October 7, 1999
The Honorable Donna E. Shalala
Department of Health and Human Services
200 Independence Avenue SW
Washington, D.C. 20201
Dear Secretary Shalala:
On behalf of the National Committee on Vital and Health Statistics (NCVHS), I am pleased to inform you of our progress on the next report we are preparing for you as mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
HIPAA directs the NCVHS to “study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information” and to report to you “not later than 4 years after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996 recommendations and legislative proposals for such standards and electronic exchange …[HIPAA Section 263].” The Computer-based Patient Record Work Group within NCVHS’ Subcommittee on Standards and Security has the responsibility for studying the issues and preparing the Committee’s report by August 21, 2000.
We believe this report will be important to you and the nation because it will make recommendations about standards that will lead to significant improvements in the efficiency and effectiveness of the health system for the delivery of high quality care. This reflects the first of ten guiding principles for selecting patient medical record information standards (Attachment 1). These principles are based on the guiding principles for selecting standards for HIPAA.
This report will address the following seven focus areas as they relate to patient medical record information (Attachment 2):
- Message Format Standards
- Medical Terminologies
- Business Case Issues
- Standards Necessary to Support NCVHS’ Vision of a National Healthcare Information Infrastructure (NHII)
- Standards for Data Quality, Accountability, and Integrity
- Effects of Inconsistencies Among State Laws
- Protection of privacy, confidentiality and security
In gathering information for this report, so far we have heard from 79 testifiers during five hearings over a total of nine days in 1998-99. We plan for additional hearings during the next few months.
So far testimony has shown some areas of significant accomplishment in standards for patient medical record information by both the private and public sectors. However, the witnesses believe that we need additional areas to be covered by standards as well as more widespread adoption of existing standards. First and foremost, this would improve direct patient care, such as by fostering decision support systems to reduce adverse events. Second, these advances in standards are essential for addressing health care system needs in areas such as clinical efficiency, effectiveness, performance measurement, and research. The witnesses also believe the government can find ways to play a constructive role to advance progress. The committee is developing recommendations on how best to proceed.
Many testifiers stressed the importance of legislation to protect the privacy and confidentiality of healthcare information. The Committee recommendations will address these issues as well as security requirements with respect to patient medical record information.
The NCVHS looks forward to delivering a cogent report on time with the recommendations and legislative proposals. We welcome any comments.
John R. Lumpkin, M.D., M.P.H.
John Eisenberg, M.D.
Margaret Hamburg, M.D.
Attachment 1: Guiding Principles for Promoting Patient Medical Record Information Standards
The Administrative Simplification section of Public Law 104-191, The Health Insurance Portability and Accountability Act (HIPAA) of 1996, directs the National Committee on Vital and Health Statistics (NCVHS) to assist and advise the Secretary of Health and Human Services, to “study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information,” and to “report to the Secretary not later than 4 years after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996 recommendations and legislative proposals for such standards and electronic exchange …[HIPAA Section 263]” The Computer-based Patient Record Work Group (CPRWG) of NCVHS’ Subcommittee on Standards and Security has the responsibility for studying the issues and preparing the Committee’s report by August 21, 2000, four years after the date of enactment (August 21, 1996) of HIPAA.
The principles proposed below for guiding the work of CPRWG are derived from the guiding principles developed to guide choices for the standards to be adopted by the Secretary of Health and Human Services, which were published in each notice of proposed rulemaking for HIPAA administrative simplification standards.
- Improve the efficiency and effectiveness of the health system for delivering high quality care.
- Meet the data needs of the health community, particularly providers, patients, health plans, clearinghouses, and public health organizations.
- Bring consistency and uniformity to the uses of the other HIPAA standards–to their data element definitions and codes and their privacy and security requirements–and, secondarily, with other private and public sector health data standards.
- Have low additional standards development and implementation costs relative to the benefits of using patient medical record information standards.
- Will be supported by an ANSI-accredited standards developing organization, or other private or public organization that will assure continuity and efficient updating of the standard over time.
- Have timely developmental, testing, implementation, and updating procedures to achieve benefits faster.
- Are technologically independent of the computer platforms and transmission protocols used in the electronic exchange of patient medical record information, except when it is explicitly part of the standard.
- Are precise and unambiguous, but as simple as possible.
- Keep additional data collection and paperwork burdens on users as low as is feasible.
- Incorporate flexibility to more easily adopt to changes in the health care infrastructure (such as new services, organizations, provider types) and changes in information technology.
Attachment 2: Patient Medical Record Information Focus Areas
The report will define patient medical record information as “information about a single patient. This information is generated by health care professionals as a direct result of interaction with the patient, or with individuals who have personal knowledge of the patient, or with both.” This definition was chosen after receiving input from the health industry and other developers and users. It comes from the Institute of Medicine’s report entitled The Computer-based Patient Record: An Essential Technology for Health Care. The focus areas of the Committee’s report with respect to patient medical record information are:
- Message format standards. This area will focus on message format syntaxes, document format standards, the role of information models to enable the development of message format standards, and the need to coordinate standards.
- Medical terminologies. This area includes data element definitions, data models, code sets, and the development of an overall framework into which existing and developing terminology efforts can be integrated and coordinated. It will include issues related to the convergence of medical terminologies, coordination and maintenance of vocabularies, coordination of drug knowledge bases, and other issues related to medical terminologies.
- Business case issues. Focusing on the development and implementation of uniform patient medical record information data standards, this area includes return on investment issues and the burden of participating in national standards development processes.
- Standards necessary to support NCVHS’ vision of National Health Information Infrastructure (NHII). Working with the NHII Work Group of NCVHS, the CPR Work Group will identify the standards issues that support this vision.
- Standards for data quality, accountability, and integrity. This area of focus will consider standards for accountability and data integrity (e.g., accuracy, consistency, continuity, completeness, context, and comparability).
- Effects of inconsistencies among state laws. These laws can discourage or prevent nationwide consistency in the creation, storage, or communication of patient medical record information. Inconsistencies include laws pertaining to record retention, document authentication, and access to records.
- Protection of privacy, confidentiality and security. The prior reports of the Committee and documents released by the Department will be reviewed in the context of the Committee recommendations.