FDA's Sentinel Initiative
In May 2008, the U.S. Food and Drug Administration launched the Sentinel Initiative to create a national electronic system, the Sentinel System, for medical product safety surveillance. The first phase of this initiative was the Mini-Sentinel Pilot to inform the development of the Sentinel System. In 2008, FDA awarded Harvard Pilgrim Health Care Institute a contract for the Mini-Sentinel pilot. HPHCI developed a distributed data network using PopMedNet to meet the goals and objectives of the pilot. In February 2016, FDA launched the Sentinel System. HPHCI serves as the prime contractor for FDA Sentinel and is responsible for all aspects of the distributed network, including secure hosting and maintenance, development of analytic tools and query capabilities, and sending queries to partners to answer FDA safety questions.
PCORI’s National Patient-Centered Clinical Research Network (PCORnet)
In 2014, the Patient Centered Outcomes Research Institute (PCORI) created PCORnet: The National Patient-Centered Clinical Research Network, designed to empower people to make informed healthcare decisions by enabling clinical research that is faster, easier, less costly and, most important, more relevant to their needs. PCORnet is a “network of networks” that uses a distributed health data network approach based on PopMedNet to answer comparative effectiveness questions. HPHCI serves as the analytic coordinating center for PCORnet, with responsibility for hosting the secure data network, developing query tools, and sending queries to the PCORnet network partners.
In addition to FDA Sentinel and PCORnet, HPHCI serves as the coordinating center for several other initiatives that use PMN and its associated software ecosystem. These include the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and IMEDS. The BBCIC was established in 2015 to address anticipated needs for post-market evidence generation for novel biologics, their corresponding biosimilars, and other related products. IMEDS is a program of the Reagan-Udall Foundation, established to provide access for private-sector entities, such as regulated industry, academic institutions, and non-profit organizations, to a system based on the FDA Sentinel Initiative. HPHCI serves as the IMEDS Analytic Coordinating Center and is responsible for secure hosting of the IMEDS network, sending queries to the participating data partners, and aggregating results. The National Institutes of Health, the HHS Assistant Secretary for Planning and Evaluation, and others have provided funding for PopMedNet.
The PMN ecosystem also includes Complementary Tools including purpose-built systems for medical code management and analysis, scripts to integrate workflow management systems with PopMedNet, tools to generate custom synthetic data sets, and business intelligence systems for analytics.