{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Use of Electronic Health Record Data in Clinical Investigations.\" The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance finalizes the draft guidance issued in May 2016.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2018/07/19/2018-15390.html","cfr_references":[],"citation":"83 FR 34137","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on July 19, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-1224"],"dockets":[],"document_number":"2018-15390","effective_on":null,"end_page":34138,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/07/19/2018-15390.xml","html_url":"https://www.federalregister.gov/documents/2018/07/19/2018-15390/use-of-electronic-health-record-data-in-clinical-investigations-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-15390?publication_date=2018-07-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-07-19/2018-15390/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1285,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-07-19/pdf/2018-15390.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-15390.pdf?1531917928","publication_date":"2018-07-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/07/19/2018-15390.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-1224","supporting_documents_count":0,"docket_id":"FDA-2016-D-1224","regulation_id_number":null,"title":"Use of Electronic Health Record Data in Clinical Investigations","checked_regulationsdotgov_at":"2018-08-08T10:00:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":34137,"subtype":null,"title":"Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry; Availability","toc_doc":"Use of Electronic Health Record Data in Clinical Investigations","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}