what is interoperability? really… aami 2013 june 2, 2013 j

65
What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Upload: melinda-cameron

Post on 26-Dec-2015

223 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

What is Interoperability?Really…

AAMI 2013June 2, 2013

J

Page 2: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

John Rhoads

Philips HealthcareIHE PCD Technical Committee Co-Chair

Monroe PattilloPractical Health Interoperability, LLC

IHE PCD Planning Committee Co-Chair

Page 3: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Medical DeviceInteroperability

Impact on Healthcare

Page 4: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

What is Interoperability?

• IEEE defines Interoperability1 – the ability of two or more systems or components to

exchange information and to use the information that has been exchanged

• AAMI Medical Device focused definition2

– the ability of medical devices, clinical systems, or their components to communicate in order to safely fulfill an intended purpose.

1 Institute of Electrical and Electronics Engineers. IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries. New York, NY: 19902 AAMI White Paper – “Medical Device Interoperability”, AAMI MDI/2012-03-30

Page 5: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Is there an Interoperability Problem?

• EHRs can connect to devices.• Growing number of vendors provide device

integration middleware and services.• Patient monitoring vendors provide

integrated systems incorporating third party devices.

• Clinicians have developed many demonstrations and applicationsshowing device integration.

• However…

Page 6: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Top 10 Health Technology Hazards of 20131

1. Alarm hazards2. Medication administration errors using infusion pumps3. Unnecessary exposures & radiation burns from diagnostic

radiology procedures4. Patient/data mismatches in EHRs and other health IT systems5. Interoperability failures with medical devices and health IT

systems6. Air embolism hazards7. Inattention to needs of pediatric patients when using “adult”

technologies8. Inadequate reprocessing of endoscopic devices and surgical

instruments9. Caregiver distractions from smartphones and other mobile

devices10. Surgical fires

1Health Devices Vol. 41 Number 11, November 2012 - ©ECRI Institute

Page 7: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

So, Interoperability is an Issue!

• Difficult to achieve • Potential for patient harm1

– interfaces - not functioning as desired• allowed dangerous conditions

– systems not able to exchange data – or exchange goes awry

– changes to one device/system potential unintended effects on other devices or systems.

• Equals Dysfunctional Interoperability!1Points from Health Devices Vol. 41 Number 11, November 2012 - ©ECRI Institute

Page 8: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

“Houston, we have a Problem”

• Dealing with “Dysfunctional Interoperability”– Each new interface a custom effort

• Months of work • Acquire device interface spec.• Develop software “driver”• Acquire ‘actual device’ to test • Test ‘actual device’ • Release the new driver• Maintain and update

– Multiply by 100s of Devices!

Page 9: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

This is the Result!

9

Medical Device

DataConsumer

Page 10: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

“Houston, we have a Problem”

• Impact of “Dysfunctional Interoperability”– Expense of Device Integration into an EHR – Availability of interface drives device

purchasing and replacement decisions– Interfacing complexity may hinder valuable

research to improved patient outcomes– Increased complexity maintaining each link in

the communication chain – Exponentially increases potential for failing

links

Page 11: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Functional Interoperability Savings

• The West Health Institute recently published “The Value of Medical Device Interoperability1” which uncovered $30B in annual health care savings.– Increased capacity for treatment due to shortening

length of stay $17.8B– Increased clinician productivity due to decreased

time spent manually entering information $12.3B

1Available at http://www.westhealth.org/institute/interoperability

Page 12: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Functional Interoperability Savings

• Additional Savings:– Reduced cost of care due to avoidance of

redundant testing $3B– Quality improvement through reduction of adverse

events due to safety interlocks $2B– Avoided development testing and integration costs

through use of commonly adopted standards $1B

Page 13: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Coming to your Enterprise!

• Invasion and Infestation of the ‘BYODs’!• Growth of patient Personal Health Devices• Advent of ‘BYOMDs’ (BYO Medical Device) in

hospital care settings– HIPAA Issues– Security Issues– Interoperability Issues– Service and Helpdesk

Page 14: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

How will these Devices Communicate with each other?

Page 15: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Is There a Solution?

Page 16: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Standards?

• Numerous sets of Standards– HL7– IEEE 11073-10101, 10201, 10xxx, etc.– ASTM F2761 (ICE)– DICOM– ISO TC215– CEN TC251– IEC 62A

• Standards are “just” a starting point

Page 17: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

17

Organization Short Scope /Overview(MD Interoperability Context)

Physical Layer Standards

Syntax Standards

Semantic Standards

Profile Standards

Architecture Standards

Test Standards

Testing / Test Tools

Certification/Accreditation

Advocacy / Sponsors

IEEE 802 develops standards for wired and wireless ethernet, bluetooth, etc.

