FAQs Cardiac Rhythm Management BIOTRONIK Home Monitoring / Programmer EHR Integration IT Specialists BIOTRONIK EHR DataSync Frequently Asked Questions
Index Documentation....3 What are the new international IEEE 11073-10103 standards for exporting cardiac device data into a hospital EHR system?...3 Which data are specifically defined in the latest IEEE 11073-10103 standards?...3 Which Home Monitoring parameters are exported to the IEEE 11073-10103 XML?...3 Where is the technical documentation of the BIOTRONIK IEEE 11073-10103 XML format found?...3 Once the data files are exported to the PC-database, how do the files get into the hospital EHR system?. 3 Configuration of BIOTRONIK Home Monitoring data export...4 What could be the reason if the export button does not appear on the patient status page in the Home Monitoring website?...4 Who triggers the routine (ongoing) data export from the BIOTRONIK Home Monitoring website?....... 4 Configuration of BIOTRONIK programmer data export...5 Who triggers the routine (ongoing) data export from the BIOTRONIK programmer device?...5 What data formats and transmission media are supported by the BIOTRONIK programmer in order to facilitate EHR integration?....5 Content of the XML file in BIOTRONIK Home Monitoring...6 Does the exported BIOTRONIK Home Monitoring XML contain data for more than one patient?...6 How can a patient be identified in the BIOTRONIK Home Monitoring XML data?...6 Which parameter(s) can be used to order all received XML data for one patient chronologically?...6 Can the IEGM-Online HD (intra-cardiac electrogram) episodes be included in the BIOTRONIK Home Monitoring XML data?....6 How many IEGMs can be included in the BIOTRONIK Home Monitoring XML data?...6 What is the average size of an XML-file exported from BIOTRONIK Home Monitoring?...6 2
Documentation What are the new international IEEE 11073-10103 standards for exporting cardiac device data into a hospital EHR system? The IEEE 11073-10103 standard represents a new industry-wide profile to the IHE Patient Care Device Technical Framework (see below) describing a means to transfer information from an interrogated implantable cardiac device to healthcare information management systems (EHRs): Institute of Electrical and Electronics Engineers (IEEE) has created a subgroup association IEEE 11073 to govern the creation of nomenclature (naming convention) for cardiac devices. Integrating the Healthcare Enterprise (IHE) uses standards already created by other organizations (like HL7) to establish a framework (or profile) for transmitting important medical data efficiently and correctly. Health Level Seven (HL7) is an American National Standards Institute (ANSI) accredited standards organization which creates and publishes standards for the healthcare domain. The HL7 subgroups create the basic standards used in the technical exchange of information. Data defined by the standards may include device measurements (battery, capacitor, etc.), device settings (zones, ranges, tachy therapy), statistics (therapy, brady), and specific episodes. Which data are specifically defined in the latest IEEE 11073-10103 standards? As soon as the newest standards have been fully ballotted and released, they will be published in the following locations http://standards.ieee.org and http://ieeexplore.ieee.org/xpl/standards.jsp. Which BIOTRONIK Home Monitoring parameters are exported to the IEEE 11073-10103 XML? The most important BIOTRONIK Home Monitoring and programmer data are exported in alignment with the new international IEEE 11073-10103 data standards for cardiovascular implanted electronic devices (CIEDs). Actual information about the IEEE 11073-10103 standard can be found at http:// standards.ieee.org or at your regional standardization authority (ASA, DIN, etc.). Files provided by BIOTRONIK EHR DataSync may include status report PDFs, episode PDFs, measurements (lead impedance, battery, capacitor etc.), device settings (zones, ranges, tachy therapy etc.), statistics (therapy, brady etc.), trend data, and selected episodes. The parameters which are exported to the standard XML depend on the device model. However, all essential parameters which are displayed on the BIOTRONIK Home Monitoring website will also be exported. A list of IEEE 11073-10103 parameters that are supported by BIOTRONIK EHR DataSync is provided within the BIOTRONIK IEEE 11073-10103 XML format documentation in a file titled BIOTRONIK Export XML Content found under http://www.biotronik.com/ehr-datasync. Where is the technical documentation of the BIOTRONIK IEEE 11073-10103 XML format found? For the technical documentation and other useful information installation, configuration and system testing, please visit the BIOTRONIK EHR DataSync installation website at http://www.biotronik.com/ ehr-datasync. Once the data files are exported to the PC-database, how do the files get into the hospital EHR system? The exported data is filed within the local PC-database. To complete EHR data integration, the files in the PC-database are then transferred into the EHR system according to hospital practice (i.e., transferred manually via Flashdrive/USB or automatically with the installation of a customized adapter). 3
