Health Information System Standards

Chapter 7 of 11


Health information systems are pervasive in the delivery, tracking, and administration of healthcare and involve a wide variety of actors, from healthcare professionals and organizations, payment bodies, the pharmaceutical industry, to the government. These systems support health outcomes, decision-making, and funding, among others.

Health information standards ensure better operation of healthcare organizations through planning, management, and goal-oriented standards. Such standards are set, updated and maintained by Standards Development Organizations (SDOs).


The International Organization for Standards (ISO) defines standardization as the process of agreeing to standards, the universal language facilitating the exchange of information among two different data systems. Following a health information standard means having a set of rules or guidelines that establishes uniform technical specifications, methods, criteria, practices, and processes approved by a respected standard health information-development organization.


Professionals use standards that are approved by general consent and specified by communication protocols and data definitions. These standards serve as detailed guides for addressing health information and technology for instrumentalities, texts, and images. Experts adopt these standards to:

  • Transfer health data using predictable business processes and conform to regulatory and ethical demands
  • Enable the electronic exchange of information between computer systems by adopting a uniform format and sequence of data for efficient interoperability
  • Foster electronic transmission as a business strategy
  • Promote efficient sharing of information among individual computer systems and healthcare institutions
  • Maintain patient data consistently by having clinical and administrative data in both electronic data systems and paper


Standards for software and hardware development quickly became a necessity with the arrival of the first computers. Computers work with values and numbers, but humans needed a more readable language. Thus, the development of standard character sets such as Extended Binary Coded Decimal Interchange Code (EBCDIC) and American Standard Code for Information Interchange (ASCII) were devised. Common Business-Oriented Language (COBOL), the first computer language, was formulated to simplify program development. American Standards Institute (ANSI) proclaimed COBOL as the official standard language of software development and data information exchange. Hardware components also required standards for exchanging essential information to make them interchangeable. The ISO stated in its 1987 technical report that meaningful exchange of information greatly depends on the prior existence of an agreed-upon set of syntactic and semantic rules.

In the late 1960s, the American Society for Testing and Materials (ASTM) established and revolutionized health informatics standards. It created the first healthcare informatics standards for electronic health records systems, laboratory message exchange, health information system security and data content. In 1965, the College of American Pathologists (CAP) developed a pathology nomenclature, which is now internationally recognized as the Systematized Nomenclature of Human and Veterinary Medicine. In 1974, the Secretary of the Health and Human Services (HHS) officially proclaimed the first Uniform Hospital Discharge Data Set. In 1987, Health Level-7 (HL7) began formulating a wide range of message format standards for patient record registration, observation reporting and orders and released its first standard version in October of that year.

Different clinical specialty groups and professional associations identified the need for standards in specific areas. The National Council for Prescription Drugs Programs (NCPDP) saw a need for a standard focused on a particular area of healthcare, which motivated its members to initiate the development of standards on transactions between pharmacies, pharmacy benefits managers and payers. In 1985, the American College of Radiology (ACR) and National Electrical Manufacturers Association (NEMA) realized a need for a data interchange protocol. This led to the formation of the Digital Imaging and Communications in Medicine (DICOM).

In 1991, the Health Informatics Standards Board (HISB) was created to consider the European efforts toward establishing a uniform healthcare informatics standard. Currently, it aims to coordinate national healthcare informatics standards by conducting an extensive inventory of standards that affect the selection process of code set and transactions under the Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification.

As of today, the healthcare delivery system employs different information systems from different vendors across multiple organizations, even within a single healthcare organization. Laboratories, pharmacies, health records departments, and physician offices all operate different systems, making it difficult to access data and other patient-related information. By not implementing a standard manner, existing message format standards to achieve interoperability between diverse information systems becomes optional and not a priority. Software options exist to make possible the variability of workflow and availability of information in different healthcare settings. However, this optionality also causes costly and time-consuming custom programming, enormous variability of vocabulary, and non-standard implementation of standards.


In February 2006, the Health Information Technology Standard Panel (HITSP) identified seven components of health information technology standards.


