Wednesday, June 10, 2015

Standards Alone are not the Answer for Interoperability

Today I have the honor of presenting a guest blog by David McCallie MD, SVP Medical Informatics, Cerner.   He summarizes the collective feeling of the industry about the trajectory of interoperability.

"I have been honored to have served on the HIT Standards Committee from its beginning in 2009. As I reach my term limits, I have reflected on what we have all learned over the past six years of helping to define the standards for the certified EHR technology that lies behind the Meaningful Use program.

But before diving into those reflections, we should acknowledge what we have accomplished.  It's fashionable to complain that we haven't 'solved interoperability.'  This is certainly true, but we have come a long way, and have achieved significant and lasting advances.

In particular, we have mostly settled the vocabulary questions for encoding the record.  We have widely deployed a good ePrescribing standard. We have established a standard for secure email that will eventually replace the fax machine, and we have widely (but not yet universally) deployed a good standard for document-centric query exchange.  We are close to broad support for a stable standard for encoding complex clinical data into summary documents.  And perhaps most interestingly, we have opened the door to the promising world of API-based interoperability.

Nonetheless, the refrain we hear from Capitol Hill is that we have failed to achieve the seamless interoperability that many had expected. This has lead to numerous legislative attempts to 'fix' the problem by re-thinking government approaches to the standard setting processes authorized by HITECH.

We should be careful not to overreact in light of any disappointments and perceived failures around interoperability.  There are many things we must improve, but we should not inadvertently take steps backwards.

I think the biggest mistake Congress appears to be legislating is to assume that standards alone are what creates interoperability.

Standards are necessary, but are not sufficient, for interoperability to occur.

Standards organizations (SDOs) can create standards, but they do not create the additional entities that are necessary for standards to deliver useful interoperability.

I believe that the sufficient conditions for interoperability include the following:

*A business process must exist for which standardization is needed. As Arien Malec put it recently, 'SDOs don't create standards de novo. They standardize working practices.'

*A proven standard then needs to be developed, via an iterative process that involves repeated real-world testing and validation.

*A group of healthcare entities must choose to deploy and use the standard, in service of some business purpose. The business purpose may include satisfying regulatory requirements, or meeting market pressures, or both.

*A 'network architecture' must be defined that provides for the identity, trust, and security frameworks necessary for data sharing in the complex world of healthcare.

*A 'business architecture' must exist that manages the contractual and legal arrangements necessary for healthcare data sharing to occur.

*A governance mechanism with sufficient authority over the participants must ensure that the network and business frameworks are followed.

*And almost no healthcare standard can be deployed in isolation, so all of the ancillary infrastructure (such as directory services, certificate authorities, and certification tests) must be organized and deployed in support of the standard.

The Jason Task Force (which I was privileged to co-chair with Micky Tripathi) summed up these requirements into what they called a 'Data Sharing Arrangement (DSA).' DSAs do not emerge from SDOs. DSAs cannot be simply created by legislative fiat.  They require the active engagement and collaboration of the many entities who are willing to do the hard work to create the necessary infrastructure for an interoperability standard to find real-world, widespread use.

We've learned that forcing providers to simply deploy standards and then to expect interoperability to happen is ineffective policy. The most rapid progress has happened when DSAs have emerged because provider organizations, Health IT developers and SDOs agree to work together to achieve a clear mission, focused on meaningful outcomes. Congress should accordingly define the 'what' and let the U.S. health care stakeholders define and achieve the 'how.'"

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