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The biggest gains to patient safety could be obtained by retooling Office of the National Coordinator for Health Information Technology (ONC) certification program to require more rigorous interoperability testing, according to comments jointly released by the College of Healthcare Information Management Executives (CHIME) and the Association of Medical Directors of Information Systems (AMDIS).
The comments were in response to the tri-agency Food and Drug Administration Safety and Innovation Act (FDASIA) health IT report, which contained a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications.
The two organizations said they felt the government’s proposed approach to regulating health care IT provides federal regulators an opportunity to adapt its health information technology certification program to focus on the twin goals of improving patient safety and interoperability.
“Designing a certification program that more closely resembles the software development lifecycle would have a tremendously positive impact on both interoperability and patient safety,” Russell Branzell, president and CEO of CHIME, said in a statement. “The single biggest action federal regulators could take to improve patient safety is to identify clear standards and require strict adherence to those standards. We think certification is the lever and now is the time to re-evaluate what is working and what is not.”
Among the recommendations was ensuring that providers have an open pathway to report technology failures with implications for patient safety before such failures inflict patient harm.
The organizations also recommended that federal officials engage with private-sector testing bodies that are developing tools to more consistently test and continuously monitor adherence to standards.
“By relying heavily on existing policies and programs, we believe federal regulators have articulated a sound strategy to help the private and non-profit sector establish a learning health system, characterized by continuous improvement and consistent accountability,” Randy McCleese, CHIME board chair, and vice president and CIO at St. Claire Regional Medical Center, said in a statement. “The industry has made great strides towards improving patient safety, and we must continue this trend by leveraging innovative technology, supported by consistent standards and best practices.”
Other suggestions included forming a public-private partnership to develop an adaptable process for identifying standards and best practices, especially related to local implementation, customization and maintenance of health IT, and develop, as part of certification, a mechanism to monitor post-market use of health IT in live settings.
CHIME and AMDIS also recommended that ONC retool the certification program to focus on beta-testing, post-certified performance and standard adherence in live settings.
