HL7 preparing for EHR functional model upgrade

CHICAGO—With more than 30 Health Level 7 affiliates, it’s an international effort to update healthcare standards, said R. Lenel James, MBA, senior project director at the Blue Cross Blue Shield Association and member of Health Level 7’s Electronic and Personal Health Record Work Groups, speaking at the 84th American Health Information Management Association’s (AHIMA) Conference & Exhibition.

There is a wide range of standards covering clinical practice, administrative tasks, research, electronic claims attachment and public health, among other topics.

The EHR is the underlying, logical patient record, James said. “It may be longitudinal or episodic, but it is a physical thing that has data elements." An EHR system provides functionality to maintain and update the record, and accomplish various clinical, research and business requirements. “It could be monolithic or be a system of systems.”

The functional model summary was first approved in 2007 and is now undergoing its first major upgrade to release 2.0 (R2). The published standard is expected in March 2013. The model does not mandate messaging, design or implementation specifications but is a system specification with a reference list of functions that may be present in an EHR system.

The original release was passed to the federal government as the foundation for the current Meaningful Use certification program. Those behind R2 efforts have had discussions about getting it into Stage 3 so that the next generation of EHRs will feed into the Meaningful Use effort, he said.

R2 offers significant changes, James said, including reorganized chapters and much more granularity. There is a chapter on overarching criteria, enhancement and enforcement of the glossary, an increase in the number and granularity of conformance criteria and an increase in the number of functions and profiles. Interoperability and lifecycle models are merged into the model so it now reflects functions and makes sure the system supports better interoperability.

A new conformance clause is an important concept that “ties to certification and how to actually understand and use the model as we built it,” James said. It defines the minimum requirements for functional profiles claiming conformance to the EHR system functional model. Since this is an international model, the workgroup wanted to make sure it worked anywhere in the world. For example, you won’t see HIPAA mentioned other than as an example but “the U.S. profile would be very clear about the HIPAA standards required.

No entity can claim conformance to the model, James explained, but rather to a profile. Functional profiles vary depending on the domain, such as small hospital, integrated delivery system and even vendor. “We also realized that sometimes you want to talk about something that doesn’t involve the entire system, such as clinical research.”

The glossary is not officially part of the standard but serves as guidance for preparing and interpreting HL7 functional profile specifications and conformance statements. “The goal is to promote clarity and consistency when interpreting and applying the text of the HL7 EHR system functional model.” The R2 glossary has undergone a complete review and is more complete, including all terms used in the model, he said.

An action verb hierarchy was redeveloped and extended from a simple list of definitions contained in R1.1 to add extensive discussion on how key terms are used in the functional model. It now includes 238 active terms and 56 deprecated terms.

The data management category, for example, has action verbs for the complete range of data-handling actions conducted by a system. That includes capture, maintain, render, exchange, determine and manage data visibility.

Every function in the functional model is associated with a set of conformance criteria. R1 had 972 performance criteria while R2 has 2,310. “I’m sure we’ll still be more than 2,000 criteria but I’m hoping we don’t break 2,500” when all is said and done, James said. The largest category, trust infrastructure—“behind-the-scenes mechanics”—contains 681 criteria.

With wireless, print and other channels, communication is a much more sophisticated process now, James said. On-call location, for example, would be expected to be in a large hospital system’s profile but probably not that of a small practice. “These are the kinds of decisions people make when doing profiling with this model. Managing the practitioner-patient relationship has gotten more complex based on the setting.”

R1 focused on records, record entries and record management, James said, including which is the record of truth, how clear are duplicates and how to match when the wrong data are merged. R2 includes lots of description on how to handle data and the kinds of things to look for in a sophisticated system handling those kinds of challenges.” Lifecycle used to be its own separate standard but the EHR system functional model should be concerned with recordkeeping, including retention, transmission, disclosures, reidentification and deidentification. An EHR system can do that depending on how sophisticated it’s been managed and tracked, he said.

When asked whether any data is not supported by this model, James said “there probably will be something we hadn’t thought about.” But, new items and technologies can be added, including a description and how the EHR should react to it. The model allows for the adding of new functions and criteria. “If there is a new app, hopefully we can put it in our function on getting data from mobile devices.” A chapter describes how to build functions or add to one.

The functions are quite logical, James said. “We had people join the committee and by the second call, they’re productive.” The system is based on things people are already doing and “we just put them into a logical construct. Most people, when they start reading the model, they understand it. They learn where to put things because they weren’t in a logical sequence of workflow before. They can ramp up to speed fairly quickly with a two- to four-month effort.”