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Developers of electronic health records (EHR) should create or modify their products to ensure that health care organizations can meet safety recommendations of the Safety Assurance Factors for EHR Resilience (SAFER) Guides, according to researchers with The University of Texas Health Science Center at Houston (UTHealth) and Baylor College of Medicine.

The paper, "Policies to Promote Shared Responsibility for Safer Electronic Health Records" was published today in the Journal of the American Medical Association (JAMA).

The SAFER Guides are a comprehensive compendium of safety practices organized as checklists and designed to help care organizations and EHR developers conduct self-assessments of their EHRs. Their goal is to proactively optimize the safety and safe use of EHRs. The guides are sponsored by the Office of the National Coordinator for Health Information Technology (ONC) within the Department of Health and Human Services.

"Earlier this year, the Centers for Medicare & Medicaid Services (CMS) published new payment rules that required all eligible hospitals to use the SAFER Guides," said Dean Sittig, Ph.D., professor of biomedical informatics at UTHealth School of Biomedical Informatics and co-author on the paper. "What this new rule didn't do is require EHR developers to use the SAFER Guides. So, we are recommending that developers of EHR systems should annually assess their products as well. This will ensure that their customers can implement and use the EHR as recommended in the SAFER Guides."

"We see the new CMS rules as a landmark development in EHR safety that impacts all U.S. hospitals," said Hardeep Singh, MD, MPH, co-author on the paper, a professor of medicine at Baylor and researcher at the Center for Innovations in Quality, Effectiveness and Safety (IQuESt) and Michael E. DeBakey VA Medical Center. "But for hospitals to achieve quality and safety improvements promised by state-of-the-art EHRs, we also need to engage EHR developers in implementation of safety practices." 

While the new CMS policy requiring hospitals to perform annual self-assessment using the SAFER Guides creates a solid foundation, authors say the responsibility for safety must be shared with EHR developers.

Sittig and Singh recommend three specific strategies to complement the new CMS rules. They suggest:

  • EHR developers self-assess their products annually against SAFER recommendations and indicate whether their EHR can be configured to meet each SAFER recommendation.
  • ONC should conduct yearly reviews of SAFER recommendations to keep up with EHR design, development, and configuration changes.
  • EHR developers should disseminate guidance to their customers on how to implement safety practices related to their product.

They say these strategies reinforce the robust EHR safety foundation laid by the new CMS regulations and more evenly distribute the responsibility for making between those who design and develop the EHRs and those who configure, implement, and use these systems.

"Certain EHRs have already used the SAFER Guides to assess their products and developed guidance for their customer," said Sittig. "The vast majority of the time the EHR works well. No one expects the computer or use of the computer to lead to a mistake, but when it does happen, it can lead to significant patient harm. Collaborative use of SAFER Guides can prevent such problems."

More information: Dean F. Sittig et al, Policies to Promote Shared Responsibility for Safer Electronic Health Records, JAMA (2021). DOI: 10.1001/jama.2021.13945

Journal information: Journal of the American Medical Association