The U.S. Core Data for Interoperability: A National Policy Journey

On April 15, 2021, the Health Information Technology Advisory Committee, established by Congress in the 21st Century Cures Act, unanimously approved recommendations from its U.S. Core Data for Interoperability (USCDI) Task Force to significantly expand the data elements included in the core data for nationwide interoperability. UC San Francisco’s Center for Digital Health Innovation (CDHI) has been championing such expansion since 2018 and believes that this multi-stakeholder consensus vote represents a major leap forward on the journey to interoperability and better care. The Office of the National Coordinator for Health Information Technology (ONC) will make the final decision when it releases USCDI version 2, expected July 2021.

It has been a remarkable journey. Much like ONC’s landmark regulations in May 2020, to advance health data access and interoperability for patients, providers, and app developers using a standardized application programming interface (API) infrastructure,¹ we are on the cusp of a landmark decision to add:

• Social determinants of health
• Care team members defined broadly to include all care team members in the home and community
• Gender identity and sexual orientation
• Diagnostic studies and image reports
• Encounter dispositions
• Orders including orders for end-of-life care
• Discharge medications
• And more²

The USCDI is the set of structured health data essential for nationwide interoperability, electronic health information exchange, and usability without special effort. It is the core set of data included with electronic exchanges for referrals and transitions of care, data exchange through standardized application programming interfaces (APIs), and patient access to view, download, and transmit health data to any third party, including patients’ third-party health applications (apps).³ Clearly, what ONC does and does not include in the U.S. Core Data for Interoperability matters.

ONC released the original draft of U.S. Core Data for Interoperability and Proposed Expansion Process in 2018. The draft listed 50 data elements for potential addition to the predecessor Common Clinical Data Set, noted that all are “critical to achieving nationwide interoperability,” and acknowledged that technical specifications were already available for 46 of the 50 data elements and classes.⁴ As CDHI stated even then,⁵ from the perspective of a health care provider, these standardized datasets cannot come fast enough to help meet national health imperatives. The better question, CDHI submitted then, is not whether the data elements must wait another one, two, three, or more years before being considered for addition, but conversely, whether there are objective reasons to delay adding all of them now. Merely postulating a “burden” that significantly expanding the USCDI could cause⁶ did not change our real-world experience that we need these standardized datasets now, as fast as possible, to help provide better health care and a better national digital health ecosystem. The benefits far outweigh any potential burden.

In May 2020, however, ONC made only a “modest expansion” of the Common Clinical Data Set (although there were some important additions such as clinical notes and provenance).⁷ If the past 16 months of responding to the COVID-19 pandemic have taught us anything, they have taught us that America’s providers, patients, and health IT developers need far more than a “modest” addition to the U.S. Core Data for Interoperability version 2.

In one policy letter, CDHI illustrated the importance of adding missing data elements now by testing them against two COVID-19 use cases, and asked one of CDHI’s most knowledgeable doctors in the area which missing structured data elements are necessary or important now for health care in the midst of the COVID-19 pandemic.⁸

In another policy letter, we explained that the same data element often serves multiple use cases, multiplying its importance.⁹ Structured data elements missing from the USCDI and version 2 are essential across a number of key national use cases, such as:

• COVID-19 and remote care
• Patient-generated health data, patient-reported outcomes, and social determinants of health
• Health equity and health disparities
• Value-based care delivery
• Interoperability and the 2015-2024 Nationwide Interoperability Roadmap
• Patient access, shared care planning, and care coordination across clinical and non-clinical settings
• CMS’s work to build digital quality measures
• Precision Medicine Initiative and research
• A robust health app ecosystem, which is constrained by the standardized data available to design and use innovative health apps with FHIR APIs

We appreciate the considerable work that ONC has devoted to the Common Clinical Data Set (CCDS), the U.S. Core Data for Interoperability version 1, and now draft version 2. After three years, we are on the cusp of a “robust expansion” of the U.S. Core Data for Interoperability to meet national health imperatives, paralleling the landmark expansion of interoperability with FHIR-based APIs. All eyes are on ONC’s release of version 2 in July 2021!

¹Letter from Mark Laret, Michael Blum, and Joe Benfort, UCSF Health, to Secretary Alex Azar II (Feb. 18, 2020), available here.

²https://www.healthit.gov/sites/default/files/facas/2021-04-15_USCDI_Task_Force_Recommendations_508.pdf; https://www.healthit.gov/sites/default/files/facas/2021-04-15_USCDI_TF_2021_HITAC_Phase_1_Recommendations_Report_508.pdf.

³Office of the National Coordinator for Health Information Technology, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, 85 Federal Register 25642, 25670 (May 1, 2020), available here.

⁴Office of the National Coordinator for Health Information Technology, Draft U.S. Core Data for Interoperability and Proposed Expansion Process, p. 9 (Jan. 5, 2018), available here.

⁵Comment Letter from Michael Blum, Aaron Neinstein, Mark Savage and Ed Martin, UCSF’s Center for Digital Health Innovation, to Donald Rucker, Office of the National Coordinator for Health Information Technology (Feb. 20, 2018), available here.

⁶84 Federal Register at p. 7441.

⁷Id. at 25665.

⁸Letter from Aaron Neinstein, Nathaniel Gleason, Mark Savage, and Ed Martin, UCSF’s Center for Digital Health Innovation, to National Coordinator Donald Rucker (Oct. 22, 2020), available . First, we assessed which are necessary or important to test for COVID-19 and provide outpatient care, end to end. This would include, for example, scheduling the appointment, a visit for the test, processing the test, processing the results, and consulting with the patient. In this use case, we assumed that the COVID-19 test result was positive, but outpatient care was sufficient. Secondly, we assessed which missing data elements are necessary or important assuming instead that full emergency hospitalization were required.

⁹Letter from Aaron Neinstein, Nathaniel Gleason, Mark Savage, and Ed Martin, UCSF’s Center for Digital Health Innovation, to National Coordinator Donald Rucker (Apr. 14, 2021), available here.