The College of Healthcare Information Management Executives (CHIME) is calling on the Food and Drug Administration (FDA) to collaborate with other federal agencies to ensure that medical devices are truly interoperable with electronic heath records (EHR) systems in order to provide clinicians with real-time information needed to delivery patient care.
CHIME, which represents healthcare chief information officers and senior health IT leaders, provided comments on the FDA’s draft guidance “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices,” which was published in late January. Essentially, CHIME believes that a set of suggested principles for device interoperability is not enough and that interoperability standards for devices need to be more transparent and uniform.
The letter was written by CHIME CEO and President Russell Branzell and CHIME Chairman and Intermountain Healthcare CIO Marc Probst.
In the letter, CHIME points out that hospitals and physicians have invested billions of dollars adopting electronic health records (EHRs), purchasing devices, installing interfaces and pursuing an interconnected ecosystem. “They have made significant strides over the past decade in digitizing health care with an eye towards improving quality and increasing efficiency. However, significant barriers remain to creating a truly interoperable system,” CHIME stated.
While CHIME supports the FDA’s efforts to improve device interoperability, the organization cited concerns that the draft guidance represents a set of suggested principles.
“CHIME members seek assurance that the devices they purchase are able to connect with other devices and systems. For instance, our members struggle with ensuring that the devices they purchase and the data that is generated (to the degree that a device is even able to do this) will connect with their EHR systems and that they provide clinicians with the real time information they need to deliver patient care,” the CHIME letter stated.
According to CHIME, many providers are told when purchasing devices that the devices are “interoperable,” yet once purchased, providers often learn that in many instances they need third party software to connect the device to the EHR, which adds “unanticipated costs and complexity to the health care system.” And, CHIME states, “is a barrier to providing clinicians with the information they need at the point of care.”
“Additionally, our members also report a lack of transparency around the standards used by manufacturers impacts interoperability and data flow. Finally, we also believe that transparency is necessary in order to achieve a more secure healthcare ecosystem,” CHIME wrote.
CHIME provided a number of recommendations for the FDA to address these concerns. CHIME is calling on the FDA to collaborate with the Office of the National Coordinator for Health IT (ONC), providers, device manufacturers and other appropriate stakeholders to establish greater transparency around standards used by device manufacturers.
“Data formats and transmission protocols vary across devices, pediatric or for adults; yet providers need a uniform set of standard. Having this would go a long way to furthering interoperability,” CHIME wrote.
CHIME also calls on the agency to work with ONC to establish a baseline set of uniform interoperability standards for devices that must be met in order to receive FDA approval.
And, CHIME would like to see the FDA work with ONC and other stakeholders to establish a “more robust definition of interoperability.”
“There is also no recourse for a provider if they experience challenges with device interoperability. While members report that manufacturers are generally more responsive to critical issues with devices that has not been the case with interoperability. One member commented that device interoperability challenges are a, ‘black hole when you report to the manufacturer and FDA.’ There is, however, a strong nexus between patient safety and interoperability, which is something we urge the FDA to recognize,” CHIME wrote.
And, CHIME noted that the challenges with device interoperability could also be perceived as “data blocking.” And the organization argues that the need to constantly purchase middleware is a drain on the healthcare system and is unsustainable. “As provider reimbursement evolves to a system that is increasingly focused on outcomes, the ability to move data seamlessly will drive better care coordination and ultimately better patient outcomes. If providers are forced to continue to invest in middleware to move data, then these costs will come at the expense of other patient care investments,” CHIME wrote.
CHIME also recommends that device functionality receive the same level of transparency as EHRs, and that device manufacturers be required to perform a risk assessment annually on their devices.
Other recommendations for the FDA include:
- Work with ONC to have them certify APIs
- Synchronize efforts with other federal agencies in applying risk management principles.
- Ensure alignment between the FDA’s cybersecurity guidance for device manufacturers and the interoperability guidance
- Create a central, online database that includes key functionality of devices (i.e. interoperability and security)
In its draft guidance, the FDA calls on device manufacturers to design systems with interoperability in mind and perform a risk analysis and appropriate performance testing that considers the risks associated with interoperability.
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