Regulated Product Submission (RPS) Clear First Hurdle

Our posting this time is from Jason Rock, GlobalSubmit CTO and Chair of the HL7 RPS Specification Development Group.

The Draft Standard for Trial Use (DSTU) ballot of the Regulated Product Submission Release 2 standard barely passed ballot on Monday January 11th. The ballot passed by two votes with a result of 53 affirmative and 33 negative.

Even though the ballot passed, the process is not over. Every comment must be evaluated. This process can take months. Most projects try to resolve comments to the satisfaction of the commenter, but this is not a requirement.

One of my responsibilities as Chair of the HL7 Specification Development Group is to manage the ballot process. In that role, I have already compiled all of the comments. There are over 180 comments in total. Each comment has a proposed resolution. Nearly 150 of the comments were accepted or accepted with minor alteration. It is the last 30 comments that will be most difficult to resolve. I believe that the comment evaluation should run smoothly though, and not hold up the process.

Of the 150 comments that were accepted, some were related to words that addressed two-way communication which is not supported at this time. These words were originally added for release one, but will now be removed. The vast majority of comments were updates to text, either in relation to correcting typos or offering suggestions to help make the text more clear.

I expect that the ballot will be altered with the text changes, but that the model will not change. I also expect the FDA to start testing at the beginning of the third quarter, 2010.

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