HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-10-31

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

October 31, 2011

Attendees:

Norman Gregory (CVM), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), and Art Griesser (Promethues)

• The new set of schemas added more max and min occurrences of 1, ultimately should not effect the schematron.
• Had a meeting to exchange information and ideas on 10/27/11/ at PhRMA with Industry representatives and CDER, OPS to discus eStability. Some concerns are the cost (getting information to XML), benefit to Industry, how to get vendors on board (without it being required yet), and the usability of the standard by the rest of the world. The way the data is presented in the style sheet was well received. There is talk about publishing a CFR Q&A for eStability for comment.

Agenda for November 7, 2011 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
• Final changes to IG
• Schematron progress update
• eStabilty Validation Procedures document
• Outstanding issues