2017-10-30 TSC Call Agenda

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TSC Agenda/Minutes

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HL7 TSC Meeting Minutes

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Date: 2017-MM-DD
Time: 11:00 AM U.S. Eastern
Facilitator: Ken McCaslin Note taker(s): Anne Wizauer
Quorum = chair + 5 including 2 SD represented yes/no
Chair/CTO ArB International Affiliate Rep Ad-Hoc
x Ken McCaslin x Tony Julian x Jean Duteau x Freida Hall, GOM Expert
x Wayne Kubick x Lorraine Constable x Giorgio Cangioli .
Domain Experts Foundation and Technology Structure and Semantic Design Technical and Support Services
x Melva Peters . Russ Hamm x Calvin Beebe . Andy Stechishin
x John Roberts x Paul Knapp x Austin Kreisler Regrets Sandra Stuart
x Floyd Eisenberg, Co-chair Elect . . Mary Kay McDaniel, Co-chair Elect .
ex officio Invited Guests Observers HL7 Staff
. Pat Van Dyke (HL7 Chair) w/vote x Hans Buitendijk . obs1 x Anne Wizauer
. Chuck Jaffe (CEO) vote . . . obs2 .


. . . . .

Agenda

  1. Housekeeping
    1. Introduction of visitors (including declaration of interests)
    2. Agenda review and approval -
    3. Approve Minutes of 2017-10-23 TSC Call Agenda
  2. Review action items –
    1. Austin to draft communication to WGs giving them clarification and instructions on how to handle ballot reconciliation using the language currently in the GOM and HL7 ER
    2. Publication request template
      • Freida to forward discrepancy between 13.02.07 and 13.02.07.02 to the GOC for review
        • Freida is working on this with the GOC; has submitted the change request which is now under discussion
    3. Anne to post a link to January minutes regarding Withdrawal process
      • Link to minutes available here
    4. Wayne to determine what the ONC needs in terms of trial period being open or not in terms of items cited in government regulation.
  3. Approval items from previous weeks with followup:
    1. Normative Publication Request by the BR&R WG of the DESD for HL7 Version 3 Standard: Structured Product Labeling Release 8 at Project Insight 1314 and TSC Tracker 14039
      • Referred by Freida: Needs date/URL of WG approval minutes, date on which final material was sent to HQ, and response to if substantive changes were made since last ballot. They also probably need to at least update the existing product brief re: what changed in the last ballot.
        • Anne to resend request copying Melva and John
          • Update: Resent request; no response as of yet.
  4. Approval items for this week:
    1. STU Publication Request by the CQI WG of the DESD for HL7 FHIR Profile: Quality, Release 1 - US Realm at Project Insight 1125 and TSC Tracker 14106
    2. Project Approval Request by the Public Health WG of the DESD for FHIR Electronic Case Reporting (eCR) at Project Insight 1366 and TSC Tracker 14107
    3. Informative Publication Request by the CIC WG of the DESD for HL7 Domain Analysis Model: Common Clinical Registry Framework, Release 1 at Project Insight 1271 and TSC Tracker 14108
    4. STU Extension Request by the Structured Docs WG of the SS-SD for HL7 Implementation Guide for CDA® Release 2: Questionnaire Form Definition Document, Release 1 at Project Insight 335 and TSC Tracker 14110 for 12 months.
    5. STU Extension Request by the Structured Docs WG of the SSD-SD for HL7 Implementation Guide for CDA® Release 2: Questionnaire Response Document, Release 1 at Project Insight 336 and TSC Tracker 14109 for 12 months.
  5. Discussion topics:
    1. Continued review of requested GOM changes for the next update cycle (Freida/Hans)
    2. Review of Withdrawal Process
      • Withdrawal form here
    3. Product Life Cycle Management Strategy from SGB - Paul/Austin
    4. Revised SGB Mission and Charter and boilerplate Mission and Charter - Paul/Austin
    5. Essentialism
  6. Open Issues List/Parking Lot

