Health Data Standards: Development, Harmonization, and Interoperability


Health Data Standards: Development, Harmonization, and Interoperability

Joyce Sensmeier

Today’s healthcare landscape consists of a variety of care settings and stakeholders, which all leverage a number of different information systems in their delivery of care. Standards are foundational to the development, implementation, and exchange of electronic health records (EHRs). The effectiveness of healthcare delivery is dependent on the ability of clinicians to securely access health information when and where it is needed. The capability of exchanging health information across organizational and system boundaries, whether between multiple departments within a single institution or among a varied cast of providers, payers, regulators, and others, is essential. A harmonized set of rules and definitions, both at the level of data meaning as well as at the technical level of data exchange and access, is needed to make this possible. Additionally, there must be a sociopolitical structure in place that recognizes the benefits of shared information and incentivizes the adoption and implementation of such standards to improve health outcomes.

This chapter examines health data standards in terms of the following topic areas:

Need for health data standards

Standards development process, organizations, and categories

Knowledge representation

Standards coordination and harmonization

Innovation and interoperability

Health data standards initiatives

Role of the healthcare consumer

Business imperative for health data standards


The ability to communicate in a way that ensures the message is received and the content is understood is dependent on standards. Data standards are intended to reduce ambiguity in communication so that the actions taken based on data are consistent with the actual meaning of that data. The healthcare transformation that is underway requires data capture and sharing and advanced clinical processes, which will enable improved health outcomes. This ultimate end state can only be achieved through the organized structuring and effective use of information to support better decision-making and more effective care processes, thus improving health outcomes and reducing costs.

While current information technology (IT) is able to move and manipulate large amounts of data, it is not as proficient in dealing with ambiguity in the structure and semantic content of that data. The term health data standards is generally used to describe those standards having to do with the structure and content of health information. However, it may be useful to differentiate data from information and knowledge. Data are the fundamental building blocks on which healthcare decisions are based. Data are collections of unstructured, discrete entities (facts) that exist outside of any particular context. When data are interpreted within a given context and given meaningful structure within that context, they become information. The term interoperability describes the ability of different information systems, devices, or applications to connect, in a coordinated manner, within and across organizational boundaries to access, exchange, and cooperatively use data among stakeholders, with the goal of optimizing the health of individuals and populations (HIMSS, 2018). Data standards represent both data and their transformation into information. Data analysis generates knowledge, which is the foundation of professional practice standards.

Standards are created by several methods (Hammond, 2005): (1) a group of interested parties comes together and agrees upon a standard; (2) the government sanctions a process for standards to be developed; (3) marketplace competition and technology adoption introduce a de facto standard; and (4) a formal consensus process is used by a standards development organization (SDO). The standards development process typically begins with a use case or business need that describes a system’s behavior as it responds to a request that originates from outside of that system. Technical experts then consider what methods, protocols, terminologies, or specifications are needed to address the requirements of the use case. An open acceptance or balloting process is desirable to ensure that the developed standards have representative stakeholder input, which minimizes bias and encourages marketplace adoption and implementation.

Legislated, government-developed standards are able to gain widespread acceptance by virtue of their being required by either regulation or in order to participate in large, government-funded programs, such as Medicare. Because government-developed standards are in the public domain, they are available at little or no cost and can be incorporated into any information system; however, they are often developed to support particular government initiatives and may not be as suitable for general, privatesector use. Also, given the amount of bureaucratic overhead attached to the legislative and regulatory process, it is likely that they will lag behind changes in technology and the general business environment.

Standards developed by SDOs are typically consensus-based and reflect the perspectives of a wide variety of interested stakeholders. They are generally not tied to specific systems. For this reason, they tend to be robust and adaptable across a range of implementations; however, most SDOs are non-profit organizations that rely on the commitment of dedicated volunteers to develop and maintain standards. This often limits the amount of work that can be undertaken. In addition, the consensus process can be time consuming and result in a slow development process, which does not always keep pace with technological change. Perhaps the most problematic aspect of consensus-based standards is that there is no mechanism to ensure that they are adopted by the industry, since there is usually little infrastructure in place for SDOs to actively and aggressively market them. This has resulted in the development of many technically competent standards that are never implemented. The U.S. Standards Strategy (ANSI, 2005) states, “The goal of all international standards forums should be to achieve globally relevant and internationally recognized and accepted standards that support trade and commerce while protecting the environment, health, safety, and security.”

There are a number of drivers in the current standards landscape that are working to accelerate health data standards adoption and implementation through innovative efforts and incentives that address this charge.


Four broad areas are identified to categorize health data standards (Department of Health and Human Services, 2010). Transport standards are used to establish a common, predictable, secure communication protocol between systems. Vocabulary standards consist of nomenclatures and code sets used to describe clinical problems and procedures, medications, and allergies. Content exchange standards and value sets are used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents. Security standards are used to safeguard the transmission of health data through authentication and access control.

