KR Tutorial Module 5

With the advancements in information and communication technologies, mandates to improve the efficiency and quality of health care transactions, and recent efforts to revitalize the capacity of the public health system to fulfill its core functions, the nation is calling for an improved health information infrastructure based on data standards. This National Health Information Infrastructure (NHII), facilitated by the Department of Health and Human Services in conjunction with public and private sector organizations, can be defined as the development of a comprehensive, knowledge-based, network of interoperable systems capable of providing information for sound decisions about health when and where needed.(1) Data standards are described as the foundation for the NHII. “One of the ways the NHII can be strengthened is through more rapid adoption of and compliance with existing standards and accelerated development of other needed standards.”(2)

Data standards are the common language that allows information to be shared and compared across individual data systems, electronically linked in a secure environment, and presented in ways that are clear and relevant. We follow standards in our daily activities, e.g., we use a ten digit standard format to place a telephone call; we use inches and pounds to track the physical growth of our children; we follow a universal clock to tell time. Standards exist in industry. For example, the banking industry relies on standards to support users’ ability to access account information from any automatic teller machine (ATM). In medical care, providers, insurers, and vendors of health care claims data are mandated under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 to adopt standards to support electronic data interchange for a variety of administrative and financial transactions.

As the clinical environment becomes electronic and standardized, public health, which relies on hospital and physician claims data, medical record data, and laboratory data for decision making, should not be far behind to improve public health practice as well as to preserve and strengthen its ties to the medical care system. In addition, public health has an abundance of rich and valuable individual data systems that, with automation and standards, could become more accessible and useful to achieve its core functions and deliver its essential services to the public. (See Module 1 for more information about the core functions and essential services of public health. See Module 6 for the rationale for moving to data standards in public health.)

The following sections define data standards, describe the various types of data standards that are used in medical care and public health, and summarize some of the areas in which continued development of public health data standards is needed. In addition, the last section of this module outlines briefly the national process for setting data standards.

A formal definition of data standards comes from the International Organization for Standardization (ISO). ISO is a major international standards organization (the American National Standards Institute (ANSI) is the U.S. member), which coordinates and develops international voluntary consensus standards that facilitate world trade and contribute to public safety and health. According to ISO, standards are “documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose.”(3)

Existing and emerging data standards fall into several different categories. Exhibit 1 includes a description of the types of standards that are most relevant to public health, health statistics and public health informatics.(4)

Standard Type	Definition	Examples	Links
1. Terminology(5)	Ways to define and classify individual health terms and/or relate terms to one another so that they are easily and consistently understood.
1.a. Code Sets	Representation assigned to a term so that it may more readily be processed; code sets are lists of codes and their associated terms.(6)	The Logical Observations, Identifiers, Names, and Codes (LOINC) code sets or terminology standards are widely used by public health or clinical laboratories that support electronic reporting. LOINC includes a set of universal names and identification codes for identifying laboratory and clinical observations developed by the Regenstrief Institute. The Current Procedural Terminology (CPT) is used widely for professional services billing and analyses.	LOINC
1.b. Classification Systems	Classification systems organize terms for easy use of information for retrieval, analysis and decision support.	The International Statistical Classification of Diseases and Health Related Problems (ICD) is used widely for hospital billing and statistical analyses.
1.c. Nomenclature	“… a set of specialized terms that facilitates precise communication by minimizing or eliminating ambiguity.”(7)	The Systemized Nomenclature of Medicine (SNOMED) is a structured nomenclature and classification of the terminology used in human and veterinary medicine. The Unified Medical Language System (UMLS) is a system maintained by the National Library of Medicine (NLM) made up of hundreds of thousands of search concepts and terms which links medical classification systems (e.g., ICD) to NLM’s medical index subject headings (MeSH codes) and to each other. These linkages increase the use of UMLS by the clinical and public health communities.	SNOMED UMLS
2. Message Format or Electronic Data Interchange Standards	Message format standards ensure that the electronic exchange of information is efficient, unambiguous and secure. These protocols make communication or the exchange of data between disparate computer systems possible (interoperability) without human intervention. These standards should be universal enough that they do not require negotiation of an interface agreement between the two systems in order to make the two systems communicate.(8)	The two major standards for messaging are Accredited Standards Committee (ASC) X12 and Health Level 7 (HL-7) Standards. eXtensible Markup Language (XML) is an emerging standard for clinical information designed especially for Web documents.(9)	HL7 ASC-X12 XML
2.a. Transactions	The HIPAA legislation calls for message format standards for administrative and financial transactions, i.e., billing or claims data.	The Secretary of the Department of Health and Human Services specified the consensus standard X12 N (N refers to X12’s insurance committee in which health industry standards setting takes place) for all administrative and financial transactions, with the exception of retail pharmacy.	HIPAA Trans- actions-FAQs
2.b. Claims Attachments	HIPAA calls for the adoption of electronic standards for the transmission of additional information necessary to fulfill provider/payer contracts and process bills, referred to as claims attachments. In some cases, administrative and financial data transmitted under HIPAA transaction standards are not sufficient to process bills. This additional information is usually clinical information from the medical record.	HL-7 standards are used in combination with X12 N standards, which represent a bridge between clinical and administrative information. Vendors are typically responsible for modifying provider and payers systems to support claims attachments. These are the same vendors who may supply public health data relevant to public health professionals and health services researchers.
3. Semantic Structure	Used to facilitate the browsing of terms related to a potentially matching term in search of the most appropriate match.(10)	Hierarchies or term associations
4. Data Content	Data content that will be included in an electronic health record, the storage format and the level of complexity of the format	Storage formats include a variety of flat files or database files. Flat files are simple formats formats for storage and messages while relational files and object-oriented approaches are more complex.
5. Product and Process	Establish requirements for reporting of health data as well as ensure that data collection and processing do not compromise the completeness, confidentiality, quality, or comparability of the data.	Standard process for collecting race and ethnicity data, standard way of reporting births and deaths or infant mortality.
6. Data Capture Forms	Specify data requirements, in terms of the content or core data elements of specific data sets, for ongoing and uniform data collection efforts.	The uniformity of hospital discharge data is attributed to standard forms used by the majority of hospitals, that is the Uniform Bill for Hospitals (UB-02). In addition, the uniformity of the vital records system is due in part to core data elements on the birth and death certificate forms.
7. Other Standards	Additional standards’ types, which may overlap with the categories above include privacy standards, security standards and identifier standards.	The privacy standards under HIPAA spell out permissible uses of patient identifiable health care information in paper or electronic form. The security standards under HIPAA provide uniform protection of electronically maintained and transmitted health information. Identifier standards include universal ways to uniquely specify each patient, provider, site-of-care, and product.(11)	HIPAA Privacy-FAQs HIPAA Security and Electronic Sig. FAQ

The standards identified in Exhibit 1 may differ in terms of their origins and adoption, as well. Some standards are known as de facto standards. While defined for a specific purpose in a particular geographic area, because of their usefulness, these standards are adopted more broadly by the marketplace, e.g., other organizations in the industry. Many of the standards used in health statistics are de facto standards.(12) In addition to de facto standards, several organizations are accredited by ANSI to develop and maintain consensus-based standards. (See the last section of this module for more information about the national standards setting process.) Consensus-based standards are developed by an official, consensus-based process and, unlike de facto standards, users come to agreements at the outset to create standards. Consensus-based standards can be both voluntary and mandatory. Mandatory standards, also known as de jure standards, are enacted by law or regulation. Standards to comply with HIPAA Administrative Simplification provisions are de jure standards.(13)

The National Committee on Vital and Health Statistics (NCVHS), advisor to the Secretary of the Department of Health and Human Services (DHHS) on the implementation of HIPAA, refers to standards as the “fundamental building blocks of an effective health information system; … essential for efficient and effective public health and health care delivery systems.”(14) However, most public health data transactions are not subject to the HIPAA mandates. Even though HIPAA Administrative Simplification standards are focused on insurance transactions, health care encounters that trigger insurance claims also trigger the reporting of most public health data. Failure to adopt these data standards will make it more difficult to communicate with the clinical care delivery system, especially for those databases that rely heavily on administrative data (e.g., hospital discharge data sets). (See Module 3 for more information about public health data. See Module 6 for more information about the rationale for adopting data standards in public health.)

HIPAA also requires the adoption of standards for claims attachments and the investigation of standards for the electronic medical record. The medical record is a primary source of data for disease registries (e.g., tumor, reportable disease databases), trauma registries, vital statistics, immunization registries, and other public health databases. The adoption of clinical data standards for both health care delivery and public health will allow for electronic interchange of data, which is now primarily paper-based. Other features of HIPAA, such as the development of unique identifiers and standards to protect the privacy and security of data, will also have an impact on how public health data are collected, transmitted, stored, and used.(15)

Parallel to but broader than HIPAA related standards development efforts, the 2001 Spring Congress of the American Medical Informatics Association identified two major standards gaps that need to be specified and filled to improve public health practice:(16)

Continuing development of public health data standards in the following areas is a start:

Several organizations and committees contribute to the process of setting health data standards in the United States. Standard setting organizations include Standards Development Organizations (SDOs) and Data Content Committees (DCC).

