📊FDA Seeks Comments on RWD Submissions Using HL7 FHIR Standards
Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created From Real-World Data Sources for Submission to the Food and Drug Administration; Establishment of a Public Docket; Request for Comments
Summary
The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket for public comments exploring the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) for submission of data collected from real-world data (RWD) sources. In alignment with the new Department of Health and Human Services (HHS), Assistant Secretary for Technology Policy/Office of the National Coordinator for Health (ASTP/ONC) policy on health information technology (health IT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are exploring approaches to optimize the submission of structured and standardized clinical study data collected from RWD sources. FDA is seeking public comment from interested parties on specific questions. Interested parties may include regulated industry, health IT vendors, academic medical centers, and electronic data capture vendors as well as other interested parties.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA is establishing a public docket to collect comments about utilizing Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) for data submissions from Real-World Data (RWD) sources. This could affect compliance and regulatory requirements for businesses in the healthcare sector looking to submit clinical study data. Businesses must prepare for potential changes in submission protocols and standards.