Transport Standards

Transport standards primarily address the format of messages that are exchanged between computer systems, document architecture, clinical templates, the user interface, and patient data linkage (Committee on Data Standards for Patient Safety, 2004). To achieve data compatibility between systems, it is necessary to have prior agreement on the syntax of the messages to be exchanged. The receiving system must be able to divide the incoming message into discrete data elements that reflect what the sending system wishes to communicate. The following section describes some of the major SDOs involved in the development of transport standards.

Accredited Standards Committee X12N/Insurance. Accredited Standards Committee (ASC) X12N has developed a broad range of electronic data interchange (EDI) standards to facilitate electronic business transactions. In the healthcare arena, X12N standards have been adopted as national standards for such administrative transactions as claims, enrollment, and eligibility in health plans, and first report of injury under the requirements of the Health Insurance Portability and Accountability Act (HIPAA). HIPAA directed the Secretary of the Department of Health and Human Services (HHS) to adopt standards for transactions to enable health information to be exchanged electronically, and the Administrative Simplification Act (ASA), one of the HIPAA provisions, requires standard formats to be used for electronically submitted healthcare transactions. The American National Standards Institute (ANSI) developed these, and the ANSI X12N 837 Implementation Guide has been established as the standard of compliance for claims transactions.

Institute of Electrical and Electronic Engineers. The Institute of Electrical and Electronic Engineers (IEEE) has developed a series of standards known collectively as P1073 Medical Information Bus (MIB), which support real-time, continuous, and comprehensive capture and communication of data from bedside medical devices such as those found in intensive care units, operating rooms, and emergency departments. These data include physiological parameter measurements and device settings. IEEE standards for IT focus on telecommunications and information exchange between systems including local and metropolitan area networks. The IEEE 802.xx suite of wireless networking standards, supporting local and metropolitan area networks, has advanced developments in the communications market. The most widely known standard, 802.11, commonly referred to as Wi-Fi, allows anyone with a “smart” mobile device or a computer to connect to the Internet wirelessly through myriad access points. IEEE 11073 standards are designed to help healthcare product vendors and integrators create interoperable devices and systems for disease management, health, and fitness.

National Electrical Manufacturers Association. The National Electrical Manufacturers Association (NEMA), in collaboration with the American College of Radiologists (ACR) and others, formed DICOM (Digital Imaging and Communications in Medicine) to develop a generic digital format and a transfer protocol for biomedical images and image-related information. DICOM enables the transfer of medical images in a multi-vendor environment and facilitates the development and expansion of picture archiving and communication systems (PACS). The DICOM standard is the dominant international data interchange message format in biomedical imaging.

World Wide Web Consortium. The World Wide Web Consortium (W3C) is the main international standards organization for development of the World Wide Web (abbreviated WWW or W3). W3C also publishes XML (Extensible Markup Language), which is a set of rules for encoding documents in machine-readable format. XML is most commonly used in exchanging data over the Internet. XML’s design goals emphasize simplicity, generality, and usability over the Internet, which also makes it desirable for use in cross-enterprise health information exchange. Although XML’s design focuses on documents, it is widely used for the representation of arbitrary data structures such as Web Services. Web Services use XML messages that follow the Simple Object Access Protocol (SOAP) standard and have been popular with traditional enterprises. Other transport protocols include the Representational State Transfer (REST) architectural style, which was developed in parallel with the Hypertext Transfer Protocol (HTTP) used in Web browsers. The largest known implementation of a system conforming to the REST architectural style is the World Wide Web.

Communication Protocols. In telecommunications, a protocol is a system of digital rules for data exchange within or between computers. When data are exchanged through a computer network, the rules system is called a network protocol. Communication systems use well-defined formats for exchanging messages. A protocol must define the syntax, semantics, and synchronization of the communication. Examples of communication protocols include the Transmission Control Protocol/Internet Protocol (TCP/IP), which is the suite of communication protocols used to connect hosts on the Internet. File Transfer Protocol (FTP) is a standard network protocol used to transfer files from one host to another host over a TCP-based network, such as the Internet. Simple Mail Transfer Protocol (SMTP) is an Internet standard for electronic mail (e-mail) transmission.

Vocabulary Standards

A fundamental requirement for effective communication is the ability to represent concepts in an unambiguous fashion between both the sender and the receiver of the message. Natural human languages are incredibly rich in their ability to communicate subtle differences in the semantic content, or meaning, of messages. While there have been great advances in the ability of computers to process natural language, most communication between health information systems relies on the use of structured vocabularies, terminologies, code sets, and classification systems to represent health concepts. Standardized terminologies enable data collection at the point of care, and retrieval of data, information, and knowledge in support of clinical practice. The following examples describe several of the major vocabulary standard systems.

Current Procedural Terminology. The Current Procedural Terminology (CPT) code set, maintained by the American Medical Association (AMA), accurately describes medical, surgical, and diagnostic services. It is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes. In addition to descriptive terms and codes, it contains modifiers, notes, and guidelines to facilitate correct usage.

International Statistical Classification of Diseases and Related Health Problems: Tenth Revision. The International Statistical Classification of Diseases and Related Health Problems: Tenth Revision (ICD-10) is the most recent revision of the ICD classification system for mortality and morbidity, which is used worldwide. The transition to ICD-10-CM and ICD-10 Procedural Coding System (ICD-10-PCS) in 2015 was anticipated to improve the capture of health information and bring the United States in step with coding systems worldwide.

