HL7 Stability Standard Implementation Guide Teleconference Minutes 2014-11-10

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HL7 Stability Standard Teleconference Minutes

November 10 2014

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), John Bishop (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Tammy Wright (Dechra), and Donald Palmer (Acuta)

  • 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. Also, the current message in Version 3 is up for its 5 year re-ballot and has major revisions.
  • 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 info@module3solutions.com. 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 11/17/14.

Agenda for November 24, 2014 Teleconference: