Desperately Seeking Better Standards

With billions of dollars invested in health IT adoption, EHR use is up but many think health IT’s ability to live up to its promise of improving healthcare delivery and outcomes is compromised unless systems can talk to each other. Health information exchange (HIE) between hospitals and other providers rose 41 percent between 2008 and 2012, according to a study published in the August issue of Health Affairs. The article also identifies the need to define the standards for interoperability as essential to fueling more widespread information exchange.

However, while these numbers show progress, the call for clear, open and nonproprietary standards is booming across the industry as providers struggle to interoperate.

Defining Terms

Ideally, a clinician should be able to positively identify a patient and query a network—which may query broader networks behind it—to retrieve a meaningful abstract about the patient and allow for effective care, says College of Healthcare Information Management Executives (CHIME) CEO and President Russell Branzell, who shared his views at the Center for Medicare & Medicaid’s August eHealth Summit.

But that level of care coordination is not happening. “What is really needed are clear, executable standards that are mandated, that we can make work across the country in a way that data can be used by our physicians for care,” says Branzell.

Speaking at the same event, Indranil Ganguly, vice president and CIO of CentraState Medical Center in Freehold Township, N.J., says the lack of clear standards is causing a lot of waste in the quest to achieve true value proposition.

He cites the wide variation in laboratory test compendium among providers, who often use different EHR vendors. Integrating physician practices’ EHRs into the private HIE and regional health organization has thus become a major headache.

“We face massive mapping challenges to get a standardized definition of complete blood count (CBC). It is taking us weeks to complete mapping just to transport data from one EHR to an HIE. Imagine rolling that out among thousands of practices. Where are the resources to do that?”

Also at the event, Ryan Bosch, MD, CMIO of Inova Health System, based in Falls Church, Va., says linking the 5,000 physicians in his system is wrenchingly difficult as they all use different labs and their lab vendors all have unique propriety numbers for what they call their unique blood count. “The laboratory still runs the CBC, but it’s got a different proprietary number at each location,” he says. 

“We have to go to great lengths to teach the computer that they are the same thing. Small steps to mandate certain criteria would help us gain momentum to more broadly deal with the choices out there,” he says.

A Change in Conversation

The increasing talk of standards is a sign that EHR adoption is alive and well and providers are “starting to change the conversation” as they look to take the next step to interoperate, says Doug Fridsma, MD, PhD, chief science officer and director of the Office of the National Coordinator for Health IT’s (ONC’s) Office of Science & Technology.

“It’s not about standards development organizations pushing for these standards. It’s about the industry coming to us and saying we need a standard to do X, Y and Z because now that we have an electronic format, we realize the inadequacy of systems and the need to accelerate standards development,” says Fridsma.

ONC is strongly committed to open, non-proprietary standards, he says. “That, all along, has been one of the evaluation criteria we are trying to use around the standards that we’ve adopted for Meaningful Use.”

Stage 2 Meaningful Use (MU) goes into effect during the end of 2013 for hospitals and the beginning of 2014 for ambulatory care practices. Under Stage 2, providers must be able to prove they can exchange data with at least one provider or an ONC testing platform.

In the MU program, Fridsma cites two open, nonproprietary standards that give certified health IT the ability to exchange information: (1) secure email (i.e., SMP, Direct); and (2) optional criteria, based on service-oriented architecture or web services. 

Alex Lippitt, Jr., senior director of interoperability and standards at the Healthcare Information Management and Systems Society (HIMSS), says MU requirements in Stages 1 and 2 only scratch the surface of what is needed for true healthcare interoperability to drive such workflows as transitions of care.

He advocates for an Interoperability Maturity Model, which allows for incremental stages of interoperability enabling key workflows, raising the interoperability common denominator that can be expected in clinical usage, while respecting the capacity for healthcare organizations to manage change. ONC’s first two stages of MU are a good start, he says, but they need to press further.

Some industry groups are participating in voluntary advanced certifications in interoperability programs. “The dream would be that Meaningful Use Stage 2 would be extended and Meaningful Use Stage 3 would include these advanced interoperability requirements as part of the Meaningful Use certification process required for each stage,” Lippitt says.

The incremental approach is not enough for some industry players, however.

