Michael J. Rozen, MD
Chief Privacy Officer
WellMed, Inc.
503-279-9010
michaelr@wellmed.com
Mr. Chairman and ladies and gentlemen of the National Committee on Health and Vital Statistics and guests, it is with humility that I accept your invitation and present my comments on a Draft Framework for the first phase in the selection of Patient Medical Information Standards (PRMI) for recommendation to the Secretary of Health and Human Services. While this draft framework focuses on the selection of message format standards for the PMRI, I feel I must start my comments at a higher level.
Inscribed on the National Archives building in Washington is the quote: “The Past is Prologue.” When I was a medical student, I remember one afternoon spent in the historical section of the medical school library reading about the indiscriminate use of leaches. They were very popular prior to the 1900’s and books abound with information about the various species of leaches, how often to apply them, in what pattern, for how long, how many, etc. Indeed standards existed for their use, but nowhere did anyone really stop and document their value. At the highest level, the question begged, “Were they of any value?” Today we know they do have benefit in re-implantation surgery.
The electronic medical record has been in existence for approximately forty years and I can trace much of its history through my practice in Medicine. Adoption has always lagged behind potential and technology has frequently been the reason provided for its failure. In 1974 when I entered private practice, we computerized much of our internal functions including not only billing and payment, but also scheduling and other transactional activities. We did not have cost effective communication capabilities for ubiquitous connectivity that exist today. Medical records existed as flat files in whatever location the patient went. When information needed to be shared, a copy was frequently sent with the patient.
In the 1980’s, we continued to upgrade our computer capabilities and incorporated fax as a standard mode of data interaction. In the late 80’s, I became active in leading efforts to develop Community Health Information Networks. In Southwest Ohio and the State of Ohio, which was one of the original Hartford Foundation Grant sites, we explored technical and political realities of medical information sharing. Important to this effort was the adoption of an electronic medical record. This record was healthcare system centric and did not provide for patient input. Implementation was difficult because most health information did not exist in electronic format and interpretation of the data required thick application interface programs. Thin browser technology had not yet occurred.
Also we were reminded of the political reality of the healthcare industry - that stakeholders are unwilling to give up control of their information. They are willing with proper authentication and authorization safeguards to share access to information, which remains under their control. If a single record were created, who own it and who would maintain it? How would it follow the person through their life? During our work with Community Health Information Networks we were able to make more progress when we focused on “rights” rather then “ownership” of the information. Who had a right to access that information? How was that right obtained? How was that right executed?
We learned in the early 90’s that healthcare stakeholders did not want to keep their information in a single database or location. The distributed nature of healthcare data and the need to access it from multiple locations meant we needed stakeholders to store the data in a format that would provide access at time of need to those with proper credentials. The advent of browser technology provided a cost effective solution.
In late 1996 I started an Internet Company dedicated to creating an electronic consumer/patient personal health record that would provide people with a place to store and access their health information. Initially the information was self-reported. Recognizing the need for an integrated suite of personal health improvement programs including health risk analysis and energizing the patients self reported data, I merged my company with WellMed in Portland, Oregon.
Today we witness the evolution of eHealth, a consumer centric Internet experience, which takes advantage of the four driving characteristics of the Internet: thin browser interfaces, ubiquitous connectivity, data empowerment and interactivity. This eHealth revolution, composed of non-traditional healthcare stakeholders-consumers- has now been joined by traditional healthcare stakeholders who are moving to deliver eCare, using the above driving characteristics for patient treatment plans and management of chronic illness.
PMRI needs to be able to enhance remote monitoring and facilitate patient management of their chronic illnesses. According to the Robert Wood Johnson Foundation, chronic conditions are now the leading cause of illness, disability, and death. They affect almost half the U.S. population accounting for a majority of healthcare expenditure. According to the Medical Expenditure Panel (2000) Survey, the top 15 conditions are: cancer, diabetes, emphysema, high cholesterol, HIV/AIDS, hypertension, ischemic heart disease, stroke, arthritis, asthma, gall bladder disease, stomach ulcers, back problems, Alzheimer’s Disease, other dementias and depression and anxiety disorders.
