Strengthening our Health Information Foundation with the U.S. Core Data for Interoperability

As providers, patients, and caregivers, we often wish that our health information could move seamlessly and securely wherever it was needed. But as we've seen in this pandemic, far too often, people traverse the healthcare system faster than their information does. Getting health information when and where it is needed requires information technology (IT) systems that use common data standards so that data producing systems and receiving systems can understand each other.

The Office of the National Coordinator for Health Information Technology (ONC) is charged with creating the U.S. federal strategy for health IT. Since its inception, ONC has championed health improvements through a nationwide interoperable health IT infrastructure. In July 2020, the ONC published a landmark specification called the United States Core Data for Interoperability (USCDI).

The USCDI is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. Its current version (V1) includes content such as laboratory tests, vital signs, diagnoses, and clinical notes. In March 2020, the 21st Century Cures Act Final Rule (from ONC) and the Interoperability and Patient Access Final Rule (from the Centers for Medicare and Medicaid Services) were enacted that both require data exchange of USCDI content. Because of these regulations, the USCDI represents a key set of clinical data that provider and payer health IT systems will be capable of sending to patients and their healthcare providers. Widespread availability of this standardized data has significant potential for advancing research as well, and NIH has encouraged the use of USCDI clinical data in research studies too.

ONC's intent is that the USCDI will continue to expand and evolve over time. They have designed a regular update process that takes input from public data element submissions to the ONDEC system. Submissions are reviewed against established criteria, and those with sufficient maturity and value are incorporated into draft and final versions of the USCDI on a predictable schedule. The first round of public submissions for consideration in USCDI Draft V2 are being accepted through October 23, 2020.

RTI is leading health IT projects that leverage the availability of USCDI data, such as a pilot test of an electronic care plan application, and projects that are informing USCDI's potential expansion, such as the development of standardized data elements in post acute care assessments. Recognizing USCDI's significant promise for directing future interoperability efforts, we seek to improve its foundation for continued expansion.

In particular, we believe that clear USCDI entity definitions are necessary for the industry to interpret them consistently. Here, we use USCDI "entities" as an umbrella term for the things that USCDI contains, such as Data Classes, Data Elements, and other structures that might emerge as USCDI continues to evolve. We seek to add precision to the entity specifications at this early stage to enable a principled approach for users to understand, implement, extend, and refine them with future submissions for new USCDI content.

This proposal offers two primary recommendations to improve the clarity of the USCDI. First, we offer a clear and extensible structure for USCDI entities to specify data content with different levels of precision.

Consider the range of implications if a regulation made requirements about these different statements for what every health IT system should be able to send:

• clinical measurement results
• the code identifier, result value, units of measure, reference range, physiologically relevant time, and observed specimen for each clinical measurement result
• results for the subset of clinical measurements known as vital signs
• a "heart rate" clinical measurement result

We believe that the USCDI will be most helpful to advancing interoperability when it has a precise structure for defining these kinds of statements. The need for clarity is now, as new submissions in various shapes and sizes are coming into the USCDI review process and the present definitions.

Over time, as industry alignment and capabilities for standardized exchange grow, it is expected that additional data elements will be enumerated for existing data classes in the USCDI. With our proposed approach, these details can be added in a principled way thereby making the "shape" more precisely drawn. Likewise, new Data Classes with clear delineations from existing types may be added to expand the kinds of health information represented, thereby making the picture more complete.

Our second recommendation is a bit simpler: that the USCDI publication identify examples of vendor-neutral technical specifications that have represented its entities. The requirements for submitting new content to USCDI includes identifying which standards and technical specifications are being used to exchange the data between systems. We propose that those specifications are publicly documented so that USCDI users can easily find them as exemplars to inform system development and encourage consistent interpretation.

We hope these proposals are useful for advancing the conversation of how the USCDI can best enable nationwide health information exchange.