FDA, medical instrumentation group say interoperability of health information must include data coming from medical equipment, not just IT systems.
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Interoperability of health information has been heralded for decades as a way to make medicine more effective, efficient and safer. But the focus at the national policy level on electronic health records (EHRs) might be neglecting another important part of the equation, namely interoperability of vast amounts of data coming from increasingly smarter medical devices.
"Many events, publications and conversations have focused on the information side of what technology can do. Little attention to date has been focused on the device side of that connectivity, especially as it relates to patient safety," said a recently issued report on medical device interoperability from the Association for Advancement of Medical Instrumentation (AAMI) and the U.S. Food and Drug Administration (FDA).
The report stems from a joint AAMI-FDA summit last October on medical device interoperability that included 14 other organizations, including the Joint Commission, the Healthcare Information and Management Systems Society (HIMSS), and the National Institute of Standards and Technology (NIST). It is intended to serve as a "community" document summarizing what participants said at the October event and to serve as a reference point for future dialogue, according to the AAMI and FDA.
"The advancement and availability of new technologies, coupled with a growing number of serious public health concerns and adverse patient events in which interoperability issues have been a root cause, spurred AAMI and the FDA to convene the summit," the report explains. "Interoperability matters first and foremost because it affects patient safety."The groups found that, like with many other aspects of interoperability, human and organizational factors were more likely than technical shortcomings to stand in the way of better data sharing.
"Challenges impeding progress include uneven leadership; limited cooperation, collaboration, and expertise; and inconsistent clinical workflow. However, while the challenges are becoming more acute, many of them are not new or exotic," the document said. Indeed, the authors referenced a November 2011 Institute of Medicine (IOM) report that said, in part, that health IT has not lived up to its promise for many of the same reasons.
In their report, the AAMI and FDA identified seven "clarion" themes from the summit that might be viewed as a roadmap to interoperability:
1. Standardize to achieve success. Widespread adoption of standards and shared goals will not only improve patient safety, it will promote innovation, they said.
2. Align incentives, expectations, roles and responsibilities. Leadership with a focus on patient safety and clinical need should lead to better technology, safer care and lower costs.
3. Take a systems approach. Design, implementation, and management of medical devices will benefit because a systems approach draws on expertise in specific biomedical and engineering disciplines.
4. Focus on human behavior first.
"Understanding interoperability as a sociotechnical system will reduce risk, improve clinical efficacy and optimize the value of medical technology investments," the report said.
5. Clarify regulations and the regulatory process. This will streamline the approval and integration of new medical technologies.
6. Standardize and coordinate clinical workflow. This will improve return on investment in technology and promote scalability of interoperable medical technology.
7. Remove barriers to interoperability by instituting shared, continuous learning processes. "Transparency about successes and failures, and better use of data from robust, interoperable medical technology, will create a platform for wisdom and knowledge that supports clinical practice and patient care," the report said.
Reaching the goal of device interoperability will not be easy, the AAMI and FDA noted. "Healthcare organizations are focused on getting electronic health records (EHRs) up and running. Very few are stepping into the even more complex space of device interoperability," they said. But the payoff for the effort could be huge.
"Getting it right protects patients, contributes to clinical decisions and positive patient outcomes, and improves efficiency. Getting it wrong introduces significant risk and the likelihood of adverse patient events. Worse, getting it wrong doesn't mean returning to the baseline risks of an unconnected world -- it will lead to more serious situations than exist now. Safe interoperability is central, not peripheral, to the core mission of healthcare," the groups caution.
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