Configuration of BIOTRONIK Home Monitoring data export The final XML that is exported by BIOTRONIK Home Monitoring is automatically converted to IEEE 11073-10103 XML which means there is no requirement for additional data format conversions in order to generate the IEEE-XML. What could be the reason if the export button does not appear on the patient status page in the BIOTRONIK Home Monitoring website? The export feature has to be activated and configured by the BIOTRONIK Home Monitoring website Administrator before the export function is capable of exporting data to the hospital EHR. The configuration can be accessed by the Administrator via Clinic settings on the website s left menu toolbar. The EHR export feature from the Home Monitoring website is currently available for the Lumax and Evia device series and will be available for all new device introductions thereafter. Who triggers the routine (ongoing) data export from the BIOTRONIK Home Monitoring website? The users with full or read-only access to the BIOTRONIK Home Monitoring website may trigger a data export on the appropriate web pages by simply clicking an Export button, or via export button on the BIOTRONIK programmer (ICS 3000 or Renamic). 4
Configuration of BIOTRONIK programmer data export In order to implement data transfer with BIOTRONIK EHR DataSync, the BIOTRONIK XML (BIO-XML) that is exported by the programmer has to be converted to IEEE 11073-10103 XML. An application that provides this functionality (the Programmer adapter ) can be downloaded from http://www.biotronik.com/ehr-datasync. Who triggers the routine (ongoing) data export from the BIOTRONIK programmer device? The programmer user initiates the routine data export by clicking on the Export button under Data manager in the BIOTRONIK programmer (ICS 3000 or Renamic). What data formats and transmission media are supported by the BIOTRONIK programmer in order to facilitate EHR integration? The programmer supports the following data formats: Paceart* XML v.2.0 or higher for transmitting data into Paceart BIOTRONIK XML (optionally in combination with PDF) for transmitting data into GE Centricity Carddas ** for conversion from BIOTRONIK XML into IEEE 11073-10103 XML format as part of the BIOTRONIK EHR DataSync solution for customized access to programmer followup data (direct access to programmer without using IEEE 11073-10103 XML) The programmer supports the following transmission media: Export via USB-stick Export via Bluetooth (requires PC with Bluetooth component) Export via CD (ICS 3000 only) * Paceart is a registered trademark of Medtronic, Inc. Medtronic Inc. is not affiliated with BIOTRONIK SE & Co. KG. ** GE Centricity Carddas is a trademark of General Electric Company and GE Healthcare, a division of General Electric Company. GE Centricity Carddas is not affiliated with BIOTRONIK SE & Co. KG. 5
Content of the XML file in BIOTRONIK Home Monitoring Does the exported BIOTRONIK Home Monitoring XML contain data for more than one patient? The exported XML file currently contains only the data for one patient. How can a patient be identified in the BIOTRONIK Home Monitoring XML data? For BIOTRONIK device patients, the device serial number is the unique key. The IEEE 11073-10103 parameter MDC_IDC_PG_SERIAL can be used for patient identification. With BIOTRONIK Home Monitoring, patient demographics can also be delivered in the XML ( MDC_ATTR section) if this data was previously entered in the Home Monitoring Service Center (HMSC3) website. How many IEGMs can be included in the BIOTRONIK Home Monitoring XML data? As many IEGM episodes as are selected by the BIOTRONIK Home Monitoring user. The Home Monitoring Service Center (HMSC3) allows a maximum of 3 episodes per patient data download. What is the average size of an XML-file exported from BIOTRONIK Home Monitoring? The size of an XML-file without a PDF is less than 100KB. With a PDF included in the XML, the size is depends on the number of selected episodes (for example, an XML with PDFs enclosed for 3 episodes has a size of approximately 2.5 MB). Which parameter(s) can be used to order all received XML data for one patient chronologically? The export request date or ID (BIO_REQUEST_DATE or BIO_REQUEST_ID) are unique identifiers for files per patient. The session date is also transmitted with an IEEE 11073-10103 standard parameter (MDC_IDC_SESS_DTM). The transmitted session date is the specific timestamp for which the Home Monitoring Service Center (HMSC3) receives data from the implant and calculates a new status for the patient based upon that data. With every new data set created, a new status is calculated and a new session is initiated. The session date is not a unique identifier per patient because the same session can be exported more than once. Can the IEGM-Online HD (intra-cardiac electrogram) episodes be included in the BIOTRONIK Home Monitoring XML data? Yes, episodes can be included. The user can select IEGMs of episodes for a file download. Only the user-selected episodes are included. The IEGM- Online HD is included in the XML data within the BIO section as base64 encoded PDF (for further details see technical documentation, available at http://www.biotronik.com/ehr-datasync). 6
BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 sales@biotronik.com www.biotronik.com 379 097 / A / 1011 BIOTRONIK SE & Co. KG All rights reserved. Specifications are subject to modification, revision and improvement.