The West Health Institute, which has also served as an incubator for and investor in mobile health app firms, has been trying to raise awareness of the medical device interoperability issue for the past year and a half. Last March, the institute released a report asserting that improving interoperability among devices and EHRs could save more than $30 billion a year while improving patient care and safety.
A West Foundation press release presented the case for this interoperability: "In a hospital today, patients are connected to six to 12 medical devices in a typical intensive care unit, including defibrillators, electrocardiographs, vital sign monitors, ventilators and infusion pumps. These point-of-care devices are often from different manufacturers and not connected to each other or to the electronic health record system, requiring redundant efforts to transfer data manually and a costly, complex information technology (IT) infrastructure, both of which introduce the potential for miscommunication and errors that adversely affect patients."
[ Why are electronic health records so hard for the medical profession to share? Read Sharing Electronic Medical Records Still Too Hard. ]
The U.S. Food and Drug Administration (FDA) agrees with this perspective. In a recent blog post, FDA senior advisor Bakul Patel gave examples of how the lack of such data-sharing ability can endanger patient health. He noted that a 2012 summit organized by FDA and the Association for the Advancement of Medical Instrumentation (AAMI) brought together 266 experts to discuss interoperability. Following the summit, FDA recognized a set of voluntary standards "that will help manufacturers create devices that work well together and are secure."
Nevertheless, said Ed Cantwell, executive director of the Center for Medical Interoperability, much more needs to be done, because what he calls "point standards" don't provide an end-to-end data sharing capability. "We don't think there's a lack of standards," he told InformationWeek Healthcare. "There's a lack of reference architecture that embraces the standards and the process by which vendors can demonstrate adherence to the reference architecture."
Moreover, he said, the hospitals and health systems that use these devices need to have a strong voice in how the technical solutions are framed. That's why the Center for Medical Interoperability was formed.
The center's initial aim is to recruit a 16-member board of directors representing healthcare organizations. At least half of the members, Cantwell said, will be recruited from large organizations. Michael M. E. Johns, MD, former chancellor of Emory University and CEO of its Health Sciences Center, is the founding chairman of the center's board. Another board member, according to a West Health Institute spokesman, is Jeffrey Balser, vice chancellor for health affairs at Vanderbilt University and dean of Vanderbilt University School of Medicine.
Cantwell said that his conversations with hospital CEOs over the past several months have convinced him that the issue of medical device interoperability is important to them. The role of their organizations as purchasers of medical devices, he noted, can have a major effect on vendors' willingness to subscribe to a common reference architecture.
"The only thing that gets the attention of the vendors is procurement," he said. "If you don't use the procurement power to drive this, I don't think the free market will give it to you."
Cantwell doesn't believe the FDA should "overly regulate" the device industry in this regard, he said. Yet he stressed that after hospitals and device makers agree on the technical solution, the FDA should endorse it.
EHR vendors also have to be part of the equation, he said, because it's critical for device data to be documented in EHRs. However, he said, providers should not have to pay up to $10,000 per bed for a single interface. Having a common architecture for these connections should make these interfaces easier and less expensive to write, he said.
The center hopes to assemble its board by the end of the year and to receive its IRS approval as a nonprofit organization in the first quarter of 2014, Cantwell added.