Chapter 2

Standards Development Organizations

2.1What are Standards Development Organizations (SDOs)?

SDOs are member-supported organizations, often accredited by the American National Standards Institute (ANSI), who develop and maintain standards to meet industry needs. Members include health care providers, insurers, health IT software developers, patients, care givers, and others. Many SDOs are international organizations with U.S. branches, and there are at least 40 SDOs who currently develop and maintain standards for the healthcare field. A single SDO may only develop one standard, or they may have hundreds of standards, depending on the mission or interests of the organization.

2.2Who is involved in SDOs

Many of the largest SDOs have a set of paid staff members who manage the administrative aspects of the organization, like finances, scheduling, organizing workgroups, etc. But for the most part, the individuals who participate in the SDOs and who build the standards are volunteer members who participate in SDO activities outside of their normal jobs (though some are paid by their companies to participate). Building good standards requires a wide range of knowledge and skills, so that standards meet business/clinical needs and work well from a technology perspective. Workgroup members, include but are not limited to: clinicians and healthcare administrators who understand the business need, clinical informaticists who understand clinical ideas and technology, software developers, engineers, IT professionals who understand technology, and government agencies who understand regulatory requirements.

2.3How do SDOs work?

The majority of SDOs have detailed internal processes on how standards are developed and maintained, most often through the use of workgroups. When accredited by ANSI, an SDO has to follow certain processes for its decision making and to ensure consistency and fairness in the standard’s development. This ensures that there is consensus among participants and that no one participant can control the standard. Workgroups typically focus on a single standard or piece of a standard, or a single business need. SDOs use workgroups to pull together the right mix of individuals who have enough knowledge to develop and maintain a particular standard.

Though each SDO has a slightly different process for developing new standards, generally they follow the workflow process below, though there are reasonable and acceptable variations to the process. Note that developing a new standard may take two or three years in order to develop consensus, move through the balloting and piloting process, and fix issues. In particular, piloting a standard for a length of time is important to make sure the final standard works well in the real-world. Once a standard has been developed, SDOs must maintain them to fix issues based on implementation experience and to add new capabilities based on user needs. While the maintenance process is similar to the development process, there is some variation. Again, each SDO has a slightly different process, but the process to make updates may take months or more than a year to complete, depending on the priority level of the fix.