Health Information Exchanges (HIEs) as Novel Sources for Population-Based Post Marketing Surveillance of Medical Products: A Pilot Study from the FDA Sentinel Innovation Center

Anjum Khurshid; David Kendrick; Haritha S Pillai; Jenny Sun; Eliel Oliveira; Alexis Jaquish; Sarah K Dutcher; Patricia Bright; Youjin Wang; Jie Li; Tiffany Austin; Patrick J Heagerty; Michael E Matheny; Sebastian Schneeweiss; Rishi J Desai

doi:10.1007/s40264-026-01669-3

Health Information Exchanges (HIEs) as Novel Sources for Population-Based Post Marketing Surveillance of Medical Products: A Pilot Study from the FDA Sentinel Innovation Center

Drug Saf. 2026 Apr 13. doi: 10.1007/s40264-026-01669-3. Online ahead of print.

Authors

Affiliations

¹ Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA.
² MyHealth Access Network, Tulsa, OK, USA.
³ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street (Suite 3030), Boston, MA, 02120, USA.
⁴ Connxus, Austin, TX, USA.
⁵ Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
⁶ Department of Biostatistics, University of Washington, Seattle, WA, USA.
⁷ Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.
⁸ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street (Suite 3030), Boston, MA, 02120, USA. rdesai@bwh.harvard.edu.

PMID: 41975169
DOI: 10.1007/s40264-026-01669-3

Abstract

Introduction: Health information exchanges (HIEs) provide the capability to electronically move health care information among different health care information systems and store these data for downstream use cases. However, use of data from HIEs for postmarketing surveillance of medical products has not previously been explored.

Objectives: To conduct a pilot descriptive study characterizing data from MyHealth Access Network, a statewide HIE for Oklahoma, to understand its utility for conducting pharmacoepidemiology studies.

Materials and methods: MyHealth Access Network connects 95% of all hospital activity, 100% of federally qualified health center activity, and most community behavioral health clinics, tribal health systems, and independent providers in the state. As a use case to understand data in MyHealth Access Network, we characterized patients aged ≥18 years with type 2 diabetes mellitus (T2DM), and treated with one of two common antidiabetic drug classes: sodium-glucose co-transporter 2 inhibitors (SGLT-2i) and dipeptidyl peptidase 4 inhibitors (DPP-4i) in a new user cohort design. A cohort entry date was defined based on records of medication initiation for either of the two drug classes, using dispensing data from insurance claims (when available) or prescribing data from electronic health records (EHRs) when claims were not available. Patient characteristics including demographics, comorbidities, comedications, clinical and lifestyle-related factors, and healthcare utilization factors were summarized for the two exposure groups.

Results: A total of 65,225 DPP-4i initiators and 98,863 SGLT-2i initiators met our inclusion criteria. The mean age was around 60 years and nearly half were women in both the groups. While there was a large proportion of those with unknown race information (31% DPP-4i, 24% SGLT-2i), the majority were White (47% DPP-4i, 57% SGLT-2i). The second most reported race category was American Indian or Alaskan Natives (15% DPP-4i, 10% SGLT-2i), which is in line with their representation in the 2024 US Census for Oklahoma. Hemoglobin A1c (HbA1c) results were available for 68% and 67% of the DPP-4i and SGLT-2i groups with mean ± SD of 8.0± 2.0% and 8.1 ± 1.9%, respectively. Serum creatinine was recorded for 72% DPP-4i and 71% SGLT-2i initiators with mean ± SD of 1.2 ± 0.8 mg/dL and 1.1 ± 0.5 mg/dL, respectively.

Discussion: Health information exchanges may offer a promising resource that can contribute to population-based postmarketing surveillance of medical products infrastructure owing to their longitudinal capture of information across various healthcare settings.

Grants and funding

75F40119D10037/U.S. Food and Drug Administration