Oral Statement to the
National Committee on Vital and Health Statistics
Members of the National Committee on Vital and Health Statistics, as the Internet2 lead for Health Science initiatives, I would like to thank you for the opportunity to be here today to discuss the criteria for selection of Patient Medical Record Information (PMRI) standards. My past experience with a variety of healthcare standard development organizations, and with implementations of healthcare application systems, has given me a broad perspective on criteria for PMRI standards. As a past chair of the Object Management Group (OMG) Healthcare Domain Task Force (the organization formerly known as CORBAmed) and the current OMG Healthcare liaison to ISO TC 215 (Healthcare Informatics), I have had the opportunity to explore many aspects of advanced healthcare applications and the technologies that support them.
My comments today will focus on the draft framework for criteria of PRMI standards, and the four areas identified as requested by the committee. This testimony provides perspectives on how to bridge to technological advances in engineering systems and opinions about emerging electronic health record architectures.
Draft Criteria for Selection of Message Format Standards
Interoperability, Data Comparability and Data Quality, Accountability and Integrity are issues that software engineers across the nation deal with on a daily basis. Our industry is not unique in its requirements for sound software engineering principles. The July 6, 2000 report to the Secretary on “Uniform Data Standards for Patient Medical Record Information” focuses on terminology and current message based standards to address the complexity of viable engineering solutions to support electronic health record systems. Although these areas are key elements of electronic health record systems, feasible systems require a broader focus. Let us further explore the reasons for this.
Today’s network capabilities demonstrate that it can provide high-performance service for digital video, remote haptics, and remote control of medical devices. However, the overall network doesn't today routinely provide instructors, clinicians, and researchers with performance sufficient to support network-demanding applications such as videoconferencing and large-scale data transfer. Bottlenecks and problems exist at a variety of points along the end-to-end network path between a local display and a resource at the other end of the connection.
A predictable experience is required for medical applications. The challenge is to provide standards electronic health record systems that are powerful, but not time consuming and coordinates the amalgamation of interoperable computing resources necessary to complete healthcare business processes. It is not only important to consider data quality but also quality of service requirements for PMRI standards. End-to-End Performance issues must also be considered. Setting data standards, classification and coding standards, messaging standards and information storage standards for the PMRI will not adequately address the broader end-to-end performance issues that must be addressed to enable a deployable national electronic health record.
The Big Picture. This is a very important diagram, referenced from the Numerical Aerospace Simulation systems division at NASA Ames Research Center. Consider various components of the Information Power Grid as cross-functional requirements critical to provide end-to-end PRMI standards. Potential cross-functional criteria for PMRI standards include:
System Users need computation to accomplish a variety of business processes. In my experience, Human Computer Interaction (HCI) requirements are left to vendor solutions. The standardization of information representation to human users is generally not addressed by healthcare standard development organizations. Recent developments in the XML community may positively impact the medical domain, such that consistent representation of electronic health record data may be accomplished in the future. The PMRI report references the need for HCI, but it is not factored into the criteria for the selection of PMRI standards.
Intelligent Interfaces provide a knowledge-based environment that offer users guidance on complex computing tasks, and provide for data capture. Interoperability and data comparability are provided via message-based standards; however, they rely on ASCII streams of text and only work well for message-based technology mechanisms. As the market has proven, this works extremely well for interoperability between two legacy healthcare applications, and data comparability may be proved through standard vocabularies and implementation guidelines. However, technology has evolved forward and the need to create redundant stores of information on multiple application systems is no longer required or feasible. Data synchronization becomes impossible to operationalize, with data quality and data integrity inconsistencies resulting from application dependencies. Standard application programming interfaces (API) provide functional semantics for intelligent interfaces.
Middleware provides software tools that enable interaction among users, applications and system resources. Internet2 defines middleware as “glue” or a layer of software between the network and applications. This software provides services such as identification, authentication, authorization, and directories. In today's Internet, applications usually have to provide these services themselves, which leads to competing and incompatible standards. Standard interoperable middleware services make networked applications easier to use.
Today’s healthcare delivery systems utilize message format standards to achieve interoperability via message based middleware mechanisms. However, the notion of object oriented software component services for interoperability between systems is not addressed in the PMRI Report, and should be included in the criteria for PMRI standards.