The Designated Standards Maintenance Organizations (DSMO) are the specific DCCs and SDOs who have agreed to maintain those standards designated as national standards in the HIPAA Administrative Simplification standards for electronic transactions final rule. SDOs include:

All of these organizations review and comment on modification proposals and make recommendations to NCVHS. (See Exhibit 2.)

In brief the national standard setting process is consensus-based consisting of several steps: 1) presenting the need for a standard to an appropriate American National Standards Institute (ANSI) – accredited or alternative organization; 2) designating an SDO to develop the standard; 3) developing the concept, drafting the proposed standard, commenting, and reaching consensus among industry representatives, professional associations, consumer groups, government agencies, vendors; 4) approving and publishing the standard; and 5) revising the standard based on comments about implementation.(23)

The following are links to other sources of information regarding public health data standards.

(1) Yasnoff, William A. (December 2, 2002). National Health Information Infrastructure (NHII): Presentation at the National Association of Health Data Organizations Annual Meeting.
(2) National Committee on Vital and Health Statistics.(November 15, 2001). Information for Health. A Strategy for Building the National Health Information Infrastructure. Report and Recommendations from the National Committee on Vital and Health Statistics. Washington, DC.
(3) International Organization for Standardization. (December 5, 2002). What are standards? [On-line], Available: http://www.iso.ch/iso/en/aboutiso/introduction/index.html
(4) Public health data standards are informed by the field of public health informatics.
(5) Greenberg, Marjorie and Gib Parrish. (December 2002). Standards and Their Use in Health Statistics: Unpublished draft paper.
(6) The National Committee on Vital and Health Statistics. (July 6, 2000). NCVHS Report to the Secretary on Uniform Standards for Patient Medical Record Information [On-line], Available: http://ncvhs.hhs.gov/hipaa000706.pdf
(7) Ibid.
(8)Ibid.
(9) Glossary of Selected Terms. [April 2001]. Distributed at National Electronic Disease Surveillance System (NEDSS) Stakeholder Meeting in Atlanta, GA.
(10) Chute, CG. (2000). Clinical classification and terminology: some history and current observations. Journal of the American Medical Association, 7 (3), 298-303.
(11) Blair, Jeffrey S. and Computer-based Patient Record Institute (CPRI) and Healthcare Open Systems and Trials (HOST) (CPRI-HOST). (September 22, 2000). An Overview of Healthcare Information Standards [On-line], Available: http://www.cpri.org/resource/docs/overview.html
(12) Greenberg, Marjorie and Gib Parrish. (December 2002). Standards and Their Use in Health Statistics: Unpublished draft paper.
(13) Nelson, Donald AF. (August 1997). Why does medicine need standards? Medical Computing Today [On-line], Available: http://www.medicalcomputingtoday.com/0astandwhy.html
(14) National Committee on Vital and Health Statistics. (November 15, 2001). Information for Health. A Strategy for Building the National Health Information Infrastructure. Report and Recommendations from the National Committee on Vital and Health Statistics. Washington, DC.
(15) The Lewin Group, National Association of Health Data Organizations and the Public Health Data Standards Consortium Education Strategy Work Group. (May 2001). National Center for Health Statistics: Public Health Data Standards Consortium Education Strategy Final Report.
(16) Yasnoff, William A., et. al. (November/December 2001). A National Agenda for Public Health Informatics: Summarized Recommendations from the 2001 AMIA Spring Congress. Journal of American Medical Informatics Association Vol 8 No 6.
(17) Ibid.
(18) Ibid.
(19) Ibid.
(20) Interviews with Robert Kambic and Anna Orlova, Johns Hopkins University. October/November 2002.
(21) National Committee on Vital and Health Statistics. (November 15, 2001). Information for Health. A Strategy for Building the National Health Information Infrastructure. Report and Recommendations from the National Committee on Vital and Health Statistics. Washington, DC.
(22) Department of Health and Human Services. (March 2000) Memorandum of Understanding among Organizations Designated to Manage the Maintenance of the Electronic Data Interchange Standards Adopted under the Health Insurance Portability and Accountability Act of 1996 [On-line], Available: http://www.aha.org/aha/key_issues/hipaa/resources/HIPAA%20Standards%20-%20Resources%20-$20MOU.htm and http://www.hipaa-dsmo.org.
(23) Public Health Data Standards Consortium Education Strategy Final Report. Prepared for the National Center for Health Statistics. Prepared by The Lewin Group, in conjunction with the National Association of Health Data Organizations and the Public Health Data Standards Consortium Education Strategy Work Group. May 2001.