Data standards provide a method for making valid, meaningful, actionable, and comprehensive codes for health information technology purposes and serve as combined documented agreements on formats, the definition of common health data, and other representations useful in the health sector.


Information Content Standards and the contents of information exchanges are interrelated. They consist of two basic levels:

The first level: Defines the structure and content organization of the electronic document or message information content (e.g., HL7 Reference Information Model, the pictorial representation of the application domain data organization which serves to identify the life cycle of different events)

The second level: Defines the complete package of content standards in a document of message forms (e.g., HL7 Continuity of Care Document)


Information Exchange Standards define the syntax and structure of electronic communication and serve as the standard way of sending and receiving health information across different departments within a healthcare facility as well as between two separate healthcare organizations.


Identifiers Standards provide a universal method of recognizing different entities such as a healthcare provider, a consumer, a payer, a healthcare organization, and other parties concerned in establishing and using health information technology applications.


Privacy and Security Standards aim to preserve information security and confidentiality. Information security protects information and information systems from unauthorized use, disclosure, access, modification, disruption or destruction by using technological, physical or administrative tools or safeguards to shield identifiable health information from access or disclosure to unauthorized individuals.

Confidentiality ensures that the information is accessible only to those authorized. Confidentiality is one of the cornerstones of security in health information technology.


Information Technology experts use functional standards to meet the required functions and features, operational capabilities, and organized formats needed to develop software applications as dictated by a qualified group of users.

Functional requirements are derived from the purpose of the user’s business activities. In the healthcare setting, the patient’s visit to a doctor creates encounter data that the doctor needs to collect for the Electronic Health Record System. This record is checked for quality, added into the patient’s existing medical record and compared to the patient’s previous encounters. It is then sent to a pharmacy information system or reported to a Public Health Agency. This serves as a medium to ensure that work processes involving electronic data exchange between users of business activity are well- understood and agreed upon by the group of users and clearly communicated to the developers as functional requirements for a software application.


Other Standards include health information technology standards, other standards may influence the development of a healthcare software application. These include:

Business requirements: Information technology experts also base the development of a healthcare software application on the business requirements of the organization they are concerned with. These requirements are elicited by software engineers via business process analysis to help organizations define their strategic goals and make internal changes necessary to improve organizational capabilities, practices, policies and use of information technology.

Technical standards: Technical standards refer to the information technology, information exchanges and telecommunication standards needed to develop a software application beneficial to a healthcare organization.


SDOs are organizations accredited by the American National Standards Institute (ANSI). These organizations are responsible for creating and maintaining standards aimed at meeting industry needs. There are about 40 SDOs currently creating and maintaining healthcare standards. Most of the organizations are international having branches in the U.S. SDOs develop standards based on the goals of the organization.


Several big SDOs hire paid staff for administrative positions such as finances, scheduling, organizing workgroups, and other administrative duties. However, other significant areas like standards development are handled by volunteer staff participating in SDO activities outside their regular jobs although some are compensated by their companies to participate in SDOs activities.

Developing excellent standards relies heavily on skilled and knowledgeable individuals, who can set up standards that meet business/clinical needs and work well from a technological viewpoint.


Many SDOs create and maintain their standards based on internal progressions, usually through workgroups. However, ANSI-accredited SDO follows certain processes to ensure consistency and fairness in the development of standards. This further ensures agreement among participants as well as prevents control of standards by participants. Workgroups are utilized by SDOs to get the right individuals with expert knowledge to create and maintain a standard. Workgroups typically focus on a single standard.

Different SDOs may have different processes for developing new standards, but they follow similar workflow process. The process of developing a standard usually takes two or three years to establish a consensus, go through the balloting stage and piloting process, as well as fixing of issues. SDOs work to ensure the maintenance of the standard including fixing issues based on implementation experience and adding new features based on what the users may require. The maintenance process is similar to the development process.