The Committee on the Quality of Health Care in America latest report “Crossing the Quality Chasm: A New Health System for the 21st Century” stated that “a highly fragmented delivery system that largely lacks even rudimentary clinical information capabilities results in poorly designed care processes characterized by unnecessary duplication of services and long waiting times and delays…overuse of many services-services for which the potential risk of harm outweighs the potential benefits.” The report makes many excellent recommendations that time does not permit me to present, but genuine to this discussion, the report focuses on information interchange between the patient and the physician and discusses the need for patient documentation and involvement in management of treatment of chronic disease.
ASTM workgroup E31.26 is working on Standards for the Personal (Consumer) Health Record-a lifetime record of the patient’s/consumer’s health. E31.26 defines the Personal (Consumer) Health Record as “an electronic application where individuals can maintain and manage their health information and that of others for whom they are authorized in a private, secure, confidential environment that allows the individual or other authorized persons to access and share such information.”
The ability of the PMRI to provide continuous connectivity and reach out to access information is emphasized in Stephens Inc. 2001 report “Healthcare Information Technology and e-Health—The Sun Also Rises” which stresses the need for dynamic real time value-added transactions versus batch processing. They note that integrating clinical and transactional billing systems produce more “clean claims” and lower bad debt expense. They state eligibility determination and claims status are two healthcare transactions that can be Web-enabled with real time respond. Companies like Passport Health and MedUnite are providing platforms for real-time interactivity.
At the highest level, I am concerned that the proposed Patient Medical Record Information Standard focuses on an old paradigm of medicine that is health system centric, not patient –centric; that fails to incorporate the advances in communication technology and thin browser interfaces; and is mired in a vision that failed to capture adoption twenty years ago.
A Patient/Consumer Centric Model for Healthcare Information
My current role is Chief Privacy Officer for WellMed. To provide you an insight into what the eHealth community has been doing and how the face of medicine has changed, I will present a few slides showing a little of the functionality of our company. . We have a unique and forward-thinking approach that effectively blends patient self-reported data with professionally sourced data using data interchange, thereby raising the respect of self-reported information and giving consumers greater equity in the healthcare process through access and control of information.
We see the healthcare universe as being patient-centric and use the Internet as a channel for communications.
Our programs are based on a platform that combines patient self-reported information with professionally sourced information; indexes content based accepted referenced terminologies and then applies business rules to create a personalized health management experience.
Our personal health manager helps people assess, record, improve and manage their health and health information.
Under assess we have a general health risk assessment tool and over 45 condition specific assessment tools. All this information is recorded in the personal health record with other self-reported data, which is entered as structured content with concept unique identifiers being attached. To facilitate semantic interpretation, we have created a consumer health thesaurus that now contains over 20,000 terms and maps to the UMLS. We also receive patient specific information from healthcare stakeholders including PBMs, insurers and providers.
The information contained in the record is dynamic and helps the person receive highly filtered content about their health conditions based on their unique characteristics and behaviors. We work with the stakeholders to establish improvement goals based on monitoring of activity.
In addition to self-reported information we collect professionally sourced information about the individual from their healthcare providers through data interchange.
Communication is at the core of our functionality. We help the individual pull information together and communicate it to healthcare stakeholders. Included in this are doctor visit forms that help the person organize their information for a doctor visit. Messaging includes personalized emails, secure messaging within the record, preventive service alerts and reminders and wireless messaging.
Another way to look at our platforms and desired functionality is demonstrated by the following slide. On our assessment platform we have layered a health record platform and then a care management platform that interacts with a messaging platform and a personalization platform to form a Health Communication Platform.
As I look at these proposed standards and then review the document on which they are based-Uniform Data Standards for Patient Medical Record Information, I am struck with the notion of trying to do the same old thing and somehow get a different end result. Why do I say this? The report speaks of patient history as one element of the PMRI but fails to incorporate the concept of a patient/consumer personal health record and patient access or storage of information within the PMRI. Issues such as patient access, ownership and control while important in the HIPAA Privacy and Security Regulations, are left largely outside this report. The failure of distributed healthcare information to be available on a 7x24 basis is also not adequately addressed in the report.
