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The Data COUNTS™ (Collect Data Once, Use Numerous Times) effort is built on collaboration between patients and advocates, government, health systems, technology companies, and the private sector as illustrated in the top rectangle. The Data COUNTS program enables the NIH’s Real-World Data initiative and will provide high quality, standardized data that is provenanced and available through approved access to the research community, as illustrated in the larger circle. Real-World data sources are illustrated on the left side of the larger circle and the research opportunities are illustrated on the right hand side of the larger circle. Data Sources include pharmacy chains, health organizations, claims & billing, clinical data, environmental, sensors & wearables, SDOH (social determinants of health), and mortality. Research opportunities include real-time health monitoring, drug development, precision medicine, longitudinal studies, regulatory approvals, public health policy & decision making, and research competitions. The bottom panel illustrates the tenants of the Data COUNTS program, 1. Trusted partnerships and secure data stewardship, 2. Enabling a Patient Consent model, and 3. Providing zero-trust security.
Vision
Data COUNTS™ (Collect Data Once, Use Numerous Times) aims to enable high-quality, secure, and reusable health data by collecting data once at the point of care and using it numerous times to support biomedical research, public health, and regulatory decision-making. Through a federated, zero-trust architecture, Data COUNTS partners with healthcare professionals, healthcare systems, government agencies, and the research community to reduce data collection burden, improve data quality, transparency and provenance, and accelerate access to real-world evidence. Data COUNTS supports the NIH vision to enable a Real-World Data Network that will provide clinicians, healthcare professionals, and researchers with access to RWD to address chronic diseases to improve the health of the nation.
Mission
NIH envisions a national learning health system in which health data functions as a trusted public resource that is secure, interoperable, and can continuously improve health outcomes. By strengthening data foundations, preserving full lineage, and enabling rapid, reproducible research across institutions, Data COUNTS seeks to transform how health data are shared, learned from, and fed back into care, research, and policy.
Data COUNTS Description
Data COUNTS™ (Collect Data Once, Use Numerous Times) is a federal initiative that enables faster, higher-quality use of real-world health data while reducing the burden of collection on healthcare systems.
Data COUNTS deploys modern data technologies at healthcare partner organizations to extract and de-identify electronic health record data once, preserve full data provenance and lineage, and make the data securely reusable for multiple research and public health purposes while preserving patient confidentiality and privacy.
Data COUNTS healthcare partner organizations have full control and oversight of Data COUNTS processes at their site. De-Identified (Safe Harbor) Data is aggregated within a Trusted Data Broker for quality assessments and to engage healthcare partners in data improvement options. The Trusted Data Broker is currently hosted by the Foundation for the National Institutes of Health (FNIH).
Data COUNTS data is shared with the research community through NIH’s Controlled Access Data Repositories that support sharing real-world data. Examples include the National Clinical Cohort Collaborative, the NCI Clinical and Translational Data Commons, and the All of Us Research Program. Researchers can request data through the Data Access process within the NIH repositories, and data governance follows NIH policies for controlled access data.
The initiative supports biomedical research, disease surveillance, regulatory science, and population health by enabling rapid, reproducible access to high-fidelity data through a trusted, privacy-preserving architecture.
Partnerships with NIH Institutes, Centers, and Offices
| Name of Institute | Brief Description of Institute | Brief Description of Partnership | Link to Institute Webpage |
|---|---|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NCATS works to accelerate the development of diagnostics and treatments by transforming the translational science process. | Leveraging the N3C platform data to improve cross-institutional research collaboration and support scalable translational research infrastructure. | NCATS |
| National Institutes of Health Office of the Director (DPCPSI/ODS) | The Office leads the federal government in addressing the scientific exploration of dietary supplements | Supporting research enabled by dietary supplements to improve health outcomes. | ODS |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIAMS supports research into arthritis, musculoskeletal, and skin diseases to improve health outcomes. | Supporting Lupus research to advance treatments for chronic diseases, evidence generation, and clinical insights. | NIAMS |
| National Heart, Lung, and Blood Institute (NHLBI) | NHLBI supports research into the prevention and treatment of heart, lung, blood, and sleep disorders | Supporting research into adverse events leading to heart failure | NHLBI |
| National Cancer Institute (NCI) – Cancer Research Data Commons | NCI leads the national effort to eliminate cancer through research, training, and dissemination of health information. | Leveraging the Cancer Research Data Commons services to support harmonized cancer research data sharing and interoperability through data commons infrastructure. | NCI |
| National Cancer Institute (NCI) | NCI leads the national effort to eliminate cancer through research, training, and dissemination of health information. | Supporting the Cancer Registry: to explore the feasibility of using Data COUNTS’s existing pipelines and processes to produce cancer registry early reporting data elements, per NAACCR standard, that can be utilized for cancer reporting. | NCI |
Participating Institutions
- Baylor College of Medicine
- Community Clinic of Northwest Arkansas FQHC (CCNWA)
- Ohio State University
- North Dakota University
- Sanford Health
- Tampa General Hospital & USF Health
- University Hospitals Cleveland Ohio
- University of California Irvine
- University of Chicago Medicine
- University of Kentucky
- University of Nebraska Medical Center
- The University of Texas MD Anderson Cancer Center
For more information, updates, or partnership inquiries, please contact the Data COUNTS team datacounts@nih.gov.