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Tuesday, November 2, 2010

How open should a standards project be?

David Tao asks on the Direct Project Blog:  How Open and Broad Should an Interoperability Project, like the Direct Project, Be? John Moerhke provided his response focusing on numbers (which for Direct seemed to be of a good enough size to generate the necessary code, and on process).  I want to look at it from a slightly different angle.

It's a great question, but I want to analyze it a bit further:  How are decisions about who gets to participate made, and under what rules of governance?  One of the very early complaints (and I know because I made some of them), is that the "rules" under which the Direct project operates are not clear, written down or or even developed through any sort of consensus process.

The goal of the Direct project was to support the "little guy" in the small physician practice, without even an EHR system.  If the bar is set to high, little guys won't be able to participate unless there is some other mechanism established to pull them in.

As David points out:
On the other hand, if an arbitrary limit is set (e.g., no more than 20 organizations) then a project might face credibility problems down the road due to lack of openness, and lower probability of people "buying into" and adopting specifications in which they could not participate.
The notion of openness is so important that the Federal government has public OMB circular A-119 which provides guidelines on use of and participation in the development of concensus based standards.

This circular defines a consensus standards thus (see the second link in the sentence above):
... A voluntary consensus standards body is defined by the following attributes:
  1. Openness.
  2. Balance of interest.
  3. Due process.
  4. An appeals process.
  5. Consensus, which is defined as general agreement, but not necessarily unanimity, and includes a process for attempting to resolve objections by interested parties, as long as all comments have been fairly considered, each objector is advised of the disposition of his or her objection(s) and the reasons why, and the consensus body members are given an opportunity to change their votes after reviewing the comments.

ANSI (The American National Standards Institute) publishes ANSI Essential Requirements which includes in its table of contents the following headings:
1.1 Openness
1.2 Lack of dominance
1.3 Balance
1.4 Coordination and harmonization
1.5 Notification of standards development
1.6 Consideration of views and objections
1.7 Consensus vote
1.8 Appeals
1.9 Written procedures
I highlight that last point, because that is what the Direct project lacks, and before any limits are set on participation, what is needed are those procedures, and they surely ought to be agreed to by a consensus process.  I applaud David for ensuring that there was a forum in the Direct project to have this discussion...

So, Direct, and more broadly, ONC, if you want to play in the standards game, you should do so under the rules that have already been established for Federal agencies and for SDOs.


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