The Office of the National Coordinator for Health IT has released a draft of the 2016 Interoperability Standards Advisory for public comment—a document ONC calls a list of the best available standards and implementation specifications.

The advisory is meant to “provide the industry with a single, public list of the standards and implementation specifications that can best be used to fulfill specific clinical health information interoperability needs,” according to ONC. However, some industry observers contend that several of the standards and specifications in the draft advisory are not widely deployed in the healthcare industry and are unproven in common practice.

According to Micky Tripathi, president and CEO of the Massachusetts eHealth Collaborative, the question being asked should be: “Where is this standard with respect to adoption and maturity? Because there are lots of standards out there that haven’t really stood the test of experience.”

Also See: ONC Proposes 'Critical Action' to Advance Interoperability

The draft 2016 advisory provides six informative characteristics associated with each listed standard and implementation specification to “give readers an overall sense of maturity and adoptability.” But, Tripathi believes adoption—rated using a 1-to-5 dot scale—is not adequately defined.

“One dot indicates 0% to 20% adoption, two dots indicates 21% to 40% adoption, three dots indicates 41% to 60% adoption, four dots indicates 61% to 80% adoption, and five dots indicates 81% to 100% adoption,” he says. “But, for the life of me, I have no idea what that means. They really need to define that a little bit better, or at least be explicit about how they are defining that—rather than just saying 0% to 20% adoption, which is arbitrary.”  

In addition, Tripathi calls into question the draft 2016 advisory’s inclusion of some standards. “They gave something four dots and I’ve never even seen that standard,” he exclaims. “For some of these standards, like Basic Patient Privacy Consents (BPPC) and Healthcare Provider Directory (HPD), those are really not widely deployed and widely adopted. They’re really probably dead-ends in many ways.”    

Quality Reporting Document Architecture (QRDA) is another implementation specification listed in the draft advisory that left Tripathi scratching his head. “QRDA is a means of reporting quality measure output,” he comments. “It’s a very complicated, complex XML implementation. To my knowledge, EHR systems were required by ONC in the certification rule to do it but no one uses it.” 

Tripathi also believes the draft standards advisory mischaracterized Health Level Seven International’s Fast Healthcare Interoperability Resources (FHIR), an interoperability framework leveraging the latest web standards including a RESTful application programming interface.

“Their description of FHIR was unclear,” says Tripathi, who is manager of the Argonaut Project to accelerate development and adoption of FHIR. “They gave some indications of where FHIR might be used in the future. But it seemed like a really weird hodgepodge of things.”

For example, he cites the fact that the standards advisory referenced FHIR as being used for “case reporting to public health agencies.” However, Tripathi observes: “That’s not even close to an Argonaut use case.” 

Nonetheless, in testimony on Thursday before the Senate health committee, National Coordinator for HIT Karen DeSalvo, M.D., told lawmakers that the draft 2016 advisory is a non-binding “sub-regulatory” document that enables ONC to “continue to iterate it and keep up with the times.” This “federally-recognized list of national standards” is the second version of the document and “we are continuously getting feedback and making it better,” according to DeSalvo.       

“We want to make sure that we are giving guidance and setting guard rails but not getting in the way,” she testified. “What we want to do is raise the floor and get everybody on a set of shared standards that make sense, that are common but do not get in the way of innovation.”

In general, Tripathi agreed that “in the absence of industry-led governance of standard activities and because the health IT market is so fragmented, right now—at least—ONC is probably the only organization in the country who can start to provide a little bit of a coalescing force for some of this.”   

The public can comment here on the draft 2016 advisory until 5 p.m. on Friday, November 6.  A final advisory will be published by the end of 2015.

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