Networks and Users

In May 2008, the FDA 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 (HPHCI) 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 Partner for FDA Sentinel and is responsible for all aspects of the distributed network, including secure hosting and maintenance, development of analytic tools and query capability, and sending queries to partners to answer FDA safety questions.

Learn more about the Sentinel network

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 PopMedNetTM) similar to FDA Sentinel 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.

Learn more about the PCORnet network

In addition to FDA Sentinel and PCORnet, HPHCI serves as the coordinating center for several other initiatives that use PMN and the associated software ecosystem. These include:

• Biologics and Biosimilars Collective Intelligence Consortium (BBCIC):The BBCIC was established in 2015 to address anticipated needs for post-marketed evidence generation for novel biologics, their corresponding biosimilars and other related products

• IMEDS: A 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

• NIH Collaboratory: An initiative by the NIH that conducts pragmatic clinical trials in real-world clinical settings with highly generalizable populations to generate actionable clinical evidence at a fraction of the typical cost and time needed to conduct a traditional clinical trial

• CRN: The Cancer Research Network (CRN) is an NCI-funded initiative to support and facilitate cancer research based in non-profit integrated health care delivery settings

The PopMedNet ecosystem has also been implemented and utilized by groups without HPHCI as a central coordinating center. The two largest implementations are:

• MDPHNet: Also called ESP, its an initiative by the MA Department of Public Health to organize and map electronic health record data and analyze the data for conditions of public health interest
• CHORDs: The Colorado Health Observation Regional Data Service (CHORDS) is a collaborative regional pilot project that uses electronic health record (EHR) data to monitor public health trends, as well as to measure the efficacy of public health interventions