Clinical Data Interchange Standards Consortium (CDISC)

CDISC is one of the popular SDOs out there. The organization has established open global standards to aid the collection, exchange, submission/reporting and documentation of medical data. CDISC is aimed at developing platform-independent data standards to ensure information system interoperability for the improvement of medical research and other healthcare-related areas. In 2001, CDISC and HL7 entered into a Charter Agreement to harmonize healthcare standards and clinical research.

European Committee for Standardization/Technical Committee 251 (CEN/TC 251)

CEN/TC 251 is a European based (regional) SDO between international or specific domain SDOs, whose focus is almost exclusively on content technology, not communication technology. The organization encourages interested parties to have interoperable and enforceable standards for secure and reliable information exchange. CEN/TC 251’s focuses on the application of information and communication technology in healthcare, social care and wellness.

CEN/TC 251 work items are prioritized to meet European Union (EU)/European Commission (EC) requirements. This is meant to support work in the Member States in need of approval to meet the requirements of other SDOs and to provide updates and revisions of existing CEN/TC 251 standards, specifications and reports. In 2007, the EC issued a mandate to European Standardization Organizations (ESO), CEN, European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI), to develop a coordinated work program for health informatics standardization (Mandate M/403).

Digital Imaging and Communications in Medicine (DICOM)

DICOM is an international standard for biomedical imaging and related data. DICOM represents a collection of network services that are meant for transfer, storage and access to images. DICOM defines products of image analysis applications, as well as services for imaging department workflow management. DICOM is used in all radiology and cardiology imaging devices and systems and other fields of health imaging, such as dentistry, ophthalmology, and pathology.

Health Level-7 (HL7)

HL7 is an international SDO that comprises healthcare experts and information scientists. They work together to develop accredited standards for the exchange, administration and integration of electronic healthcare information. HL7 created a family set of standards in the mid-1990s following a common Reference Information Model (HL7 RIM). The RIM standards include exchanging of information and support inter-system cooperative processing via messages, electronic documents and services.

A terminology developed and maintained by other standards organizations such as International Health Terminology Standards Development Organization (IHTSDO), World Health Organization (WHO) and others encode the most data elements exchanged by HL7. Moreover, HL7 partners with many other international and local standards groups that focus on information domains different from the HL7 domain.

Integrating the Healthcare Enterprise (IHE)

IHE was established by healthcare professionals and other industry experts with the goal to improve healthcare information systems. IHE encourages the use of established standards in a coordinated manner. Such standards include DICOM and HL7 and address detailed clinical needs in support of the best patient care.

Systems standards developed in line with IHE specifications communicate better with one another, are implemented more easily and allow carers to make use of the information more effectively.

International Health Terminology Standards Development Organization (IHTSDO)

IHTSDO was established in 2007 as a Danish non-profit association by nine charter members (Netherlands, New Zealand, Sweden, United Kingdom, Australia, Canada, Denmark, Lithuania, and the United States). They purchased Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT) from the College of American Pathologists (CAP) in April 2007, which currently handles its maintenance, development, quality assurance, and distribution. The major aim of changing ownership was hinged on promoting international adoption and the use of SNOMED CT.

In June 2009, Singapore, Cyprus and Spain became members and other nations are working to become members as well. Recently, IHTSDO announced the availability of free SNOMED CT licenses in 49 other countries designated as low-income economies.

International Standards Organization Technical Committee 215 (ISO TC 215) on Health Informatics

ISO TC 215 on Health Informatics was established in 1998. Its formation came after ten years of progressive cooperation among international health informatics standards organizations. The parent ISO organization, situated in Geneva, is recognized by law in many countries as a non-governmental organization.

TC 215 is organized into four major Working Groups:

  • Data Structure – for frameworks and models
  • Data Interchange – for harmonization and messaging
  • Semantic Content – for terminology and knowledge
  • Security – for confidentiality, integrity, and availability.

The activities of these groups are complemented by two application groups – Pharmacy and Medication as well as Business Requirements for an EHR. These organizations meet twice a year for working group efforts and plenary council. There is an internationally recognized agreement between the European CEN TC251 and HL7 to “fast track” standards balloted in those organizations.


