The level of interest from leading clinical and corporate customers in the XML format for the transmission, storage, and output of ECG data has increased dramatically from 2002 into 2003. This is partly due to requirements from the FDA that require all ECG data submitted as a part of a formal drug application to be provided in a digital, XML-based format. It is also due to rising expectations from an increasing number of customers that newly purchased cardiographs and systems provide platform independent, long term access to ECG records, for clinical as well as research purposes.
As one of the world’s leading manufacturers of cardiographs, ECG management systems, and other solutions for management of the ECG across the medical enterprise, Philips recognizes the importance of standards-based design and open architecture. The changes proposed are not just about digital ECG storage and transmission, which have been available from Philips and other suppliers for over two decades. The changes are more broadly about a new XML-based ECG storage and transmission standard that provides a replacement for the closed, proprietary systems of the past.
Philips Leadership Role
Philips Healthcare has been active in multiple areas concerning the use of a standard digital ECG format. First, Philips has been an active member of the HL7-V3 committee that proposed the XML format for ECGs.
Knowing that the interest in the XML format is based upon interest in moving away from the proprietary systems of the past, Philips has been aggressively incorporating XML-based storage, transmission, and access of ECGs across its product line. Philips has, for example, introduced what it believes to be the first implementation of built-in XML for ECG storage and transmission in cardiographs in its PageWriterTouch. Likewise, we use XML transmission protocols for transfer of ECGs from the IntelliVue Patient Monitoring System to the TraceMaster ECG Management System. And the TraceMaster can output files in XML format to meet further research requirements. Each of these products is available today. Also, for cardiographs that do not provide such standard XML output capability, solutions are available to convert to the Philips standard XML format.
Philips is also fully documenting and publishing its XML schema for digital ECGs in order to support the increasing customer demand for open systems.
Pharmaceutical Industry Support
Philips Healthcare today provides a standard, fully documented, XML output of high resolution, 12-lead by 10-second ECG records from the PageWriterTouch cardiograph, IntelliVue Patient Monitoring System, and TraceMaster ECG Management System. Standard industry approaches (such as XSLT) provide for the rapid transformation of this data-rich, XML-based digital ECG record into the format desired for internal research as well as FDA clinical data submissions.
Philips is fully committed to supporting its pharmaceutical and research customers by ensuring that products comply with the relevant FDA guidelines and support the greater workflow demands expected with the new clinical trial requirements.
Clinical and Research User Support
Philips has taken proactive steps to ensure that its cardiograph and system solutions provide open, XML storage, transmission, and access capabilities. We expect that these capabilities will streamline the way clinicians and researchers read, analyze, transcribe, copy, store and share ECGs across the care continuum both today and long into the future.
Specifically, our PageWriterTouch cardiograph, IntelliVue Patient Monitoring System, and TraceMaster ECG Management System are among the industry’s first products to support integrated XML ECG protocols. The new Philips 12-Lead Algorithm takes full advantage of the high resolution ECG data that is provided in the new XML format. In addition, Philips is fully committed to an “open system” design philosophy. Thus, we publish the XML schema for interested clinicians and researchers. Additionally, solutions are available to convert older, non-XML cardiographs to take advantage of Philips’ standard XML capabilities.
For customers that currently own TraceMaster ECG Management Systems, ECGs stored on the TraceMaster system can be converted to the new XML format.
Commitment to Clinical Excellence
Philips’ 75-year expertise in cardiography - combined with its commitment to world-class technology and best-in-class support - continues to help clinicians worldwide to provide more accurate patient assessments and higher quality cardiac care. Across the cardiac care spectrum, clinicians turn to Philips cardiography solutions, including 12-lead electrocardiographs, Holter monitoring, stress testing, ECG management systems, patient monitoring systems, and data integration services, to make better informed diagnostic decisions and to manage more effectively patient data from a broad range of sources.
Philips leadership in the definition and implementation of a XML digital format for ECGs is just another way Philips is helping its customers achieve clinical excellence without compromise.