A new Health IT Safety Center Roadmap lays out a five-year plan for creating a federal center focused on aggregating data on health IT-related adverse events.
The roadmap, produced by RTI International for the Office of the National Coordinator for Health IT, grew out of a series of meetings with selected stakeholders including federal agencies, patient safety organizations (PSOs), researchers and clinicians.
"The task force did not propose for the center to have a regulatory function, but to promote health IT safety by convening interested parties, doing focused work to identify and disseminate best practices, and serve as the leading voice in addressing patient safety generally and health IT-related safety issues more specifically," Andrew Gettinger, M.D., acting director of ONC's Office of Clinical Quality and Safety, writes in a blog post at Health IT Buzz.
The public-private partnership initially would be federally funded for its first five years, with an "optimal" center estimated to cost between $17.8 million and $20.6 million. However, the roadmap also describes reducing the capabilities of the center down to 25 percent of that level, beyond which the stakeholders say the center would be ineffective. Other methods of achieving sustainability are to be developed within the five years.
The center's three major tasks will be convening groups of stakeholders to learn more about health IT-related risks; researching hazards and disseminating information gleaned from these activities, which could include real-world pilot testing and implementation; and evaluation of health IT safety solutions.
At the same time, the roadmap makes clear what the center will not do, which includes:
- Engaging in direct investigation or surveillance
- Operating or funding operations of a PSO
- Directing data collection
- Duplicating the activities of other federal entities
The Food and Drug Administration Safety and Innovation Act report, released jointly by ONC, FDA and the Federal Communications Commission, included a recommendation to create the safety center. However, lawmakers--in particular, four members of the House Energy and Commerce Committee--had expressed concern about ONC's plans to "regulate software and other health IT products" via the safety center.