medical device interoperability and relevant standards efforts ieee 802.15.4j meeting july 18, 2012...
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Medical Device InteroperabilityMedical Device Interoperabilityandand
Relevant Standards EffortsRelevant Standards Efforts
IEEE 802.15.4j Meeting IEEE 802.15.4j Meeting July 18, 2012July 18, 2012
Ken FuchsMindray North AmericaSecretary IEEE 11073
Co-Chair IHE PCD Domain
OverviewOverview
– Medical Device Requirements
– What is Interoperability?
– MD Interoperability Players• ISO/IEEE 11073• IHE PCD• Continua• Other Interoperability “Players”
– Discussion
Point-of-Care: The NeedPoint-of-Care: The Need
Clinicians are Clinicians are starting to starting to assemble MDs assemble MDs at the patient at the patient bedside.bedside.
These devices These devices need to talk to need to talk to each other as each other as well as to local well as to local data data aggregators.aggregators.
Aggregators Aggregators need to get the need to get the data to the data to the EMR/EHR…EMR/EHR…
Point-of-carePoint-of-care
Fixed configuration, e.g. anesthesiaFixed configuration, e.g. anesthesia
– – but changing but changing periodically, and periodically, and evolving over evolving over timetime
Patient Patient MonitorMonitor
RespiratoRespiratorr
Syringe Pumps and InfusorsSyringe Pumps and Infusors
Additional Additional PumpPump
Additional Additional MonitorMonitor
Data Data Processing Processing System / PDMSSystem / PDMS
Point-of-carePoint-of-care
Variable configuration, e.g. intensive care Variable configuration, e.g. intensive care
Patient Patient MonitorMonitor
RespiratorRespirator
Many Syringe Pumps and Many Syringe Pumps and InfusorsInfusors
Data Data Processing Processing System / PDMSSystem / PDMS
- changing - changing frequently and frequently and within minuteswithin minutes
Easy to Use and SafeEasy to Use and Safe
• These systems need to operate safely under all conditions yet be easy to assemble.
• In the future many of these devices will be wireless.– Only covers Layer 1…
• Usable solutions will require a complete “stack”– For Medical Devices Layer 7 is
the “Wild West” …
What is Interoperability?What is Interoperability?
• IEEE defines Interoperability as:– the ability of two or more systems or components to
exchange information and to use the information that has been exchanged
• AAMI has recently offered a Medical Device focused definition…– the ability of medical devices, clinical systems, or their
components to communicate in order to safely fulfill an intended purpose.
• Includes concepts of safety and intended purpose• Not very specific as to the amount of “glue”
required to get these systems to talk to each other.
Do we have MD Interoperability?Do we have MD Interoperability?
• While most acute care devices are built around proprietary interfaces…– Most, if not all, EMRs can connect to devices– We have a growing contingent of vendors (Capsule, Nuvon,
iSirona, Cerner, etc.) providing device integration middleware and services.
– Patient monitoring vendors have created interoperable systems incorporating many 3rd party devices.
– Clinicians have developed many demonstrations and applications showing device interoperability.
• Maybe we already have Interoperability…
Do We Have MD Interoperability?Do We Have MD Interoperability?
• Probably not …– Each new device integration is a custom effort
requiring months of nursing/engineering skills• It can cost between $6,750 and $10,000 per bed to integrate
the devices, including ventilators, in a typical ICU (Moorman, 2010)
– Clinicians desiring to use a new device must wait for their application vendor to develop a new driver (which may never happen)
– The complexity of device interfacing may be hindering research which could lead to improved patient care
– Purchasing decisions are driven by whether an interface to specific devices exists
Do We Have MD Interoperability?Do We Have MD Interoperability?
• More issues with our current reality…– Safety issues can arise due to the sizable SW effort
and on-site customization required to integrate devices
– Costs to the Providers for system integration services are very high
– Not all required data to accomplish a Use Case may be available
– There can be finger pointing when trying to resolve problems
– Too much complexity in maintaining each link in the communication chain
– As device or system software is updated solutions break
Current State of MD Interoperability?Current State of MD Interoperability?
Is this the best we can do?Is this the best we can do?
• When we say systems are Interoperable, does that mean that as long as there is some way of getting “stuff” from one system to another, we are happy?– BASIC Interoperability
• Or, do we expect that we only need to point these systems at each other and stand back, satisfied that the job is done?– SEAMLESS Interoperability
• Clearly we should be focused on achieving SEAMLESS Interoperability…– Sometimes referred to as Plug and Play
Interoperability
Are Standards the Solution?Are Standards the Solution?
