The IHE XDM (Cross-Enterprise Document Media interchange) Profile defines how data are exchanged on a media (USB stick, DVD, email). In particular, it specifies the content of the ZIP archive being exchange on those media.
ANS requires the XDM profile to be used when documents (for examples CDA) are exchanged over MS Santé (Messagerie Sécurisée en santé).
As of March 2022, the following conformance checker tools are used and involved in the verification of the XDM requirements:
- Message Content Analyser (MCA) detects the various parts of the ZIP archive and allows to validate those parts independently the ones from the other
- Schematron Validator is called to verify the conformance of the CDA files included in the XDM archive
- XD* Client is called to verify the conformance of the XDS metadata
- Gazelle X Validator is used to verify the consistency of the XDS metadata with the CDA file it describes.
Although this verification requires several clicks, it is integrated in EVSClient and achieves a lot of work.
However, there are several issues that needs to be considered:
- The XDM archive might contain more than one CDA document; in that case the XDS metadata describes the submission set and each CDA file;
- The X Validation is only specified/performed between the XDS medatada and a single CDA document
- The output of the Message Content Analyser module reports failures to find optional content
- For each CDA, the user has to select manually which validation profile (aka Schematron) to use whereas it could be selected based on the templateIds contained in the document;
- There is no automation of the validation process; as a consequence, many clicks are required to obtain a comprehensive report about the conformance of the whole archives.
ANS expresses the need to review the workflow in EVSClient to perform the XDM archive validation in one-click.
This high level need implies the following:
- As a SUT Operator, I want to see the results of the message content analyser, the analyses logs shall not be displayed since they content misleading level of details.
- As a test designer, I want to link a given schematron with one or several CDA template Ids that shall be present in the file, to allow an automatic selection of the schematron to be applied.
- As a SUT Operator, I want EVSClient to detect automatically the validator to use when validating a CDA document
- As a test designer, when developing a X Validation profile for an XDS Submission set, I would like to tell the tool to iterate some of the rules with a different file each time
- As a test designer, when developing a X validation profile for an XDS submission set, I would like to tell the tool to automatically select the file on which the rule applies based on the document the metadata describes.
For those last two points, it relates to the structure of the XDS submission set within the XDM archive. The XDS metadata are gathered in a file that has:
- one section that describes the whole submission set;
- one section per file within the submission set; this section contains a location attribute that gives the name of the file the metadata relates to
The number of files, as well as their names, are not known in advance when developing the X validation rules. Thus, the test designer need a way to tell the tool that rules A applies on element Metadata[f] of the metadata and on File f; and the X Validator will automatically iterate and choose the relevant file and element for each execution.
Offering an integrated validation workflow to the user for him to save time and clicks.
Offering a better experience and a test report to the user, including:
- One X Validation report per CDA
- One conformance validation report per CDA
- A report about the conformance of the structure of the ZIP archive