Interoperability challenges in the health management of patients with implantable defibrillators Catherine E. Chronaki FORTH-Institute of Computer Science Manuela Plößnig2, Fulya Tuncer3, Mustafa Yuksel3, Gokce Laleci Erturkmen3, Christian Lüpkes4, Marco Eichelberg4, Xavier Navarro5, Wolfgang Pecho6, Asuman Dogac3

28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

Outline The problem: The opportunity: The interoperability challenge: How to support health professionals in making the most of innovation in remote monitoring? How to support people with cardiac implants in leading a better life? The opportunity: patient empowerment frameworks medical knowledge as reflected in the latest guidelines Interoperability initiatives Collection & management of health and lifestyle information The interoperability challenge: technological / organizational / policy Trust and confidence in technology – sustainability The gain: Health professional decision support & Patient empowerment 28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

iCardea: an EU co-funded project: state of the Art DataCenters currently operated: CareLink by Medtronic, USA HouseCall Plus by St.Jude Medical, USA HomeMonitoring by Biotronik, Germany Latitude PMS by Boston Scientific,USA Data Center Collected Data Data analysis and Correlation Physicians access diagnosis data via a web-based portals GSM network Telephone lines There has been an exponential growth in the number of cardiac implantable devices: 800.000 CIED patients in EU with 5.8 million follow-up visits CIED electronic and software complexity have widen their function and application. However, due to their limited processing capabilities restricted by their size, CIEDs need to be supported with external software running on “data centers” Currently, the data center processing is standalone with their own custom software and proprietary interfaces Patient and device data is stored in data centres operated by the vendors Presented via secure Web-sites to the access of responsible healthcare professionals Access to follow-up information often requires clinicians to use multiple vendor specific systems and interfaces, reducing efficiency Goal: To reduce the number of visits, To improve the quality of care CIED implanted on patient Transmitter / Interrogator Follow-up visits (normally three times a year) 4 [REF] A. Dogac: iCARDEA Kick-off Meeting, Salzburg, Austria, Feb 2010 4

Introducing remote monitoring into the clinical practice: data sources Cardiovascular Implantable Electronic Devices Pace Maker Implantable cardioverter defibrillators (ICD) Cardiac Resynchronization Therapy (CRT) device EHR in the hospital Previous or ongoing healthcare problems Medications Family History PHR Dietary Daily usage of medications Allergies Physical Activities guidelines Environment CIED EHRs PHR 28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

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IHE Profiles and Connectathons http://www.ihe.net IHE promotes the coordinated use of standards such as DICOM and HL7 to address specific clinical needs in support of optimal patient care The IHE process is defined in ISO28380 Start is an existing interoperability problem E.g. scheduled workflow in radiology Develop using existing standards a domain specific profile IHE profiles address critical interoperability issues related to information access for carers & patients, clinical workflow, security, administration, information infrastructure IHE technical frameworks : IHE actors, IHE transactions IHE connectathons: at least 3 independent companies prove interoperability according to a profile in this week long event. Integration statement: Documents published by vendors to describe conformance of their products. 28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

Patient Care Coordination http://www.ihe.net HL7 Clinical Document Architecture and CCD Final Text Medical Summaries (XDS-MS), Emergency Department Referral (EDR), Exchange of Personal Health Record Content (XPHR) Trial Implementation Emergency Department Encounter Summary (EDES), Antepartum Record (APR), Labor and Delivery Record (LDR), Functional Status Assessments (FSA), Immunization Content (IC), Patient Plan of Care (PPOC), EMS Transfers of Care (ETC) New for 2010 Perioperative Plan of Care Post-Partum Visit Summary Newborn Discharge Summary Perinatal Workflow 28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

Key Aspects of HL7 CDA documents Derive their meaning from the HL7 v3 Reference Information Model (RIM ) and use HL7 v3 Data Types Consist of a header and a body Header provides information on patient, provider, encounter, and authentication Body contains narrative text / multimedia content (level 1) optionally augmented by coded equivalents (levels 2 & 3) (Release 2 (2005) CDA documents are encoded in Extensible Markup Language (XML) CDA Implementation Guides ASTM/HL7 Continuity of Care Document (CCD) CDA Implementation Guide for Personal Health Monitoring Report IHE Patient Care Coordination Templates CDA documents derive their meaning from the HL7 v3 Reference Information Model (RIM ) and use HL7 v3 Data Types A CDA document consists of a header and a body Header consistent across all clinical documents provides information on patient, provider, encounter, and authentication Body contains narrative text / multimedia content (level 1), optionally augmented by coded equivalents (levels 2 & 3) CDA documents are encoded in Extensible Markup Language (XML) 10