IEEE 11073 develops point-of-care medical device communications standards.

HL7develops standards for the exchange, integration, sharing, and retrieval of electronic health information

ISO TC215international organization which develops global health informatics standards

CEN TC251organization working on standardization of Health Information and Comm. Technology for the EU

DICOMcreates international communication and workflow standards for medical imaging modalities

WEDIpromotes the use of Electronic Data Interchange to improve healthcare administrative processes

IHE ITIdevelops technical profiles that are used by other IHE Domains. For example the Continuous Time profile.

IHE PCDdevelops profiles that deal with patient care MD to MD and MD to Healthcare IT interoperability.

IHE RADdevelops profiles that deal with imaging workflow - based on DICOM and HL7

IHE LAB develops profiles that deal with the exchange of laboratory information

Continuadevelops profiles and certification leading to interoperable Personal Healthcare Devices.

GS1develops global standard to improve supply chain efficiency including device and person identification

HIBCCHealth Industry Business Communications Council develops bar code, EDI and other standards

ASTM F29 responsible for the Integrated Clinical Environment standard.

UL develops standards as well as provides MD testing services.

NIST creates automated test solutions for various IHE profiles.

MDPNPis focused on accelerating the development and adoption of MD interoperability solutions

Regenstrief maintains the LOINC nomenclature which is focused on laboratory

IHTSDO maintains the SNOMED nomenclature

IEC SC62Astandards relating to the manufacture, installation and application of medical electrical equipment

ISO/IEC JWG7joint WG between ISO TC215 and IEC 62A developing standards and guidance - eg 80001

FDA regulates medical devices (among other things) in the US

FCC regulates and coordinates the use of the airwaves in the US

ONC creates and coordinates healthcare IT policy in the US

AAMIstandards relating to the manufacture, installation and application of medical electrical equipment

HIMSSpromotes a better understanding of health care information and management systems

ACCEpromotes professionalism and causes important to Clinical Engineers - sponsors IHE PCD

AHIMAAmerican Healthcare Information Management Assoc. is the secretariat for ISO TC215

ADVAMEDadvocates for a legal, regulatory and economic environment that advances health care through technology

CDISCestablishes standards to support acquisition, exchange, submission of clinical research data.

Medical Device (MD) Interoperability Technical Landscape

Page 18: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Is Interoperability the Solution?

• As discussed we already have “Interoperability” in the medical device space.

• Based on the evidence, this can be termed “Dysfunctional Interoperability”

• So, how do we get to a state of Open, Functional Interoperability?– Refining our understanding of Interoperability

should help

Page 19: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Interoperabilitya Deeper Dive

Page 20: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Refining Interoperability

• There are some resources which provide more complex definitions of Interoperability which include the concept of Interoperability Levels and Dimensions.

• We will discuss concepts from– HL7– Turnitsa

Page 21: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Interoperability Concept – HL7

• HL7 has categorized interoperability as:– Technical Interoperability - ensures that systems can send

and receive data successfully. It defines the degree to which the information can be successfully “transported” between systems.

– Semantic Interoperability - ensures that the information sent and received between systems is unaltered in its meaning. It is understood in exactly the same way by both the sender and receiver.

– Process Interoperability - is the degree to which the integrity of workflow processes can be maintained between systems. This includes maintaining/conveying information such as user roles between systems.

• These concepts build on each other.

Page 22: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

HL7’s Interoperability Concept

Page 23: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Interoperability Model - Turnitsa

• Turnitsa proposes 7 Level Conceptual Interoperability Model (LCIM):– Level 0 – No Interoperability

• The situation in which two systems have no need to, or cannot, interoperate.

– Level 1 - Technical interoperability• Achieved when two systems have the means to communicate, but

neither has a shared understanding of the structure or meaning of the data communicated.

• For example a receiving system simply records what is received, not understanding structure or meaning.

– Level 2 – Syntactic Interoperability• Occurs when information is communicated with structure but

without any meaning.

Page 24: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Interoperability Model - Turnitsa

– Level 3 – Semantic Interoperability• Achieved when the data have meaning, but a full understanding of

the relationships between elements of data and the context of the data is missing.

