My name is Edward Larsen. I am an independent business strategy consultant with over 25 years experience in the healthcare information and medical technology industries. I am here representing the Healthcare Information and Management Systems Society (HIMSS) and our analysis of the Summary and Analysis of Terminology Questionnaires draft report of March 25, 2003, but within the broader context of NCVHS' mandate concerning the Patient Medical Record.1 I also should note that I prepare a bi-monthly analysis of interoperability standards initiatives, the Standards Insight, which HIMSS provides to all its members. HIMSS is the largest membership organization representing healthcare information systems users, vendors and consultants.
We applaud the Subcommittee and the report for providing a solid framework for analyzing one of the most thorny and longstanding issues in healthcare informatics. However, we would offer several points for further analysis. And more importantly we would like to ask a fundamental question: for what purpose is this analysis and report and the eventual "recommendations" to HHS being made? We will address these issues in reverse order.
Let us assume that the analysis of candidates for a "Core Terminology Group" correctly identifies the scope, technical merits and administrative requirements for a national standard medical terminology. Does that move us any closer to a universal electronic Health Record (EHR)?
It may not. Within the healthcare information technology industry, primary and secondary EHR users and citizen/patients in general have not agreed on a definition for a universal EHR. Or, perhaps we are simply able to perceive many diverse functions from the conceptual EHR. In our recently published Standards Insight for April 2003, attached as an appendix, we examined the issue of definitions and functions.
If, as we maintain, we do not know what the EHR/PMR and its system are to be in the United States, then will the impending recommendation be useful for this purpose? If your recommendation to HHS is to "encourage" adoption of a core terminology group and this encouragement is an essential and timely step in developing the EHR, then it eliminates alternatives and freezes technology, which quite frankly are in great flux as we begin to see the possibilities of the "semantic web", distributed ontologies, and alternative structured documents.
If, on the other hand, a recommendation to HHS for a core terminology group is not on the critical path to the EHR, then why proceed now to fix in time and space that which is not yet needed? In that case market pressures and EHR initiatives will make the selection clear. We strongly commend NCHVS in its previous messaging recommendations for recognizing the need to accommodate "emerging" standards.2
Clearly your hearing today would rule that defining the purpose of and producing the business case for the EHR/PMR as out of scope. However, we submit that the decision on recommending a core terminology group has significant impact on progress to an EHR/PMR.
First, we all recognize that concepts embodied in codes and terminology are but one component of a medical record. These must be put into context through structure and embodied in a secure system. The more semantic meaning that is contained in the code the less that is required in the structure and vice versa. While NCVHS has looked at structure as provided in messages, it has not looked at structure provided by documents, e.g., the EHR. However, by anointing a coding scheme of great strength to terminology purists and this report reflects such expertise, without consideration of the other components of context, structure and system, one may negatively impact standards development elsewhere. For example, if one knew in advance that SNOMED CT were the recommended general code set for the EHR, one might well develop the EHR document and structure differently than if one were deliberately agnostic about the capabilities of the coding system. This becomes a real issue when looking at international standards initiatives where code sets, of varying capabilities, are matters of realm choice. While this may not be a reason for the U.S. to defer its choice of code sets, we do need to understand the impact on other standards necessary for the EHR.
Second, without explicitly defining the purpose of the EHR and making it viable by addressing the business case), we do not know the value of the code set. For example, if one viewed the EHR as a container in which to transfer an individual's care records from one provider to a new provider, one might not need comprehensive codes except in some well-defined summaries, e.g., current prescriptions. Or if we wanted to insure rapid recognition and transmission of emergency department and physician office encounters with potential public health or bioterrorism-induced markers, we might want a different clinical code set than that used for capturing data for long-term quality outcomes studies. Moreover, do we impose coding on those who create medical records, which are after all the best source of a concept, or do we envision post-capture natural language processing, coding and mapping? These will have great impact on costs, scalability, usability and system design. Should we know the se things before recommending a core terminology group?
As noted at the outset, we believe that the report has done an excellent job at quantifying and making an objective evaluation of existing terminology and code sets. However, in reading the draft report we were not able to discern whether this analysis confirms a single general code despite obvious limitations or recognizes that there is none currently available.
