The Assistant Secretary for Technology Policy has released an update of guidance documents that healthcare organizations use to assess and optimize the safety of their electronic health record systems.
The new 2025 Safety Assurance Factors for EHR Resilience Guides contain revisions related to the 21st Century CURES Act — including the use of artificial intelligence for clinical care, cybersecurity and integration of U.S. Food and Drug Administration-approved medical device data into electronic health records — and software testing procedures.
WHY IT MATTERS
Several subject matter experts worked on the 2025 update of the SAFER Guides – seven publications featuring 524 examples – according to the Journal of the American Medical Informatics Association.
A large group of “clinicians with extensive informatics training or informaticians with extensive clinical experience” iteratively reviewed and revised the guides “often multiple times,” authors from leading health systems and the Veterans Affairs Medical Centers said in their case study published Saturday.
Many reviewers also had experience working for commercial EHR vendors or healthcare organizations that developed their EHRs, they noted.
The updated EHR operations safety guides now incorporate current recommendations based on perspectives in clinical medicine, patient safety, informatics, quality improvement, risk management, human factors engineering and usability.
Evolving practices driven by the 21st Century CURES Act, such as patient-clinician communication and patient access to clinical notes and test results, and the integration of new practices, are contained in the 2025 SAFER Guides, they said.
There are also new tools to aid in self-assessment scoring and evidence-level analyses, such as a new five-point rating scale that estimates the percent adherence to the implementation guidance suggestions and a new three-level evidence hierarchy that helps to evaluate the quality of evidence for each SAFER recommendation.
Other upgrades include revised literature references, simplified descriptions and a reconfigured High Priority Practices SAFER Guide that compiles key recommendations specifically for merit-based incentive payment system-eligible clinicians.
THE LARGER TREND
First released in 2014, the SAFER Guides were last updated in 2016.
As hospitals worked to comply with the new regulatory rules, they indicated that they needed help from their EHR vendors, according to an op-ed published in the Journal of the American Medical Association.
Meanwhile, healthcare leaders called for policies that promote shared responsibility for safer EHRs, asking vendors to default product default settings to conform to SAFER recommendations and for clear guidance on how they should address safety practices.
They also asked HHS to perform yearly reviews of SAFER recommendations.
In 2021, the Centers for Medicare and Medicaid Services proposed changes for interoperability. The agency updated its Medicare Promoting Interoperability Program, requiring eligible hospitals to complete an annual self-assessment of their EHRs using the SAFER Guides at the beginning of 2022.
ON THE RECORD
“We expect that most organizations will be implementing additional best practices for safe and effective EHRs and hence the score should increase year-to-year,” said policymakers in the case study.
Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.
