Health IT Firms Want ONC to Explain Future of Standards in Policy, Regulation

Keep up with the latest developments and legal issues in the telecommunications and emerging technology sectors, with exclusive access to a comprehensive collection of telecommunications law news,...

By Alex Ruoff

May 4 — Health IT developers Cerner, McKesson and Epic Systems want more information about a key element of the federal government's plan for improving the electronic sharing of patient data among health-care providers.

The companies, in a May 1 letter penned by the Electronic Health Record Association (EHRA), requested more information about how the Office of the National Coordinator for Health IT plans to use its recently released list of “best available and most widely used” health IT standards.

The ONC certifies EHR systems for use in the meaningful use program. Part of that certification process is ensuring that EHRs incorporate certain standards, which are technical protocols built into EHR systems that, when aligned properly, are designed to allow the systems to exchange data or perform other tasks.

The EHRA said it generally agrees with the list of standards the ONC included in its draft standards advisory, but asked for more information about how they'll eventually be incorporated into agency policy and regulations. The group said the ONC needs to better explain the intended use of the standards advisory to “avoid misinterpretations, especially in relation to regulation and the Interoperability Roadmap.”

“The current approach for the advisory to list current standards may not be helpful without first asking: ‘Best available standard for what?' ” Meg Marshall, the director of government health policy at Cerner told Bloomberg BNA in an e-mail May 4. “To support fully the future for health IT, any interoperability standards bound by regulation to certification should be focused and associated with identified goals; driven by the private market in a voluntary manner that best supports pilot experimentation and maturation; and staged toward broader adoption.”

The EHRA is part of the Healthcare Information and Management Systems Society (HIMSS), the nation's largest health IT industry group. EHRA members include health IT developers Cerner, Epic, General Electric (GE) Healthcare, Greenway Health, McKesson, Meditech, Practice Fusion, Wellsoft and others.

The ONC Jan. 30 released the first complete draft of its Interoperability Roadmap, the agency's 10-year plan for improving the interoperability of health IT, an ambitious effort meant to allow health-care providers to more easily share patient health records. The first deliverable from that plan was the draft 2015 Interoperability Standards Advisory, a set of technical standards meant to enable “core interoperability functions” in EHRs and other health IT.

Comments on the standards advisory were due May 1.

Clarifying Purpose

The ONC said 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 achieve a specific clinical health information interoperability purpose.”

However, the EHRA said determining the best standards are just those selected by the ONC. The group said the ONC should consider that standards change over time, meaning the best standards today won't be the best standards next year.

“Nowhere is there a consideration for the expected stability/sustainability of the selection made over time,” the EHRA said. “This consideration is critical as interoperability progresses only if stability and backward compatibility are ensured.”

The EHRA also asked that the ONC appoint a special committee to oversee the selection of standards incorporated into the final standards advisory. The group said the ONC's current advisory body on health IT standards, the Health IT Standards Committee, “isn't the right body to conduct the comment resolution” and asked for a special group with a “broader and more expert representation.”

“We believe that a dedicated advisory committee for this task would be more effective and provide more technical rigor,” the EHRA said.

Using Newer Standards

Surescripts sent its own comment letter to the ONC May 1. The company, which operates the nation's largest clinical health information network, recommended that the ONC be more foward-thinking in its approach to setting data exchange standards.

Surescripts said the ONC should focus on “pilot or emerging standards.” In particular, the company recommended that the ONC include the use of FHIR standards in its standards advisory.

“FHIR is leveraging technologies from the broader commercial web world as well as defining a simpler set of nouns and verbs,” Surescripts said. “While Surescripts will continue to support the older service standards while there is demand, we see FHIR rapidly eclipsing those standards for both fine-grained request/response services and for moving larger–grained structured documents.”

FHIR, which stands for Fast Healthcare Interoperable Resources, is being developed by the international standards organization Health Level Seven (HL7), which has lauded it as “a next generation standards framework” suitable for creating connections between health IT tools and mobile phone applications and cloud communications. FHIR is expected to lay the groundwork to allow health-care organizations to more easily integrate health data in their electronic health record systems with mobile applications and medical devices.

Lacking Security

HIMSS, in a letter separate from the EHRA's, said the ONC's standards advisory doesn't include enough standards for securing EHRs and other health IT from cyberattack.

HIMSS said the ONC should consider adopting standards for security controls such as authentication, audit logs and risk assessment. The group recommended standards developed by the National Institute of Standards and Technology (NIST).

To contact the reporter on this story: Alex Ruoff in Washington at

To contact the editor responsible for this story: Kendra Casey Plank at


Request Tech & Telecom on Bloomberg Law