– Level 4 – Pragmatic Interoperability• Encompasses a shared understanding of data, the relationships

between elements of the data, and the context of the data; however, pragmatic interoperability cannot accommodate changing relationships or context.

– Level 5 – Dynamic Interoperability• Allows for changing contexts and relationships over time or within

the scope of specific transactions.

– Level 6 – Conceptual Interoperability• Complex concepts are exchanged and understood.

Page 25: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Turnitsa’s Model - Adapted

None

Technical

Syntactic

Semantic

Pragmatic

Dynamic

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

Connectable

Integratable

Interoperable

Page 26: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Turnitsa’s Model - Adapted

None

Technical

Syntactic

Semantic

Pragmatic

Dynamic

Stand-alone

RS232, Ethernet, 802.11,USB, TCP/IP…

HL7, IEEE 11073,DICOM…

Snomed-CT, IHE-PCD RTM,IEEE 11073, 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

Connectable

Integratable

Interoperable

Page 27: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Turnitsa’s Model – AdaptedAdditional Requirements

None

Technical

Syntactic

Semantic

Pragmatic

Dynamic

Level 0

Level 1

Level 2

Level 3

Level 4

Level 5

Incr

easi

ng C

apab

ility

for I

nter

oper

ation

Connectable

Integratable

Interoperable

Ass

oci

atio

nA

uth

enti

cati

on

Au

tho

riza

tio

nD

isco

very

Saf

ety

Sec

uri

ty

Cer

tifi

cati

on

Page 28: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

How do we Improve Interoperability?

• The solution is…– 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)

• In other words “Functional Interoperability”• There are many organizations that are working towards

this in the medical device space.

Page 29: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Integrating the

Healthcare Enterprise

Patient Care Device Domain

IHE-PCD

M

Page 30: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Open Interoperability - Standards to Profiles

Profile Development

Base Standards from SDOs eHealth Projects

IHTSDO

IETF

CPs

Page 31: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

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 CareDevices

Laboratory

Pathology

Eye CareRadiationOncology

Public Health, Quality and Research

Pharmacy

ACCACCEACEP

JAHISJIRAJRS

METI-MLHWMEDIS-DCJAMI

RSNA SFRSFIL

SIRMBIREuroRec

COCIREAR-ECRDRG

ESCAAMI

Professional Societies / SponsorsACPACOGHIMSS

IHE InternationalIHE International Board

Page 32: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

IHE-PCD

• Formed 2005 to address issues related to integration of Point-of-Care Medical Devices.– ‘With each other’ & ‘Within enterprise systems’

• Mission - enable ‘Out of The Box’, Reliable, ‘Functionally Interoperable’ Solutions

• Using open Process and open Standards• Co-sponsors - HIMSS, ACCE and AAMI

PCD’s Sponsors

Page 33: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Trial

IHE Profiles Drafted & Revised

month 6-13

Implementation Posted

Install Interoperable products in Clinical Settings worldwide

Install Interoperable products in Clinical Settings worldwide

IHE Improves, Safety, Quality and

Efficiency in Clinical Settings.

month 14-18

IHE Call for Proposals Opens

IHE Call for Proposals Opens

Profile Selection by Committees

month 1-5

Publish in IHE’s Product Registry

Test at IHE Connectathons

PublishedFor PublicComment

IHE Technical Framework Developed

Demonstrate at aDemonstrate at a

IHE Development Process

Page 34: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Example Profile Life Cycle

IHE Profile Cycle Stages Open Date

CloseDate

Learn More

Call for Proposals (2011) July 2011 Sept 2011 Examples of Brief Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/Cycle_5_Proposals/

Profile Selection Oct 2011 Dec 2011 Examples of Detailed Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr5-2009-2011/Cycle_5_Proposals/

Profiles drafted in Committees Feb 2012 May 2012

Public Comment on Supplement June 2012 June 2012

Call for Proposals (2012) July 2012 Sept 2012

Trial Implementation (TI) Published

N/A Aug 2012 ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFrameworkforTrialImplementation/

Test at Connectathon H1 2013 N.A., EU, Korea, etc.

Update Profile TI H2 2013

Re-Test at Connectathons 2014, 2015

Need minimum of 3 Test Cycles

Update Profile TI, Final Text 2014, 2015

Public Comment on Final Text Q1 2015 Q2 2015

Publish Final Text Q2 2015 Q3 2015

Page 35: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

IHE PCDFrom Use Cases to

Profiles

Page 36: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

From Use Cases to Profiles

• The IHE process starts with an open call for Work-Item Proposals to all stakeholders.– The proposals are reviewed and voted on by the Planning

Committee.– Proposals are evaluated on clinical benefit, technical feasibility

and volunteer availability.• So far most accepted proposals are related to enterprise

connectivity (as contrasted with Point of Care).– Vendor gateways (MDDS) to enterprise systems are easier to

modify than regulated devices.• Profiles are typically developed in 18 months or less.