• We have many Lower Layer Standards• And we have many Upper Layer standards:
– HL7– IEEE 11073-10101, 10xxx, etc.– IEEE 11073-20601, 40xxx, etc.– ASTM F2761 (ICE)– DICOM– ISO TC215, CEN TC251, IEC, etc.
• So, what is the problem?– Standards are just a starting point.
Organization ID Clinical Req.Physical
Layer Standards
Syntax Standards
Semantic Standards
Profile Standards
Arch.Standards
Test Standards
Testing / Test Tools
Certif'n/Accredit'n
Advocacy / Sponsors
IEEE 802
IEEE 11073
HL7
ISO TC215
CEN TC251
ISO TC 121 (including SC1-8)DICOM
WEDI
IHE ITI
IHE PCD
IHE Radiology
IHE LAB
Continua
GS1
HIBCC
ASTM F29
UL
NIST
MD PnP
Regenstrief
IHTSDO
IEC SC62A
IEC TC 62 / SC62A-D
ISO/ IEC J WG7
FDA
FCC
ONC
AAMI
HIMSS
ACCE
AHIMA
ADVAMED
CDISC
NCHS
CMS
MD Interoperability LandscapeMD Interoperability Landscape
Understanding Understanding InteroperabilityInteroperability
HL7’s Model of InteroperabilityHL7’s Model of Interoperability
Turnitsa’s ModelTurnitsa’s Model
NoneNone
TechnicalTechnical
SyntacticSyntactic
SemanticSemantic
PragmaticPragmatic
DynamicDynamic
Stand-alone
Common Physical and Transport Layers
Common Format
Meaningunderstood
Contextunderstood
Dynamic Contextunderstood
Level 0
Level 1
Level 2
Level 3
Level 4
Level 5
Incr
easi
ng C
apab
ility
for I
nter
oper
ation
Interfaceable
Integratable
Interoperable
Definition
Turnitsa’s Model - AnnotatedTurnitsa’s Model - Annotated
NoneNone
TechnicalTechnical
SyntacticSyntactic
SemanticSemantic
PragmaticPragmatic
DynamicDynamic
Stand-alone
RS232, Ethernet, 802.11,Zigbee, BT, USB, TCP/IP…
HL7, IEEE 11073,Continua…
Snomed, IHE-PCD RTM,IEEE 11073-10101, LOINC…
IHE PCD / ContinuaUse Case based Profiles…
Resource and LoadManagement
Level 0
Level 1
Level 2
Level 3
Level 4
Level 5
Incr
easi
ng C
apab
ility
for I
nter
oper
ation
Interfaceable
Integratable
Interoperable
Example
Interoperability Eco-SystemInteroperability Eco-System
NoneNone
TechnicalTechnical
SyntacticSyntactic
SemanticSemantic
PragmaticPragmatic
DynamicDynamic
Level 0
Level 1
Level 2
Level 3
Level 4
Level 5
Incr
easi
ng C
apab
ility
for I
nter
oper
ation
Ass
oci
atio
nA
sso
ciat
ion
Au
then
tica
tio
nA
uth
enti
cati
on
Au
tho
riza
tio
nA
uth
ori
zati
on
Dis
cove
ryD
isco
very
Saf
ety
Saf
ety
Sec
uri
tyS
ecu
rity
Cer
tifi
cati
on
Cer
tifi
cati
on
Interfaceable
Integratable
Interoperable
MD Interoperability Eco-SystemMD Interoperability Eco-System
• Device Interoperability based on Framework(s) of Open Standards
• Profiles of Standards• Conformance Testing• Certification Testing• Regulatory Pathways• etc.
– Incentives that drive all parties to comply with these Framework(s)
• There are a number of organizations that are working towards this in the medical device space.
ISO/IEEE 11073ISO/IEEE 11073Point of Care Medical Device CommunicationPoint of Care Medical Device Communication
IEEE 11073 - CharterIEEE 11073 - Charter
Point-of-care Medical Device communication:Point-of-care Medical Device communication: Provide real-time plug-and-play Provide real-time plug-and-play
interoperability for patient-connected interoperability for patient-connected medical devicesmedical devices
Facilitate the efficient exchange of vital Facilitate the efficient exchange of vital signs and medical device data, acquired at signs and medical device data, acquired at the point-of-care, in all health care the point-of-care, in all health care environmentsenvironments
… … Leveraging off-the-shelf technologies, Leveraging off-the-shelf technologies, scaling across a wide range of system scaling across a wide range of system complexities, and supporting commercially complexities, and supporting commercially viable implementations.viable implementations.