Operating Systems add another component of complexity to the coordination of interplay between user applications, computational resources, network and data storage. The PRMI standard selection criteria address operating systems through “flexibility” requirements in response to new OS developments. End-to-end performance and quality of service are greatly affected by hardware and software components on user applications. Performance prioritization by application functions is required for optimum system functionality.
Supercomputing is an aspect that brings together heterogeneous collections of high-performance computer hardware and software resources. While one may ask about the relevance of supercomputers to electronic health record systems, one only need look as far as the advances in biotechnology and genomics to realize that access to computational resources should not be an oversight as criteria are set for PMRI standards.
Networking provides the hardware and software to permit communications among distributed users and computing resources. The Internet will continue to impact the healthcare industry well into the future. Multi-media electronic health records should be considered as standards are selected for electronic health record applications. Healthcare industry standards should leverage the utilities offered by other industries, such at H.323 for video, to engineer electronic health records.
Mass Storage provides a collection of devices and software that allow temporary and long-term archival information storage. Data mining applications continue to evolve and with them growing concerns about inference of private information to unauthorized sources. A separation of concerns for information and functional semantics is a necessary criterion for PMRI standards.
Market acceptance requires more than simple percentages or statistics on the number of deployed standard system implementations. PMRI standard criteria need to address emerging business models for the information economy. Provision for Applications Service Providers (ASP), Content Providers, and others, to support the business models of the information economy, Business-to-Business, Peer-to-Peer, ASP-to-Business, and Business-to-Consumer, etc. must be addressed. Message format standards simply do not support these emerging business models adequately. The PMRI standards criteria should not constrain the development of new market avenues of potential benefit to the medical domain.
Draft Questionnaire: PMRI Message Format SDOs
General information from the SDOs is appropriate as outlined in the draft questionnaire. Contact information at the end of the questionnaire should be moved into this initial area and a URL should be included in the list of contact attributes.
Measurement criteria should also be included. At a minimum measurement criteria should address:
Another area addressed by many standard development organizations is a fast track or “Request for Consideration” (RFC) process. Commercial implementations that are defacto industry standards are expedited through the ballot process thus providing an avenue for commercially viable solutions.
The proposed list of PMRI transactions to be considered for HIPAA standardization recommendations does not take into consideration the business processes to be accomplished by an electronic health record system. It seems to begin by identifying existing standards, instead of the areas that PMRI standards need to address. Identification of workflow processes for electronic health record applications might provide a path to viable standard selection. Good starting points include user authentication and patient identification, instead of ADT transactions.
The Internet2 Health Sciences has formed a collaboratory on Electronic Health Records, to address the requirements of complex academic health systems. This group is interested in working with an international collaboration, based on open source sharing of intellectual property called OpenE H R (for Open Electronic Health Records). Internet2 Health Science participants have evaluated a methodology launched by the European Community called the Good Electronic Health Record (GEHR). The information architecture of GEHR provides a set of principles governing the logical structure and behavior of healthcare record systems to enable communication of the whole or part of a healthcare record. This architecture has been proven to allow various independent implementations of electronic health record systems in different countries. The communication model of GEHR is quite flexible and scalable. There is an open forum to share and discuss technical information.
The committee asked for an opinion regarding a broad versus narrow scope for the initial selection of PMRI standards. A broader scope should be considered in the first phase of PMRI standard selection. By excluding appropriate standards, new business models and contemporary engineering advances may inadvertently be excluded from PMRI selections. This could prove detrimental to the industry.
My final comment is in regard to overall clarification of the document terminology. “Electronic Health Record” has growing international consensus as the terminology of choice when referring to Patient Medical Records, Computerized Patient Records, or Electronic Patient Record, etc. While one terminology is no more correct than the next, ISO TC215 has a specification in process on Requirements for an Electronic Health Record Reference Architecture, which recommends Electronic Health Record (E H R) as the terminology of choice.
I would like to thank the committee for the opportunity to share my thoughts on criteria to be utilized for the selection of PMRI standards. The views represented in this testimony reflect the input of many individuals with a broad base of experience. I would be remiss to not acknowledge the contributions of Dave Forslund, Tom Culpepper, Sam Heard, Mike Gill, Ted Hanss and Steve Corbato to my increased understanding of the issues around electronic health records.
Thank you for your consideration.
Mary Kratz
Manager, Internet2 Health Science Initiatives
mkratz@internet2.edu
734.352.7004