ONC’s authority to enforce these requirements under the HITECH Act.
HITN members outlined two primary points of contention in the letter:
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 & Drug Administration. Subjecting vendors to duplicate regulatory oversight is overly burdensome and should be addressed. We are also concerned this action is not supported by underlying statutory language in the HITECH Act.
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.
The coalition stated a review of the current ONC Certification Program is necessary to ensure the program better suits provider and patient needs. Federal agencies including the FDA, HITN members maintain, reserve the authority to impose certain regulations over ONC, eliminating the need for certain redundant requirements.
The coalition believes overly-burdensome certification requirements are distracting vendors from addressing the demands of the marketplace, and the necessary adjustments would benefit product development and improve patient care delivery.
“HITN believes the start of a new administration creates opportunities to review and improve the functions of the federal government and that such efforts to clarify the role of ONC in the marketplace are patient-focused and bipartisan,” the coalition concluded.
Easing stringent certification requirements for new and developing products could go a long way toward advancing the development of new application programming interfaces (APIs) and a nationwide use of EHRs and FHIR.
Despite strict certification requirements, ONC has played a part in encouraging product development through API innovation challenges promoting EHR interoperability through applications designed to improve health data exchange.
Past API innovation challenges have given rise to applications capable of streamlining patient consent, facilitating data sharing between providers, easing exchange of end of life plans, and empowering patients to access and exchange their own information.
Additionally, these innovation challenges required developers create open APIs using FHIR standards. Stipulations like these emphasize the need for standardization in the healthcare industry across technologies, paving the way for true interoperability.
While ONC’s work in pioneering initiatives has stimulated developments in health data exchange technologies, restrictive certification requirements could slow development and stagnate production in the future.