Wednesday, November 9, 2011

A new challenge

I have recently obtained a professorship in "Medical Informatics and Documentation" at the eHealth department of the "University of Applied Sciences FH Joanneum" in Graz, Austria.
This will enable me to continue my work on the development of CDISC standards (and even being paid for it), but also to do exciting projects in the area of e-healthcare and its integration with clinical research.
My company XML4Pharma will also further exist in the future, but will concentrate more on software development (for CDISC implementation) and less on consultancy and training.

At the university, I am teaching "databases" and "medical informatics", the latter concentrating especially on hospital information systems, their architecture, standards in healthcare (HL7, DICOM, semantic standards like SNOMED, ICD-10, LOINC...).

Austria is currently, slowly but steadily, rolling out a nationwide system for electronic health records (ELGA) and I hope to also contribute to that. For example, I am currently discussing a project with 3 Master students in which they will develop an XForms implementation of the Austrian "elektronische Arztbrief", a letter that is send from one physician to another physician when the latter takes over the care of the patient. When submitted to the server, the form will then be converted into HL7-CDA format.

But I also will work on the further development of the CDISC standards. One of the teams I am in recently published the "Study Design Model in XML" (SDM-XML), an extension to the ODM standard. But that does not finish the work: we need to develop an implementation guide, and provide samples. We need to demonstrate the usefulness of the standard and convince the vendors to implement it in their tools.
I did already take some steps in that direction: the "ODM Designer" now implements SDM-XML, and I also demonstrated (also see previous posts) that an SDM-XML study design can easily be transformed in a "caBIG Patient Study Calendar" (PSC), and its workflow and timings part into a BMPN-2 workflow XML document, that can easily be read into a hospital information system.
That brings us back to the topic of integration between healthcare and clinical research, which is also taken care of by a number of IHE-profiles. So also there, I will be contributing, as I already did in the past (RDF and RPE profiles).

Of course there are already thoughts about the further development of the ODM standard (version 1.4). If you have some things that you think should be added to the "user requirements", please let us know, and we I will add them.

What I will probably discontinue, are my contributions to the further development of CDISC submission standards, such as define.xml and the "MetaData Submission Guide". Reason is that as a professor, I need to do innovative work. My strong impression (confirmed yesterday in a teleconference with people of the FDA - but that's another post) is that, even more than five years after SDTM and define.xml were first introduced (because the FDA wanted to standardize), the FDA is still not able to work with SDTM nor define.xml - the review environment is still completely absent.
So as long as the FDA is not modernizing their IT (to my opinion they are 20 years behind with respect to industry), it may be a waste of time spending time on the further development of formats for submission standards. On the other hand, proving that e.g. an XML format for SDTM submissions (NOT based on HL7-v3) is a giant step forward (which would also enable the FDA to come to a great review environment without high costs - especially statistical software licenses), might boost the modernization of IT at the agency.

But that's another story...

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