Ed Hammond, PhD
Professor, Community and Family Medicine
Chief,
Division of Medical Informatics
Duke University Medical Center
Durham,
North Carolina
Chair of Health Level Seven Executive Committee
My name is Ed Hammond. Thanks you for the opportunity to appear before this subcommittee as a representative of an ANSI approved Standards Developer Organization. I have been involved in standards activities since the early 1980s. I have been involved with HL7 since its beginning in 1987. I served as Chair of HL7 in 1991 and I am again serving as Chair of HL7 for the period of 1996-1997. I also am a developer of a clinical information system at Duke Medical Center. I have implemented HL7, ASTM, X12N, and NCPDP standards. Duke Medical Center has over 75 different HL7 interfaces and the number continues to expand. I am active in several professional organizations and have been a member of the NLM Integrated Advanced Information Management Systems (IAIMS) review team.
Health Level Seven (HL7) is in its tenth year of developing data interchange standards. The domain of focus is the exchange of clinical data and related areas. The current membership includes approximately 400 organizational members and over 1600 individual members which represent the community of vendors, consultants, health care providers, professional organizations, and interested individuals. Approximately 90% of the vendors in the clinical information system market offer the HL7 interface. On the provider side, HL7 interfaces are required in most Request for Proposals. The most recent HL7 Working Group meeting had over 350 persons in attendance. HL7 has met jointly with and has letters of understanding with ACR/NEMA DICOM, ASC X12N, ASTM, IEEE MEDIX and MIB, and NCPDP. HL7 has established working relations with CORBAMed and the OMG, CPRI, WEDI and others. HL7 works closely with many of the Working Groups of CEN's TC 251 Medical Informatics Standards organizations in Europe. We currently have formal International Affiliates in Australia, Canada, Finland, Germany, Netherlands, and New Zealand. Other countries having an interest in HL7 include Japan, Korea, Singapore, Malaysia, Mexico, Brazil, Chile, Israel, Georgia, Poland, and Russia. Version 2.2 has been translated into five languages.
Version 2.2 of the HL7 standard was the first ANSI accredited American National Standard in the healthcare domain. Version 2.3 has just completed the final balloting cycle. This version considerably expanded the domain of the standard. Version 2.3 supports Admission/Discharge/Transfer, Patient Administrative Documentation, Orders, Result Reporting, Clinical Observations, Medical Record Management, Transcription, Scheduling, Clinical Trials Reporting, Adverse Event Reporting, Financial (including UB92 and HCFA 1500), Automated Waveforms, Patient Care, and other areas.
1. What are your organization's expectations for the results of the Administrative Simplification standards requirements in the Health Insurance Portability and Accountability Act of 1996 (HIPAA)? In what ways will the outcome affect the members of your organization, both positively and negatively.
The Health Insurance Portability and Accountability Act of 1996 will potentially have the greatest impact on health care information systems and consequently on what those information system will do than any other act thus far. Beginning in the mid 80's, the market alone created an interest in creating standards which would encourage the integration and exchange of data among various systems and organizations and reduce the costs and efforts of those interchanges. The process was slow - convincing competitors to work together and share proprietary information took time. Clinical Information Systems, including Hospital Information Systems, Laboratory Systems, Radiology Systems and Pharmacy Systems, were largely independent from accounting systems. Driven by a need to solve a specific problem, several Standard Developer Organizations (SDOs) were created and developed standards within that area of interest. At the present, most organizations support this suite of standards as necessary.
The distinction between clinical and accounting systems is rapidly disappearing. Care must be taken to insure that the standards recommended by the NCVHS are not limited in vision and accommodate clearly defined clinical data interchange standards as well as standards which support the business requirements relating to benefits, claims and reimbursements. The most effective standards are created by the experts in the field. Creating image standards is best done by individuals knowledgeable in the technical and clinical applications; creating clinical data interchange standards is best accomplished by vendors and healthcare providers experienced in what is required.
We also expect NCVHS to be visionary in broader domain of standards it recommends to meet the requirements defined in P.L. 104-191. The attachments mentioned in the bill in the broadest sense will be the clinical record or components there of. The data required for performance evaluation and quality assurance will clearly be clinical data. Increased interest in decision support and knowledge management will require unambiguous exchange of clinical data elements. NCVHS has the opportunity to short cut the time and cost of producing these standards by recognizing and acting on this need now.
Finally, we expect NCVHS to anticipate changes in technology and how that will affect data interchange standards. HL7 is currently developing an object-oriented reference information model which will be used to develop Version 3 of the standard. In 1996 HL7 invested over $100,000 to complete the definition of the new methodology and to provide a foundation model upon which the organization can build. Already commercial systems are being developed to provide object request brokered messages using CORBA and OLE/ActiveX in addition to the text messages. HL7 has created Special Interest Groups in
We urge this subcommittee to recognize the importance of other related standards. Interoperability without negotiation requires all options at all levels to be specified. It is likely that most data interchange, for what ever purpose, will use the internet/intranet technology. Identified standards must be compatible with this technology. An important organization is the Internet Engineering Task Force and should be invited to discuss its activities with this subcommittee.
2. Does your organization have any concerns about the process being undertaken by the Department of Health and Human Services to carry out the Administrative Simplification requirements of this law? If so, what are those concerns and what suggestions do you have for improvements?
In general, HL7 supports the stated process of carrying out these requirements. We do, however, have concerns that DHHS fully understands the varied set of issues and consequences of decisions. From the market perspective, the millions of dollars which have been invested in existing standards and the work in creating standards which are workable should not be ignored. The work of the experts which was required to produce those standards should be recognized and changes to those standards should be made with caution. Standards also require maintenance, updating and distribution. HL7 has worked with HCFA (for HCFA 1500 and UB92 data interchange standards), the VA and the CDC.
Committees making these recommendations have varied levels of understanding in the standards process. These members should be educated in the area of standards so that informed decisions can be made. The importance of easily available and freely distributed standards must be appreciated.
3. What major problems are experienced by the members of your organization with the current transactions specified under HIPAA? For generators of data, how readily available is the information that you need to provide for the transactions and how meaningful is that information from a clinical perspective? For users of the data, are you receiving the information you need from the transactions to pay the bill, manage the care process, etc., and what is your perception of its quality?
The HL7 standard has evolved over five versions of the standard. This evolution was driven initially by developing the technology of the standard and by meeting the immediate needs of the members of HL7. In time, HL7 reached out to address other domains of interest and continued to address the more complex issues in the exchange of data. In some ways, HL7 could be defined as a "just in time" standard. Backwards compatibility is an issue which must be fully understood. The balance between the economic stability provided by backwards compatibility and taking advantage of new technology, better understanding and experience is a critical one.
HL7 provides the general framework to exchange most clinical data. Lack of a common reference model, common data elements, and a common clinical vocabulary mandate negotiations between systems who wish to exchange data. HL7 is moving ahead to solve these problems.
HL7 recognizes the importance of unique identifiers for persons and organizations; of a comprehensive clinical vocabulary; of a common data model; of acceptable and realizable solution to security, privacy and confidentiality issues. We are committed to working within HL7 and with other groups to provide and implement solutions to these problems. Data quality, an area in which neither methods of assuring or metrics for measuring have been defined, is extremely important in making exchanged data usable and acceptable.
4. How can the goal of administrative simplification best be achieved while meeting the business needs of the stakeholders?
The business needs of the stakeholders are best met by having clearly defined standards which are used and supported in the market place. Consensus standards, while painful and time-consuming to achieve, are important in representing and meeting the needs of the broad community. Health care provider needs are balanced against vender competitiveness. Interfaces have dropped from the ten-thousands dollars range to the thousands dollars range. It can and must continue to drop to the hundreds dollars range.
Organizations requiring reporting through the use of a standard must comply with the standard. The cost of dealing with state-level variations in the HCFA 1500 and UB92 standards is costly. Most vendors are required to develop one or more versions of programs supporting these standards for each state in which their product is used. Standards must have no local variations to realize the money savings afforded by standards.
It is important to note that no one standard organization provides the expertise to address all the needs of health care. Several existing standards are proving to be effective in the market place.