Nursing and Other Domain-Specific Terminologies. The American Nurses Association (ANA) has recognized the following nursing terminologies that support nursing practice: ABC Codes, Clinical Care Classification, International Classification of Nursing Practice, Logical Observation Identifiers Names and Codes (LOINC), North American Nursing Diagnosis Association, Nursing Interventions Classification (NIC), Nursing Outcome Classification (NOC), Nursing Management Minimum Data Set, Nursing Minimum Data Set, Omaha System, Patient Care Data Set (retired), Perioperative Nursing Data Set, and SNOMED-CT. These standard terminologies enable knowledge representation of nursing content. Nurses use assessment data and nursing judgment to determine nursing diagnoses, interventions, and outcomes. In 2015, the ANA (2015) reaffirmed support for the use of recognized terminologies as valuable representations of nursing practice and promoted the integration of those terminologies into information technology solutions. In this position statement, ANA noted that standardized terminologies have become a significant vehicle for facilitating interoperability between different concepts, nomenclatures, and information systems.

RxNorm. RxNorm is a standardized nomenclature for clinical drugs and drug delivery devices produced by the National Library of Medicine (NLM). Because every drug information system follows somewhat different naming conventions, a standardized nomenclature is needed for the consistent exchange of information, not only between organizations but even within the same organization. RxNorm contains the names of prescription and many nonprescription formulations that exist in the United States, including the devices that administer the medications.

Unified Medical Language System. The Unified Medical Language System (UMLS) consists of a large biomedical thesaurus that identifies relationships between concepts across multiple vocabularies, including their meanings, concept names, and relationships. There are specialized vocabularies, code sets, and classification systems for almost every practice domain in healthcare. The NLM supports the development, enhancement, and distribution of clinically specific vocabularies to facilitate the exchange of clinical data to improve retrieval of health information, as the central coordinating body for clinical terminology standards within HHS (National Library of Medicine, 2010).

Content Standards

Content Standards are related to the data content within information exchanges. Information content standards define the structure and content organization of the electronic message’s or document’s information content. They can also define a “package” of content standards (messages or documents). In addition to standardizing the format of health data messages and the lexicons and value sets used in those messages, there is widespread interest in defining common sets of data for specific message types. The concept of a minimum data set is defined as “a minimum set of items with uniform definitions and categories concerning a specific aspect or dimension of the healthcare system which meets the essential needs of multiple users” (Health Information Policy Council, 1983).

A related concept is that of a core data element. It has been defined as “a standard data element with a uniform definition and coding convention to collect data on persons and on events or encounters” (National Committee on Vital and Health Statistics, 1996). Core data elements are seen as serving as the building blocks for well-formed minimum data sets and may appear in several minimum data sets. A number of SDOs have been increasingly interested in incorporating domain-specific data sets into their messaging standards.

American Society for Testing and Materials. The American Society for Testing and Materials (ASTM) is one of the largest SDOs in the world and publishes standards covering all sectors in the economy. More than 13,000 ASTM standards are used worldwide to improve product quality, enhance safety, and facilitate trade. The ASTM Committee E31 on Healthcare Informatics has developed a wide range of standards supporting the electronic management of health information.

Clinical Data Interchange Standards Consortium. The Clinical Data Interchange Standards Consortium (CDISC) is a global, multidisciplinary consortium that has established standards to support the acquisition, exchange, submission, and archive of clinical research data and metadata. CDISC develops and supports global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

Health Level Seven. Health Level Seven (HL7) is an SDO that develops standards in multiple categories including transport and content. HL7 standards focus on facilitating the exchange of data to support clinical practice both within and across institutions. HL7 standards cover a broad spectrum of areas for information exchange including medical orders, clinical observations, test results, admission/transfer/discharge, document architecture, clinical templates, user interface, EHR, and charge and billing information. HL7 messaging standards are widely implemented by the healthcare industry and have been deployed internationally for decades.

HL7 FHIR (Fast Healthcare Interoperability Resources) is an emerging standard describing data formats and elements (known as “resources”) and an Application Programming Interface (API) for exchanging health information. The FHIR specification is rapidly being adopted as a next generation standards framework for the exchange of EHR data.

SNOMED International. SNOMED International is a not-for-profit organization that owns, administers, and develops SNOMED-CT, the global common language for health terms. SNOMED-CT has been developed collaboratively to ensure it meets the diverse needs and expectations of the worldwide medical profession and healthcare community. In the United States, the NLM distributes SNOMED-CT at no cost in accordance with the member rights and responsibilities.

LOINC. Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations. It was developed and is maintained by the Regenstrief Institute. The purpose of LOINC is to assist in the electronic exchange and gathering of clinical results (such as laboratory tests, clinical observations, and outcomes management and research). Since its inception, the database has expanded to include not just medical and laboratory code names but also nursing diagnosis, nursing interventions, outcomes classification, and patient care data set.

National Council for Prescription Drug Programs.

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Jul 29, 2021 | Posted by in NURSING | Comments Off on Health Data Standards: Development, Harmonization, and Interoperability

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