What's Happening with Sentinel

The Centers for Medicare and Medicaid Services (CMS): Medicaid and Children’s Health Insurance Program (CHIP) Claims in Sentinel Common Data Model (SCDM) Format
Cerner Enviza Collaborates with FDA to Develop Innovative AI Tools for Drug Safety and Real-World Evidence Studies
Medical Literature and Data on Cannabis Use
FDA Sentinel System's Coronavirus (COVID-19) Activities

Recent Activity

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About Sentinel

The U.S. Food and Drug Administration (FDA) leads the Sentinel Initiative. The main goal is to improve how FDA evaluates the safety and performance of medical products.

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How Sentinel Uses Data

The FDA uses Sentinel data to evaluate the safety of medical products. They also use Sentinel data to learn more about potential side effects.

Drug Studies

How Sentinel Protects Privacy

Sentinel uses a distributed data approach. In this approach, data remain with the data owner, i.e., an insurance company. Also, data owners remove patient identifiers to protect privacy.

Privacy & Security

Where Sentinel Gets Its Data

Sentinel data come from existing sources. These include insurance claims, electronic health records, and patient reports.

Who is Involved

What Data Sentinel Uses

Data from the health systems, insurance companies, or medical records can be used without personal information being shared to learn more about medical products.

Types of Data

Engage with Sentinel

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2023 Sentinel Public Training & Innovation Day, April 11-12

The 2023 Sentinel Public Training and Innovation Day took place over two days in April. The events featured speakers from the U.S. Food and Drug Administration, Sentinel Operations Center, and Sentinel Innovation Center. Materials from both events are now available for viewing. 

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Methods, Data, & Tools

Sentinel has various methods and tools to support the evaluation of medical products. U.S. Food and Drug Administration (FDA) scientists use Sentinel data to complement their data and information.

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Data-Driven Impact

63.3 million members are currently accruing new data in Sentinel
Approximately 63.3 million members are currently accruing new data in Sentinel
Key Database Statistics
Graphic displaying that since the founding of the Sentinel Initiative in 2009, 218 scientific papers have been published
Since the founding of the Sentinel Initiative in 2009, 218 scientific papers have been published
Scientific Publications
more than 35 drug studies
Since 2016, more than 35 Sentinel drug studies have contributed to FDA regulatory actions or discussion
Drug Studies

The Sentinel Community

Three images depicting people collaborating

Data Partners & Collaborators

The FDA gets data for the Sentinel System through its Data Partners. The Data Partners are the ones who access, maintain, and protect the data in a distributed system. The Sentinel Coordinating Center partners with a network of collaborators. This includes Data Partners and Collaborating Institutions. Together, they provide healthcare data and scientific, technical, organizational expertise.

Learn About the Community

Sentinel Structure

Three blue boxes representing the structure of Sentinel, including SOC, IC, CBOC

1. Community Building and Outreach Center (CBOC)
2. Innovation Center (IC)
3. Sentinel Operations Center (SOC)

These centers collaborate to advance regulatory science using the Sentinel System. However, each center operates independently and has a dedicated leadership team and staff. The three centers each carry out projects associated with their strategic objectives.

Explore the Centers