Pediatric Informatics: Computer Applications in Child Health (Health ...

32 Developing Pediatric Data Standards 421
32.3 Role of the Standards Development Organization
Standards development organizations (SDOs) are the entities that consider, create,
maintain, and distribute standards, often with the support or sponsorship of larger
entities, such as governments or specialty groups. Standards development organizations
are generally made up of individuals with expertise in the domain being
standardized and in the standardization process, often working as volunteers. Domain
experts may be anybody with practical, administrative, or theoretic knowledge and
experience from the field being standardized. For example, when creating standards
for pediatric data, the HL7 PeDSSIG assembled a group of more than 70 participants
that included physicians, nurses, pharmacists, researchers, administrators and
program directors, and system developers among others. Including a diverse array of
participants into an SDO allows for differing views and experiences to be considered
when standards are developed and evaluated. Standards development organizations
may be independent groups whose primary role is to develop standards, and they may
be a component of an organization meeting a special need or constituent. For example,
HL7 is a standalone independent SDO having the goal of standardizing clinical and
administrative data “requirements of the entire health care organization.”
The process for developing standards occurs in several stages. The stages may cover
the steps that take place from the conception of an idea all the way through publication
and general availability. The rigor with which stages are defined and followed vary with
the SDO creating the standard. The International Organization for Standardization,
for example, defines six distinct stages for standards development. 18 These include
the proposal stage, the preparatory stage, the committee stage, the enquiry stage, the
approval stage and the publication stage, as described in Table 32.2. Other SDOs may
Table 32.2 International Organization for Standardization (ISO) stages for developing and
publishing new standards 18
Stage Tasks and procedures
Proposal Propose a new standard to the relevant technical committee to determine through
voting whether the standard is needed and useful and to identify the project
leader if the group decides to proceed
Preparatory A working group of domain experts is convened and iteratively develops a draft
set of standards, which are reviewed by the technical committee who approved
developing the new standard
Committee The draft standards are registered and then evaluated by the technical committee,
which both provides feedback and votes to accept the draft. When accepted,
the draft is formatted to a “draft International Standard (DIS)”
Enquiry The DIS is reviewed for vote and comment by all organizations participating in
the ISO, with approval occurring if two thirds of the organizations vote to support
the standard but no more than one fourth vote against it. The approved
version is called a “final draft International Standard (FDIS)”
Approval The FDIS is circulated for vote again by organizations participating in the ISO,
with approval occurring if two thirds of the organizations vote to support the
standard but no more than one fourth vote against it; technical comments are
not considered at this stage
Publication The final ISO standard receives minimal copyediting and is published for use by
all stakeholders