HL7 Stability Standard Implementation Guide Teleconference Minutes 2015-05-18
HL7 Stability Standard Teleconference Minutes
May 18, 2015
Attendees: Norman Gregory (CVM), Tim Lee (CBER), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Art Griesser (Promethues), Matthew Battaglia (Merial), and Tammy Wright (Dechra)
- The CVM draft announcement that they will accept stability reports using the HL7 XML format (eStability) is on hold. FDA is in the process of issuing an announcement regarding electronic submission of information. The feasibility of using Fast Healthcare Interoperable Resources (FHIR) to submit some of the Common Technical Document (CTD) information is being evaluated and could change how eStability works (stay as V3, part V3 and FHIR, all FHIR).
- Correction to the re-affirmation of the eStability message, it is based on when it was ASNI approved. The eStability message was ANSI approved in June 2011, so the re-affirmation of the eStability message needs to be by June 2016 (all ANSI approved messages must be re-affirmed every five years).
- Working on having a free editor available.
- The editor is available for download at https://module3solutions.com/ If you have downloaded it and got a "Failure sending mail" message. launch the application again. It will bring you back to License key request page. Take a screen shot of the page and email it to firstname.lastname@example.org. You will then be sent a key. Some SMTP servers are blocking the message.
- You can go to www.eStability.com for another source for creating xml eStability reports.
- There will be no teleconference 5/25/15.
Agenda for June 1, 2015 Teleconference:
- Outstanding issues
- The phone number is 770-657-9270 and the participation code is 7485962 and we will be using WebEx now for sharing documents:
Topic: HL7 eStability Date: Every Monday, from Monday, May 11, 2015 to Monday, October 5, 2015 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00) Meeting Number: 744 956 008 Meeting Password: 1234
To start or join the online meeting
1. Go to https://fda.webex.com/fda/mc 2. On the left navigation bar, click "Support". To add this meeting to your calendar program (for example Microsoft Outlook), click this link: https://fda.webex.com/fda/j.php?MTID=mde40af8238a274d470ca66115d08066a
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IMPORTANT NOTICE: This WebEx service includes a feature that allows audio and any documents and other materials exchanged or viewed during the session to be recorded. You should inform all meeting attendees prior to recording if you intend to record the meeting. Please note that any such recordings may be subject to discovery in the event of litigation.