EHR Safety Gets AI Boost

Summary

The Department of Health and Human Services (HHS) has updated its Safety Assurance Factors for EHR Resilience (SAFER) Guides for 2025. These guides incorporate new recommendations for the safe use of electronic health records (EHRs), including the use of artificial intelligence (AI) in clinical care. The updates reflect the evolving landscape of healthcare technology and aim to ensure patient safety and data security.

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** Main Story**

HHS Updates SAFER Guides for Enhanced EHR Safety in the Age of AI

The Department of Health and Human Services (HHS) has taken a significant step toward ensuring the safe and effective use of electronic health records (EHRs) by releasing its updated Safety Assurance Factors for EHR Resilience (SAFER) Guides for 2025. These guides provide healthcare organizations with crucial tools and best practices to optimize the safety of their EHR systems, especially as the integration of AI in clinical care becomes increasingly prevalent. The 2025 SAFER Guides reflect key provisions of the 21st Century CURES Act, addressing vital areas such as AI utilization, cybersecurity, and the integration of medical device data into EHRs.

A Collaborative Effort to Enhance EHR Safety

The development of the 2025 SAFER Guides was a collaborative effort, involving clinicians, informaticians, patient safety experts, and other stakeholders. This multidisciplinary approach ensured that the guides incorporate a comprehensive perspective, covering clinical medicine, patient safety, informatics, quality improvement, risk management, human factors engineering, and usability. The guides offer 524 practical examples across seven publications, offering actionable guidance for healthcare organizations of all sizes and specialties. A notable enhancement to the guides is the inclusion of a five-point rating scale for self-assessment, allowing organizations to gauge their adherence to recommended practices and identify areas for improvement. Furthermore, a three-level evidence hierarchy helps evaluate the quality of evidence supporting each recommendation, adding another layer of rigor to the guidance.

Addressing Key Areas of Focus

• AI Integration: The updated guides specifically address the use of AI in clinical care, acknowledging its potential benefits and risks. This guidance is crucial as AI algorithms become increasingly integrated into diagnostic tools, treatment planning, and patient monitoring.
• Cybersecurity: Recognizing the growing threat of cyberattacks targeting healthcare data, the guides emphasize cybersecurity best practices. This includes measures to protect EHR systems from unauthorized access, data breaches, and ransomware attacks.
• Interoperability: The guides promote seamless data exchange between EHR systems and other healthcare technologies. This is essential for care coordination, patient access to information, and public health reporting. They address the incorporation of FDA-approved medical device data into EHRs, ensuring that clinicians have a comprehensive view of patient information.
• Patient Access: Aligned with the 21st Century CURES Act, the guides emphasize patient access to their own health information. This includes facilitating patient-clinician communication, enabling access to clinical notes and test results, and empowering patients to actively participate in their care.
• Software Testing: The guides address the importance of rigorous software testing procedures to ensure the reliability and safety of EHR systems. This includes testing for functionality, usability, security, and interoperability.

Promoting Continuous Improvement in EHR Safety

The HHS encourages healthcare organizations to use the SAFER Guides as a roadmap for continuous improvement in EHR safety. The Centers for Medicare and Medicaid Services (CMS) already requires eligible hospitals to conduct annual self-assessments using the SAFER Guides as part of its Promoting Interoperability Program. As of April 22, 2025, healthcare organizations are encouraged to review and implement the latest updates to the SAFER Guides to ensure they align with best practices. The insights gained from these assessments can inform strategies to enhance EHR safety, reduce medical errors, and improve patient care. This proactive approach to EHR safety not only benefits individual patients but also contributes to strengthening the overall healthcare system. The HHS aims to foster a culture of continuous improvement by providing updated guidance and resources to support healthcare organizations in their pursuit of safe and effective EHR implementation. By embracing these recommendations, healthcare organizations can leverage technology to deliver higher-quality, patient-centered care.