OverviewOverview
11073 is a comprehensive system of 11073 is a comprehensive system of point-of-care medical device point-of-care medical device communication standardscommunication standards
11073 device types range from real-11073 device types range from real-time-operating medical equipment to time-operating medical equipment to point-of-care testpoint-of-care test
11073 supports wired, wireless IR and 11073 supports wired, wireless IR and wireless RF network technologieswireless RF network technologies
11073 provides plug-and-play, 11073 provides plug-and-play, internetworking and application internetworking and application gateway capabilitiesgateway capabilities
11073 - Architecture11073 - Architecture
Requirements:Requirements: True interoperability across all 7-layers True interoperability across all 7-layers
from the ‘connector’ to the end from the ‘connector’ to the end applicationapplication
Mechanisms to support the strong Mechanisms to support the strong quality of service (safety) requirements quality of service (safety) requirements placed on regulated medical devicesplaced on regulated medical devices
Maintainability as communications Maintainability as communications technology and applications changetechnology and applications change
Series structureSeries structure
Data & Information Definitions11073.1xxxx
Application Profiles11073.2xxxx
Transport & Physical Layers11073.3xxxx
Internetworking Support11073.5xxxx
Related – some shared concepts11073.9xxxx
Application Gateways
11073.6xxxx
11073-1xxxx content11073-1xxxx content
Semantics needed to communicate Semantics needed to communicate a device’sa device’sstructure, application data, status structure, application data, status and control information. and control information. Three main components:Three main components:
Nomenclature: 11073.10101Nomenclature: 11073.10101 Domain Information Model (DIM):Domain Information Model (DIM): 11073.10201 11073.10201 Device Specialisations: 11073.103xxDevice Specialisations: 11073.103xx
11073-10101 Nomenclature11073-10101 Nomenclature
31 . . . . . . 23 . . . . . . . 15 . . . . . . . 7 . . . . . .0
msblsb
Codeblock Number (Hi-order 16 bits)1 Object-Oriented (OO)2 Supervisory Control and Data
Acq’n (SCADA)3 Events4 Dimensions (Units of Msmt)5 Virtual Attributes6 Parameter Groups7 [Body] Sites8 Infrastructure…256 External Nomenclature Ref's…1024 Private
Term Code (Lo-order 16 bits)Context-sensitive parts
Context-free code
Nomenclature:Nomenclature:A set of numeric codesA set of numeric codes
that identify every itemthat identify every item
that is communicatedthat is communicated
between systems.between systems.
11073-10201 Information Model11073-10201 Information Model
Domain Information Model:Domain Information Model:
An object oriented data model that specifies An object oriented data model that specifies objects, attributes, attribute groups, event objects, attributes, attribute groups, event reports, and services that may be used to reports, and services that may be used to communicate device data and to control / communicate device data and to control / configure the reporting of information . . . configure the reporting of information . . .
Medical Devices Medical Devices and and FunctionalitiesFunctionalities
Measured Data Measured Data and Settingsand Settings
Alert InformationAlert Information
Remote ControlRemote Control Patient InformationPatient Information CommunicationCommunication
Domain Information ModelDomain Information Model
11073-2xxxx content11073-2xxxx content
Application profile standards...Application profile standards... Provide specific sets of capabilities Provide specific sets of capabilities
tailored for a class of communication tailored for a class of communication needs / architecturesneeds / architectures
Limit the options that are availableLimit the options that are available Remaining options must be Remaining options must be
discovered and in some cases discovered and in some cases negotiated when a connection is negotiated when a connection is made (enabling plug-and-play made (enabling plug-and-play interoperability!)interoperability!)
11073-2xxxx content11073-2xxxx content
Application profile standards...Application profile standards... Define a generic (non-device specific) set Define a generic (non-device specific) set
of data and services needed to initiate, of data and services needed to initiate, configure, and maintain communication: configure, and maintain communication: Connect / Disconnect, Create / Delete, Connect / Disconnect, Create / Delete, Get / Set, Event Report, Invoke, etc.Get / Set, Event Report, Invoke, etc.
Specify the use of Standard Service Specify the use of Standard Service Elements: ACSE, ROSE, CMISE, ASN.1, Elements: ACSE, ROSE, CMISE, ASN.1, MDER (based on BER+), etc.MDER (based on BER+), etc.
