FDA To Expand Product Safety Pilot That Uses EHR, Claims Data
January 5, 2015 in News
Last week, FDA announced plans to expand a five-year pilot program that uses electronic health records and claims data to monitor the safety of medical products regulated by the agency, Health Data Management reports (Slabodkin, Health Data Management, 12/31/14).
The program, called Mini-Sentinel, was a pilot project of FDA’s Sentinel surveillance system.
Eighteen large U.S. health care groups — including Aetna, Humana and Kaiser Permanente — served as data partners for the program. Under the pilot project, the health care organizations provided data and expertise, while FDA provided funding, set system priorities and made all final decisions.
According to FDA, the data — which include both EHR and claims data — are maintained by each partner organization to ensure patient privacy and data security. The program uses a common data model that allows the necessary information from the various systems to be analyzed in the same way.
Specifically, FDA said the system can examine:
- More than 350 million person years of observation;
- Four billion pharmaceutical dispensings; and
- 4.1 billion patient meetings (iHealthBeat, 6/24/14).
According to Health Data Management, the Mini-Sentinel pilot program has developed secure access to about 178 million U.S. residents’ electronic health care data.
FDA Announces Full-Scale Rollout
In an “FDA Voice” blog post last week, FDA Center for Drug Evaluation and Research Director Janet Woodcock announced the program’s full-scale rollout. She wrote that “Mini-Sentinel’s successful completion marks important progress,” adding, “We look forward to continuing and expanding our active surveillance capabilities as we now transition to the full-scale Sentinel program.”
Specifically, Woodcock wrote that FDA hopes to work “with other scientific groups … to create a National Data Infrastructure that would enable other users … to access the Sentinel infrastructure for multiple purposes,” such as medical product research and quality improvement.
She continued, “Not only will such access directly serve the public health, it will also help sustain these programs because stakeholders will have an incentive to provide support (financial and otherwise) for its maintenance and growth” (Health Data Management, 12/31/14).