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

The Food and Drug Administration Amendments Act of 2007 (FDAAA) directed the U.S. Food and Drug Administration (FDA) to strengthen its postmarket safety surveillance capabilities by establishing an active risk identification and analysis system capable of monitoring the safety of FDA-regulated medical products across a population of at least 100 million individuals. FDAAA further requires FDA to determine whether available postmarket surveillance data and analytic capabilities are sufficient to assess safety concerns prior to requiring additional postmarket studies or clinical trials. In response, FDA established the Sentinel Initiative—an agency-wide effort to leverage realworld healthcare data and advanced analytic methods to support regulatory decisionmaking. Since 2009, Sentinel has evolved through multiple phases, including Mini-Sentinel and Sentinel System versions 1.0 and 2.0, expanding FDA’s ability to access healthcare data, conduct active surveillance, and respond to emerging public health needs. FDA Centers have developed complementary postmarket surveillance approaches aligned with their regulated products and statutory responsibilities. CDER implemented the Sentinel System and its Active Risk Identification and Analysis (ARIA) capability. CBER advanced biologics surveillance through the Biologics Effectiveness and Safety (BEST) Initiative. CDRH invested in medical device surveillance capabilities, including collaborations such as the National Evaluation System for Health Technology (NEST), with a continued focus on improving device identification in healthcare data (including Unique Device Identifier (UDI) capture). Building on these efforts, FDA is transitioning to Sentinel 3.0—a modernized, enterprise approach intended to improve scalability, timeliness, and responsiveness across FDA’s postmarket safety surveillance activities. Sentinel 3.0 is structured as coordinated components that include (1) data access and acquisition, (2) a Government-developed data platform for ingestion and analytics enablement, and (3) scientific services to support study execution.

• Contract 1: Sentinel 3.0 – Data Partners (Tiers 1–6, previously Tiers 1–5) providing access to multiple types of healthcare data. The FDA is considering a Data Broker–led acquisition model in which a prime contractor is responsible for acquiring, licensing, governing, and providing access to healthcare data across Tiers 1–6, including coordination with third-party data providers. Respondents should assume a single prime contractor retains full contractual, legal, and compliance responsibility for all data delivered under this model
• Contract 2: Sentinel 3.0 – Government-Owned, Contractor-Operated (GOCO) platform (Tier 7) serving as a data repository, enabling interoperability, and delivering informatics tools and capabilities. Uder this model, the Government will not require platform development, platform hosting, platform replacement, alternative architectures, or contractor-operated environments. All pricing responses should assume data is delivered to, accessed through, or integrated with the existing Government platform
• Contract 3: Sentinel 3.0 – Studies-As-A-Service(Tier 8). Provide scientific services including data analytics support (e.g., capability to conduct complex pharmacoepidemiology and pharmacovigilance studies, and advanced analytics)