The Centers for Disease Control and Prevention (CDC) would like to thank the Subcommittee for Standards and Security of the NCVHS for the opportunity to present our comments on the issues of standards for Patient Medical Record Information (PMRI). I am Steven Steindel, a Supervisory Health Scientist with the Division of Laboratory Systems, Public Health Practice Program Office, CDC and am addressing this subcommittee not in my capacity as a health systems researcher but as CDC liaison to several standards development organizations. In that capacity, I have had the opportunity to interact with many in this room, and also those implementing programs at CDC, concerning the need for standards that allow interoperability between systems.
CDC has a unique perspective on the standards process. In general, we are neither a producer nor a consumer of data. For example, we have responsibilities for protecting the public from infectious diseases, preventing chronic diseases, prompting healthy behaviors, preventing environmental exposures, understanding injury prevention, preventing workplace injuries and tackling toxic exposures. We perform most of these functions through our partners, generally at the state and local level, which are the true consumers of the data. Not only do we look for standards that function at the site of data generation, but we look for standards that will allow the information to transfer without change in meaning though the system. Eventually, this data reaches CDC programs where our epidemiologists perform their function of understanding the distribution and determinants of health-related states in specified populations and apply this knowledge to control the health of populations.
CDC has had years of experience in operating electronic disease reporting and surveillance systems. In 1995, an internal report discussed the inability of these systems to communicate outside of their limited program areas and urged CDC to develop standard systems for data collection, analysis and dissemination. Drs. Broome and Koo have addressed the NCVHS in the past about our activities, and in the future more specific updates than mine are planned. Our current efforts focus on using infectious disease surveillance as a model for developing the National Electronic Disease Surveillance System (NEDSS). CDC has funded 46 states, three cities and five public health partner organizations this year at various levels for NEDSS related activities.
When I started at CDC in 1993, the number of people, outside of the business office, who knew of electronic data interchange was very small and those formally trained in informatics even less. Today, people with those skill sets are integral in CDC programs. A training program for Public Health Informatics now exists. The Office of the Director now has an Associate Director for Informatics and a Senior Advisor for Integrated Health Information Systems. Our partners are mirroring these developments.
This background is meant to show that CDC has developed an intense interest in standards at all levels and expresses that interest, in part, through a critical analysis involving our needs and those of our partners. We have participated in all phases of the development of the PMRI report to the Secretary, and Dr. William Yasnoff has been our key representative as part of the support staff. Given that level of involvement, we find little lacking in the report’s broad recommendations. Today you ask us to focus more specifically on details of implementation of PMRI standards. Not being a standards development organization, we limit our comments to the draft criteria and proposed PMRI transactions.
CDC reporting systems include requirements for reporting that specifically describe data quality, accountability and integrity, and our programs frequently include information based on analysis of data collected, primarily through the Morbidity and Mortality Weekly Reports. Hence, we consider these attributes axiomatic in any PMRI system. Without them we would have difficultly doing a trustworthy job of describing and protecting the public’s health. We do not anticipate any deviation in our use of the terms accountability and integrity from the way they are used by others.
Our use of data quality, however, may deviate from that commonly used. First, it does not generally refer to the accuracy of data for administrative purposes, though we use these data in our vital statistics programs. It refers to the clinical accuracy of the data and then extends that description to include other attributes of the event that are described in our various case-finding/description documents. While public health does not expect more initially from the PMRI than a better case finding tool, we do hope that it will ease our burden in identifying and studying cases of public health importance by providing better, hopefully remote, access to more complete data.
Data operability and interoperability share in the next level of importance. Public health has awakened and realized that decisions today are expected and needed rapidly. In a bioterrorism event, the requirement might be instantaneous, and for a swimming pool outbreak of E. coli 0157 it might be days. Clear, complete electronic communication between providers and public health, and within public health, is now recognized as the most effective way to achieve this goal.
Public health has always had a need for rapid communication, and we need standards describing mechanical connections that allows for clear communication channels, sent in a secure fashion throughout the system at any time. We view security as integral to a communication system so that we can assure patients of the protection of their very private data. On our end, we will maintain and extend confidentiality systems already in place that allow the security systems to function.
