HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-06-22

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

June 22, 2009


Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), and Diane Miller (Alpharma)

  • Problems with the validation using xerces. Getting validation errors if capTypeCode is not there. Will not validate time period (IVL<TS>) unless it is just numeric, not allow P24M (ISO for period 24 months).
  • Message may have wrong data type, IVL<TS>. IG has data type as IVL_TS. The IVL date type has a a high, low and width., IVL<TS> is an interval of point in time, IVL_TS is not allowed for an interval of point in time. Catherine has looked into this more and it appears the message can remain the same, but the IG would have to be edited to reflect how approve, proposed, and none would look.
  • Here is a link to the HL7 data types http://www.hl7.org/v3ballot8/html/foundationdocuments/helpfiles/datatypes.htm.
  • We need input from HL7 on how this is used. How can you use ISO format for time (P24M)? Should we be using width, there is a high low and width? Catherine found the by using the high, low and width we can capture what we need (see the second bullet). Is the literal form part of what data type IVL (which take a ST or IVL<TS>?
  • What are the options for reference, will the FDA eRoom have sub folders for all external documents associated with eStability?
  • Where do we put links if not in reference@value (must be URIs), somewhere else in reference? One solution is if it is a URI put in reference@value, if not the viewer will take care of the rest (e.g., PDF).

Agenda for June 29, 2009 Teleconference: