I have a new project starting in the next couple of weeks that uses technologies I am unfamiliar with. This project is a result of FDA regulations and the requirement to send them Medical Device data via HL7 formatted messages.
Our data for MDR is stored in a Notes Database. The FDA documentation recommened 3 methods of capturing this data. The susequent subission and acknowledgements will be handled by another team. I am strictly responsible for the generation of the HL7 message.
The FDA recommends 3 possibilites for the creation of the HL7 message. They are:
XSLT (eXtensible Stylesheet Language Transformation)
• XSLT uses XSL (eXtensible Stylesheet Language) and Xpath. Xpath is a query language for finding information in an XML document; path expressions are used to navigate XML documents.
• Create an XML file based on your database tables.
• Use XSLT to transform it to an XML - HL7 message.
• Validate it against the schema.
Inject Data Into Template
• Start with a “blank” instanceMapping.xml file by removing the data (not the meta-data) from the file. This will leave you with an XML-HL7 message with place holders for your data.
• Create a program that opens your blank instance.
• Run SQL statements against your database to retrieve data.
• Use XPath to figure out where in the instance the data should be inserted.
• Insert this data into your blank instance.
Create the Message From Scratch
• Programmatically create a new XML file to walk the message structure, query the background database, and create an XML instance.
• Create a program that opens your new XML file.
• Run SQL statements against your database to retrieve data.
• Use XPath to figure out where in the instance the data should be inserted.
• Insert your data into the instance.
I am very familiar with LotusScript and so that was my first avenue of investigation. I believe I could handle this by creating the HL7 message in code (the “Create the Message from Scratch” from above), but that doesn’t seem like the best course of action. I like #1, but I am unsure how to tackle this in Lotusscript (if it is even possible).
I did a lot of searching in these forums for xpath and I didn’t find a whole ton of information. Designer help doesn’t mention it at all.
I guess what I am after is whether #1 is even possible on 6.5.2? I also have the ability to use LEI to move the data out of Domino and into Oracle, which I could then use whatever technology I want to generate the HL7 message. I’m much more comfortable performing this within Domino, but I am searching for advice on the best method for doing this.
Has anyone else ever tackled this before? My thought process is that I would export the MDR data via XML, transform it using a predefined XSLT into a HL7-XML format. Not sure this is possible in LotusScript, but I am open to whatever options anyone else could recommend.
Thanks in advance.