Minutes

  1. Housekeeping
    1. Introduction of visitors (including declaration of interests)
    2. Agenda review and approval -
      • No additions
    3. Approve Minutes of 2017-10-23 TSC Call Agenda
      • Approved via general consent
  2. Review action items –
    1. Austin to draft communication to WGs giving them clarification and instructions on how to handle ballot reconciliation using the language currently in the GOM and HL7 ER
      • Add for next week
    2. Publication request template
      • Freida to forward discrepancy between 13.02.07 and 13.02.07.02 to the GOC for review
        • Freida is working on this with the GOC; has submitted the change request which is now under discussion
    3. Anne to post a link to January minutes regarding Withdrawal process
      • Link to minutes available here
    4. Wayne to determine what the ONC needs in terms of trial period being open or not in terms of items cited in government regulation.
      • Complete
  3. Approval items from previous weeks with followup:
    1. Normative Publication Request by the BR&R WG of the DESD for HL7 Version 3 Standard: Structured Product Labeling Release 8 at Project Insight 1314 and TSC Tracker 14039
      • Referred by Freida: Needs date/URL of WG approval minutes, date on which final material was sent to HQ, and response to if substantive changes were made since last ballot. They also probably need to at least update the existing product brief re: what changed in the last ballot.
        • Anne to resend request copying Melva and John
          • Update: Resent request; no response as of yet.
            • MOTION that, in the absence of feedback from the WG, we reject the publication request because of the missing information identified by the TSC: Austin/Melva
            • VOTE: All in favor
  4. Discussion topics:
    1. Continued review of requested GOM changes for the next update cycle (Freida/Hans)
      • Last week, the question came up regarding clarifying the language in the GOM on extensions. As GOC started to look at that request, there were several areas of ambiguity, including whether the extensions were additive to the end of the trial period or the start, as well as how long the combination of extensions between TSC and EC can be - is it perpetuity? The other question was the underlying problem of extending the trial period, but is it really the trial we need to extend, or the publication? Do we really need to extend the trial period to be referenced in regulation?
      • Lorraine: There are cases in which we really want to extend the trial period because we need the comment/update loop to keep going. Wayne: Did confirm with ONC that there are no regulatory requirements that apply as far as they're concerned - they just want something that can be referenced. It doesn't need to be normative and doesn't necessarily need to be in an STU trial period before going to Normative, as long as ONC can reference it.
      • Hans: Given that info, we need to clarify the lengths of the extensions. Ken: Freida is going to provide an update to the GOM that she will submit to GOC saying we want the STU period to be 1-2 years initially, and then the TSC can extend up to five years from the end of the original STU period. Wayne: There are at least two different types of STU periods - one where comments are being actively collected and one where it's in a more mature state. This regulatory case where we're not going to update it - we're using STU as a convenience to keep it out there, but it's not a real trial use period. Discussion over if we should differentiate and how. Expired STUs are still on the main standards grid, but not on the STU page.
        • ACTION: EST to review expired STUs not appearing on STU page as they do on the main standards grid.
      • Freida: So TSC can initially approve 1-2 years for STU. Then can extend up to five years past - i.e., for 6-7 years total publication. Hans: So instead of 1-2 years it should say 1 or 2 years on the GOM update. The GOM also currently says that the TSC cannot provide a trial period for more than 5 years from the original publication date, so this would need to be updated to say 7 years. Freida: I thought we wanted TSC to be permitted to do up to 7 years, and after that, EC would have to do any further extensions. Ken: That is correct. Discussion over next steps.
        • ACTION: Freida to update the language and bring back to TSC for review
      • Lorraine notes that ARB will be updating the information in the GOM regarding being on ARB.
        • ACTION: Add ARB GOM change to January TSC agenda
    2. Review of Withdrawal Process
      • Withdrawal form here
        • Issue is there is no current step to outline the mechanism for the collection of comments. Discussion over where comments should be collected. Lorraine notes there are 5 different ways we currently collect comments. Wayne states there are even more than that. Ken asks what the target mechanism should be. Needs to be a step in here for the WG to choose where the comments will be collected.
          • ACTION: Anne to add line "Feedback collection mechanism" - describe the means by which you'll collect comments on this withdrawal and provide link.
          • ACTION: Anne to delete Gforge from tracker section and state "tracking number assigned and tracking system used."
          • ACTION: EST to evaluate comment collection mechanisms
    3. Product Life Cycle Management Strategy from SGB - Paul/Austin
      • Group reviews. Discussion over if it should be mandatory for the first 5 groups and optional for the remainder? And how would TSC monitor? Ken asks if this has to come to the TSC? Austin states yes, because the management groups report to the TSC. Lorraine states we should cut off the affected groups to those that are formalized. Could recommend best practices but not make it mandatory. Ken would suggest that you're going to be part of HL7, you need to understand and follow the expectations as part of the HL7 product family. Calvin: TSC is the de facto product management group for anything that doesn't a formal family management group. Lorraine: This is asking the families to formalize and document, which is beyond what we've done in the TSC. Paul: It may be that it should apply to niche products as well, such as SPL. Ken: Perhaps we say unless otherwise directed by the TSC, this process should be followed. Lorraine: For the things that don't have a management group, who are we asking to do it? Is it us as TSC? Or the sponsoring WG of the specification? Who is mandated to do this? Calvin: It seems like it would have to be the primary WG on a product by product basis. Austin feels that we make it mandatory for the formal management groups and make it a best practice for others. Group agrees.
        • ACTION: SGB to review comments on 2017-11-08 call. Need to remove individual products, groups that haven't been stood up yet, and add best practice language for non-product management groups.
        • ACTION: Add review of remainder of document to homework and further discussion
    4. Revised SGB Mission and Charter and boilerplate Mission and Charter - Paul/Austin
      • Add to next week
    5. Essentialism
      • Add to next week

Next Steps

Actions (Include Owner, Action Item, and due date)
  • .
Next Meeting/Preliminary Agenda Items


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