MedBiquitous is a non-profit organization founded by Johns Hopkins Medicine and leading professional medical societies. It is made up of an international group of professional medical and healthcare associations, universities, and commercial and governmental organizations. Their aim is to advance healthcare education with the help of technology standards that improve professional collaboration and patient care.

Logical Observation Identifiers Names and Codes (LOINC)

LOINC serves laboratory and other clinical measures as well as documents used in electronic transactions among independent computer systems. LOINC is a coding system whose codes identify the variables in measurement or test result from the laboratory, survey questionnaire items, and packages. This coding system is used by local hospitals and laboratories, healthcare provider networks, public health departments, and related fields. LOINC recorded about 800 downloads of its database per month in 2008 by users from 86 different countries with about 9,500 for the year.


Software application developers produce new healthcare software application standards using four basic methods:

Ad hoc Method

Groups of concerned people and organizations agree on a standard specification. In most instances, these specifications are informal and are accepted as standards through an agreement between involved participants. The popular standard created through this method is the DICOM standard for medical imaging, formulated by the ACR and the NEMA.

De facto Method

A single vendor monopolizes a portion of the market large enough to make its product the market standard. Microsoft’s Windows is the most widely known application that uses this method.

Government-Mandate Method

A government agency creates a standard and legislates it for common use. The UB92 insurance claim form of the Health Care Financing Administration (HCFA) is one of the most well-known standards that use this method.

Consensus Method

A group of volunteers coming from different interested parties work together to create a standard. Most healthcare standards were created using this method, including HL7.


Lack of agreement on terms and meanings in healthcare computer systems gives way to the complication disrupting the flow of health information exchange, capture, storage and use of clinical data within various healthcare establishments and across different organizations. The encoding of medical and healthcare information is the most basic operation in any clinical setting. Following standards for encoding serves two different purposes, namely:

  • Save system developers from continually reinventing the wheel
  • Facilitate data exchange between different systems of various institutions

The available standards are often inadequate for system developers. As a result, no standard terminology is enough to facilitate the exchange of coded healthcare information. To understand the coding systems, one must understand the difference between terminology, vocabulary and nomenclature. Creators of different coding systems use them interchangeably. Fortunately, despite the existence of limited accepted standard terminologies, a generally accepted standard about terminology exists – the ISO Standard 1087.

Data-Interchange Standards resulted from the need for healthcare applications to interconnect. Interested individuals belonging to the American Association for Medical Systems and Informatics (AAMSI), first formulated and conceptualized this set of standards in 1980. Two standards, the HL7 and the MEDIX, were formed by the American College of Radiology (ACR) together with the National Electronic Manufacturers Association (NEMA). Two other groups developed related standards independent from these two mentioned medical communities: (1) the ANSI X12, the standard used for the transmission of business transactions, including health claim information and benefit data, and (2) the National Council for Prescription Drug Programs (NCPDP), the standard for the data exchange of third party drug claims.

The sole purpose of developing the data-interchange standards is to allow one system (the sender) to transfer data to the receiver in a precise fashion. Both systems must fully understand the content and format of the message or data being sent.


Collaboration between different SDOs can organize resources and also help improve the quality of standards developed. Limited resources can prove this challenging. Most SDOs meet a several times a year to work out plans for the development of standards. Apart from resources, the collaboration ensures harmonized standards that are not competitive.

Collaboration brings value and the significance is not only in resource management and increased efficiencies but also by ensuring harmonized and noncompetitive standards. CDISC and HL7 have effectively increased the number of meetings and teleconferences.

Consistency developed standards is also a product of collaboration among SDOs. Development and sharing of standard tools is not possible without collaboration, and this is important for the development of better and consistent standards. When SDOs collaborate in the development of standards the end-user benefits.

End User Benefits

Collaborations of SDOs in meaningful and complementary ways can benefit both stakeholders and different communities. When SDOs come together, they can develop standards effectively and quickly with reduced cost. This means low cost for the end-user and also more effective standards.