Provide optional packages, e.g for remote Provide optional packages, e.g for remote controlcontrol
11073-3xxxx content11073-3xxxx content
Lower Layer Profiles:Lower Layer Profiles: Point-to-Point transport standards…Point-to-Point transport standards…
IrDA-Based Cable ConnectedIrDA-Based Cable Connected(11073.30200)(11073.30200)
IrDA-Based Infrared WirelessIrDA-Based Infrared Wireless(11073.30300)(11073.30300)
At various time also considered…At various time also considered… RF Wireless – high emphasis on RF Wireless – high emphasis on
QoS! QoS! IP-Based (Ethernet)IP-Based (Ethernet)
TR: Guidelines … RF wirelessTR: Guidelines … RF wireless
Use case topological overviewUse case topological overview
TR: Guidelines … RF wirelessTR: Guidelines … RF wireless
Possible difficulties to be overcome…Possible difficulties to be overcome… High importance of data High importance of data
communicatedcommunicated ‘‘Unknown’ communication capacity Unknown’ communication capacity
availableavailable Security implications for different Security implications for different
types of medical information remain types of medical information remain difficult to determine – and difficult to determine – and standardisestandardise
POC Devices co-existencePOC Devices co-existence
POC Dev w/ DMI4.
Monitor
IEEE 1073& IrDA AP
ECG Device
POCT Device
MDC Devices
Ventilator
IV Pump
POCT Device
10
73 C
able
d
1. Acute Care
POCT1 IR
POCt Device
ECG Cart
Other Dev.
Pocket PC
Palm PDA
PO
CT1 IR
2. General Clinic
IrDA AP
POCt Device
Other Dev.
POCT Device
Other Dev.
3. Remote Device using Modem
Terminal Server
modem modem
Analog Phone Linemodem modem
modem modem
modem modem
POC Dev w/ EDI5.
DMI
POC Data Mgr.
HIS
CIS
EDID
o
o
11073’s Evolution11073’s Evolution
A history of collaborative and A history of collaborative and complementary efforts:complementary efforts:
Arrows indicate effective transfer of development Arrows indicate effective transfer of development and/or maintenance responsibility.and/or maintenance responsibility.
IHE PCD DomainIHE PCD Domain(Integrating the Healthcare Enterprise - Patient Care (Integrating the Healthcare Enterprise - Patient Care Device)Device)
From Base Standards to From Base Standards to Profile StandardsProfile Standards
Profile Development
Base Standards from SDOseHealth Projects
IHTSDO
IETFIETF
CPsCPs
Contributing &Participating
Vendors
Regional Deployment
IHE Europe
IHE North America
France
USA
Canada
IHE Asia-Oceania
Japan
Korea Taiwan
Netherlands
Spain Sweden UKItaly
Germany
Norway
China
Austria
Global Development
Radiology
Cardiology
ITInfrastructure
Patient CareCoordination
Patient CareDevice
Laboratory
Pathology
Eye CareRadiationOncology
Public Health, Quality and Research
Pharmacy
ACCACCEACEP
JAHISJIRAJRS
METI-MLHWMEDIS-DCJAMI
RSNA SFRSFIL
SIRMBIREuroRec
COCIREAR-ECRDRG
ESCProfessional Societies / Sponsors
ACPACOGHIMSS
IHE Organizational StructureIHE Organizational Structure
IHE International Board
Role of IHE PCDRole of IHE PCD
• IHE PCD was formed in 2005 to address issues related to integration of Point-of-Care medical devices:– With each other– With enterprise systems
• IHE PCD wants to “raise the bar” from the current state of integration projects to out of the box, open, interoperable solutions.
• PCD Profiles tend to use HL7 and IEEE 11073 Nomenclature and DIM
IHE Profiles Drafted & Revised
6-13 mos.
Implementation Implementation PostedPosted
Install Interoperable products in Clinical Settings worldwide
Install Interoperable products in Clinical Settings worldwide
IHE Improves, Safety, Quality
and Efficiency in Clinical Settings.
14-18 mos.
Profile Selection by Profile Selection by Committees Committees
1-5 mos.
