September 28, 2005
Mortara Certified Partner Program to provide XML certification to HL7 FDA annotated ECG standard
September 28, 2005 - Milwaukee
Today Mortara Instrument, Inc. announced the inauguration of the Mortara Certified Partner Program. The program will serve central laboratories and academic institutions engaged in the annotation of digital ECG data. Mortara Certified Partners will have demonstrated compliance to the HL7 FDA annotated ECG standard required for upload of datasets into the E-Scribe ECG Warehouse.
The E-Scribe ECG Warehouse, developed by Mortara in collaboration with the FDA, is the repository into which all annotated ECG datasets will be uploaded for regulatory review. In order to be uploaded into the warehouse, all annotated ECGs must pass through a validation step within the E-Scribe ECG Warehouse system that checks for adherence to the HL7 XML standard. Annotated ECGs failing to pass this step will not be imported into the E-Scribe ECG Warehouse.
Working with Mortara Certified Partners, sponsors can be assured of receiving annotated ECG datasets that conform to the HL7 FDA standard and that will be smoothly imported into the E-Scribe ECG Warehouse. The first Mortara Certified Partners are expected to complete their certification before the end of 2006.
"Creation of the Mortara Certified Partner Program represents further investment by Mortara in the digital ECG initiative," commented Randy Spaulding, VP of Clinical Research. "As we have worked with multiple central laboratories and sponsors we have noticed the lack of strict conformance to the HL7 FDA annotated ECG standard. This raised concern on our part, in particular as the creator of the E-Scribe ECG Warehouse, since it will be our mission to provide a storage mechanism for all of these ECGs. Lack of adherence to the standard would make this task impossible. With the Mortara Certified Partner program we are able to proactively invest and educate both central laboratories and sponsors about the importance of standards compliance."
Additional information about the E-Scribe ECG Warehouse and procedures for sponsors to upload data to the warehouse can be found at www.ecgwarehouse.com.
Mortara Instrument headquarters are located in Milwaukee, Wis., with European operations based in Bologna, Italy . Mortara is distinguished in the field of non-invasive cardiology innovations that are the core of its complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company website is www.mortara.com.