LAUSR

BACKGROUND  Pilot-testing is important in standards development because it facilitates agile navigation of the gap between needs for and use of standards in real-world settings and can reveal the practicalities of implementation. As the implementation and use of health data standards are usually more complicated than anticipated, the Office of the National Coordinator for Health Information Technology (ONC) routinely oversees and organizes relevant pilot projects. OBJECTIVES  This article provides an in-depth look into a sample of ONC's standards-focused pilot projects to (1) inform readers of the complexities of developing, implementing, and advancing standards and (2) guide those seeking to evaluate new standards through pilot projects. METHODS  The ONC's approach to conducting pilot projects begins with identifying a clinical care need, research requirement, or policy outcome that is not well supported by existing standards through a landscape review. ONC then selects a testing approach based on the identified need and maturity of relevant standards. Next, ONC identifies use cases and sites to pilot-test the relevant standard. Once complete, ONC publishes a report that informs subsequent projects and standards development. RESULTS  Pilot projects presented here are organized into three categories related to their demonstrated focus and related approach: (1) improving standards for presenting and sharing clinical genetic data, (2) accelerating the development and implementation of new standards, and (3) facilitating clinical data reuse. Each project illustrates the pilot approach from inception to next steps, capturing the role of collaboration among standards development organizations, stakeholders, and end-users to ensure standards are practical and fit for purpose. CONCLUSION  The ONC approach identifies implementation difficulties prior to broader adoption and use of standards, and provides insight into the steps needed to scale use of standards. The ONC's organization of pilot projects serves as a natural accelerator for building communities of practice, often providing a well-connected beneficiary of lessons learned.