Data exchange between remote monitoring databases and local electronic patient record system Implementation based on international standards

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Data exchange between remote monitoring databases and local electronic patient record system Implementation based on international standards Enno T. Van der Velde, FESC Medical Physicist, dept of Cardiology Leiden University Medical Center, The Netherlands

DECLARATION OF CONFLICT OF INTEREST none

Increasing number of ICD implants SCD-HeFT MADIT II * estimate Lehmann Brothers, 2004 3

Regular follow-up Follow-up intervals Actions at follow-up 6 5 4 3 2 1 0 pacemaker ICD-single ICD-Dual ICD-CRT 4

Follow-up burden 5

Remote follow-up: the solution? 6

Remote monitoring solutions (all different!) Patient s Home RENEWAL 3 RF CRT-D Guidant (Latitude) Biotronik LATITUDE Communicator LATITUDE Web Server St Jude Medtronic (Carelink) 7

Remote follow-up solution: benefits... Data transfer from remote monitoring database to local hospital system Remote follow-up (FU) of implanted pacemakers or ICD s offers a solution to the problem of overcrowded clinics, and brings considerable convenience to patients. All major device vendors have developed a remote FU solution. Data from the remote FU are stored in a central database, operated by the device vendor. The physician can log into a secure website and view the remote FU data for each patient.. However, 8

Remote Monitoring system still completely separate from local EHR 9

Same problem with pacemaker/icd programmers 10

Need for standardization Need for standard set of observations, communicated in standard messages Therapy settings Events Device self-monitoring Consistent presentation of data from all devices 11

IHE Data integration/exchange: IHE IHE (Integrating the Healthcare Enterprise) is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. In various domains, IHE integration profiles specify how for that specific domain and topic data can be exchanged, based on existing standards. 12

IHE Data integration/exchange: IHE Therefore, IHE is not a standard, it merely specifies which standards should be used in a certain domain, and how they should be used. Systems that support IHE Integration Profiles work together better, are easier to implement, and help care providers use information more effectively 13

IHE 14

IHE-PCD The IHE Patient Care Devices (PCD) domain The IHE domain concerned with electronic medical devices is the patient care devices domain (IHE PCD). 15

IHE-PCD IDCO Remote monitoring data exchange: IHE-PCD IDCO profile To address the requirement of integrating remote monitoring data in the local information system, the IHE-PCD Implantable Device Cardiac Observation (IDCO) profile defines a standards based transfer of device interrogation information from the interrogation system to the information management system. The IHE IDCO profile is part of the IHE Patient Care Devices (PCD) domain. 16

IHE PCD IDCO IHE profile: Implantable Device Cardiac Observations (IDCO) Standard set of observations Communicated in standard messages Consistent presentation of data from all devices direct link between interrogating device and local EHR 17

IHE-PCD IDCO Nomenclature Nomenclature: IEEE 11073-10103 XML Structure An important part of the IHE-PCD IDCO profile is the nomenclature, the definition of the variables that are exchanged. The IEEE Standards Association is defining sets of terminology for point-of-care medical device communication. One of these sets is IEEE 11073-10103 which supports terminology for implantable cardiac devices. A draft version of this standard is available, but still subject to change. 18

IEEE 11073-10101 point-of-care medical device communication 19

IHE-PCD IDCO implementation IHE-PCD IDCO implementation @LUMC In our hospital, we have implemented the IHE-IDCO profile to import data from the remote databases from two device vendors (Biotronik and Boston Scientific) into our in-house developed Cardiology Information System (EPD-Vision ). Data is exchanged via a HL7/XML communication protocol, as defined in the IHE-PCD IDCO profile. 20

IHE PCD IDCO Data Exchange; BSCI implementation 21

IHE-PCD IDCO implementation Data transfer Data from the remote monitoring database is transferred either automatically by querying the remote database (BSCI) or by manually exporting data from the remote monitoring database or programmer (Biotronik). In both cases, the data is available in the format as defined in the IEEE 11073-10103 standard (see example in next slide). All variable names start with MDC_IDC which is short for Medical Device Communication Implantable Device Cardiac. Data is stored in a temporary location in the EPD-Vision database. 22

IEEE 11073-10103 example 23

IEEE 11073-10103: real-life example 24

IHE-PCD IDCO Implementation Mapping of variables The variables from the remote database (in IEEE 11073-10103 format) were mapped to the corresponding values in the EPD- Vision database. The data from the remote monitoring database were then copied to the corresponding fields in the EPD-Vision database. 25

IHE-PCD IDCO Implementation Mapping of variables As a result, remote follow-up data is visible in the pacemaker follow-up module in EPD-Vision in the same manner as the data from the in-house follow-up. Combined data from in-house and remote follow-up can also be viewed as a graph, where blue dots represent the in-house FU and red dots the remote FU (see figure) 26

Conclusion (1) The growing number of ICD recipients and their more complex devices are leading to rapidly increasing workload for the follow-up of these patients. All device companies have developed a system for remote monitoring of the ICD. Remote monitoring will lessen the burden of follow-up s on the clinic and staff, it will improve the efficiency of patient care. 27

Conclusion (2) It is also attractive from a patient s perspective, since it may lead to greater reassurance and prevents long and timely trips to the hospital. However, as a result, part of the patient s clinical information is stored in the local electronic health record (EHR) in the hospital, while another part is only available in the remote monitoring database. The IHE-PCD IDCO profile is developed to bring a solution to this problem. 28

Conclusion (3) In our hospital, we are presently implementing the IHE-PCD IDCO profile to store data from the RM database in our local information system (EPD-Vision ). In this way, remote FU data can be viewed as if it was acquired during in-house FU. Implementation of the IHE-IDCO profile also allows for transfer of data from the interrogation device (programmer) to the local information system, which overcomes the need for manual entry of the in-house FU data. 29

IEEE Standards Association & Google discussion group: IHE PCD IDCO WG 30