Health Information System Standards
The International Organization for Standards (ISO) defines standardization as the process of agreeing to standards, the common language facilitating the exchange of information between two different data systems. In the healthcare sector, 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. 
Health information technology professionals use standards that are approved by a 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. 
Overall, these experts adopt them to:
- Transfer health data using predictable business processes and conform to regulatory and ethical demands
- Enable the electronic exchange of information between two or more computer systems by adopting a uniform format and sequence of data for more efficient interoperability between different computer systems
- 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 on paper
Although the first computers were without standards, standards for software and hardware development quickly became a necessity. Computers work with values and numbers, and with computer “words” such as 10101100; however, human beings need a more readable language. Thus, the developments of standard character are sets, such as EBCDIC and ASCII. 
Common Business-Oriented Language (COBOL), the first computer language, was formulated to simplify program development. Its introduction to information technology gave way to the sharing of codes and the development of ready-to-integrate software components. As a result, the American Standards Institute (ANSI) proclaimed COBOL as the official standard language of software development and data information exchange. 
Hardware components, in like manner, also needed standards for exchanging essential information to make them interchangeable. In fact, 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 properties 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. In 1991, the Accredited Standards Committee (ASC) X12N Insurance subcommittee initiated standards for the interactive communication of health claims and other administrative transactions. 
Different clinical specialty groups and professional associations identified the need for a standard in a specific area. The National Council for Prescription Drugs Programs (NCPDP) saw a need for a standard focused on a specific 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, file structure for biomedical images and image-related information and digital image format, causing them to form the Digital Imaging and Communications in Medicine (DICOM). 
The diverse needs of different healthcare specialties resulted in the formulation of different standard sets and the fragmentation of different standards development organizations. These groups focused on highly specific needs causing uncoordinated standard development in different healthcare sectors. In the absence of coordinated point for healthcare informatics standards, gaps and overlaps occurred 
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. The HISB’s efforts fostered the development of multi-lateral agreements among groups. 
As of today, the healthcare delivery system employs different information systems from different vendors across multiple organizations and even within a single healthcare organization. Laboratories, pharmacies, health records departments and physician offices operate different systems. The use of different systems makes 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 become optional and not a priority. Options make the variability of workflow and the availability of information in different healthcare settings possible. 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, namely:
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. 
Data Content Committees (DCCs), Designated Standard Maintenance Organizations (DSMOs), Standards Setting Organizations (SSOs) and Standards Development Organizations (SDOs) continually develop and maintain health information technology standards. 
Information Content Standards
Information Content Standards and the contents of information exchanges are interrelated.  They consist of two basic levels:
- 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)
- Second level: Defines the complete package of content standards in document of message forms (e.g., HL7 Continuity of Care Document)
Information Exchange Standards
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 provides 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
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. 
On the other hand, confidentiality ensures that the information is accessible only to those people who are authorized to do so. Confidentiality is one of the cornerstones of security in health information technology. In fact, many information technology experts design systems with this goal in mind. 
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 business activity – which is 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 assurance, 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. 
A functional standard serves as a medium to ensure that work processes involving electronic data exchanges between users of a 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. 
Aside from the six above-mentioned components of 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 (which are the business activities) 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.
Tools and Techniques
Software application developers produce new healthcare software application standards using four basic methods. 
Ad hoc Method
In 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 agreement between involved participants. The popular standard created through this method is the DICOM standard for medical imaging which was formulated by the ACR and the NEMA.
De facto Method
In 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.
In the 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.
In 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. In fact, HL7 – the standard for clinical-data interchange – was formulated using this method.
Coded Terminologies, Vocabularies, and Nomenclature
Currently, the 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 constantly reinventing the wheel
- Facilitate data exchange between different systems of various institutions and organizations
However, 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. Therefore, to understand the coding systems, one must understand the difference between a terminology, vocabulary and nomenclature. In most instances, 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 of 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. Different events took place in the development stage. 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 another system (the receiver) in a precise fashion. To accomplish this task, both systems must fully understand the content and format of the message or data being sent, as well as the vocabulary and the delivery mode involved in the transmission. 
Health information standards play an important role in electronic data management. Therefore, it is important for Health Information Management (HIM) professionals to go beyond the basic familiarity with informatics standards and gain specific knowledge to serve as a professional resource for different healthcare organizations. The following are the best practices each HIM professional should consider:
- 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. Exploring other standards can follow.
- Acquire adequate knowledge about HIPAA regulatory requirements for claims processing, billing and eligibility. Being familiar with HIPAA compliance plans and understanding how these affect different healthcare organizations is necessary to implement timelines.
- 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.
- Be up-to-date with the healthcare industry’s standards development. Be familiar with The Guiding Principles for Selecting Patient Medical Record Information Standards to improve 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, health plans 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. However, 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. However, 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 consensus standard process will be widely used and accepted, and the “plug and play” goals will be realized and obtainable within the next few years. 
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