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HL7 Stability Standard Implementation Guide Teleconference Minutes 2015-03-23

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HL7 Stability Standard Teleconference Minutes

March 23, 2015

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Jake Hays (Merial), and Brian Wachter (Merial)

  • 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 eStability message passed normative ballot at HL7 in May 2010, the re-affirmation of the eStability message as is will occur in 2015 (all HL7 messaged 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 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 3/30/15.

Agenda for April 6, 2015 Teleconference: