How to Participate in the Collaboration
Building a nationwide post-market surveillance initiative will require the cooperation and involvement of nearly every sector of health care. eHI's Connecting for Drug Safety Collaboration is an inclusive, open, multi-stakeholder initiative that welcomes and encourages the involvement of every stakeholder in health care, including clinicians, consumers, federal and state government, health plans, health care IT vendors, hospitals and other providers, laboratories, the pharmaceutical industry, pharmacies, and state and regional initiatives.
During the first phase of the Collaboration's work, we tested the feasibility and value of using electronic health care information to support post-market surveillance and drug safety--with successful results--using three use cases in two advanced stage environments--Partners HealthCare System and the Regenstrief Institute. As part of the second phase of work, the Collaboration is inviting national, state and local initiatives to participate in this research--and share their experiences, to inform the FDA's creation of a distributed, decentralized post-market surveillance system.
There are a number of ways to get involved in the Collaboration.
- By joining our network of national, state and local organizations with interests in supporting drug safety in the U.S., you can gain early access to and provide input to our work, which includes the collaborative development of methods, data collection and reporting tools, strategies for effectively managing legal aspects as well privacy and security, and effective methods for communication.
- By agreeing to pilot test our three well-defined use cases, you can help the Collaboration--and the FDA--gain a better understanding of how post-market surveillance can be effectively operationalized in multiple markets across the U.S.
- By contributing the results of your experiences and lessons learned in using electronic health care information to support post-market surveillance--or even initiatives with similar goals, such as public health surveillance, clinical research, and outcomes research, you can significantly assist in furthering a national agenda that will improve drug safety in our country.
Again, this is an open, voluntary initiative. Through your involvement and contributions, we'll significantly improve our nation's ability to detect and evaluate drug safety signals. Join our Collaboration today!