– Some vendors are starting to implement PCD profiles directly in point-of-care medical devices.

Page 37: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

CPOE/ Pharmacy

System

FuturePCD

CurrentPCD

Infusion Pump

Barcode Med Admin System

Other Devices

CMMS and RTLS Systems

Future Non- PCD

Clinical Decision Support System

Implantable Device

IDCO

ACM, ECM, DEC, WCM

ACM, ECM, ADQ, DEC, WCM

ACM, DMC, ECM

ACM, ECM, DEC, WCM

ACM: Alert Communication ManagementADQ: Asynchronous Data Query

DEC: Device Enterprise CommunicationDMC: Device Management Communication

IDCO: Implantable Device – Cardiac – ObservationIPEC: Infusion Pump Event Communication

PIV: Point-of-Care Infusion VerificationWCM: Waveform Content Module

Home BasedSystems

Anesthesia,

Ventilation and OtherSystems

EMR/EHR

CIS

Physiologic Monitoring

System

DEC

ACM, DECIPEC

ACM, DEC, ECM, WCM

In Demo

PIV

Phones and Other Devices for Clinicians

ACM, ECM, WCM

Device Interoperability for the Integrated EMR

J

Page 38: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Technical Underpinnings

• IHE PCD Profiles use:– HL7 version 2.6– IEEE 11073 Standards:

• 10101 – Standardized Nomenclature– Created cross-vendor “harmonized” dictionary ‘Rosetta’– Supported by tooling developed by NIST

• 10201 – Standardized Domain Information Model– Network Time Protocol (NTP)– Wireless Communication Transfer Protocol

(WCTP)

Page 39: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[RTM]Rosetta Terminology Mgmnt.

Page 40: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[DEC]Device to Enterprise Communication

Page 41: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

© 2010 Elliot

Sloane, all rights

reserved.

41

[DEC]As Used by Continua Alliance

With permission, Continua Alliance

Page 42: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[WCM]Waveform Content Module

MobileAccess

Continuous WaveformData

Alarm Evidentiary Data

WCM WCM encodedwaveform

In-HospitalAccess

RemoteAccess

WaveformEvents

WaveformFilter Descr.

WaveformDisplay Attr

.•{1..1} Filter Freq/Type•{0..1} Filter Order•{0..1} Filter String

•{0..1} Sweep Speed•{0..1} Grid•{0..1} Color •{0..1} Scale•{0..1} Phys. Range

•{0..*} Annotations / Events

{0..*}

WaveformData Attr.

•{1..*} Technical Cond. Map•{1..1} Sample Rate•{1..1} Wave Count•{0..1} Encoding•{0..1} Resolution•{0..1} Range

{0..1}{0..*}{1..1}

WaveformGroup

Waveform Attributes

Waveform Data

•{1..*} Data {Num Array}

{1..*}

MobileAccess

Continuous WaveformData

Alarm Evidentiary Data

WCM WCM encodedwaveform

In-HospitalAccess

RemoteAccess

WaveformEvents

WaveformFilter Descr.

WaveformDisplay Attr

.•{1..1} Filter Freq/Type•{0..1} Filter Order•{0..1} Filter String

•{0..1} Sweep Speed•{0..1} Grid•{0..1} Color •{0..1} Scale•{0..1} Phys. Range

•{0..*} Annotations / Events

{0..*}

WaveformData Attr.

•{1..*} Technical Cond. Map•{1..1} Sample Rate•{1..1} Wave Count•{0..1} Encoding•{0..1} Resolution•{0..1} Range

{0..1}{0..*}{1..1}

WaveformGroup

Waveform Attributes

Waveform Data

•{1..*} Data {Num Array}

{1..*}

Page 43: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[ACM]Alert Communication Management

HL7 Messagesper ACM andWCM profiles

HL7 Messagesper ACM andWCM profiles

Parameters, waveforms, etc.as evidentiary data items

Parameters, waveforms, etc.as evidentiary data items

DeviceSpecificgraphics

DeviceSpecificgraphics

Alert InformationSource, Phase, State, Priority

PatientLocationInstanceAlert textCallback

TimestampEvidentiary data

Dissemination StatusInstance

Accepted by ACUndeliverable

DeliveredRead

AcceptedRejectedCancelled

Callback start/stop

AlertCommunicator

AC

AlertCommunicator

AC

AlertManager

AM

AlertManager

AM

AlertReporter

AR

AlertReporter

AR

Report AlertPCD-04 →← PCD-05Report Alert

Status

Disseminate AlertPCD-06 →← PCD-07

DisseminateAlert Status

AlertSource

M

Page 44: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[RDQ]Retrospective Data Query

Supports retrospective query of PCD data from databases. Supports Use Cases such as Clinical Decision Support, back-filling of EMR databases, etc.