Branzell of CHIME says that semi-optional standards will not fly, and urges federal agencies to hardwire mandatory standards into the certification requirements. “If we don’t do the right things now, it’s going to take a lot longer to get where we want to go.”

“Having just worked through 5,000 physicians, 120 clinics and five hospitals in the past month and ripping out 120 unique pieces of software to come down to 12 pieces of software, I’d echo the term and the tone: mandate standards,” adds Bosch.

ONC Initiatives

The pursuit of standards should be an “incremental and iterative” process, Fridsma says. “We try to focus on things we feel will have high value knowing that there are other things that remain to be done.”

Part of that process is putting systems in place, such as standards implementation and testing sites, which can compile, test and share specific, reported standards and interoperability concerns with other stakeholders, he says. “It helps to have the community identify best practices and raise issues with standards organizations or the ONC,” he says.

ONC is investigating several mechanisms to bolster information exchange. These include email approaches, connection, commercial-grade approaches on the back end of systems and restful approaches. Fridsma cites two initiatives he feels will have a significant impact.

First, the Standards & Interoperability Framework Initiative’s (S&I’s) Data Access Framework (DAF), launched in July, focuses on building the standards and framework necessary for healthcare professionals to gain access to patient data within their own organization and from external organizations. The DAF will leverage existing standards to create a modular framework based on the identified business requirements of the community, he says.

Secondly, Fridsma references the S&I’s structured data capture (SDC) initiative, which seeks to identify how EHR interoperability technology can be used to: access a template that contains structured data or common data elements (CDEs); automatically populate the template with the correct CDEs from existing EHR data; and store or transmit the completed template to the appropriate organization or researcher.

“We expect that the SDC Initiative will leverage existing EHR interoperability standards, harmonize them and agree on a common approach to support structured data capture,” he says.

Collaboration around Standards

While mandatory, open, non-proprietary standards remain elusive, industry and standards organizations are quickening their pace on collaboration initiatives.
Lippitt says he has observed an intensification of collaboration between groups. While individual standards help, how they work in concert with other standards must be hammered out between standards development organizations in a process called “harmonization.”

HIMSS, in particular, focuses on advocacy for standards on a global scale. It is one of two major sponsors of Integrating the Healthcare Enterprise (IHE), a worldwide organization of common standards. Members pull together standards in profiles, which are harmonized with one another.

HIMSS also is working with medical device groups to bring together standards groups that provide for medical devices like IEEE with  standards groups like SNOMED which focus more on EHRs. The goal is addressing problems such as the inability of medical devices sto end readings, like blood pressure, directly into the EHR because of data coding mismatch issues.

Lippitt cites HIMSS’ involvement in the IHE USA implementation workgroup, which includes representatives from the HIMSS EHR Association (EHRA), hospitals and standards organizations, among others, “to close the clinical quality improvement feedback loop” so the standards that are developed meet the challenges of real-life practice.

“The idea behind the workgroup is to get input from the EHRA, other IT vendors, hospitals, ambulatory groups, providers and clinicians and have a more unified voice, so as a group we can address key issues and present solutions.”

The Issue of Proprietary

Interoperability is possible without mandatory, open and non-proprietary standards, Fridsma says. However, “to us, that would not be in keeping to the policy objectives we have.”

Industry efforts like the CommonWell Health Alliance, which seeks to promote and certify a national infrastructure with common standards and policies, have their heart in the right place, Lippitt says, but with qualifiers. “If they are working independently and they come up with something really cool, so long as the rest of us has access to it— that’s fine. We can’t really have a series of proprietary networks. That’s not going to work.”

In the meantime, more pressure has been exerted on standards organizations to open up their intellectual property. Some of it has paid off, as global standards organization Health Level Seven International (HL7) announced in April that it changed its policy to make much of its intellectual property freely available under licensing terms.

With MU Stage 3 on the horizon, it remains to be seen whether federal agencies will wield their regulatory authority to require mandatory open standards. 
For now, it is one step at a time, Lippitt says. “We’ll continue to have to press forward with new use cases, new ways of creating better value and better standards so people can get to that learning healthcare system where people are actually using the data, driving innovation, and learning how to do a better job because the data are open, transparent and accessible.”