Cerner Corporation would like to thank all members of the Sub Committee on Standards and Security for giving us the opportunity to present the following information to you. We hope that our comments allow the sub committee to move forward with the goals of the National Committee on Vital and Health Statistics.
Cerner Corporation is a visionary leader in providing information management systems designed to improve healthcare. Cerner’s clinical and financial applications enhance the managerial efficiency and clinical effectiveness of healthcare delivery worldwide. Cerner designs all of its solutions to accomplish one mission: to connect the appropriate persons, knowledge and resources at the appropriate time and location to achieve the optimal health outcome.
Cerner Corporation would like to offer the following opinions about the strength, weakness, and appropriateness of healthcare message formats standards. In general, Cerner Corporation is in favor of any technology that will reduce IT costs for our clients and potential clients. We are not convinced that the idea of tightly regulated transaction and message formats without data content definitions will reduce costs for our clients. Specifically, when the transaction or message formats do not require corresponding data content definitions, the benefits of standardization cannot be achieved. We believe that data content standards are needed before standardized message-structured formats can be developed and implemented efficiently in the marketplace.
To begin Cerner Corporation would like to offer the following general observations regarding the body of currently available standards.
Regulations have helped with message and transaction formats, but the lack of specific data content references or standards as a part of these regulations has caused additional confusion, delay and costs. One obvious example of this is the confusion created by the delay in finalizing the National Person ID number as part of the current HIPAA regulations.
Cerner Corporation offers the following comments related to the specific standards listed in the written request.
The HL7 Version 2.x standards are the most requested standard from Cerner’s current clients. This standard is highly market driven, but it is important to note that currently no site is pushing to the HL7 Version 2.4 standard. A majority of the provider sites currently supported by Cerner are HL7 Version 2.1. An important note also, is that other countries are using the HL7 standard but with a specific tone. An example of country specific implementation would be the ‘Australian HL7 Implementation Guide’, which includes a citizen ID number.
The major weakness of HL7 2.x in addition to the variation created by the number of versions (2.1 to 2.4) is that HL7 is primarily a message format, which defines very little in the way of data content standardization.
The strength of the HL7 2.x standard is current scope of implementation, which has been achieved in large part by not being rigid about the interpretation of standard. This lack of rigidity has resulted in a standard that is broadly adopted by suppliers and deployed in the marketplace. This lack of rigidity is also a weakness because no two implementations of an HL7 interface by the same two suppliers are ever the same and thus many of the benefits of standardization are lost.
The major weakness of HL7 version 3.0 is that it has not yet been proven and thus is not yet ready to be considered as a major national regulatory requirement. Balloting by HL7 for version 3.0 was completed at the end of September 2001 and as expected was not passed. When version 3.0 does pass the ballot, we do not expect adoption by healthcare organizations or suppliers for several years. When adoption begins we do not expect that any of the over 3500 interfaces currently in use by our clients will be retrofitted to this new standard due to the costs involved and the lack of specific benefits.
The strength of HL7 version 3.0 is that this standard uses object oriented modeling to create a standard, which is both more flexible than version 2.x from an implementation perspective and more rigid from a programmer perspective. Version 3 is also an improvement in the area of data content definition, however it is still not robust enough for a plug and play implementation process.
This standard exhibits virtually no support in the current market. We believe there is only one supplier (Siemens) that has introduced a line of respiratory ventilators to the market supporting this standard. We believe this standard is too rigid, encompassing specific hardware that is not widely available, prohibiting widespread adoption. The hardware specifications outlined in the standard are too expensive for many of the suppliers to implement in low cost bedside devices. At this time Cerner does not have an interface to a 1073 device, and has not had a request for one.
Our current clients have not requested this draft XML standard, thus we cannot comment on the standard or the implementation of ASTM E31.25.
Again, Cerner has not received any requests for this standard for the past several years. It is our belief that these two standards are not a significant force in the current market.
In summary, Cerner Corporation would like to see standards for data definition and content, via a controlled medical vocabulary prior to any regulations regarding the format for clinical data messages. A consistent controlled medical vocabulary would not only benefit the message format standards explored in this document, but is key to the portability of medical records required by our mobile population, and more importantly, is the key to comparable outcomes data that is required to improve the quality of the care provided. Unfortunately, there are currently no well-accepted standards for a comprehensive controlled medical vocabulary. There is a body of work defined by the UMLS and a body of work defined by SNOMED that represent the best efforts in this area to date.
Cerner Corporation would like to recommend that the Department of Health and Human Services consider investing in the creation of an affordable controlled medical vocabulary in synchronization with UMLS and SNOMED.