V3 support discussion

20170104-Vada Perkins

I don’t believe anyone is suggesting a modification to the currently planned discussion for the overarching state of V3 modelling (Monday Q2) or that this meeting is intended to get rid of V3.

My understanding, per Ed’s email which was specific to RCRIM in its distribution, was to have a discussion during a RCRIM (Wednesday Q2) meeting to address RCRIMs specific needs in relation to what you presented in your initial email regarding a potential change to the organizational infrastructure for future V3 modeling. There wasn’t much information to go off per the initial email so we are being proactive about this given that it has direct impact. That said, it would appear that what we are proposing for our QTR is a bit pre-mature since it is the first meeting and you’re still sorting out the agenda. Ed, maybe it’s best that RCRIM reps. simply attend the general meeting and we can then discuss internally within RCRIM and provide input based on the outcome?

I agree with Wayne’s proposal below in that a separate strategy (potentially) for V3 regulatory standards in relation to the "future approach to V3 overall” may be warranted; this should be a specific discussion with RCRIM at some point, but not as a part of this initial general meeting.

This is my take, but defer to Ed/John/RCRIMers for their thoughts regarding next steps.

20170104-Mary Ann Slack

This is exactly right. At present the v3 messages are a key component to a number of regulatory submission types. As Vada has mentioned, RCRIM is entering into FHIR projects that have application for regulatory use, but for the foreseeable future, V3 will also continue to be actively used.

201611128-Vada Perkins

This is correct. We have had many discussions surrounding V3 and its utility for regulatory submissions. Take into account that ICSR, IDMP, RPS are V3. In addition, the volume, complexity, and business process for regulatory content within a dossier is well supported by V3. There may have been a drop-off in V3 for other domains/use cases due to FHIR, but that would not be the case here as FHIR is not suited for what I’ve described as discussed and confirmed with FHIR experts on numerous occasions.

We would like a discussion on how we can come up with the most appropriate organizational infrastructure to support V3 for stakeholders who will continue to utilize it for their intended purposes.

Regarding FHIR: RCRIM is actively engaged with FHIR experts and have FHIR activities on the books to examine how it can best be utilized in the regulatory domain directly and to support secondary downstream use of content in the healthcare domain. That said, it doesn’t change the fact that V3 will need to be actively supported for both national and international regulatory activities.

20161228-Jean Duteau

We would like a discussion on how we can come up with the most appropriate organizational infrastructure to support V3 for stakeholders who will continue to utilize it for their intended purposes.

This discussion will be happening in Monday Q2 hosted by the ArB. I encourage everything who has thoughts to come to this quarter to discuss. RCRIM is one of a few groups that has V3 models so it does not make organizational sense to have this meeting just with the RCRIM stakeholders. I can certainly come to Wed Q2 and give an update but the entire organization will be constantly updated as our conversations continue and progress.

And to be clear, the meeting on Monday is not discussing how to get rid of V3 modelling. That would be the furthest goal from its purpose. The intent is to look at the entire suite of V3 products that the organization has and how best to support those and how best to focus our efforts. We will be looking at the RIM, the MIF files, Core Principles, V3 tooling, V3 publishing, etc.and determining how best to support what needs supporting.

20161228-Ed Helton

Jean --- I think we were wanting some discussion for the future of V3 messages, since most, if not all RCRIM Normative messages are V3. As per Vada, this is till the only format capable presently to contain submission a dossier/eCTD -- correct Vada.. if you would have time, we would like to talk that QTR. And, of course, Myron’s comments certainly express our interest as we – very accurate.

20161227-Myron Finseth

However, I think a discussion of the format or process of V3 modeling would be very pertinent to RCRIM/BRIDG. We expect that SPL R7 will be updated to SPL R8 soon. It would be nice to exchange thoughts on how to we might proceed.

20161130-Jean Duteau

With the advent of FHIR, there has been a drop off in v3 modelling (well, it might not have just been FHIR’s fault, but they are a good scapegoat!). In the January 2017 ballot, there is exactly one set of models being balloted - Nutrition Orders - and that is a 2nd version of previously balloted material. There are also two reaffirmations of previous v3 material.

We (the co-chairs) have noticed this drop off in new v3 modelling for some time and are now trying to decide what, if anything, the organization and our workgroup can or needs to do about it.

Thus I am looking at scheduling a meeting during the January WGM in San Antonio with all interested parties to basically have a “Fresh Look” discussion of how we handle v3 modelling and the organizational infrastructure that currently supports it.

The main topics would be something along the lines of: - what v3 artifacts do we care about (RIM? Vocabulary? Datatypes? Core Principles?) - what energy do we have to work on them, both within the workgroup and organizationally - how do we support existing Normative and STU v3 artifacts - how do we support any future balloted v3 artifacts

I’ll be thinking more on the agenda as we get closer to the meeting, but I wanted to get this note out ASAP.