Outbreaks do not stop at geographic borders. We expect our monitoring of those borders to increase in the future and require interoperability to achieve that goal. In our experience to date, however, we are seeing that the needed interoperability is difficult to achieve. Our intent is to adhere to industry standards for both transport and the format of the message. Our focus on transport systems is the Internet, but we find a complex mix of similar systems to envelope, address, encrypt, authenticate, and verify the integrity of the message, and we need to work with others to resolve these differences.
Our emphasis on format is HL7. We, like many others, are having difficulty expressing our clinical needs within the message framework of Version 2 and await the release of Version 3. Like HL7, we are looking toward XML to better express our needs. We do not see an easy solution to the question of message interoperability without an adequate clinical model that allows us to relate similar concepts. We are using XML to relate clinical concepts in the HL7 Reference Information Model (RIM) to our developing Public Health Conceptual Data Model with great success. Meanwhile, we are putting systems in place through what are commonly called interface engines to allow us to function in a world of dissimilarity. Given the time it takes to replace legacy systems and realizing that today’s systems are tomorrow’s legacy systems, we do not see the elimination of these translators.
Data comparability represents our ability to understand what we receive primarily from the private sector. Within public health, we work with our partners to achieve data comparability and, excepting the usual time lag in any consensus process, do not foresee difficulty. The PMRI report illustrates quite clearly the problems we face in data comparability from the private sector in sections C.1, Interoperability and C.2, Comparability and we would like to mention the following specific points:
Naturally, in the world of interoperability we envision above, we expect all this to be done electronically and are focusing on XML to provide the syntax to allow us to express these needs.
CDC is and will continue to be a major payer for our partner’s data systems. We are concerned about the implementation cost required to connect these systems to a PMRI. Our current concept is to develop once to common standards and use many times to reduce costs. We would like external interfaces of PMRI systems to allow us to continue to use this approach. CDC is also concerned about the selection of standards with reasonable implementation costs so that the reporting of public health information does not require burdensome additional expenditures by our partners and data sources. In fact, our expectation is that the widespread use of standards and electronic reporting should materially reduce both cost and time required for public health reporting.
The other criteria listed, market acceptance, consistency with other standards, and timely development, we view as having lesser but very real importance. Many of these we see as having more importance in the clinical or private sector.
For the last few moments, I would like to discuss the proposed list of PMRI transactions. CDC presently focuses our highest priorities on the first four: admission/discharge/transfer, laboratory order and diagnostic study information, laboratory and diagnostic study results, and treatment/medication orders. Of the others, we are finding prescription information to be an interesting case-finding tool and see it becoming more important. Documentation naturally would help in our remote investigation of cases, particularly if it was structured to provide the elements of our case definitions. Several of our programs, such those dealing with tuberculosis, have needs for radiological images. Our developing programs in emergency department monitoring and bioterrorism have needs for vital signs. We now use charge (administrative) information to help describe the nation’s health and access to health services but view it as surrogate data. We are hoping that more complete access to actual clinical information in the PMRI will make our use of this data unnecessary. In summary, we have real needs for all of the transactions mentioned, but in reality we are most interested in the subset of these transactions that relate to surveillance data that allows the integration of the PMRI to our case definitions and directly to public health surveillance.
Development of PMRI standards is a complex task. Our needs at CDC illustrate the inter-relationship of the various components of the system. Our limited experience shows that all our needs will not be meet by standards. Implementation of the PMRI standards should focus on meeting the needs of most users. Questionnaires and hearings such as this one allow the identification of those standards. Once key standards are identified, the standard development organizations should be charged with producing them. In the charge to them, they should be told that a standard that will meet most of the users’ needs in a timely fashion is required. Testing and refinement of the proposed standard will extend its utility. Once we apply these criteria, CDC believes we will identify a set of existing transactions for the PMRI and these can be implemented rapidly as “low hanging fruit.”
Our NEDSS effort has a long-term objective of developing closer integration between public health and the health care systems, which should lead to improved provision of health care as well as public health. Those working on NEDSS see the connection to the PMRI as vital to future success. We thank you for the opportunity to comment on your developing process.