CIC Overview CIC Introduction and Overview (Current Draft)

Health Level Seven (HL7) Clinical Interoperability Council

Overview

Background Early efforts in creating health data standards in the Information Technology community were lead primarily by the vendor community with strong encouragement from the provider community. That was appropriate, because most of these standards addressed technical issues related to interfacing best of breed systems or transmitting transaction data for reimbursement. We have progressed far beyond that beginning. Current standards are addressing data items, electronic health records, data flow, clinical decision support, research and other topics related to content and use of clinical data. These are driven almost exclusively by persons who are technical experts but are limited in patient care experience and knowledge. Fortunately, the clinical communities are becoming aware of the need for clinically oriented health data standards such as data elements and associated terminologies and have begun independent efforts to creating these resources. There are over 50 groups who have active projects in this specific area. Unfortunately these efforts are not coordinated; often lack technical awareness and the overlapping and inconsistent results defeat the goals of semantic and functional interoperability.

Objectives The purpose of Health Level Seven’s newly formed Clinical Interoperability Council (CIC) is to bring the healthcare community together to coordinate the process and form of developing content and clinical functionality standards for the entire health community. HL7 is recruiting from all the professional clinical specialty organizations and other appropriate groups (such as the US National Institutes of Health and the Clinical Data Interchange Standards Consortium) to participate in defining the processes, generating clinical content and influencing the dissemination processes critical to true interoperability.

Each clinical group is requested to identify 2-5 individuals to represent their clinical domain in helping to define the shared methodology, lead their organizations contributions, and advocate the production and use of health data standards. Largely, the work in the clinical domain is expected to be performed within the regular forums of the clinical society, consistent with agreed procedures, and delivering the products into a common resource. Across domains, the overlaps, interfaces, key decisions, and shared issues will be dealt with at HL7 meetings following proven, well documented, decision making practices. Further, common interests and future projects will be identified and defined at these joint Council meetings. The first of such meetings is scheduled at the HL7 Plenary meeting in Atlanta, Georgia on September 20, 2007.

Importantly, the Clinical Interoperability Council is expected to deal only with clinical content and other clinical aspects of the standards being created. The products of the CIC will then be passed into the “technical” part of HL7 to populate the appropriate standards. We believe that it is important to focus the CIC only on the clinical component and not try to make informaticians or technologists of this community.

Initial Focus Interoperability absolutely depends on having precise, unambiguous, atomic terms with a full set of attributes including name (terminology), definition, data type, units, value set and other attributes. If a master set of these data elements are defined and maintained, most of the impediments associated with obtaining interoperability can be overcome. A given organization would not be expected to use all of the data elements, but any group would first look to data elements that are defined in the master set.

We propose that the initial activity of the CIC be the creation of a master set of data elements. Initially this will include creating a well documented set of procedures, inventory of existing collaborators, initiatives and resource tools to support the creation and loading of data elements and terminology into a shared repository - significant experience exists that will expedite this phase. Then the terminology and data elements generated and robustly defined by the clinical organizations will be compiled, enabling electronic dissemination, usage and integration with data models and technical standards.

It is important to note the value, methodology, necessary collaborations and technical validity of these activities have already been experienced. Examples include: • CDISC - The Clinical Data Acquisition and Standards Harmonization (CDASH) effort has been particularly successful, widely collaborative and productive program developing clinical data elements and terminology common to research studies. • Anesthesiology: The International Organization of Terminology in Anesthesiology (IOTA) has been very successful developing controlled terminology. • Cardiology: Significant work has been accomplished within the clinical community, for example generating consensus-based data standards, care guidelines and quality programs lead by the American College of Cardiology and American Heart Association. Additional work in publishing data standards in relation to HL7, CDISC and Domain Analyses Models is underway. • Tuberculosis: A broad set of stakeholders are participating in the development of a Domain Analyses Model along with common data elements, data collection forms and HL7 and CDISC usages. • Emergency Medicine: The Data Elements for the Emergency Department (DEEDS) group has a mature set of data elements and has made significant contributions to the emerging EHR requirements. • Pediatrics has provided an excellent example of work done within the HL7 organization contributing to EHR requirements and technical standards from a clinical domain perspective.

Conclusion The CIC is anticipated to become a very important group in influencing policy as well as methodology decisions in the area of health data standards. Future activities might include defining data element sets transmitted based on clinical workflows, (such as an acute cardiac patient being transferred from a community hospital to a fully equipped cardiac care center), or the content and knowledge definitions for decision support algorithms, disease management protocols, query scenarios and information flows.

Fostering the interactions between this clinical community and the technical activities of HL7 are critical. The CIC must leverage the success and technical knowledge of the HL7 organization while supporting clinical experts in understanding what and how to influence the content of standards. There are already several groups within HL7 that would interface with the CIC. These groups include the Electronic Health Records, Vocabulary, Patient Care, Structured Documents and Regulated Clinical Research Information Management Technical Committees, as well as existing a number of clinical domain specialty Special Interest Groups representing Cardiology, Anesthesiology, the Pediatrics and Emergency Medicine. The CIC is expected to compliment and serve as additional resource to the many activities already underway in HL7.

It is necessary that the community come together in a coordinated effort to generate a single, interoperable product to solve a critical problem we all share. With the proliferation of initiatives time is important. HL7 provides an open consensus-based process and your leadership, support and contributions are valuable.