Despite all the progress and safety improvements from electronic ordering and clinical decision support, researchers continue to find hazards to patient safety associated with the introduction of these systems. Now a task force of experts and health IT safety stakeholders convened by the Office of the National Coordinator for Health Information Technology has crafted a roadmap to guide the development of a proposed national Health IT Safety Center.
In 2014, the Federal Communications Commission (FCC) issued a report that proposed a strategy for a risk-based regulatory framework for health IT. The draft FDASIA report identified the potential creation of a Health IT Safety Center as a key non-regulatory component of an effective risk-based framework for health IT.
The task force, convened by RTI International at ONC’s request, determined that the center should improve identification and sharing of information on health IT-related safety events and hazards. It also supported strengthening and augmenting existing ways to identify and classify health IT-related safety events.
The roadmap envisions the federal government providing seed funding of between $17.8 million and $20.6 million for the first five years of operations, after which the organization would work on developing sustainable funding models.
Task force members advocated that the center identify ways to encourage better reporting of health IT-related events by improved training, easier reporting mechanisms that are better integrated into workflows, and reduction of other barriers to reporting.
They also stressed the need for the industry to consider tools that allow for automated detection, identification, and reporting of safety issues. Recognized methods include “trigger tools” run on information in electronic health records to identify adverse events and EHR computerized point of entry (CPOE) evaluation tools or “flight simulators” also run on EHRs to improve detection of potential adverse events.
Their idea is that the center would be a trusted, learning, non-punitive environment. Center stakeholders may choose to share analysis of data, examples of safety risks and adverse events, solutions, and resources—always in accordance with privacy, confidentiality, nondisclosure, and intellectual property obligations and laws.
The task force also stressed that the Health IT Safety Center:
• Will not engage in direct investigation or surveillance.
• Will not include operating or funding the operations of a patient safety organization.
• Will not include direct data collection.
• Will not include performing functions of federal advisory committees
• Will not include activities that are exclusively the responsibility of federal entities, and, therefore, cannot be delegated to outside parties, such as the exercise of regulatory authority, establishing government programs, and decision making related to federal budget expenditures and priorities.
Task force members thought that the Center should serve as a clearinghouse for health IT safety educational resources by maintaining a central Web-based directory that is well organized and searchable, frequently updated and open to the public.
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