The Assistant Secretary for Technology Policy has recently unveiled an updated version of guidance documents aimed at helping healthcare organizations evaluate and enhance the safety of their electronic health record systems. The new 2025 Safety Assurance Factors for EHR Resilience Guides have been revised to align with the 21st Century CURES Act, incorporating aspects such as the utilization of artificial intelligence in clinical care, cybersecurity measures, and the integration of FDA-approved medical device data into electronic health records. Additionally, enhancements have been made to software testing procedures.
Importantly, the 2025 update of the SAFER Guides involved the collaboration of numerous subject matter experts who meticulously reviewed and revised the guides, incorporating insights from various fields including clinical medicine, informatics, patient safety, quality improvement, risk management, human factors engineering, and usability. The updated guides now reflect evolving practices driven by the CURES Act, such as improved patient-clinician communication and enhanced patient access to clinical notes and test results.
Among the notable upgrades in the 2025 SAFER Guides are new tools for self-assessment scoring and evidence-level analyses, including a five-point rating scale to assess adherence to implementation guidance suggestions and a three-level evidence hierarchy for evaluating the quality of evidence supporting each SAFER recommendation. The guides also feature revised literature references, simplified descriptions, and a revamped High Priority Practices SAFER Guide tailored specifically for merit-based incentive payment system-eligible clinicians.
Originally introduced in 2014 and last updated in 2016, the SAFER Guides have been instrumental in assisting hospitals to comply with regulatory requirements. Healthcare leaders have emphasized the importance of shared responsibility for ensuring the safety of EHRs, urging vendors to align product default settings with SAFER recommendations and requesting clear guidance on safety practices. In response to these calls, the Centers for Medicare and Medicaid Services proposed changes for interoperability in 2021, mandating eligible hospitals to conduct an annual self-assessment of their EHR systems using the SAFER Guides.
In conclusion, the updated 2025 Safety Assurance Factors for EHR Resilience Guides represent a significant step forward in promoting the safe and effective use of electronic health record systems in healthcare organizations. By incorporating the latest advancements in technology and best practices, these guides are poised to enhance the overall quality and safety of EHR systems across the healthcare industry.