xEnterprise Docoment Sharing [ITI-17] Retrieve Document (1654b3de-8b51-420e-839e-b1c39e35bb90.xml ) Importer/ converter SALK XDS Document Repository [ITI-14] Register Document Set docURI, {(11488-4, LOINC), (11348-0, LOINC)} [ITI-15] Provide & Register Document Set [PCC9 ]Care Management Data Query Care Plan Engine XDS Registry [PCC10 ]V3 Care Management Update <ClinicalDocument> <code code=“11488-4” codeSystem=“2.16.840.1.113883.6.1” codeSystemName=“LOINC”/> …. ….. <section> <code code=“11348-0” <entry> <observation classCode=OBS moodCode=EVN> <code code=“F-20250” codeSystem=“2.16.840.1.113883.6.96”/> </observation> <code code=“I21” codeSystem=“2.16.840.1.113883.6.3”/> ...... </entry> ....... HL7 CDA When the guideline is registered Creates a Registry Object XDSDocumentEntry with docURI: 1654b3de-8b51-420e-839e-b1c39e35bb90.xml 28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

IHE PCD Profile: IDCO http://www.ihe.net IDCO (Implanted Device Cardiac Observation -specifies the creation, transmission, and processing of discrete data elements and report attachments associated with implantable cardiac device interrogations (observations) or messages. Implantable Cardiac Device Leads for Sensing or Delivering Electrical Therapy 12

IHE PCD Profile: IDCO http://www.ihe.net Device is interrogated via inductive or wireless telemetry in clinic or home environment using vendor proprietary equipment Information is transferred to clinic system as structured HL7 v2.6 ORU message using IEEE 11073 IDC nomenclature [PCD-09] IHE Connectathon 2010 13

EHR interoperability Infrastructure Data Correlation and Analysis Common Terminology (CTS) Medical Service Registry IHE IDCO IHE Care Management Adaptive Care Planner XDS repository Active Subscriptions XDS registry Update Log Personal Health Record IHE XDS Clinical Data Converter library Patient Index Activity Log Continua Guidelines, IEEE EHR Adapter Home Environment: sensors & wellness devices Shared space Patient Data Queries IHE xEnterprise Document Sharing export EHR Adapter Legacy EHR systems Hospital Information Systems Cardiology Department Outpatient Systems, General Practitioner systems, Emergency Systems …. 28/9/2010

The Continua Health Alliance Mission: “to establish an eco-system of interoperable personal health systems that empower people & organizations to better manage their health and wellness” Objectives: Guidelines: Developing design guidelines that will provide vendors with the information needed to build interoperable sensors, home networks, health compute platforms, and health & wellness services. Certification and Logo: Establishing a product certification program with a consumer recognizable logo signifying the promise of interoperability with other certified products. FDA and EU Regulations: Collaborating with government regulatory agencies to provide methods for safely and effectively managing diverse vendor solutions. Reimbursement: Working with leaders in the healthcare industries to develop new ways of addressing the costs of providing personal health systems. 28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

Continua Health Alliance End-to-End Connectivity Standards Telehealth Service Center Devices aka Agents Aggregation Manager Health Records PAN LAN WAN HRN SDE #1 SDE #2 SDEs #3+ REF: P Schluter, E Sloane, 2010

Integration efforts: An old story.. Problem: lack of medical device interoperability, consistently implemtented standards OpenECG is a European initiative with world-wide impact that actively promotes interoperability and open standards in electrocardiography since 2002. Motivated by the need for multimedia EHRS implementation assistance open source tools specifications and data sets interoperability testing For OpenECG interoperability is: “A patient safety issue, a quality label for eHealth!”

Interoperability Challenges Legacy systems EHR/HIS/LIS a multitude of systems in the healthcare environment CIEDs/Programmers / Devices / Vendor Portals Mobile health/ PHR/ personal health devices Legal & Regulatory framework Security / privacy / safety directives Software treated as a device Standards and Interoperability initiatives Functional models of EHRs & devices – interoperability certification Adoption / closing the loop – supporting consistent implementations Sustainable solutions fostering organizational change New roles: nurses easing citizens into technology New models for financing health care – reimbursement - incentives Evidence based guidelines part of the healthcare process Trust in remote monitoring & EHRs Quality & performance criteria 28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr

Summary iCARDEA aims to bring innovation into health management of patients with implants Implement professional guidelines in GLIF and link them to CIED data (x-manufacturers), EHR data (x-providers), PHR (x-providers) Pilot in Saltzburg Austria, planned for 2011-12 Interoperability Challenges Technical- legacy systems Organizational – business model & reimbursement Cultural –resistance to change Beyond iCARDEA Dealing with emergencies (technical – operational) Engaging primary care Capturing the wider context of everyday living Cultivate trust and confidence through reliable unobtrusive technology that weaves itself into the fabric of life… 28/9/2010 Computing in Cardiology 2010 - Belfast, Northern Ireland, Catherine Chronaki chronaki@ics.forth.gr