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HL7 FHIR initiative targets medical device interoperability
A new HL7 FHIR accelerator aims to close medical device interoperability gaps by creating FHIR implementation guides and supporting real-world testing and adoption.
As the use of electronic medical devices grows, the ability of health IT systems to safely, securely and effectively exchange and use medical device data becomes critical. However, while the healthcare industry has made major strides in EHR data exchange, medical device interoperability has lagged.
Devices like infusion pumps, ventilators and patient monitors often operate in data silos, requiring manual transcription of information into health IT systems. Not only does manual transcription add to clinician burden, but it also introduces documentation errors that could impact patient safety.
In a recent webinar, Viet Nguyen, MD, HL7's chief standards implementation officer, and Todd Cooper, co-chair of HL7's healthcare devices working group, discussed how HL7 is looking to drive medical device interoperability through a new FHIR accelerator.
HL7 FHIR accelerators support emerging FHIR use cases by assisting communities in creating and adopting FHIR implementation guides. HL7 provides basic team collaboration infrastructure tools and other support services for FHIR accelerator groups, ranging from self-service guidelines to contracted project management.
"The accelerator program is really looking at creating communities of practice that are multi-stakeholder, multi-vendor who understand that by working together to develop standards, we can address high priority business needs and get them implemented earlier to improve patient care efficiency and many other things," said Nguyen.
Accelerating data exchange through HL7 FHIR
The medical device interoperability accelerator will add to the work of previous HL7 interoperability initiatives like Devices on FHIR.
Launched in 2016, Devices on FHIR is a collaborative initiative involving HL7, Integrating the Healthcare Enterprise (IHE) and other stakeholders that aims to drive standardized device data exchange using FHIR. The group has published a FHIR implementation guide for personal health devices and is working on releasing one for point-of-care devices.
However, Cooper noted that despite FHIR Connectathon events -- where stakeholders can support implementation guide maturity through testing with peer organizations -- a lack of implementation testing has stalled the initiative's efforts.
"We have participated in FHIR Connectathons two or three times annually for many, many, many years, but we still have the implementation community emerging," Cooper noted. "So, though we show up, who shows up to actually do testing of these resources, of these implementation guides? Very few."
"We need to have an implementation community step up to really put the pieces together, so we haven't published that point of care devices FHIR implementation guide -- not because it doesn't have all the content it needs to be published, but because we haven't been able to have the implementation testing that is necessary," he said.
Recently, the Devices on FHIR initiative added a device alert resource, which Cooper hopes will help drive the maturity of the point-of-care device implementation guide.
"That device alert resource is huge to opening the door to products now that otherwise we had a hard time using FHIR for, so a lot of vendors are looking at that and saying, 'Okay, now I have the pieces I need to move forward with real products,'" said Cooper.
Future opportunities
The top priority of the FHIR accelerator is to put together a comprehensive conformity assessment program that is regulatory-ready, according to Cooper.
"No. 1 is that conformity assessment and regulatory ready program," he said. "That is something we have to advance as an accelerator community and then start to address all those Devices on FHIR core backlog areas, implementation guides, maturity, terminology, all of that stuff."
Further, standards development, testing and conformity assessment drive the need for governance.
While significant funding has been invested and a strong foundation of experts is in place, Cooper said sustaining and scaling medical device interoperability will require more resources and broader engagement.
“We need to create tools, test tools, reference implementation, and training materials so we can get more experts,” he emphasized. “We need to expand the global implementation community.”
Hannah Nelson has been covering news related to health information technology and health data interoperability since 2020.
