CDRH staff has created a packet of files to assist in implementing software for generating the HL7 ICSR XML for an eMDR submission.
- Complete Packet: eMDR_HL7ICSR.zip (Updated September 1, 2015)
The following provides a description of each of these files.
There are two sheets in this file. The mm.dd.yyyy in the file name indicates the date of the most recent update.
ReadMe Sheet – Provides an overview of all the files in the package
ChangeLog Sheet – Documents all changes made to the files in the package with the exception of the HL7Medwatch.xls file, which has its own ChangeLog sheet for ease of use
|ICSRImplTechSpecv1_1Release.doc||Technical specifications to be used to implement a high volume submitting solution. Also contains information on Acks.|
|HL7Medwatch.xls||3500A_HL7 Sheet – Lists each MedWatch element, current instructions, HL7 pointers, and field lengths|
Vocabulary Sheet – Lists all the vocabulary items required by the ICSR message
X_Path Sheet – Used to find the particular nodes in the XML document that are used in the 3500A form
|ICSRDiagrams.xls||ICSR diagrams for CDRH implementation|
|Con061019.xsd||Primary XML schema file to which all eMDR HL7 XML will be validated. Note that this file is also available in the implementation package under the eMDRHL7\coreschemas folder.|
|datatypes.xsd, datatypes-base.xsd, infrastructureRoot.xsd, voc.xsd, narrativeBlock.xsd||Secondary XML schema files referenced by Con.xsd during XML validation|
|3500A_Sample_HL7_Submission.xml||Example MDR submission XML. Your MDR submission should look similar to this. This file is a sample HL7 message validated against the Con061019.xsd schema file.|
When creating your own messages, the data may change from one message to the next, but the structure should stay the same.
|3500A_Sample_HL7_Submission.pdf||The human-friendly 3500A PDF representation of the example XML file (see mappinginstance.xml).|
|sample_attachment.pdf||This file provides the sample document used as an attachment to the mappingInstance.xml.|
|Ack3Schema.xsd||Schema document for Acknowledgment 3 in xml format|
|ACK3_SUCCESS_Single_Report.html, ACK3_SUCCESS_Single_Report.xml||Sample Ack3 file for a single report submission that passes|
|ACK3_SUCCESS_Multiple_Reports.html, ACK3_SUCCESS_Multiple_Reports.xml||Sample Ack3 file for multiple report submission via a batch file that passes|
|MFR_REPORT_ALL_DATA_2_ACK3_FAILURE.html, Ack3SampleFail.xml||Sample Ack3 file for a submission that fails with invalid content|
|ACK3_PARTIAL_FAILURE_PARTIAL_PASS.html, ACK3_PARTIAL_FAILURE_PARTIAL_PASS.xml||Sample Ack3 file with at least one report that failed and at least one report that passed.|
|ACK2_SUCCESS.txt||Sample Ack2 file from CDRH|