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Is Interoperability Standards Advisory Helpful?

July 2, 2015
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Goal of ONC’s sub-regulatory guidance is to provide clarity, consistency, and predictability, but some question its value

At the most recent Health IT Standards Committee meeting, Chris Muir of the Office of the National Coordinator for Health IT, described the public comments about and next steps for an Interoperability Standards Advisory (ISA), ONC’s attempt to provide the industry with a single, public list of the standards and implementation specifications. But from the written submitted comments and verbal comments by some committee members, questions remain about how the list would work and how much value it would provide.

Muir reminded the Standards Committee that the ISA is envisioned as providing stakeholders who administer programs, procurements, and testing or certification programs with an advisory to help achieve their interoperability goals. 

Muir said that when ONC was talking to stakeholders about the interoperability roadmap, a common theme it heard was the need to have a list of standards and implementation specifications that would enable interoperability for a learning health system. “The only thing we had was a list of standards in regulation in relation to certification and meaningful use,” he said. “That wasn’t adequate. Therefore, something like ISA became a need within the roadmap.”

ONC published the first version of ISA in 2015 at the same time as the roadmap. After input from the Standards Committee and a second round of public input, ONC will prepare the next year’s Interoperability Standards Advisory for publication in 2016.

Of the 59 entities that provided public comments, ONC categorized 32 as supportive, eight as not supportive and 19 as neutral. Muir said there was a lot of interest in expanding the scope of ISA but not a lot of consistency as to which areas, except: security standards, which had been left out of the 2015 ISA. There was lot of interest in the ISA update process and the criteria for “best available” standard. There was also interest in the ISA telegraphing future changes to standards or implementation specifications, he said.

At the Standards Committee meeting, John Halamka, M.D., vice chair of the committee and CIO of the Beth Israel Deaconess Medical Center in Boston, noted one problem with the ISA. “The tension we face is that some standards are mature and suitable for regulations. Some are directionally appropriate and sub-regulatory guidance like this is appropriate, and some should never see the light of day,” he said. “But just because there is a use case and an existing standard doesn’t mean it should be listed in sub-regulatory guidance.”

David McCallie, Jr., M.D., senior vice president, medical informatics at Cerner Corp., was more critical. He said the ISA could actually do harm. Standards should follow business drivers, he said. “Listing those standards in absence of those drivers might create the impression that the standard is sufficient and leads to regulatory approaches that don’t work because someone picks a standard from a list of regulatory approved standards and says therefore we are done. “Standards are necessary but not sufficient,” McCallie said. “Standards follow business purposes, but they don’t drive business purposes. I think in healthcare if you have to go consult a list of standards to solve a problem, you are probably in the wrong business. Healthcare is so complicated you are going to run across these standards just by understanding the problems you are trying to solve. It seems extremely unlikely that a developer is going to find a missing standard by consulting a list, if they are a serious player in healthcare. So I question the value in the long run of the whole notion of the ISA.”

In written comments, the Electronic Health Records Association raised questions about how ONC would determine which standard is best:

Although not in the executive summary, as stated in the body of the document, the present ONC intent is that the judgment for “best” be ultimately that of (1) ONC with input from and (2) a review by the HIT Standards Committee, and two (3) public consultations. (1) and (3) are appropriate, but EHRA believes that the “HIT Standards Committee or one of its sub-groups” is not the right body to conduct the comment resolution. We believe that a dedicated committee for this task would be more effective and provide more technical rigor.

• A broader and more expert representation is needed, as it is not a regulatory action.

• Avoid confusion with the regulatory process

• It is important to get input from the standards development organizations (SDOs) as sources of standards and implementation specifications.

• Establish an explicit process to measure actual use.

 • Include other key stakeholders, including NCVHS for administrative standards and associations representing developers and providers.

The EHRA also noted that the relationship with the regulatory process is not entirely clear: “We understand that the Advisory is not intended to be an early heads-up about what standards and implementation specifications are intended to be included in certification in the future (although this action may happen, but is in no way assured or required). We suggest clarifications on the potential inferences that could be made or not made about the presence of a standard or implementation specification in relation to the regulatory process would be very helpful to set appropriate expectations.”

So whether ONC maintaining such a sub-regulatory listing of standards and implementation guides proves valuable to provider organizations remains an open question. What do HCI readers think?

(By the way, at the beginning of July, the HITSC workgroup structure was disbanded, with the workgroups to be replaced by new task forces beginning with one focused on the Interoperability Standards Advisory and another on the Precision Medicine Initiative.)