Draft of USCDI Version 7 Includes Adverse Events Data Class

The newly released draft version 7 of the United States Core Data for Interoperability (USCDI v7) has a focus on patient safety and introduces a new Adverse Events data class with two complementary data elements. 

Mandated by the Cures Act, the USCDI is stewarded and adopted by ASTP/ONC on behalf of the Department of Health & Human Services (HHS), establishing the foundation for the access, exchange, and use of Electronic Health Information (EHI) to enable nationwide interoperable health information exchange.

“Adverse Event” details a change to patient condition that could be an unintended effect of clinical interventions (such as medication reaction or vaccination reaction), providing essential information for patient safety monitoring and quality improvement activities. 

“Adverse Event Outcome” documents the patient’s clinical outcome resulting from an adverse event, with examples including hospitalized, recovered, recovered with sequelae, death. Together, these data elements support comprehensive adverse event tracking across care settings, enabling healthcare organizations to identify patterns, implement preventive measures, and improve treatment protocols. ASTP/ONC states that interoperable exchange of adverse event information enhances patient safety by ensuring that all members of a care team are aware of previous adverse events, supports regulatory reporting requirements, and provides the data foundation necessary for analyzing and reducing preventable harm in healthcare delivery.

Another new data element is “Allergy Intolerance Criticality,” which indicates the potential severity of harm if a patient is re-exposed to a substance that has caused or is expected to cause an allergic or intolerance reaction. ASTP/ONC said this data element addresses a critical gap in allergy documentation by enabling clinicians to distinguish between reactions that are potentially life-threatening—such as anaphylaxis to peanuts—and those that are uncomfortable but less severe, such as a mild rash from a medication. 

By supporting clinical decision support, allergy notification prioritization, and safe ordering of medications, foods, contrast agents, and other substances across care settings, criticality information becomes a vital component of patient safety infrastructure, the draft states. The standardized exchange of this data element will help health IT developers and implementers align allergy documentation and alerting behavior, reduces alert fatigue by differentiating high-priority from lower-priority allergies, and improves patient safety during care transitions, emergency encounters, and pharmacy dispensing workflows.

“Reason Not Performed” specifies structured information about why an ordered test, procedure, immunization, or other planned intervention did not occur, such as patient refusal, clinical contraindication, or logistical constraints. This supports accurate quality measurement by helping distinguish between true care gaps and documented decisions not to proceed with care, interpreting apparent gaps in population health analytics, and can be leveraged in safety and operational reviews to identify systemic issues that prevent care delivery.

Another new data element, “Diagnostic Imaging Reference" represents a link or other computable reference that enables access to diagnostic imaging studies, a series, or individual images associated with a patient encounter. The ability to consistently exchange imaging references across networks and organizations directly supports improved diagnostic decision-making by ensuring that relevant prior studies are available when and where they are needed, the draft states Realizing these benefits requires interoperability agreements with the organizations hosting the PACS (Picture Archiving and Communication System) or imaging servers where studies are stored. This capability reduces duplicative imaging and associated radiation exposure, benefiting both patient safety and healthcare efficiency.

ASTP/ONC also is working with the public and other federal agencies to find areas that need more attention in future versions of USCDI. To help address specific use cases that need aligned datasets beyond USCDI, ASTP/ONC continues to work with governmental and industry partners through the USCDI+ Program. Where appropriate, ASTP/ONC said it will consider data elements from the USCDI+ Program for inclusion in USCDI.

The Draft USCDI v7 is open for public comment until April 13, 2026, at 11:59 pm ET. ASTP/ONC is targeting release of the final USCDI v7 in July 2026.