AMIA, CHIME voice concerns over ONC certification role

Expanded role for the agency in HIT oversight could have unintended consequences, but changes could help the agency address patient safety issues.

Two large healthcare IT professional organizations are raising concerns with a proposed rule that would increase a federal agency’s oversight for the Health IT certification program.

The American Medical Informatics Association and the College of Healthcare Information Management Executives filed responses to the notice of proposed rulemaking filed by the Office of the National Coordinator for Health Information Technology on March 2, “ONC Health IT Certification Program: Enhanced Oversight and Accountability.”

The new rule would give ONC a role in directly reviewing software currently certified as appropriate for use by healthcare organizations in meeting requirements for the meaningful use program. Currently, ONC delegates its authority to Accredited Certification Bodies to issue certifications for health IT.

In the rule, ONC proposes an expansion of its authority to review health IT, including certified electronic health records, independent of the accrediting bodies. The proposed rule also would allow ONC to address testing issues in a timely and direct manner, and would provide other oversight on the testing of EHRs.

Both CHIME and AMIA say that agency oversight of the accreditation process could serve useful purposes. Specifically, AMIA sees a need for “systemic oversight of health IT for purposes of safety and effectiveness,” the organization said in its response letter. “Evidence gathered through experience in the last six years of certified EHR deployment confirms that software design, implementation decisions, user training and maintenance processes can all have a material impact on the safety of health IT.”

For its part, CHIME believes that ONC oversight could be valuable in ensuring that EHRs are usable by clinicians and developers address usability concerns and questions about performance issues.

However, both organizations’ comments request that the final rule be narrowed in scope with an eye toward reducing potential unforeseen consequences.

AMIA believes ONC oversight of software certification be limited to focus on potential patient safety concerns. “We strongly recommend ONC narrow the scope to non-conformities involving potential medical errors or those that potentially contribute to patient safety harms,” its response letter said.

Similarly, CHIME cited a list of potential unintended consequences that the proposed rule could cause. Most of its comments focus on policy implications “surrounding how the proposed expanded authority would be executed.”

CHIME says that while “much of ONC’s proposal appears to center around patient safety,” the rule gives ONC authority to handle matters that extend well beyond safety concerns. CHIME members “have also expressed concern that patient safety has become a catchall phrase that can mask other problems with EHRs, such as clinician frustration with workflow. We have similar concerns around medical errors. We caution ONC to proceed carefully here.”

AMIA believes ONC could improve its oversight by strengthening control over existing testing processes. “AMIA recommends that ONC continue to utilize its established regulatory processes to implement and improve its certification program,” the organization suggests.

In its response, CHIME notes concerns about decisions to decertify software, saying ONC’s proposal could hurt providers’ ability to meet Medicare reimbursement requirements of the Centers for Medicare and Medicaid Services. “We urge ONC to clarify how they plan on protecting providers from unnecessary violations of meeting Medicare payment policies if they are using products that are under appeal or have been decertified,” CHIME’s response said.

CHIME’s response letter can be found here; AMIA’s comment letter can be found here.

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