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 including:
Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) 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.
Office of the Assistant Secretary for Planning and Evaluation (ASPE) & Food and Drug Administration has supported multiple PMN-related initiatives:
- Utilizing Data from Various Data Partners in a Distributed Manner to develop the capability of conducting automatable and secure distributed regression analysis in distributed networks with horizontally partitioned data, a data environment where information about an individual is available in two or more data sources. Visit the Distributed Regression Analysis page and the Privacy-Protecting Methods website for more details.
- Cross Network Directory Service project that created an open source interoperable service to allow: 1) a way for data partners to easily participate in multiple data research networks, 2) a way for queries to seamlessly move across such networks, and 3) a mechanism to share analytic capabilities and knowledge across networks. This project also will pilot test this cross-network directory service across at least two existing networks: FDA’s Mini-Sentinel and PCORI’s PCORnet. Visit the CNDS page for more details.
- Standardization and Querying of Data Quality Metrics and Characteristics for Electronic Health Data project aimed at understanding the characteristics of a data source is critical for investigators in their determination regarding whether the data is fit for use, but currently no standards exist for describing the quality and completeness of electronic health data. Metadata standards are needed to describe the quality, completeness, and stability of data sources, and to enable metadata querying. Effective use of the growing number of data sources and distributed networks will require adoption of a uniform approach to describing the quality characteristics of electronic health data, as well as the data capture characteristics at the institutional, provider, and health plan level and data domain level. This project will develop, test, and implement a standards-based approach to describing data quality and presenting data quality metrics.
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.