Introduction to EHR Safety Guides
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, as well as software testing procedures.
Why it Matters
Several subject matter experts worked on the 2025 update of the SAFER Guides – seven publications featuring 524 examples. A large group of clinicians with extensive informatics training or informaticians with extensive clinical experience iteratively reviewed and revised the guides, often multiple times. Many reviewers also had experience working for commercial EHR vendors or healthcare organizations that developed their EHRs.
Key Updates
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.
New Tools and Upgrades
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. 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.
Recent Developments
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.
Conclusion
The updated SAFER Guides provide healthcare organizations with the necessary tools and guidance to assess and optimize the safety of their electronic health record systems. With the inclusion of new practices and technologies, such as artificial intelligence and cybersecurity, the guides aim to promote safer and more effective EHRs.
FAQs
Q: What are the SAFER Guides?
A: The SAFER Guides are a set of guidance documents that healthcare organizations use to assess and optimize the safety of their electronic health record systems.
Q: What is new in the 2025 SAFER Guides?
A: The 2025 SAFER 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.
Q: Who worked on the 2025 update of the SAFER Guides?
A: Several subject matter experts, including clinicians with extensive informatics training or informaticians with extensive clinical experience, worked on the 2025 update of the SAFER Guides.
Q: What are the benefits of using the SAFER Guides?
A: The SAFER Guides provide healthcare organizations with the necessary tools and guidance to assess and optimize the safety of their electronic health record systems, promoting safer and more effective EHRs.
