As the chief endorser of U.S. standards, ANSI recognizes SDOs and their standards through three methods:

  • ANSI determines that a U.S. national standard is needed, but there is no work in this area. An organization to develop the needed standard is either created or contracted from existing sources. ASC then recognizes and oversees the standards development process.

  • An SDO independently develops standards following ANSI-prescribed rules and processes (i.e., balloting) for consensus standards.

  • An SDO submits an independently developed standard to ANSI for endorsement as a national standard, after canvassing the sector for objections and comments.

In the consensus balloting process (used by Health Level Seven [HL7], the Institute of Electrical and Electronics Engineers [IEEE], and the National Council for Prescription Drug Programs [NCPDP]), a draft standard is circulated to the SDO members and other interested parties for comment over a 6-week period. Care is taken to ensure balance among voters, with no more than 50 percent being vendors. All comments are considered, and negative ballots must be specifically addressed. If a negative ballot is persuasive, the standard is modified and must be reballoted, particularly if the changes are significant. If a negative ballot is not persuasive, the SDO requests its removal. If neither of these situations occurs, comments are sent to the entire balloting group for consideration. The resulting vote determines the content of the standard; for health care data interchange standards, over 90 percent agreement among the parties is usually required for a standard to be approved (American National Standards Institute, 2002). In fact, some SDOs, such as HL7, also have a preliminary approval process by a technical committee before a new or revised standard is presented for open balloting by ANSI rules (Health Level Seven, 2002).

For the canvassing process (used by the American Society for Testing and Materials [ASTM] and Digital Imaging and Communication in Medicine [DICOM]), a notice of a proposed standard is published in an official registry, and interested persons may provide objections and/or comments. In the absence of negative comments, the standard is approved. This process is generally not preferred over the consensus process because public notices are often ignored as the result of a lack of immediate need for interoperability, use of other data standards, or other reasons, resulting in a much less open or scientifically rigid process for achieving standardization.

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