ECG Data Interchange Formats and Protocols – Status and Outlook
Thomas Norgall Fraunhofer-Institut für Integrierte Schaltungen - Angewandte Elektronik Erlangen, Germany
OpenECG Workshop, Berlin, 1-3 April 2004
Content:
ECG Data Interchange Formats and Protocols – Status and Outlook n ECG Data Interchange Standards - ENV 1064 SCP-ECG - ENV 13734/35 (CEN ISO/IEEE 11073.xxxxx) - prENV 14271 FEF - DICOM Waveform Supplement 30 - HL7 / XML / FDA requirements
n Interoperability: Definitions and Concepts - Functional and Semantic Interoperability - IHE (HL7 / DICOM) Interoperability - Micro-System Level Interoperability (IMEX) - XML
n Conclusions
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OpenECG Workshop, Berlin, 1-3 April 2004
CEN SCP / ECG ENV 1064 n enables the exchange of ECG information between various computerised ECG systems (ECG recorder, ECG management systems, other computer systems) - “cart-to-host” - “cart-to-cart” n specifies a complex sequential ECG data format built of mandatory and optional sections comprising - patient data (demographic, recording...) - ECG signal data - ECG measurement result data - ECG interpretative data n meets the ECG-related requirements of cardiac experts, users and manufacturers Slide 3
OpenECG Workshop, Berlin, 1-3 April 2004
CEN ISO/IEEE 11073 Standard
CEN ISO/IEEE 11073 Standard - Familie
CEN ISO / IEEE 11073.xxxxx Family of Standards n integrates contributions from IEEE 1073 („Medical Information Bus“, since 1983 ) and CEN TC 251 (ENV 13734 „VITAL“, ENV 13735 „INTERMED“, since 1993). n enables „Plug-and-Play“, (both functional and semantic) interoperability by: - object-oriented modelling of functionality and areas of application ("Domain Information Model“: devices, functionality / modalities, data acquisition and parameter settings, alarm information, remote control, demographic information, communication interface) - systematic and unambiguous coding of all relevant information elements: "Nomenclature" and "Data Dictionary“ - optional components for specific communication needs / device functionalities („Application Profiles“/ „Device Specializations“). n modality categories range from real-time-operating medical equipment to Point-of-Care Test devices n supports wired, wireless IR (and future wireless RF) network technologies Slide 4 OpenECG Workshop, Berlin, 1-3 April 2004
CEN ISO/IEEE 11073 Standard
CEN ISO/IEEE 11073 Standard - Familie
CEN ISO/IEEE11073 Standards history : Development towards co-operative and complementary work:
Arrows indicate effective transfer of development and/or maintenance responsibility. OpenECG Workshop, Berlin, 1-3 April 2004
Slide 5
CEN prENV 14271 ”File Exchange Format” n based on CEN ENV 13734 “VITAL“, ENV 13735 “INTERMED” n specifies a modified Domain Information Model, which is mapped to a section-based file structure n using CEN ENV 13734/35 nomenclature and coding scheme n aims at file exchange both by exchanged media (disks) and communication systems n provides persistent aggregations of demographic data, administrative data and time -related medical information (vital signs information) n intended to replace earlier format, particularly for sleep lab data exchange n provides ASN.1 format definitions Slide 6
OpenECG Workshop, Berlin, 1-3 April 2004
DICOM: (ECG) Waveforms - Supplement 30 n DICOM: Digital Imaging and COmmunication in Medicine (in particular Radiology) n DICOM 3.0 (1992) is accepted by whole industry and is permanently growing („Supplements“) n DICOM 3.0 Supplement 30 provides “Waveform Object Definitions” for “General ECG”, “Ambulatory ECG”, “12-Lead ECG”, “Cardiac Electrophysiology” (as well as for language and hemodynamics) n DICOM Waveform Objects enable combined processing of DICOM Images and related waveforms n DICOM provides adequate synchronisation mechanisms n DICOM image(sequence-)related Waveform Objects are also part of DICOM “Structured Reporting” concept (in combination with coded diagnostic information). Slide 7
OpenECG Workshop, Berlin, 1-3 April 2004
