STANDARDS DEVELOPMENT PROCESS
When seeking to understand why so many different IT and health care information standards exist, it is helpful to look first at the standards development process that exists in the United States (and internationally). In general the methods used to establish health care IT standards can be divided into four categories:
1. Ad hoc. A standard is established by the ad hoc method when a group of interested people or organizations agrees on a certain specification without any formal adoption process. The Digital Imaging and Communications in Medicine (DICOM) standard for health care imaging came about in this way.
2. De facto. A de facto standard arises when a vendor or other commercial enterprise controls such a large segment of the market that its product becomes the recognized norm. The SQL database language and the Windows operating system are examples of de facto standards. XML is becoming a de facto standard for health care and other types of industry messaging.
3. Government mandate. Standards are also established when the government mandates that the health care industry adopt them. Examples are the transaction and code sets mandated by the Health Insurance Portability and Accountability Act (HIPAA) regulations.
4. Consensus. Consensus-based standards come about when representatives from various interested groups come together to reach a formal agreement on specifications. The process is generally open and involves considerable comment and feedback from the industry. This method is employed by the standards developing organizations (SDOs) accredited by the American National Standards Institute (ANSI). Many health care information standards are developed by this method, including Health Level Seven (HL7)
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standards and the health-related Accredited Standards Committee (ASC) standards.