How does the committee decide which standards are most necessary? Compliance with the proposed standards should be weighted to facilitate comparison between competing systems.
Demonstration projects should be encouraged with the purpose of proving which solutions add value to the most important stakeholder: the patient. Implementing standards on an unproven hypothesis of healthcare improvement and cost savings may impede not promote health for patients.
Section 1. Draft Criteria for Selection of PMRI Message Format Standards
Does this adequately address the need for information to be posted by healthcare stakeholders for access by others who have proper authentication and authorization?
Does it provide a mechanism for secure patient communication with healthcare system stakeholders including physicians in the distributed patient environment?
Section 2. Draft Questionnaire:
VIII. Indicators of interoperability, please add
G. Is the standard capable with thin browser interfaces?
IX. Indicators of Data Comparability, please add
G. Identify usability testing for implementing this standard
Additional areas for questioning:
X. Education and Training
a. Provide documentation of education and on going training required by users to maintain efficient implementation of this standard
XI. Facilitate Communication
a. Data availability 7x24
b. Authentication Standards
c. Standards for documenting Access Authorization
d. Mechanisms for providing access in distributed healthcare environment
Section 3. Proposed list of PMRI transactions to be considered for HIPAA standardization recommendations.
Most health information resides with patients and their families. While initial focus is on transactional standards, current and evolving clinical processes need to be recognized so that systems being implemented are able to take advantage of these changes.
11. Patient personal health information from Personal Health Records including health risk analysis and interests and behavioral characteristics and trends of the patient.
12. Mechanisms for integrating information from remote monitoring of parameters for managing chronic illnesses.
13. Within the record, there needs to be a big focus on communication between patient and physician.
Section 4. Additional Comments or Critiques
I would recommend adding the following two:
5. Are there additional functions, e.g. communication, for which standards have not yet evolved but other criteria for use exist?
6. What standards will be adopted to facilitate posting and remote accessing of information on a hospitals website?
7. How do these standards permit variation in who is the keeper of the PMRI? Does functionality change when the keeper changes?
8. How does authentication occur in the absence of a single unique personal identifier?
I offer the following suggestions to facilitate Criteria for Selection of PMRI Standards:
I. Prior to finalization of the Standards Selection Criteria, I would encourage a review of the definition of the PMRI.
a. Clinical and transactional data integration needs to occur with real time messaging processes.
b. The patient needs to be at the center of their healthcare management and their health information.
c. Patient (consumer) health records provide a mechanism for people maintaining a lifelong record of their health.
d. Integration of patient self-reported information, such as Health Risk Assessments, can add richness to the healthcare system’s medical record.
e. Data interchange of professionally sourced medical information to the personal health record can improve health by encouraging compliance and monitoring.
II. Timely communication is core to PMRI functionality. The PMRI is no longer a flat file.
a. Communication capability needs to be at the core of all functionality
b. As already recognized, data interchange requires not only syntax standards, but semantic standards through the use of standard terminology as well. An important aspect of this is ensuring that complicated, technical concepts and codes can be interpreted and translated into consumer-understandable terms.
c. Mechanisms for authentication and authorization must be part of proposed standards.
III. Specific to the criteria for Standards Selection presented in your report to the Secretary:
a. Weighting of the selection criteria will facilitate selection based on compliance with standards
b. More attention needs to be focused on emerging technologies that facilitate real time posting of data and interaction.
To use a metaphor, the PMRI should not be an elephant that is big, heavy and slow moving, but rather a Cheetah that is sleek agile fast and able to reach out quickly for what it needs.
1. National Academy of Sciences. Crossing the Quality Chasm: A New Health System for the 21st Century. Copyright 2000.
2. The Robert Wood Johnson Foundation. Chronic Care in America: A 21st Century Challenge. Princeton, NJ: The Robert Wood Johnson Foundation, 1996. Online. Available at http://www.rwjf.org/library/chrcare/
3. ASTM E31.26 Subcommittee on Personal (Consumer) Health Record. Draft Standard Version 1.5.
4. Stephens, Inc. Healthcare Information Technology and e-Health—The Sun Also Rises. E-Health Industry report. January 22, 2001.