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

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-0287]</DEPDOC> <SUBJECT>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</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice; establishment of a public docket; request for comments. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the notice must be submitted by June 23, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 23, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2025-N-0287 for “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.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Ethan Chen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7626, <E T="03">ethan.chen@fda.hhs.gov,</E> or Hussein Ezzeldin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-8629, <E T="03">hussein.ezzeldin@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> Sponsors are increasing their use of RWD to support claims of safety and effectiveness for FDA-regulated medical products. FDA defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status” (Ref. 1). As stated in FDA's guidance for industry entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” (Data Standards Guidance) (Ref. 2), the Agency recognizes challenges involved in standardizing clinical study data collected from RWD sources for inclusion in applicable submissions. The Agency is currently considering how data standards specific to data derived from RWD sources might help accurately and consistently represent data obtained from RWD sources when submitting study data to the Agency. FDA will also consider the recently adopted HHS Health IT Alignment Policy (Ref. 3), which requests that all HHS operating and staff divisions (including FDA) align on health IT policy that is being developed and implemented by ASTP/ONC. ASTP/ONC defines health IT as “hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information” (Ref. 3). The policy asks for “greater alignment of health IT-related activities in support of [HHS'] health IT and interoperability goals” (Ref. 3) and, as such, creates an opportunity for FDA to explore such alignment with respect to clinical study data collected from RWD sources. In 2020, the final rule entitled “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” (85 FR 25642; May 1, 2020) was published by ASTP/ONC, establishing the HL7 FHIR standard as a nationwide standard for access, exchange, and use of data for healthcare delivery organizations. The capabilities that the final rule requires from ONC-certified health IT will enable patients, clinicians, researchers, and other appropriate parties to access data from certified electronic health records (EHRs) and other certified health IT in a Representational State Transfer manner, utilizing application programming interface (API) technology. Beginning in 2022, more than 50 data elements in the United States Core Data for Interoperability (USCDI) are consistently and routinely available through certified health IT using FHIR (see <E T="03">https://www.healthit.gov/isp/united-states-core-data-interoperability-uscdi#uscdi-v1</E> ). The data elements contain a wide array of clinical concepts, including patient demographics, vi ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 21k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━