{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T19:52:00Z","timestamp":1764100320940,"version":"3.46.0"},"reference-count":46,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Department of Biomedical Informatics, Harvard Medical School"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess whether HL7 Fast Healthcare Interoperability Resources (FHIR) can underpin a fully standards-based, end-to-end digital research architecture, demonstrate it in a live study, and quantify its benefits for interoperability and development efficiency.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>We designed a generalizable standards-based architecture to accelerate digital health research relying on FHIR as the sole transactional model throughout a participant research lifecycle starting from API-based study discovery to results. It was instantiated for People Heart Study, a real-world digital health cardiovascular-risk assessment study with its protocol transformed into FHIR resources (eligibility, consent, tasks, and results). Evaluation examined workflow coverage, validator conformance across independent servers, and points requiring custom extensions or app logic.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The architecture was implemented using cloud managed FHIR stores including an illustrative public research discovery API for first-\/third-party apps. A participant-facing iOS app was published on the App Store. Our evaluation reveals that 6 of 10 research app workflows could be executed entirely from FHIR artifacts; 2 were partially standards-driven and 2 remained limited requiring custom development. All FHIR resources passed structural, semantic validation with minimal custom extension usage and terminology integrity issues.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Our approach addresses persistent challenges in digital health research by enhancing data interoperability, minimizing redundant development, and supporting the full research lifecycle. The architecture aligns with national priorities and complements healthcare standardization efforts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>By leveraging FHIR, our architecture enables generalizability, interoperability, and reuse across diverse digital health research contexts, transforming study design into data modeling rather than software development, and fostering a more inclusive and agile digital health ecosystem.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jamia\/ocaf163","type":"journal-article","created":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T12:39:31Z","timestamp":1758112771000},"page":"1811-1821","source":"Crossref","is-referenced-by-count":0,"title":["A standards-based approach to digital health research: implementing the people heart study"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8810-2471","authenticated-orcid":false,"given":"Raheel","family":"Sayeed","sequence":"first","affiliation":[{"name":"Department of Biomedical Informatics, Harvard Medical School , Boston, MA 02115,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Kreda","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, Harvard Medical School , Boston, MA 02115,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua C","family":"Mandel","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, Harvard Medical School , Boston, MA 02115,","place":["United States"]},{"name":"Computational Health Informatics Program, Boston Children\u2019s Hospital , Boston, MA 02115,","place":["United States"]},{"name":"Microsoft , Redmond, WA,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bryan","family":"Larson","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, Harvard Medical School , Boston, MA 02115,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William","family":"Gordon","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, Harvard Medical School , Boston, MA 02115,","place":["United States"]},{"name":"Department of Medicine, Brigham and Women\u2019s Hospital , Boston, MA 02115,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth D","family":"Mandl","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, Harvard Medical School , Boston, MA 02115,","place":["United States"]},{"name":"Computational Health Informatics Program, Boston Children\u2019s Hospital , Boston, MA 02115,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isaac","family":"Kohane","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, Harvard Medical School , Boston, MA 02115,","place":["United States"]},{"name":"Department of Medicine, Brigham and Women\u2019s Hospital , Boston, MA 02115,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,10,1]]},"reference":[{"key":"2025112514464804900_ocaf163-B1","doi-asserted-by":"publisher","first-page":"88","DOI":"10.1038\/s41746-023-00841-8","article-title":"Digital health technology in clinical trials","volume":"6","author":"Mittermaier","year":"2023","journal-title":"NPJ Digit Med"},{"key":"2025112514464804900_ocaf163-B2","doi-asserted-by":"publisher","first-page":"101","DOI":"10.1038\/s41746-020-0302-y","article-title":"Digitizing clinical trials","volume":"3","author":"Inan","year":"2020","journal-title":"NPJ Digit Med"},{"key":"2025112514464804900_ocaf163-B3","doi-asserted-by":"publisher","first-page":"e238-e254","DOI":"10.1016\/j.landig.2025.01.011","article-title":"Effectiveness of home-based cardiac rehabilitation interventions delivered via mHealth technologies: a systematic review and meta-analysis","volume":"7","author":"Li","year":"2025","journal-title":"Lancet Digit Health"},{"author":"Executive Board","key":"2025112514464804900_ocaf163-B4"},{"key":"2025112514464804900_ocaf163-B5","doi-asserted-by":"publisher","first-page":"160011","DOI":"10.1038\/sdata.2016.11","article-title":"The mPower study, Parkinson disease mobile data collected using ResearchKit","volume":"3","author":"Bot","year":"2016","journal-title":"Sci Data"},{"key":"2025112514464804900_ocaf163-B6","doi-asserted-by":"publisher","first-page":"83","DOI":"10.1038\/s41746-021-00454-z","article-title":"Mobile health: making the leap to research and clinics","volume":"4","author":"Ku","year":"2021","journal-title":"NPJ Digit Med"},{"author":"Health and Medicine Apps Using ResearchKit and CareKit","key":"2025112514464804900_ocaf163-B7"},{"key":"2025112514464804900_ocaf163-B8","doi-asserted-by":"publisher","first-page":"147","DOI":"10.1186\/s12890-018-0671-z","article-title":"Mobile health applications in self-management of patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis of their efficacy","volume":"18","author":"Yang","year":"2018","journal-title":"BMC Pulm Med"},{"key":"2025112514464804900_ocaf163-B9","doi-asserted-by":"publisher","first-page":"759","DOI":"10.1126\/science.1196187","article-title":"Health care delivery. Open mHealth architecture: an engine for health care innovation","volume":"330","author":"Estrin","year":"2010","journal-title":"Science"},{"key":"2025112514464804900_ocaf163-B10","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1186\/s12916-023-02833-7","article-title":"Navigating the complexities of mobile medical app development from idea to launch, a guide for clinicians and biomedical researchers","volume":"21","author":"Mannino","year":"2023","journal-title":"BMC Med"},{"year":"2022","author":"Moore","key":"2025112514464804900_ocaf163-B11"},{"key":"2025112514464804900_ocaf163-B12"},{"year":"2016","author":"Bonamici S","key":"2025112514464804900_ocaf163-B13"},{"author":"About The ONC Health IT Certification Program","key":"2025112514464804900_ocaf163-B14"},{"key":"2025112514464804900_ocaf163-B15"},{"key":"2025112514464804900_ocaf163-B16"},{"key":"2025112514464804900_ocaf163-B17"},{"key":"2025112514464804900_ocaf163-B18","doi-asserted-by":"publisher","first-page":"1642","DOI":"10.1093\/jamia\/ocac105","article-title":"HL7 FHIR-based tools and initiatives to support clinical research: a scoping review","volume":"29","author":"Duda","year":"2022","journal-title":"J Am Med Inform Assoc"},{"key":"2025112514464804900_ocaf163-B19"},{"key":"2025112514464804900_ocaf163-B20"},{"author":"SMART Markers Instruments","key":"2025112514464804900_ocaf163-B21"},{"key":"2025112514464804900_ocaf163-B22"},{"key":"2025112514464804900_ocaf163-B23"},{"key":"2025112514464804900_ocaf163-B24","doi-asserted-by":"publisher","first-page":"e0152722","DOI":"10.1371\/journal.pone.0152722","article-title":"C3-PRO: connecting ResearchKit to the health system using i2b2 and FHIR","volume":"11","author":"Pfiffner","year":"2016","journal-title":"PLoS One"},{"key":"2025112514464804900_ocaf163-B25","doi-asserted-by":"publisher","first-page":"1204","DOI":"10.3390\/life12081204","article-title":"Mobile access to medical records in heart transplantation aftercare: mixed-methods study assessing usability, feasibility and effects of a mobile application","volume":"12","author":"M\u00fcller","year":"2022","journal-title":"Life (Basel)"},{"key":"2025112514464804900_ocaf163-B26"},{"key":"2025112514464804900_ocaf163-B27","doi-asserted-by":"publisher","first-page":"e596-646","DOI":"10.1161\/CIR.0000000000000678","article-title":"2019 ACC\/AHA Guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology\/American Heart Association Task Force on Clinical Practice Guidelines","volume":"140","author":"Arnett","year":"2019","journal-title":"Circulation"},{"year":"2012","author":"Office for Civil Rights (OCR)","key":"2025112514464804900_ocaf163-B28"},{"key":"2025112514464804900_ocaf163-B29"},{"key":"2025112514464804900_ocaf163-B30","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1038\/s41746-020-0218-6","article-title":"SMART Markers: collecting patient-generated health data as a standardized property of health information technology","volume":"3","author":"Sayeed","year":"2020","journal-title":"NPJ Digit Med"},{"key":"2025112514464804900_ocaf163-B31"},{"key":"2025112514464804900_ocaf163-B32"},{"key":"2025112514464804900_ocaf163-B33"},{"key":"2025112514464804900_ocaf163-B34"},{"key":"2025112514464804900_ocaf163-B35"},{"key":"2025112514464804900_ocaf163-B36","doi-asserted-by":"publisher","first-page":"e20470","DOI":"10.2196\/20470","article-title":"Prototypical clinical trial registry based on Fast Healthcare Interoperability Resources (FHIR): design and implementation study","volume":"9","author":"Gulden","year":"2021","journal-title":"JMIR Med Inform"},{"author":"Rzyszkiewicz","key":"2025112514464804900_ocaf163-B37"},{"year":"2018","author":"Apple","key":"2025112514464804900_ocaf163-B38"},{"key":"2025112514464804900_ocaf163-B39"},{"key":"2025112514464804900_ocaf163-B40"},{"key":"2025112514464804900_ocaf163-B41","doi-asserted-by":"publisher","first-page":"631","DOI":"10.1038\/s41591-023-02783-w","article-title":"Integration of AI in healthcare requires an interoperable digital data ecosystem","volume":"30","author":"Mandl","year":"2024","journal-title":"Nat Med"},{"key":"2025112514464804900_ocaf163-B42"},{"key":"2025112514464804900_ocaf163-B43"},{"key":"2025112514464804900_ocaf163-B44"},{"author":"United States Core Data for Interoperability (USCDI)","key":"2025112514464804900_ocaf163-B45"},{"key":"2025112514464804900_ocaf163-B46","doi-asserted-by":"publisher","first-page":"ooae023","DOI":"10.1093\/jamiaopen\/ooae023","article-title":"Integrating clinical research into electronic health record workflows to support a learning health system","volume":"7","author":"Goldhaber","year":"2024","journal-title":"JAMIA Open"}],"container-title":["Journal of the American Medical Informatics Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jamia\/article-pdf\/32\/12\/1811\/64464958\/ocaf163.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jamia\/article-pdf\/32\/12\/1811\/64464958\/ocaf163.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T19:46:53Z","timestamp":1764100013000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jamia\/article\/32\/12\/1811\/8270741"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,1]]},"references-count":46,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2025,10,1]]},"published-print":{"date-parts":[[2025,12,1]]}},"URL":"https:\/\/doi.org\/10.1093\/jamia\/ocaf163","relation":{},"ISSN":["1067-5027","1527-974X"],"issn-type":[{"type":"print","value":"1067-5027"},{"type":"electronic","value":"1527-974X"}],"subject":[],"published-other":{"date-parts":[[2025,12]]},"published":{"date-parts":[[2025,10,1]]}}}