More healthcare industry groups have penned letters to the Office of the National Coordinator for Health Information Technology (ONC) recommending revisions to the notice of proposed rulemaking on its health IT certification program.
The American Hospital Association (AHA) and American Medical Informatics Association (AMIA) wrote similar letters that urged the ONC to increase transparency of certification review results and narrow the specifications for direct ONC intervention in non-conformity cases.
ONC requested feedback from healthcare stakeholders on its proposed rule to expand the agency’s role in surveying certified health IT and EHR systems, including direct review of developers, implement of suspension and corrective action plans, and termination of certifications.
In its letter, the American Hospital Association expressed general support for the ONC’s effort to increase transparency of surveillance results. However, AHA suggested that the agency should collaborate more with industry groups and federal entities to improve transparency of certification results.
“In order to revise the health IT certification program to accomplish this goal, the AHA supports the ONC’s proposal for increased transparency of surveillance results,” wrote Thomas P. Nickels, AHA’s Executive Vice President in a letter to ONC. “We recommend that ONC prioritize actions that will increase confidence in the certification criteria and testing of health IT. Finally, the AHA recommends that ONC support existing initiatives to develop a framework to identify health IT safety incidents to inform certification and surveillance.”
Under the proposed rule, ONC would regularly publish the surveillance results on its website. AHA recommended that the website add a section that publicizes the interoperability capabilities of certified health IT products. Through the added functionality, vendors could compare its products and improve them based on provider needs.
ONC should also work with the National Institute of Standards and Technology to develop a conformance testing infrastructure, such as technical test beds, reported AHA. The proposed rule allows ONC to evaluate health IT based on its conformity with strategic goals listed in the HITECH Act, such as increasing HIE, securing patient information, and decreasing medical errors.
“Given the significant investments hospitals have made already, the AHA recommends a more robust testing and certification infrastructure as a starting point to improve the certification program,” stated Nickels. “Additionally, as part of the conformance testing infrastructure, the AHA renews the call for the federal government to support processes that permit the end user to access the testing infrastructure.”
Additionally, AHA suggested that the ONC should partner with CMS to create a process for healthcare providers to contribute feedback on certified health IT.
Through collaborations with industry groups and federal agencies, AHA noted that ONC would eliminate duplicate efforts to monitor and improve certified health IT. For example, private-public initiatives, such as the ECRI Institute, are already working to establish a framework for identifying health IT patient safety incidents and CMS has created reporting systems for certified health IT products through its EHR Incentive programs.
While the American Medical Informatics Association commended ONC on increasing transparency of its health IT certification program, it also suggested that the agency refine its requirements for direct intervention.
“Generally, AMIA is supportive of ONC’s proposal to initiate a direct review process of software certified under the Program, as we see a need for systemic oversight of health IT for purposes of safety and effectiveness,” wrote Douglas B Fridsma, MD, PHD, FACP, FACMI, AMIA President and CEO, and Thomas H. Payne, MD, FACP, AMIA Board Chair in a letter. “However, we strongly recommend ONC narrow the scope to non-conformities involving potential medical errors or those that potentially contribute to patient safety harms.”
AMIA urged ONC to only intervene in certified health IT assessments if there is a clear and present danger to patient safety, such as potential medical errors. By narrowing its requirements for direct review, ONC would reduce duplicate efforts to monitor health IT products.
ONC should also align its certification requirements with existing regulations and frameworks related to certified health IT, AMIA pointed out. ONC would promote health IT innovation and decrease the burden on developers to conform to multiple requirements by coordinating certification criteria.
“AMIA understands this NPRM does not impact policies and procedures outlined by other agencies, but ONC must be cognizant of the many ways its determinations could impact users of certified technology, and work to coordinate policies across various programs that reference, or require, the use of certified health IT,” stated Fridsma and Payne.
Several industry groups, including AHA and AMIA, have cautioned ONC on expanding its authority to suspend and terminate health IT certifications. Healthcare providers are already encountering challenges with certified EHR and health IT systems, including lackluster interoperability and improper HIE. The groups noted that the ONC could create more issues for providers and developers by overextending its disciplinary role.
