– Further transparency in EHR testing and development is imperative to improving EHR usability and reducing patient harm associated with EHR use, according to AMA and Medstar.
The organizations offered recommendations for three information blocking regulations that may improve EHR usability and safety in a recent JAMA Network perspective.
“A major impediment to addressing usability and safety issues has been the inability of clinicians, researchers, and developers to communicate openly and share specific usability and safety challenges associated with EHR technology,” wrote AMA and Medstar.
“Although medical device companies are required to share usability and safety issues, some EHR vendors have resisted sharing this information — even information related to events that have resulted in substantial harm,” the duo continued.
EHR contracts often include clauses preventing healthcare organizations from sharing certain information about EHR systems, such as gag clauses that require authorization from the vendor to share screenshots, videos, and other information about purchased products.
These clauses may prevent the transparency necessary to allow researchers studying EHR usability and safety issues to gain an accurate and complete view of how products work.
“Even though it is important to recognize the need to protect intellectual property — the issue vendors generally raise when discussing gag clauses — the inability to share critical usability and safety information can affect product improvement and patient safety initiatives,” the organizations maintained.
Lack of transparency restricts independent review of EHR products by outside entities and can negatively affect a healthcare organization’s ability to make a truly informed EHR purchasing decision.
Additionally, the inability of third parties to fully assess a purchased EHR product may give EHR vendors less incentive to improve usability.
Provisions of the 21st Century Cures Act require state that EHR vendors who seek ONC Health IT Certification cannot prohibit or restrict the communication of information related to EHR usability.
“Although this is a major step forward, the specific details of what constitutes prohibition and restriction of usability information has not been defined, and it is unclear what actions by an EHR vendor may be included under this provision,” noted the team.
AMA and Medstar recommended ONC consider three main criteria when defining information blocking in forthcoming information blocking regulations.
First, the organizations suggested ONC ensure EHR vendors provide information to support usability and safety research and testing by enabling researchers to access test environments and rigorous test cases.
“Without EHR environments that support testing, effective studies of usability and safety threats with appropriate experimental designs are not possible,” the organizations stated. “Policies should require basic EHR functionality for usability and safety testing, such as the ability to enter test cases into the EHR system, and require reasonable access to EHR testing environments.”
Second, AMA and Medstar urged ONC to consider policies that prohibit EHR vendors from blocking their clients from participating in EHR usability and safety testing.
“Health care organizations are often completely reliant on their EHR for delivering clinical care and on their EHR vendor for technical support, upgrades, and numerous other aspects of the technology,” wrote the organizations.
This power dynamic may prevent healthcare organizations from participating in EHR usability and safety testing or contributing information about specific usability and safety challenges out of concern for their relationship with their vendor.
“Policies should prohibit adverse actions that may be taken by EHR vendors to dissuade health care organizations and clinicians from participating in usability and safety research or acting in good faith to report usability and safety issues,” stated AMA and MedStar.
Finally, the organizations suggested ONC develop policies that require EHR vendors to allow healthcare organizations to share information related to EHR usability and safety problems in a timely manner so users can compare usability challenges across products from different vendors.
“Overall, the inability to address the issues of usability represents a market failure,” AMA and Medstar wrote.
By including policies in information blocking regulations that promote transparency surrounding EHR usability and safety, federal entities can help healthcare organizations make better-informed purchasing decisions for improved clinician satisfaction and patient safety.