Publish in IHE’s Publish in IHE’s Product RegistryProduct Registry
Test at IHE Connectathons
PublishedPublishedFor PublicFor PublicCommentComment
IHE Technical IHE Technical Framework Framework DevelopedDeveloped
IHE Development ProcessIHE Development Process
Demonstrate at aDemonstrate at a
IHE Call for IHE Call for Proposals OpensProposals Opens
CPOE/ Pharmacy
System
FuturePCD
CurrentPCD
Infusion Pump
Barcode Medication
Administration System
Other Devices
EquipmentManagement
System
Future Non- PCD
Clinical Decision Support System
Implantable Device
IDCO
ACM, DEC, WCM, ADQ,
PCIM
ACM, MEM
ACM: Alarm Communication ManagementADQ: Asychronous Device Query
DEC: Device Enterprise CommunicationIDCO: Implantable Device – Cardiac – Observation
MEM: Medical Equipment ManagementPCIM: Point-of-Care Identity Management
PIV: Point-of-Care Infusion VerificationWCM: Waveform Content Module
Home BasedSystem
Ventilation/Anesthesia
System
EMR/EHR
CIS
Physiologic Monitoring
System
DEC
ACM, DEC
ACM, DEC, WCM
PIV
ACM, DEC, WCM, ADQ,
PCIM
ACM, DEC, WCM, ADQ
IHE PCD ProfilesIHE PCD Profiles
ConnectathonConnectathon
PCD @ HIMSS 2010PCD – HIMSS 2011PCD – HIMSS 2011
Continua Health AllianceContinua Health Alliance
“…to establish an eco-system of interoperable personal health systems that empower people & organizations to better
manage their health and wellness”
• Continua Process Includes:– Standards Development– Profiles Development– “Plugfests”– Public Demonstrations– Certification Program
PC
PersonalHealth
System
Cell Phone
Set Top Box
Aggregator
Based on Connectivity StandardsBased on Connectivity Standards
WeightScale
PulseOximeter
Independent Living Activity
Cardiovascular and Strength
Fitness Monitor
MedicationMonitor
GlucoseMeter
Pulse /Blood
Pressure
Medical Device Profile Specification
Personal Health Device Class Specification
11073-10404 = Pulse Oximeter 11073-10406 = Pulse / Heart Rate 11073-10407 = Blood Pressure 11073-10408 = Thermometer 11073-10415 = Weighing Scale 11073-10417 = Glucose 11073-10441 = Cardiovascular Fitness Monitor 11073-10442 = Strength Fitness Equipment 11073-10471 = Independent Living Activity 11073-10472 = Medication Monitor
11073-20601 = Base Framework Protocol
Thermometer
Public Interoperability DemosPublic Interoperability Demos
Weighing Scale
Wireless Pulse Oximeter
Blood Pressure Monitor
Device Interface XHR Interface
EHR
Heart Failure & COPD
EHR
PHR
Telehealth Service
Telehealth Service
Telehealth Service
Obesity & Diabetes
Other MD Interoperability Other MD Interoperability “Players”“Players”
MDPnPMDPnP
• Medical Device “Plug and Play” Interoperability Program (MDPnP)– Group that developed the ICE Standard
which was published as ASTM 2761– Program has obtained various grants to
develop and demonstrate interoperable solutions
– MDPnP is also working with the FDA on developing a regulatory pathway for interoperable medical devices
IEEEIEEE
• IEEE 11073 WG continues to develop many base semantic and syntactic standards which are used by other organizations.– Key contributions are the Nomenclature and
Standards support for Continua
• HL7 continues to support changes to existing standards which are required to support evolving needs.
HL7
FDAFDA
• FDA is involved in “encouraging” medical device interoperability– Instigated the MDICC (Medical Device
Interoperability Coordination Council)• Engaging all relevant SDOs
• AAMI established the Healthcare IT Interoperability (HITI) workgroup.
AAMI
Organization ID Clinical Req.Physical
Layer Standards
Syntax Standards
Semantic Standards
Profile Standards
Arch.Standards
Test Standards
Testing / Test Tools
Certif'n/Accredit'n
Advocacy / Sponsors
IEEE 802
IEEE 11073
HL7
ISO TC215
CEN TC251
ISO TC 121 (including SC1-8)DICOM
WEDI
IHE ITI
IHE PCD
IHE Radiology
IHE LAB
Continua
GS1
HIBCC
ASTM F29
UL
NIST
MD PnP
Regenstrief
IHTSDO
IEC SC62A
IEC TC 62 / SC62A-D
ISO/ IEC J WG7
FDA
FCC
ONC
AAMI
HIMSS
ACCE
AHIMA
ADVAMED
CDISC
NCHS
CMS
Why am I here?Why am I here?
• Do existing 11073 Standards meet the needs of evolving 802 wireless standards?– New Use Cases to consider?
• Should IEEE 11073 coordinate more closely with 802.x WGs?– How do we make sure there is enough bandwidth for
devices to accomplish their task?– How do we make sure all devices connected around a
critically ill patient safely interoperate?• Proper semantics, syntax, etc.
– How do we easily and unambiguously associate a device with a specific patient?
– How to report physical layer status to clinicians?• What do they need to know?
ContactContact
Thank you for your attention.Thank you for your attention.Ken FuchsKen Fuchs
Mindray North AmericaMindray North America
Mahwah, NJMahwah, NJ
[email protected]@[email protected]@mindray.com