Informatics Professionals Call for Program that Brings Transparency to How CEHRT Performs with Live Patient Data
In comments submitted to the Office of the National Coordinator for Health IT (ONC), the American Medical Informatics Association (AMIA) questioned the constrained scope of the EHR Reporting Program to “provide publicly available, comparative information on certified health IT,” to “inform acquisition upgrade, and customization decisions that best support end users’ needs.” In response, the nation’s informatics professionals strongly recommended that the EHR Reporting Program measure performance to improve CEHRT security, interoperability, and usability, and not be used simply to provide data for “acquisition decision makers.”
In August, ONC issued a Request for information (RFI) seeking input on reporting criteria for the Electronic Health Record (EHR) Reporting Program required by the 21st Century Cures Act (Cures). Cures requires that the EHR Reporting Program’s reporting criteria address security, interoperability, usability and user-centered design, conformance to certification testing, and other categories, as appropriate, to measure the performance of certified EHR technology (CEHRT).
AMIA recommended that especially when viewed alongside the additional provisions in newly developed CEHRT Conditions of Certification, the EHR Reporting Program should be leveraged to bring transparency to how CEHRT performs in production environments with live patient data. Thus, AMIA wrote, “ONC should develop an EHR Reporting Program that more closely approximates a post-implementation surveillance ecosystem, not a government-sponsored ‘consumer reports.’” AMIA argued that such an ecosystem would illuminate CEHRT performance used in production and would generate product performance data automatically, without users having to submit reporting criteria.
As proof of concept, AMIA pointed to ONC’s existing nascent surveillance and oversight program for CEHRT that could be leveraged for the EHR Reporting Program. The group additionally references the Food and Drug Administration’s (FDA) Digital Health Software Precertification Program as another example of a federal program that looks to utilize real-world production data.
In addition to the reorientation of EHR Reporting Program goals, AMIA also offered the following recommendations:
- ONC should develop interoperability reporting criteria for the EHR Reporting Program by building on previous RFIs meant to “measure interoperability,” including the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and ONC’s “Proposed Interoperability Standards Measurement Framework.”
- ONC should view health IT safety as a measurable byproduct of usable CEHRT deployed in live environments. To understand CEHRT usability performance in situ, ONC should supplement user-reported measures with measure concepts that reflect the safety of health IT.
- (ONC should prioritize an additional measure that demonstrates a capability to provide patients with “a complete copy of their health information from an electronic record in a computable form.” This focus would align with top-level HHS priorities to improve patient access to their data.
- ONC should ensure alignment between the EHR Reporting Program and other aspects of the Cures-mandated Conditions of Certification. Compliance with the EHR Reporting program constitutes one of seven distinct aspects of new Conditions of Certification, so ONC should look for ways to enable participation in this program to meet these additional requirements.
“The EHR Reporting Program is one more vital piece in improving both EHR performance and care quality,” said AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACP, FACMI. “We have a tremendous opportunity to leverage Cures provisions if we hone our focus on EHR performance in the real world.”
AMIA’s full response to RFI can found here.
AMIA, the leading professional association for informatics professionals, is the center of action for 5,500 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.