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

ken.fuchs@ieee.orgken.fuchs@ieee.orgk.fuchs@mindray.comk.fuchs@mindray.com