Cardiac Rhythm Management. BIOTRONIK Home Monitoring / Programmer. EHR Integration. FAQs. BIOTRONIK EHR DataSync Frequently Asked Questions

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1 FAQs Cardiac Rhythm Management BIOTRONIK Home Monitoring / Programmer EHR Integration BIOTRONIK EHR DataSync Frequently Asked Questions

2 Index Why is it important to integrate cardiac patient and device data into a clinic EHR system?...3 How are the data transferred from the BIOTRONIK Home Monitoring and programmer systems into the clinic s EHR?...3 Who routinely triggers (ongoing) data export from the BIOTRONIK Home Monitoring website, or from the BIOTRONIK programmer device?...3 What are the new international IEEE /HL7 standards for exporting cardiac device data into a hospital EHR system?...3 Which patient and device data are included in the files provided with BIOTRONIK EHR DataSync (e.g., in the XML and PDFs)?...4 How can the various data reports (e.g.. status, episodes, PDFs) from BIOTRONIK Home Monitoring be included in the files that are exported by BIOTRONIK EHR DataSync?...4 The EHR Integration Folder shows that an adapter is required for the BIOTRONIK Home Monitoring EHR data integration. What is this adapter and where is the adapter located?...5 How much time and effort does the installation of the EHR interface software component (i.e., customized adapter ) require?...5 Could the downloaded data files be lost when exported?...5 How can the various data reports from the BIOTRONIK programmer be included in the files that are exported by BIOTRONIK EHR DataSync?...5 Which data formats and transmission media are supported by the BIOTRONIK programmer in order to facilitate EHR integration?....6 Where can more information about the BIOTRONIK IEEE XML EHR-installation process and technical requirements be found?...6 2

3 Why is it important to integrate cardiac patient and device data into a clinic EHR system? As hospital and clinics move toward the goal of a comprehensive electronic patient record system, they must begin to integrate data from a variety of information systems and devices that do not talk to each other. With the traditional approach to data processing within the hospital, requires multiple interfaces and significant handling of the data files. Very often, the users have to navigate several applications, enter data manually at sporadic intervals, scan and print reports, re-open or re-name files and attach new documents or data to the existing patient files. All of these repetitive, manual activities surrounding data manipulation reduce the time available for essential interaction with patients and necessary medical procedures. With EHRs, the majority of these manual processes can be consolidated, potentially eliminated, resulting in considerable time savings, improved clinic workflows and increased time for medically-relevant activities with patients. How are the data transferred from the BIOTRONIK Home Monitoring and programmer systems into the clinic s EHR? After the initial set-up process, the user simply clicks the Export button to download the XML files and PDFs from the BIOTRONIK Home Monitoring website or from the BIOTRONIK device programmer for electronic filing within the local PC-database. To complete the full data integration into the hospital EHR, 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). For further details on how the patient data is transferred into the hospital EHR system and installation of the customized adapter, please see the EHR Integration Folder, or visit the BIOTRONIK EHR DataSync integration website resource at Who routinely triggers (ongoing) data export from the BIOTRONIK Home Monitoring website, or from the BIOTRONIK programmer device? The users with full or read-only access to the BIOTRONIK Home Monitoring website trigger each data export on the appropriate web pages by simply clicking an Export button, or via export button on the BIOTRONIK programmer (ICS3000 or Renamic) Data manager page. What are the new international IEEE / HL7 standards for exporting cardiac device data into a hospital EHR system? The IEEE / HL7 standards represent a new industry-wide profile to the IHE Patient Care Device Technical Framework describing a means to transfer information from an interrogated implantable cardiac device to hospital information management systems (EHRs): Institute of Electrical and Electronics Engineers (IEEE) has created a subgroup association IEEE to govern the creation of nomenclature (naming convention) for cardiac devices. 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. 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. 3

4 Which patient and device data are included in the files provided with BIOTRONIK EHR DataSync (e.g., in the XML and PDFs)? The most important BIOTRONIK Home Monitoring and programmer data are exported in alignment with the new international IEEE data standards for cardiovascular implanted electronic devices (CIEDs). Actual information about the IEEE standard can be found at 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 parameters that are supported by BIOTRONIK EHR DataSync is provided within the BIOTRONIK IEEE XML format documentation in a file titled BIOTRONIK Export XML Content found under How can the various data reports (e.g., status, episodes, PDFs) from BIOTRONIK Home Monitoring be included in the files that are exported by BIOTRONIK EHR DataSync? The XML data are routinely provided for export in the IEEE XML format; separate PDFs can be selected for inclusion in the BIOTRONIK EHR DataSync export during the EHR activation process. Once the BIOTRONIK EHR DataSync export functionality has been activated by the Administrator, the XML data are routinely included in the data export for download into the hospital EHR system. This screenshot shows where the initial XML- data selections are found in the BIOTRONIK Home Monitoring website: After selecting the IEEE format (above), Apply and Confirm to activate standardized XML data file delivery into the hospital EHR. If desired, the relevant event PDFs (Cardio Report and IEGM-Online HD ) can also be attached separately to the exported XML files. Note: Only the Home Monitoring Administrator will have the online access rights to activate the BIOTRONIK EHR DataSync export functionality. The Administrator can switch the PDF download command OFF at any later time. For full details regarding the step-by-step process of activating the EHR export functionality and exporting data from the BIOTRONIK Home Monitoring website into the hospital EHR, please refer to the BIOTRONIK EHR DataSync EHR Integration Folder. 4

5 The EHR Integration Folder shows that an adapter is required for the BIOTRONIK Home Monitoring EHR data integration. What is this adapter and where is the adapter located? The adapter consists of the software and interface components (configuration) that must be installed in the hospital s EHR system to facilitate the immediate and seamless export of patient and device data from BIOTRONIK Home Monitoring and the BIOTRONIK programmer into the hospital EHR system. A software application that provides this functionality and installation instructions can be found in the website resource at biotronik.com/ehr-datasync. How much time and effort does the installation of the EHR interface software component (i.e., customized adapter ) require? The amount of time required for the creation and installation of the software component for the EHR system depends largely on the type and design of the clinic s EHR system, as well as the internal IT capabilities of the clinic. A qualified IT-specialist in the clinic or an IT-service provider should be able to complete the work in a few hours, or less. Could the downloaded data files be lost when exported? No, BIOTRONIK EHR DataSync will not remove files from the destination folder. The user simply instructs where the exported files should be stored in the hospital s EHR system. How can the various data reports from the BIOTRONIK programmer be included in the files that are exported by BIOTRONIK EHR DataSync? On the programmer screen select BIOTRONIK XML including PDF under the Data manager options and press the Export button to transmit the data to USB-stick, Bluetooth or CD (the latter only available with the ICS 3000 programmer). The transmitted data can then be uploaded to the hospital EHR system following necessary EHR configuration, as described in the EHR Integration Folder. The screenshot example below is from the Renamic device programmer. A very similar screen view appears in the ICS 3000 device programmer under Data manager. This screenshot shows where the initial XML-data selections are found in the BIOTRONIK programmer screen. Note: for full details regarding the step-by-step process of activating the EHR export functionality and exporting data from the BIOTRONIK programmer into the hospital EHR, please refer to the BIOTRONIK EHR DataSync EHR Integration Folder. 5

6 Which 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 XML format as part of the BIOTRONIK EHR DataSync solution for customized access to programmer follow-up data (direct access to programmer without using IEEE XML) Where can more information about the BIOTRONIK IEEE XML EHR-installation process and technical requirements be found? Visit website resource for further technical details and software support regarding the BIOTRONIK EHR DataSync installation process. 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. 6

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