Greater Medical Device Data Standards Needed for Interoperability

The healthcare industry needs better data standards to support medical device interoperability, according to an article published in JAMA Health Forum.

The authors noted that much of the existing infrastructure for healthcare interoperability has focused on EHRs. ONC mandated the adoption of HL7 Fast Healthcare Interoperability Resources (FHIR) in its implementation of the 21st Century Cures Act, as did CMS in its interoperability rule.

However, the authors said that FHIR does not address the need for medical device interoperability. As clinicians continuously leverage medical devices, greater data standards are needed to ensure this information can be exchanged across the care continuum.

Medical devices—in clinical settings and those worn by patients—are increasingly network connected, the authors explained.

These devices can help enhance clinician productivity and satisfaction by automating manual documentation tasks.

“By rendering clinically relevant information available at clinicians’ fingertips in nearly real time, interoperable networked devices could yield dividends in quality, safety, and operational efficiency,” the authors wrote.

For instance, a combination of networked ventilators, pulse oximeters, and telemetry monitors could provide targeted alerts to a clinician’s phone regarding a rapidly deteriorating patient in the ICU.

The authors noted that medical device interoperability could have a great benefit for clinical research as well.

“Interoperable, networked devices may make it easier to collect patient-derived data and support its integration into medical records, helping transition clinical trials from specialized study sites into the home and community settings, and assist with the recruitment of more diverse study populations,” they wrote.

However, the experts said that medical device data is currently disjointed by device type, ranging from consumer health apps to wearables, ambulance-mounted equipment, and devices used in clinical settings.

“This fragmentation underscores the need to facilitate seamless interfacing by providing common language, protocols, principles, and ground rules,” they explained.

While the FDA indirectly supports the development of standards through its Standards and Conformity Assessment Program, the authors suggested the agency encourage the development of an industry-wide medical device data standards organization to foster public-private partnership.

“It would require technical and systems expertise, relying on industry participation through both convening and standards development organizations,” they wrote. “Device interoperability frameworks would need to address common elements such as a device identity and communication standards, while also recognizing that device identity standards will differ substantially across device classes.”

And rather than invent new data standards, stakeholders could revise existing interoperability efforts and security standards to accommodate the specific functions of medical devices, the authors added.

“The FDA is well positioned to promote medical device interoperability by supporting the development of an industry driven, third-party standards development organization,” the study authors wrote.

“By fostering research and development, improving clinical efficiency, promoting a cybersecure framework for data-sharing, and enhancing national competitiveness in the global marketplace, standards will help medical device interoperability realize its full potential, benefiting both patients and clinicians,” they concluded.