In January, FDA released a draft guidance with recommendations both for what device makers should think about when designing interoperable medical devices and for what to include in premarket submissions to the agency. That draft document, “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices,” is part of the agency’s effort to ensure medical devices can share useful information safely to offer better care for patients.
In a February 9 FDA Voice blog post about the draft guidance, Bakul Patel, MS, MBA, associate director for digital health at CDRH, wrote, “We believe now is the time for all stakeholders—including medical device manufacturers, health care organizations, researchers, and information systems firms—to come together and continue to build this case to accelerate the development and availability of safe interoperable medical devices.”
But Rob Beatty, account manager at SIGNET Electronic Systems, thinks that device makers will still have to contend with issues accessing data in electronic health records. Reflecting on the draft guidance, Beatty said, “I think it’s a good direction. It might be slightly premature because you still have issues on the EHR side especially, where you’re hearing about data being withheld or roadblocks being in place by some of the EHR vendors. This might be something where the Office of National Coordinator for Health Information Technology (ONC) may have to step in. They may have to work with a few other agencies to come up with ways to incentivize this . . . I think you’ll get much faster results by putting incentives in.
Beatty will discuss “The Future of Hospital & Medical Device Interoperability” at BIOMEDevice Boston 2016, April 13-14.
ONC released its “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap” in October 2015, pinpointing near-term and long-term steps to be taken toward health IT interoperability. The roadmap authors acknowledged the need for incentives: “The current business environment does not adequately reward, and often inhibits exchange of electronic health information, even when it is technically feasible. History has shown that without the right financial incentives in place, systems and technology components are build and used.” The report pointed to incentives that have been implemented for providers that are expected to increase the use of quality and value-based payments.
Still, the roadmap pointed out the lack of EHR interoperability, noting that “less than half of hospitals are integrating the data they received into an individual’s record” and “as of 2013, only 14 percent of ambulatory providers shared electronic health information with providers outside of their organization.” However, the report doesn’t explicitly require EHR cooperation. In her introductory letter to the roadmap, Karen DeSalvo, MD, MPH, MSc, national coordinator for health information technology, wrote, “We will all need to commit to actions that will define how we work together on behalf of the American public to empower them to improve their health . . . We hope the private sector will join us in this pledge.”
The private sector has since agreed to join in the efforts. In late February, HHS announced that major EHR vendors providing 90% of EHRs, providers including the five largest private U.S. healthcare systems, and many other stakeholder groups had pledged that they would not block EHR information, would allow easy consumer access to the information, and would put in place national interoperability standards and best practices.
“I think you can do a better job for yourself and for your customers if you are open to working with anyone and making things work better together,” Beatty said.
Designing an Electronic Data Interface
The draft guidance includes a discussion of medical device electronic data interface (EDI) design. An EDI allows for the exchange of information between the medical device and another system. FDA wrote, “manufacturers should consider the level of interoperability needed to achieve the purpose of the interface, as well as the information necessary to describe the interface.”
From a device maker’s point of view, the requirements for an EDI can range from simple or complex, Beatty said. “Maybe you’re developing a portable pulse ox that can connect to your iPhone through Bluetooth. That kind of interface is very simple and is going to connect directly from your device to another device. When you’re talking about a larger scale like an entire patient monitoring system, you’re going to want to be able to send information to all kinds of systems. Some are going to be easier to deal with than others,” he said
The type of information being sent matters too, Beatty said. “It depends on the criticality of the information. If what you absolutely need to do is get that information there, then you need to send it in a way that even if there’s some data loss, that information is guaranteed to get through. But if it’s not that critical, then you can use a different manner of transmission.”
The draft guidance has drawn almost 20 responses from commenters, including one person who identified himself as an FDA reviewer and a number of commenters interested in the impact on diabetes devices. The FDA reviewer, Ian Broverman, wrote that he has “reviewed several submissions relating to interoperable devices” and would like to see the guidance include a “Declaration of Cooperation” signed by all parties connected to that interoperable device, as well as a requirement for “simultaneous design changes.” He argues that although interoperability isn’t slated to be monitored in the postmarket setting, “a postmarket change in one device could add significant risk to the operation of other devices,” so all the parties involved should agree to handle those postmarket changes. In addition, simultaneous design changes and clearance are important in reducing regulatory burden for both device makers and FDA, he wrote.
Patients with diabetes and diabetes professionals wrote in to emphasize the need for interoperability and diabetes devices and software that work seamlessly and automatically together. One commenter wrote, “Interoperability should be required, not encouraged. I am a diabetologist and continue to struggle with the myriad devices—meters, sensors and pumps—that I regularly download before patient visits. A single platform would make that job more reliable and simpler.”
In late January, AdvaMed asked for an extension of the 30-day extension of the 60-day public comment period, which FDA granted. Comments are now due April 28.