The FDA encourages the leveraging of Sentinel capabilities through the Innovation in Medical Evidence and Development Surveillance (IMEDS) program as a national resource for broader public health and medical evidence generation. Besides surveillance activities, the IMEDS distributed database can be used for population characterization and effectiveness studies. IMEDS projects must be scientifically suitable for use by the database and should address a safety concern of public health interest. Examples are exposures to medical products, exposure-outcome relationships, or impact of risk mitigation activities.

The Reagan-Udall Foundation provides educational opportunities to learn more about how to use the IMEDS database to answer important post-market research questions. Please contact us directly at IMEDS@reaganudall.org for more information.

If you have an idea for a research project, or are interested in learning how to leverage IMEDS as a resource for evidence generation, fill out this brief form to start the conversation.

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Post Market Research

The IMEDS Distributed Network includes nine Network Partners (NPs), a subset of the Sentinel Distributed Data Network, that contribute the data and scientific expertise IMEDS leverages to conduct real-world evidence projects, including Post-Market Requirement (PMR) studies. The graphs below represent data from seven Network Partners spanning 2000 through the most recent data available as of July 2024. Data recency varied across Network Partners, with the most recent data ranging from December 2021 to April 2025.

For more on IMEDS, watch our Introduction to Innovation in Medical Evidence and Development Surveillance (IMEDS): The Research Resource webinar here.

This map shows the historic distribution of patients by geographic region from 2000-2024. Region is determined by their zip code on first day of their most recent enrollment span. Regions are based on the Health and Human Services (HHS) Region Descriptions. Data from Puerto Rico, Virgin Islands, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, and Republic of Palau are excluded from their respective HHS regions due to low cell counts.

Age of active patients (as of the most recent data from our Network Partners in July 2024) is determined on the first day of their most recent enrollment span with both medical and drug coverage.

This graph shows the historic distribution of sex in the IMEDS Network among those with medical and drug coverage in data pulled from 2000 to 2024.

Historic distribution of race and ethnicity for patients that have at least one span of medical and drug coverage in data pulled from 2000 to 2024.

The number of patients enrolled in the IMEDS Distributed Database over time spans from 2000-2024. Patients are counted if they have at least one day of medical coverage and one day of drug coverage within that year. Data in 2024 and possibly 2023 are likely to be incomplete because of varying end dates.

The distribution of cumulative enrollment with medical and drug coverage per patient within IMEDS Network covers over 110 million patients that have been enrolled for at least six months. An enrollment span is defined as having both medical and drug coverage. Cumulative enrollment is categorizing the total length of enrollment per patient, summing multiple enrollment spans if they exist. A single patient may contribute multiple enrollment spans to the IMEDS Network.

This graph shows the distribution of individual enrollment spans within the IMEDS Network. A single patient may contribute multiple enrollment spans to the IMEDS Network. Length of patient enrollment is categorizing the frequency of length of enrollment spans by enrollment record for patients with medical and drug coverage. An enrollment span is defined as having both medical and drug coverage. In this figure, gaps in coverage of less than 45 days are bridged into one enrollment span. The data visualization above shows 166.7M enrollment spans, which are derived from 132M patients.

This graph shows the distribution of linked and unlinked deliveries over time in data pulled from 2000-2024 across three IMEDS Network Partners that contribute to the Sentinel Mother-Infant Linkage table. The data reflects live births only. Data in 2024 and possibly 2023 are likely to be incomplete because of varying end dates.

Mothers and infants are matched mainly on family subscriber numbers and, when available, birth certificate data. Most matches were deterministic, though probabilistic matching methods were also used by some Network Partners. More information about the MIL table may be found in the Mother-Infant Linkage FAQ (link: https://www.sentinelinitiative.org/sites/default/files/data/distributed-database/MIL_FAQs&Appendice).

Sentinel's algorithm for determining linkage with an infant requires an assignment of an infant patient identifier within the first year of life. Potential linkages are discarded if an infant patient identifier is not assigned within one year of the linkage date.

This graph shows the distribution of linked and unlinked deliveries by mother’s age group. The IMEDS Distributed Network contains 10,400 linked deliveries among 45-54-year-olds, 3.6 million among 20-44-year-olds, and around 151,944 among 10-19-year-olds across three IMEDS Network Partners. It is more common for mothers in the 45-54 years group to have different healthcare plans than their infants, leading to challenges in linkage. The data reflects live births only in data pulled from 2000 to 2024.