Sentinel 3.0_2026 Updated Market Research

The Food and Drug Administration (FDA) is conducting market research to inform acquisition planning for the Sentinel 3.0 program. The program aims to improve postmarket safety surveillance capabilities by establishing an active risk identification and analysis system. The FDA is seeking information on commercial market capabilities to support Tiers 1-6 under a Data Broker-led acquisition model for Sentinel 3.0. The Data Broker Services Contractor will be responsible for acquiring, licensing, governing, and providing FDA access to healthcare data across multiple domains. The contractor will also be responsible for managing access to data across Tiers 1-6, ensuring data quality, and providing access to data through the FDA Data Platform. Some key features of the Sentinel 3.0 program include: * Data access and acquisition * A Government-developed data platform for ingestion and analytics enablement * Scientific services to support study execution * A flexible and cost-effective data acquisition solution * Access to high-quality, fit-for-purpose healthcare data across multiple domains * Data quality checks and delivery of data in a timely manner * Collaboration with FDA staff and other Sentinel 3.0 support contractors * Adherence to applicable federal laws, regulations, and data use agreements The FDA is looking for a contractor who can provide governed access to commercial healthcare claims data, Healthcare Insurance Claims-EHR linked data, EHR data, registry data, Centers for Medicare & Medicaid Services (CMS) data, and outpatient prescription data. The contractor should have experience in data acquisition, licensing, and management, as well as data quality checks and delivery. The contractor should also be able to provide access to data through the FDA Data Platform and collaborate with FDA staff and other Sentinel 3.0 support contractors. Some of the key requirements for the contractor include: * Acquiring, licensing, and governing access to healthcare data * Managing access to data across Tiers 1-6 * Ensuring data quality and providing access to data through the FDA Data Platform * Collaborating with FDA staff and other Sentinel 3.0 support contractors * Adhering to applicable federal laws, regulations, and data use agreements * Providing data in a timely manner and ensuring data quality * Having experience in data acquisition, licensing, and management * Having experience in data quality checks and delivery * Being able to provide access to data through the FDA Data Platform * Being able to collaborate with FDA staff and other Sentinel 3.0 support contractors