The Department of Health and Human Services, Food and Drug Administration, has a requirement for Sentinel 3.0.

The Sentinel Initiative was created as the result of a 2007 congressional mandate to strengthen post-market surveillance of medical products. In 2008, the Secretary of Health and Human Services (HHS) and FDA’s Commissioner announced the Sentinel Initiative, a long-term effort to create a national electronic system for monitoring FDA-regulated medical product safety in alignment with FDA’s mission to protect the public health. The goal of the next Sentinel 3.0 System contract is to continue meeting or exceeding the legislative requirements, promote program efficiency, support the anticipated needs of each of the distinctive underlying Sentinel 3.0 components (e.g., Active Postmarket Risk Identification and Analysis (ARIA) system), and ensure sufficient flexibility to address emerging safety issues and rapidly changing public health needs (e.g., public health emergencies).

The Sentinel 3.0 Initiative fulfills the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Sec 905) requirement for an active postmarket risk identification and analysis system. FDAAA requires that FDA access disparate data sources to link and analyze safety data to cover at least 100 million U.S. patients. CDER, CBER, and CDRH developed various approaches to conduct complementary postmarket safety surveillance activities utilizing population-based data sources tailored to the regulated products under the purview of each center. The FDA is consolidating postmarket safety surveillance activities utilizing population-based data sources conducted through the Sentinel 3.0 System, CBER Biologics Effectiveness and Safety (BEST) Initiative, and CDRH under the new Sentinel 3.0. The proposed new system will provide a collaborative, central framework for active surveillance activities for CDER, CBER and CDRH.

The purpose of this procurement is to establish a contract to support the Sentinel 3.0 System.

The Sentinel 3.0 will include the following components:

• FDA Sentinel Coordinating Center (SCC): The SCC will be managed by the Sentinel 3.0 Core Team (SCT) in CDER’s Office of Surveillance and Epidemiology (OSE), in the Office of Biologics Product Review’s (OBPV) Surveillance Program Staff (CSPS), in CDRH’s Office of Clinical Evidence and Analysis (OCEA), and Office of the Commissioner (OC)
•  Sentinel Program Management Organization (PMO): The PMO, via a contract awarded in September 2024, provides program/project management and business informatics support services (e.g., Collaboration Platform that operates outside of FDA in a Federal Risk and Authorization Management Program (FedRAMP) cloud-based environment)
•  Data Hub and Scientific Support Services: The Data Hub, comprising Data Partners and the Data Platform, along with Scientific Support Services, will provide access to:
  • a. Data Partners (a component of the Data Hub): Provides diverse healthcare data sources including commercial and CMS claims data, outpatient prescription data (subscription with user interface), claims aggregator data, and Healthcare Insurance Claims-EHR Linked Data (EHR). Specialty EHR data encompasses oncology, pediatrics, geriatrics, and hospital intensive care unit records. Additional data types include disease and product registries, registry networks, and Health Information Exchange (HIE) data. The data sources with capabilities to link healthcare data to Immunization Information Systems (IIS) nationwide for vaccine exposure supplementation and access to medical device utilization data (including Unique Device Identifier information) are particularly valuable and important to FDA operations
  • Data Platform (a component of the Data Hub): Provides AI-enabled data repository services and informatics tools that facilitate data analysis through standardized terminologies and clinical-to-operational translations capabilities. The Data Platform operates as a Contractor managed, FedRAMP authorized cloud environment supporting multiple tenants
  • Scientific Support Services: Provide scientific services including data analytics support for complex pharmacoepidemiology and pharmacovigilance studies, as well as advanced AI-based analytics capabilities.