While we would leave it for more knowledgeable informaticists to determine whether the criteria and weightings are valid, we note that it is a purist view of technology to eliminate any code set with a NOS (not otherwise specified) entry from further consideration. We are more concerned that the analysis and ranking were focused on the technology, which is not our limiting factor - at least not for the EHR. Defining the purpose and business case are the limiting factors and the criteria that impact these are not presented or considered in the analysis. In fact one might be willing to trade off "NOS" for financial viability, market acceptance and open consensus process versus a more closed process.
NCVHS has made important decisions in regards to PMR messaging standards, which we believe will serve it well as it moves forward. In its letter to the Secretary in February 2002, NCVHS recommended that HHS provide (these standards) as guidance rather than mandates and it clearly recognized the trade-off between what is current and what is emerging.
Currently the time may not be right and there may be too many EHR initiatives in play to make recommendations for national standard medical terminology. Certainly we would anticipate that any recommendations be based on further resolution of the administrative, market acceptance, intellectual property and cost issues.
We note parenthetically that vocabulary and code sets are not as large of an issue when used within enterprise clinical information systems. In most cases, an enterprise, whether a system of hospitals or an integrated delivery network, has chosen a preferred EHR/CPR vendor and system for use within its own organization. This choice and its implementation generally define the structure and codes used within the enterprise. Mapping among sub-systems may be necessary but is done within the confines of one organization. Standard code sets become more of an issue when the enterprise must send EHR derived data to an external organization, e.g., a claims attachment, or transfer the record to a new provider. For well defined functions, such as reimbursement, there are well established, if not well crafted, code sets, such as ICD or CPT. There are also standard codes used for prescriptions and EDI. In many cases these represent silo applications that integrate vertically but not horizontally. All of these functions could be subsumed into a universal EHR, which would require the national standard medical (and other domain) terminologies. However, the current market and vendor focus is on the enterprise and its internal process and workflow improvements not on global issues. This speaks to the need for defining the business case for a universal EHR. Thus for example Integrating the Healthcare Enterprise (IHE) which is a standards implementation initiative sponsored by HIMSS and the Radiological Society of North America (RSNA) has not been forced to address use of general medical terminology and code sets in its EHR project, at least yet, partly because its use case is internal to the enterprise. That is not to say that vendors would not appreciate standard codes if they did not create competitive disadvantage, nor restrict their ability to add-value to end-users and could be used internationally.
Thank you for the opportunity to present this testimony. As a strong advocate of data standards initiatives, evidenced by our co-sponsorship of the IHE initiative since 1998, HIMSS is gratified to see the progression of your work. Our commitment to standards based activities is also demonstrated by our memberships in HL7, ANSI-HISB, NAHIT, annual sponsorship of the Nursing Terminology Summit, and our recent appointment as the Secretariat of the ISO Technical Committee 215 on health informatics standards. As a recognized organization of expertise in healthcare information legislation, regulations, policies, standards and practices, HIMSS continues to dedicate resources towards data standards activities. Uniform adoption of data standards in healthcare is critical to our vision of advancing the best use of information and management systems for the betterment of human health. We look forward to working with other industry leaders and the Sub-Committee on Standards and Security to further this cause.
HIMSS (Healthcare Information and Management Systems Society) is the healthcare industry's only membership organization exclusively focused on providing leadership for the optimal use of healthcare information technology and management systems for the betterment of human health. Founded in 1961 with offices in Chicago, Washington D.C., and other locations across the country, HIMSS represents more than 13,000 individual members and some 150 member corporations that employ more than 1 million people. HIMSS shapes and directs healthcare public policy and industry practices through its advocacy, educational and professional development initiatives designed to promote information and management systems' contributions to quality patient care. Visit www.himss.org for more information. HIMSS. The Source for Healthcare Information.
1 I will use the term EHR/PMR to represent the concept of patient medical record as the electronic health record since PMR interoperability only makes sense in the context of an EHR system that moves the PMR or some of its components between systems, rather than remaining a file on single computer.
2A great strength and great weakness of HIPAA Administrative Simplification is that it must use existing standards, which by definition reflect past development efforts. Use what works. What is not yet clear is how this approach will accommodate and encourage new and different standards. In some respects we can compare this to the lasting impact of 1960's Medicare cost accounting "standards" which still underlie most of our cost accounting systems.