The Best Interoperability Game in Town

The ONC's Interoperability Standards Advisory gives providers some things they can start demanding from their vendors and service providers, and gives those same vendors and service providers some notion of which products and services customers will actually buy.

Are your health IT systems using SNOMED-CT? How about RxNorm? How about the HL7 Consolidated CDA?

Until May 1, you have a chance to weigh in on these and numerous other industry standards which, as likely as not, will eventually find their way into regulation as required technical standards in health IT systems in the U.S.

Overshadowed by the release of the proposed 10-year ONC Interoperability Roadmap on January 30, the lesser-publicized 2015 Interoperability Standards Advisory was not originally envisioned to be released at the same time, or even to exist.

But so many providers and vendors demanded it, that this non-regulatory advisory document found its way out at the same time as the Roadmap, offering solace to the health IT community which for ages has yearned for ONC to put some stakes in the ground. Some are already baked into Meaningful Use, but some are not, and some are just better defined in the Standards Advisory.

And while the work of the Roadmap itself will ultimately have the larger, more profound impact on the future of health IT interoperability, the Standards Advisory gives providers some things they can start demanding from their vendors and service providers, and gives those same vendors and service providers some notion of which products and services customers will actually buy.

The deadline for comments on the Roadmap closes at 5PM ET time on April 3, but you have until 5 PM ET time on May 1 to comment on the Standards Advisory.

Last month, I met with Steve Posnack, director of ONC's office of standards and technology, in Washington D.C. "One of the things that came out of the early part of the roadmap process from the vision paper coming out [last summer] was there was a lot of stakeholder engagement," he told me.

"We did listening sessions [and] an online public comment experience, and in that experience, with different stakeholders, there were questions of [such as], 'Where do we go to find standards? What can we use for X? What can we use for Y? Can ONC help? Can ONC provide guidance?'"

The Standard Advisory, to be updated annually each December, is an "interactive, collaborative process with the industry to identify standards," Posnack says. "It all evolved in real time, as we were looking at some of the elements of the three-, six- and ten-year Roadmap milestones, and what we could provide to the industry to get the conversation going."

Being an advisory document and not a regulatory one, it is a chance for the health IT industry to get some standards right without all the regulatory overhead that goes into rulemaking and publishing proposed rules in the Federal Register. "It's an opportunity for us in a more incremental way to work with the industry to give them a body of work that everyone can rely on," Posnack says.

After the public comment period on the 2015 Standards Advisory closes on May 1, ONC's Health IT Standards Committee will have its own opportunity to weigh in on the document, before it is finalized, well in time for the 2016 Standard Advisory to be written for an initial December release.

"Our intent would be to issue this on an annual basis, so people have an expectation, some predictability, that every December is when we plan on putting out the next one, that they would be available for public consumption," Posnack said.

Although ONC chief Karen DeSalvo, MD, describes the Standards Advisory as "sub-regulatory" instead of "non-regulatory," it's probably a distinction without a difference, even in Washington. The point is that nothing in the Standards Advisory is regulatory.

But, as ONC looks for things that could be adopted as criteria for certifying future products and services to advance interoperability, the Standards Advisories already vetted by this cooperative process between government and the governed are a natural place for ONC to look.

For instance, if ONC wants to write a regulation governing e-prescribing, it could look to the Standards Advisory. Posnack says the public "has an expectation that we're going to look to the advisory first, and not necessarily be a surprise to anyone, that things we're going to be picking off are going to be there."

That's not to say that all the answers are in the Standards Advisory. For example, there are at least two ways to transfer data from one EHR information silo to another. One such standard is Direct, listed in the Standards Advisory as "a simple way for participants to 'push' health information directly to known, trusted recipients."

But elsewhere in the document, an alternative of sorts, HL7's Fast Healthcare Interoperability Resources (FHIR) is offers as "data element based query for clinical health information." Though the protocols are different, they could both be used to accomplish the same take of moving EHR data from silo A to silo B.

"Direct is going to be great for some purposes, and FHIR is going to be great for others," Posnack says. "And they're each going to rely on other standards that we've named in there, to be paired with them to get the job done."

Standards being standards, it will also be true that once you go one way or the other, the pairings you end up choosing will make things a bit more complicated than just choosing individual standards from the list.

Dependencies, which complicate life for IT administrators and programmers everywhere, rear their heads at this point. No one ever said interoperability made things simpler in the short run. No doubt, some in the public comment period will call for less optionality, but as the ONC considers that, it also runs the risk of alienating some group or other with its own pet standards.

Grumbling in Congress is already kicking in. "Instead of offering specific objectives, deadlines, and action items, ONC's roadmap falls short on the nitty gritty technology specifics that vendors and providers need when developing IT products," wrote Senators John Thune, Lamar Alexander, Pat Roberts, Richard Burr and Mike Enzi in Health Affairs on March 4.

Get ready for a severe irony alert: This is the same Congress that has done so much already to stymie healthcare interoperability by prohibiting any sort of national patient ID from being created. I and a lot of providers would suggest that before Congress passes harsh judgment on this current round of Roadmap and Standards Guidance efforts, it look to wrestling with the very real work of crafting a national ID we all can live with.

For now, the Standards Advisory, and even the Roadmap itself, are quiet on the subject, since they are restricted by law from doing anything about it.

One more hopeful thing DeSalvo mentioned and Posnack confirmed while I was in Washington: ONC has a "certification sandbox" website where developers can access and test their products and services against some ONC implementations of various implementations of standards.

"Ultimately, our hope is that we can, again as a coordinator, help the industry consolidate testing assets," Posnack says. "We don't need to have them all on our website, but we can point people to the right places."

So while we're laboring to get healthcare's three-, six-, and ten-year interop Roadmap defined, and figure out where software certification itself is headed, it's nice to know there's also a place that vendors and others can all go to test out some things today. Since heavy regulations aren't coming any time soon if at all, it's the best interoperability game in town right now.