HL7 and Waveforms n Use of HL7 (Version 2.x ASCII) messages is a pragmatic answer to many (HIS-) communication requirements, in particular for administrative data exchange n Version 2.x messages are sequentially and hierarchically structured ASCII strings: Message > Segment > Field > Data / CodesI n Lack of modelling and excessive use of optionalities results in poor interoperability. n (OO) “Reference Information Model“-based Version 3 is still under development. n HL7 “Clinical Document Architecture“ (CDA) defines a header syntax (Level 1), the structure and semantics of “clinical documents” (Level 2 and 3 - not yet ready) n Interoperability is in the focus of all current developments (XML syntax since V.2.5) n HL7 has no practicable generic (ECG) waveform representation, but utilises 1-3 April 2004 external OpenECG Workshop, Berlin,
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Interoperability Interoperability: ability of two or more systems or components n to exchange information (“functional interoperability”: Shared Communication Architectures, Methods, Frameworks ) and n to use the information that has been exchanged (“semantic interoperability” Shared Data types, Terminologies, Coding Schemes) (without further need for user interaction) source: IEEE Standard Computer Dictionary A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990 OpenECG Workshop, Berlin, 1-3 April 2004
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Interoperability in Hospitals until today: n mostly historically grown “communication islands“ (departmental / clinical information systems with inconsistent patient-related / medical information)
Hospital
DICOM IHE
K I S
HL7
n interoperability standards n their use is a driver and a prerequisite for e-Health
11073*
Monitor
ICU
Pumpe
Respi rator
Agent
Agent
Manager
Pharmacy
...
L I S
...
... PDMS
MR Röntgen
Radiology
Intensive Care ICU
n systems linked using proprietary data conversion today: phase of transition
R I S
CT
Automat
Automat
NCCLS POCT1-A
PoC
Lab
PoC
...
* CEN ISO / IEEE 11073 (VITAL) Slide 10
OpenECG Workshop, Berlin, 1-3 April 2004
“E-Health” - Interactions and Integration E-Letter E- Consultation
E P A
DICOM
Hospital
CT
Specialist
R MR I Röntgen S Radiology
IHE
General Practitioner
K I S
EKG Ultraschall
HL7
Intensive Care Units Monitor
IC U
...
Manager
Electronic Health Record
Pharmacy
...
Pumpe
Respi rator
Agent
Agent
...
11073 / VITAL
PDMS
...
L I S
Automat Automat
POCT 1-A Lab PoC
PoC
...
E-prescription Pharmacies
Insurance Companies
Labs, Care services etc.
?
Home / mobile Slide 11
OpenECG Workshop, Berlin, 1-3 April 2004
Interoperability Standards and ISO/OSI Context Health Informatics: n generally interpreted as relating to ISO/OSI Level 7 (HL7!) Medical Device Interoperability: n implies all ISO/OSI Levels, n defines/ modifies standards in ISO/OSI Levels 7 – 5 n in Levels 1 – 4 chiefly references to other standards (such as IrDA or 802.x)
ISO/OSI Level 7: Application ISO/OSI Level 6: Presentation ISO/OSI Level 5: Session ISO/OSI Level 4: Transport ISO/OSI Level 3: Network ISO/OSI Level 2: Datalink ISO/OSI Level 1: Physical Slide 12
OpenECG Workshop, Berlin, 1-3 April 2004
CEN ISO/IEEE 11073 Standard
CEN ISO/IEEE 11073 Standard - Familie
CEN ISO/IEEE11073 Internetworking Support
11073 Agent Device
11073.3xxxx Transport A
11073.5xxxx Internetworking
11073.3xxxx Transport B
Infusion Pump Ventilator Pulse Oximeter
11073 Manager System Patient Monitor Device Manager
Use of different (Wired-, IR and RF Wireless) Network Technology Examples:
Wired-to-Wireless Transport Gateways, LAN / IR Access Points Slide 13
OpenECG Workshop, Berlin, 1-3 April 2004
CEN ISO/IEEE 11073 Standard
CEN ISO/IEEE 11073 Standard - Familie
CEN ISO/IEEE11073 Application Gateways 11073 System
11073.3xxxx Transport
11073.6xxxx Gateway
11073.3 /.5xxxx
(11073.5 Internetworking)
Transport
non-11073 Application
Interoperability among Application Protocols Example:
HL7 / 11073 Gateway (CEN ISO-IEEE 11073-60101) ”HL7 Observation Reporting Interface”: enables Device-to-HIS-level interoperability. (11073 Coding Scheme Registered HL7 Coding Scheme in 2002.)
