1. 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

2. 28/9/2010
Computing in Cardiology Belfast, Northern Ireland, Catherine Chronaki

3. 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 Belfast, Northern Ireland, Catherine Chronaki

4. 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: 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

5. 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 Belfast, Northern Ireland, Catherine Chronaki

6. 28/9/2010
Computing in Cardiology Belfast, Northern Ireland, Catherine Chronaki

7. 7

8. IHE Profiles and Connectathons
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 Belfast, Northern Ireland, Catherine Chronaki

9. Patient Care Coordination
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 Belfast, Northern Ireland, Catherine Chronaki

10. 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

11. 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, {( , LOINC), ( , 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=“ ”
codeSystem=“ ”
codeSystemName=“LOINC”/> ….
…..
<section>
<code code=“ ”
<entry>
<observation classCode=OBS
moodCode=EVN>
<code code=“F-20250”
codeSystem=“ ”/>
</observation>
<code code=“I21”
codeSystem=“ ”/>
......
</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 Belfast, Northern Ireland, Catherine Chronaki

12. IHE PCD Profile: IDCO
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

13. IHE PCD Profile: IDCO
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 IDC nomenclature [PCD-09]
IHE Connectathon 2010 13

14. 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

15. 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 Belfast, Northern Ireland, Catherine Chronaki

16. 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

17. 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!”

18. 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 Belfast, Northern Ireland, Catherine Chronaki

19. 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
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 Belfast, Northern Ireland, Catherine Chronaki