TABLE 1.

SUMMARY table of connections between examples of available standards and systems diagram blocks

Use Case: Standards Need and Availability	Link to Systems Diagram
Testing, Test Kits, Laboratory Test Results: Laboratories and Test Kits require certifications (e.g., CLIA in the US) and approvals in each country. Consensus around how to report test results is lacking. The LOINC Codelist is available; however, new codes were added for Covid‐19. Lab results requirements have been posted by HHS; these should be compared with healthcare and research data standards and aligned.	People/Patient Flow—Blocks 2.2 and 2.4 (Figure 2)
Contact Tracing: Apps are in development, piloting, and implementation; however, use is inconsistent across U.S. and there is no standardization of data across apps. Spain has recently developed an app and the Asturias region is piloting a new contact tracing methodology. Italy is also piloting a new app for this purpose.	People/Patient Flow—Blocks 2.2 and 2.4 (Figure 2)
Healthcare (EHR) Data: Disparate data standards exist among EHRs/vendors; however, the U.S. has now identified a CORE set of data, which must be provided in the future to patients, from EHRs in HL7 FHIR. HL7 FHIR is of interest globally, but adoption and resources are currently inadequate for Covid‐19 analyses or for research; further development and consensus building are needed. “Real‐world data” from EHRs at large academic institutions are now being aggregated using common codelists and the OMOP data model (N3C) or by private companies (e.g., TriNetX) with proprietary data models.	People/Patient Flow—Blocks 2.3, 2.4, 2.5, and 2.6 (Figure 2)
Clinical Research, Vaccine Development, Public Health Research, Safety (Adverse Event) Reporting; Clinical Trial Registration: Global clinical research data standards (CDISC SDTM, ADaM, and define.xml) are required by the U.S. FDA and Japan's PMDA (and are endorsed by Europe, China) to submit data in support of new treatment and vaccine approvals. Collection of data using CDISC CDASH) is strongly encouraged to minimize “back‐end” mapping into SDTM and ADaM and to enable direct cross‐study comparisons of clinical trial results. Standard controlled terminology complements the CDISC standards and is hosted by the NIH/NCI Enterprise Vocabulary Services. COVID‐19 CDISC TA standard user guide has been published. The WHO/ISARIC/IDDO data collection forms have been annotated with CDISC elements and are in use by ~40 countries. Master protocols can standardize research studies to simultaneously compare multiple therapies. These are being encouraged by policy makers and regulators. For registering clinical trials in the public domain, one standard (for Clinical Trial Registration) can populate three international registries—WHO ICTRP, EudraCT, ct.gov; all clinical trials in progress for new therapies and/or vaccines should be registered in at least one of these registries.	Medical Research and Vaccine Development—Block 3 (Figure 1)
Health System and Public Administration: The indicators driving the data for these areas are largely centered around numbers of people, case numbers, time, outcome (e.g. death or resolution), race, and sex. These are deceptively simple metrics, currently without global standards. Developing such data standards will require collaboration to build consensus on the definitions of what is being counted and how to report the information. Standards for demographics and time/date data could be adopted from CDISC or HL7; there is incentive to align these standards.	Health Regional System and Public Administration—Block 4 (Figure 1) (also relevant to People/Patient Flow Blocks 2.3, 2.4, 2.5, and 2.6)