Preparatory work: CEN SSS-HIDE (2001) : Health Informatics-Strategies for harmonization and integration of Slide 14 devicelevel and enterprise-wide methodologies for communication as applied to HL7, LOINC and ENV 13734) OpenECG Workshop, Berlin, 1-3 April 2004
- “Integrating the Healthcare Enterprise“ n
Initiative initiated in 1998 by HIMSS (Healthcare Information and Management Systems Society) & RSNA (Radiological Society of North America) to “promote and support the integration of systems in a healthcare enterprise (hospital)“
n
Motivation: Lack of interoperability among HIS / RIS / PACS systems
n
Clinical Workflow Optimisation: Definition of 7 (HL7 / DICOM) “Integration Profiles” to - provide continuity & integrity of patient information - foster communication among information systems from different vendors - avoid repeating tasks (like typing patient name) - eliminate data redundancy - eliminate rigid & costly proprietary solutions
n Paradigm: Specify the use of existing standards wherever possible
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n Further areas of activity: Clinical Laboratory, ECG communication, Point-of-Care OpenECG Workshop, Berlin, 1-3 April 2004
ISO Persistent Waveform Object: Elements (Draft) Persistent Object Class/Instance UID Patient/Order/ Procedure Context
Acquisition Context
Samples Organisation
Specific to a class of waveforms
Waveform Samples
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OpenECG Workshop, Berlin, 1-3 April 2004
Communicating ISO Persistent Waveform Objects Media Storage File Wrapper + Directory Persistent Object Class/Inst. UID Patient/Order/ Procedure Context
Network Transfer or Archiving Store, Commit Persistent Object Class/Inst. UID Patient/Order/ Procedure Context Acquisition Context
Samples Organisation
Acquisition Context
Samples Organisation
Waveform Samples
Waveform Samples
Query, Retrieve Slide 17
OpenECG Workshop, Berlin, 1-3 April 2004
IMEX* Project: Micro-System Interoperability
*VDE/BMBF IMEX: „ Implantierbare und extrakorporale modulare Mikrosystemtechnikplattform Slide 18
OpenECG Workshop, Berlin, 1-3 April 2004
XML and Co-Standards - Aspects, Pros and Cons n US FDA demands provision of original annotated ECG data along with clinical studies in XML (“FDAXML”) encoding ( > ISO / IEEE / HL7 co-operation). + XML provides meta-information about data in a systematic and consistent manner. + XML standards can be used to bridge the gap between different application-specific / protocol-specific data types / representations of information allowing their conversion using off-the-shelf tools + XML supports persistent storage / file exchange / database applications. - XML produces considerable overhead (up to 400 %) compared to other transfer syntaxes excluding it´s use for real-time / resource-critical applications. n ITU-T X.693 (12/2001) has defined a standard mapping from ASN.1 encoding rules to XML encoding rules (XER). n For the use of XML a comprehensive, unambiguous (meta-)model (providing a repository of all information elements / “atoms” involved a prerequisite! Slide 19 OpenECG Workshop, Berlin, 1-3 April 2004
Conclusions: n Health information integration (”eHealth”) requires interoperability between clinical and healthcare-related processes and stakeholders. n “Interoperability” implies different concepts (“Functional Interoperability” / “Internetworking”, “Semantic Interoperability ” / “Application Gateways” etc.). n Domain-specific (and domain-optimised!) communication and interoperability standards (exchange formats and protocols) are available and (partly) well established. n Medical device systems interoperability generally involves all 7 layers and particularly includes terminology / coding aspects. n Micro-system development implies future Body Area Networks / mobile wearable systems requiring adequate extension of interoperability chains. n Concepts and tools are in place that can be utilised to build a roadmap towards inter-domain ECG interoperability: When will it happen? Slide 20
OpenECG Workshop, Berlin, 1-3 April 2004
Thank you for your attention Thomas Norgall Fraunhofer-Institute IIS-A Am Wolfsmantel 33 D-91058 Erlangen, Germany Email:
[email protected] www.iis.fraunhofer.de
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