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HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-01-09

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

January 9, 2012

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Art Griesser (Promethues), and Sandra Spiewak (Reed Technology and Information Services Inc.)

  • Schematron is done, Josh is working on three issues reported by Mike Yang on 12/19/11. There should be a new version soon.
  • A statement from FDA on when eStability or all electronic will be mandatory would be good. It would give people a date and know that it is a reality. I"m not sure when FDA will set a date.
  • Is there a way to make eStability more appealing to industry? Change is difficult.
  • Need to work on the Guidance and get it done.
  • Will request the same time and day (every Monday, 3-4pm) for the teleconference from RCRIM.
  • There will be no teleconference on January 16, 2012.

Agenda for January 23, 2012 Teleconference: