Shared Vision and Principles
The shared vision of eHI's Connecting for Drug Safety Collaboration is a distributed postmarket surveillance network that leverages electronic health information--while effectively managing patient privacy and confidentiality--which resides within the care delivery and care payment systems, that will improve drug safety in the U.S. and support the FDA's goal of protecting the public's health
To support this shared vision, the Collaboration is testing and evaluating the value and utility of both electronic clinical and claims data for three postmarket surveillance use cases in two advanced electronic health information environments in Boston and Indiana and developing tools and resources designed to address organizational, technical, privacy and legal, financial, and communications aspects of this work. In its second phase of work, the Collaboration is expanding to test use cases in a broader number of health information environments at the national, state and local levels and develop common principles, methods, policies and processes that will inform and support the FDA's creation of an operational Sentinel Initiative.
Based upon the work of the eHI Connecting for Drug Safety Collaboration and multi-stakeholder consensus achieved through the eHealth Initiative's Blueprint: From Consensus to Common Action, which actively engaged the involvement of more than 200 organizations representing clinicians, consumers, employers, health plans, healthcare IT vendors, hospitals, laboratories, pharmacies, pharmaceutical organizations, public health and state and local health care leaders, a number of key principles have emerged related to a distributed network that would support postmarket surveillance.
The list of key principles provided below will continue to evolve as the Collaboration gains more experience.
- Engage in a transparent and inclusive process, involving all of the stakeholders who will both benefit from and participate in the network, with the critical representation of consumers and clinicians
- Leverage existing data sources that reside in the care delivery and care payment systems.
- Build an incremental model that leverages current work that can be implemented in the near-term while building the model for the future that is scalable, and adaptable.
- Utilize agreed-upon standards for interoperability.
- Build in solid policies for protecting patient privacy and confidentiality from the get-go.
- Create a sustainable model for the network and its related activities.