SDOs Collaboration Barriers

As good as SDOs collaboration may appear it is not without barriers. One of these is the over-dependence of most SDOs on volunteers, who may have an inadequate view of the vast impact of standards development, nationally or internationally. All SDOs are answerable to their stakeholders, and they take directives from them. Stakeholders (government, directorates, or customers) have different views of their values, and this leads to competitive force on the all-embracing development strategy.

Another barrier is the intrinsic belief that end-users are basically different as it applies to various organizations. This leads to rejections of initiatives that may appear unfavorable to an organization’s end-users. The difference in governance models, including balloting policies and publishing standards. One organization may support a particular policy that may not fit with another organization. This leads to disarray and thus unfruitful relationship. These are the reasons why most SDOs will not come together despite the glaring benefits of collaboration.


Health information standards play an important role in electronic data management. Therefore, Health Information Management (HIM) professionals need to go beyond the basic familiarity with informatics standards and gain specific knowledge to serve as a professional resource for different healthcare organizations.

Become an expert on health informatics standards involving patient data and business processes that affect healthcare information. At a minimum, health informatics professionals should understand the major topic areas that involve ASTM, HL7, X12N and NCPDP. Acquire adequate knowledge about HIPAA regulatory requirements for claims processing, billing and eligibility.

Learn more about the data systems in the organization, particularly those that are used in eligibility, claims and billing processes. Determine the HIM business processes that interact with these functions. Verify whether format changes and changes in data definition are necessary for the preparation of regulatory implementation.

Examine the ASTM policy and other technical standards involved in the security and confidentiality of data systems and correlate these with the privacy and security regulations set by HIPAA.

Investigate and understand how HL7 fits into the information systems environment of the healthcare organization involved. Be aware that although HL7 message standards are adopted in a healthcare organization, the manner in which these standards are used may be highly customized to meet product variability dictated by the organization.

Remain up to date with the healthcare industry’s development. Be familiar with the guiding principles for selecting Patient Medical Record Information Standards, which improves the effectiveness and efficiency of a health system within the involved healthcare organization and meet the data needs of the healthcare community, particularly the patients, providers, public health organizations, and clearinghouses.


Most healthcare information professionals believe that 20 to 30 standards are required to meet the health information needs of the United States healthcare industry. One of the most challenging issues in standardizing the healthcare data systems is the conflict between the known standard and the opportunity of the software application developers and vendors to use creativity to produce a unique product to boost sales.

Currently, no standards exist that fully support the requirements of healthcare workstations. In the future, seamless electronic interchange of healthcare data using standard formats will be implemented to include not only the written message but also the data representation images, sound and voice, motion video, signals and waveforms. Standard formats for clinical forms such as discharge summaries, progress notes and operative notes will be exchanged meaningfully between organizations. Clinical guidelines and decision-making algorithms using the consensus standard process will be widely used and accepted, and the “plug and play” goals will be realized and obtainable in the future.


  1. Public Health Data Standards Consortium (2015). Health Information Technology Standards
  2. Murphy, G., & Brandt, M. (2001). Practice Brief: Health Informatics Standards and Information Transfer: Exploring the HIM Role. AHIMA.
  3. Shortliffe, E.H., & Cimino, J.J. (Eds.). (2014). Biomedical Informatics (4th ed.). London: Springer-Verlag.
  4. Healthcare Information and Management Systems Society (HIMSS) (2013). Evolution of Healthcare Informatics Standards. Retrieved from
  5. Ibid.
  6. Ibid.
  7. Ibid.
  8. Public Health Data Standards Consortium (2015). Health Information Technology Standards.
  9. Shortliffe, E.H., Perreault, L.E., Wiederhold, G., & Fagan, L.M. (Eds.) (2001). Medical Informatics (2d ed.). New York: Springer-Verlag
  10. Op. Cit. Public Health Data Standards Consortium
  11. Ibid.
  12. Ibid.
  13. Ibid.
  14. Ibid.
  15. Op. Cit. Shortliffe & Cimino
  16. Op. Cit. Shortliffe, Perreault, Wiederhold, & Fagan
  17. Ibid.