Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24)

BACKGROUND: The FDA/Center for Drug Evaluation and Research (CDER) receives a vast and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. FDA understands the importance of the use of "Real World Data" (RWD) to support innovation and efficiencies in clinical research, submissions to FDA, and post-approval studies. Real World Data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. More information can be found at the Real World Evidence webpage at FDA.gov Developing approaches to using this type of data will translate into benefits for clinical researchers, the pharmaceutical industry, and the general public. The Fast Healthcare Interoperability Resources (FHIR) standard, developed by Health Level Seven (HL7), is becoming a de facto standard for use with RWD. Evaluation and development of approaches to using HL7 FHIR for clinical and post marketing research is of great interest to researchers, industry, and regulators. Therefore, the objective of this grant is to explore ways to utilize the HL7 FHIR standard for these purposes. The primary output of this grant will be the new FHIR components submitted for inclusion as part of the full FHIR specification for public use. OBJECTIVE: The objective of this grant is to explore the methods to use the HL7 FHIR standard to address information exchange needs of clinical research and post-market research and surveillance. A primary output of this work will be the development of FHIR components which will ultimately be submitted to become part of the public FHIR specification. As per standard procedure for all HL7 FHIR resource development, any approved submissions to HL7 will be open for use by the public to support research and development. Depending on the nature of the work proposed, the actual time for submission to an HL7 ballot may fall beyond the scheduled timeline of this grant. The applicant will identify one or more usage scenarios in clinical and/or regulatory research for which a FHIR-based solution may provide improvements in efficiency and accuracy. Potential usage scenarios may include, but are not limited to, submission of study data to CDER; utilization of real world data; and post-market research and surveillance. For each identified area(s), the applicant will utilize risk-benefit analyses to contrast FHIR with available alternatives. The focus of this grant is to develop the technology for enabling the utilization of RWD. No Protected Health information (PHI) or personal identifiable information (PII) will be exchanged. The applicant will develop and present relevant proof-of-concept FHIR resources, extensions, and profiles which will provide benefits in the identified areas and develop proposed approaches for implementing solution(s). The artifact(s) should follow the development guidelines, policies and procedures as defined by HL7 for FHIR development. The applicant will provide a comprehensive white paper summarizing the work accomplished, potential paths forward for using the products, and any best practices or concerns that should be addressed in subsequent work using their deliverables. The application must include: 1) An overall Program plan describing the approach and process to be used in developing the selected area for standardization. 2) Definition and justification of scope to be addressed during the project period, including usage scenarios and specific use cases derived from them. 3) Description of the coordination/collaboration needed to ensure engagement of subject matter experts and affected stakeholders. 4) Existing FHIR resources available to support the proposed use cases, and an estimated need for developing new/modified FHIR resources and profiles.