Their logic is similar to: "If I have a truck (transport format) that can carry cows, and the same truck can carry oranges, than I will be able to breed cows that can produce orange juice".
More reasons for not choosing for HL7-v3 for (SDTM) submissions can also be found in my old article "Ten good reasons why an HL7-XML message is not always the best solution as a format for CDISC standard - and especially not for SDTM data". Also the recent postings from Gartner have indicated that HL7-v3 messages have been a big failure.
I am getting currently getting training from HL7 Austria, which will (hopefully) make me an HL7-standards experts and especially make me even more better in working with CDA. If all goes well, this will also deliver me HL7 certification.
As I also am teaching CDA at the university (as the Austrian EHRs system "ELGA" will be based on CDA), I do see more and more clearly (also technically) how information from EHRs can be used in clinical research: the answer is NOT in using HL7-v3-XML for FDA submissions, nor in data collection: we do have CDISC ODM for that.
However, there are a few things we can learn from CDA, and which we may want to introduce in ODM, or at least allow it (though standardized extensions). Here is a first list:
- use of universal Object Identifiers (OIDs). These are not the current OIDs of ODM, but the one used in CDA and ISO-21090. For example: