In the past couple of years several reports have been calling attention to some of the patient safety issues electronic health records can create or fail to improve. In response to the growing recognition for a need to standardize how health IT adverse events are identified and reported, the Office of National Coordinator for Heath IT has published a patient safety and surveillance plan to clarify how EHR problems should be reported and tracked.
Some components of the plan are highlighted below. The goal is to improve knowledge about the types, frequency, and severity of health IT-related adverse events and hazards, as well as ways to mitigate the risks of health IT while using it to make care safer. One aspect of the safety discussion that has not been highlighted as much is the design of electronic health records and how that is contributing to errors.
Make it easier to report patient safety issues. The plan wants to make it easier for clinicians to report patient safety events and hazards. To do that the ONC is initiating a structured data capture project. It will identify standards that will make it easier to extract adverse event data from EHRs and translate it into common formats to allow clinicians to easily generate incident reports when they happen without disrupting workflows.
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Standardize the reporting of adverse events. This initiative called Common Formats will make it possible to aggregate and compare adverse events across healthcare providers and federal and state programs. It will be part of the Agency for Halthcare Research and Quality’s Quality and Safety Review System to provide national estimates of adverse events and explore the role of health IT in these events.
Working with the Joint Commission A contract with the Joint Commission will add to the commission’s existing sentinel events program. It will investigate the role of health IT as a cause of adverse events. It will also develop educational materials and identify training needs to help health care providers to better identify,investigate, and analyze health IT- related adverse events and develop follow-up and corrective action.
Work with U.S. Food and Drug Administration ONC will coordinate with the FDA to identify health IT adverse events in the FDA’s database to identify adverse events for medical devices — the Manufacturer and User Device Experience or MAUDE. It reflects how interconnected medical devices have become and will continue to be in transmitting data to EHRs.
Develop best practice and self-assessment guides As part of an ONC contract on Anticipating Unintended Consequences, 59 health IT safety researchers are developing health IT safety guides referred to as Safety Assurance Factors for EHR Resilience or SAFER Guides.
