The transition from paper medical charts to electronic health records (EHRs) has streamlined many of the ways that health care is delivered in the United States and contributed to safety improvements in a number of areas. While health information technology includes many types of products, patient records are a critical aspect of care, as they inform clinicians’ decisions and are used when medical orders are placed. Clinicians now have their patients’ information at their fingertips, along with new data tools to help guide their decisions and reduce medical errors.
But the increased use of electronic health records has also given rise to new, unanticipated safety challenges. For example, patients may receive the incorrect dose of a medication or clinicians may select the wrong person when inputting an order. The nonprofit ECRI Institute, which studies patient safety, listed health IT configuration and workflow—the design and use of EHR systems—as its top concern in 2016.
To address these and other health IT safety concerns, multiple expert panels have proposed the establishment of a safety collaborative composed of EHR developers, hospitals, government, health practitioners, and other key organizations to work together to resolve problems. These efforts emphasize that health IT has the potential to improve safety and that hospitals, clinicians, EHR developers, and others have responsibilities in reducing avoidable patient harm.
In recent years, several high-profile reports have called for broader cooperation to reduce health IT-related harm to patients. A 2012 Institute of Medicine report emphasized that health IT safety is a shared responsibility that requires involvement and action by EHR developers, users, and government. In addition, several federal agencies—following another expert panel recommendation—called in 2014 for establishing a risk-based regulatory framework for health IT, including through the creation of a health IT safety collaborative. The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC), as part of a health IT safety roadmap, in 2015 also encouraged private-public sector collaboration to address health IT safety.
The Pew Charitable Trusts and ONC held a Health IT Safety Day in December 2016 to discuss this critical issue. The event, which focused on EHRs because of the critical role they play in patient care, featured health IT developers and representatives from hospitals, government agencies, and other organizations. Participants discussed how a product’s usability—the records’ layout, design, integration within health care facilities’ workflow, and customization by institutions—can affect patient safety while recognizing that other issues can also cause patient harm. They also noted that usability can affect the effectiveness of EHRs, how satisfied clinicians are with health IT, and many other aspects of care.
The International Organization for Standardization’s ISO 9241 standard defines usability as “the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use."
Experts noted that health care facilities and health IT developers can detect safety concerns throughout a product’s development—as it is being designed, when it is submitted for government certification, during implementation in hospitals and other institutions, and through staff training and use. Safety challenges can arise from the base design of a product, customizations during installation and implementation in health care organizations, or unique workflows within a facility.
The Agency for Healthcare Research and Quality categorizes patient safety events in three ways:
- Incidents. Events that reached the patient, whether or not there is harm.
- Near misses (or close calls). Events that do not reach the patient.
- Unsafe conditions. Circumstances that increase the likelihood of a patient safety event.
Drawn from Health IT Safety Day and subsequent conversations with experts, this report explains how an EHR’s usability can affect patient safety, gaps in EHR safety monitoring, the genesis of efforts to improve health IT safety through multistakeholder activity, and the potential benefits of a national health IT safety collaborative.
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Speakers at Pew-hosted event urge collaboration to address electronic health record challenges