FDA is exploring how to use information technology to create an integrated electronic postmarket safety network. The proposed Sentinel Network would combine postmarket study efforts of both public and private sectors. The goal is to deliver comprehensive product safety information directly to clinicians. According to FDA, current postmarket safety actions are hindered by “limitations in the quality, quantity, and timeliness” of available data. The ability to quickly conduct postmarket studies is also limited. The proposed network will use electronic databases and surveillance systems to provide a “seamless, timely flow” of product information while also protecting patient privacy. Data collection, risk identification and analysis, and risk communication would be the main actions of the network. FDA held a two-day public meeting in March to discuss the network. The goal was to hear examples from industry groups that have access to “electronic, population-based data sets” that could be used for monitoring postmarket safety. The meeting also discussed

• Potential obstacles and incentives for developing the network.
• How postmarket device safety data collection can be effectively incorporated into clinical practice work flow at the point of care.
• How electronic health records can be used as a means for data collection related to device safety in the least burdensome manner for clinicians and patients.
• How the network can guarantee the privacy of patient information.

-- Maria Fontanazza