EMR,CDSS,CIS,Etc.

Data QueryPCD-12

Data ResponsePCD-13

Data QueryPCD-12

Data ResponsePCD-13

Data RequestersData Servers

FullDisclosure

Data Serverand/or

Data Requester

Data QueryPCD-12

Data ResponsePCD-13

J

Page 45: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[PIV]Point of Care Infusion Verification

Medication

Physician’s Order

Nurse Review

Pharmacist Review

Nurse confirms 6 Rights:• Right Patient• Right Medication• Right Dose• Right Time• Right Route• Right Device

Medication Administered

BCMA to Pump (PCD-03)

Pump may provide data to EMR (PCD-01)

Page 46: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[IPEC]Infusion Pump Event Communication

Patient Care Devices (PCD)

Pump provides information on infusion-related events to BCMA/EMR (PCD-10) such as:• Delivery Start• Delivery Stop• Delivery Complete

Prior to medication administration, nurse confirms the 6 Rights of administration using BCMA/EMR: • Right Patient• Right Medication• Right Dose• Right Time• Right Route• Right Device

Infusion-related events are displayed, validated, and/or recorded by the clinician using the BCMA/EMR

BCMA/EMR

Infusion Pump Event Communication enables reporting of clinical and operational events from an infusion pump to a Bedside Computer-assisted Medication Administration (BCMA) system or EMR.

Clinicians can then view and validate this information for infusion documentation.

Infusion order sent from BCMA/EMR to Pump (PCD-03)

Page 47: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[IDCO]Implantable Device Cardiac Observation

Page 48: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

PCD Domain Profiles

Under Development

Page 49: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[OMS]Optimized Message Syntax

Optimized Message Syntax is an effort to adapt IHE PCD profiles for devices that have slow legacy RS-232 serial ports. OMS will optimize the PCD messages to reduce their size but still maintain consistency with mainstream PCD messages.

Data CollectionSystem

BedsideComputer

OMSMessages

EMR,CDSS,CIS,Etc.

Page 50: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Standards to Specializations

Standards

Profiles

SpecializationsPulse Oximeter,Infusion Device,Ventilator,Etc.

Measurements,Alerts,Events,Waveforms,Etc.

Page 51: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[MEM]Medical Equipment Management

Patch ManagementPending patchesPatch history

Location ServicesCurrent locationPrevious locations (Trending)Boundary controls (Alarm when

device leaves area)

Device Configuration Management

Recall ManagementUnique device identificationHardware configuration (serial numbers, etc)Software configuration (revision numbers, etc)

Device ReconfigurationUse profiles (NICU vs. CICU)

Operational Status and Monitoring

Is the device currently in useUsage historyAlarms – which are active, what the trigger

levels, how long has the alarm been onDay/time of last self check and its resultEvent log recordingPreventative Maintanence

Last PMNext scheduled PMLast repair time/date

Battery ManagementOn A/C or D/C? Charge level (% of full)/Est.

operating time left. Charging / Discharging historyBattery type and installation date Est. battery life

Risk ManagementRisk analysisRisk evaluationVerification of risk control measuresResidual risks

Page 52: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

[MEM]Medical Device Security & Mgmnt.

HIPAA

HITECH

FDA:• 21 CFR 801, 803,

807, 812, 814, 820 • MDDS

IEC 80001

IHE PCD

MDS2

MedicalDevice

AccessControl Privacy

CE/IT Manage

mentSecurity

ConfigurationManagement

Asset Discovery

Cyber Protection

Network Access Control

Lifecycle Mgmt.

Encryption

ePHIBreach Risk

Key ManagementAuthenti-cation

Page 53: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

IHE PCDFrom Profiles to Release

M

Page 54: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Trial

IHE Profiles Drafted & Revised

month 6-13

Implementation Posted

Install Interoperable products in Clinical Settings worldwide

Install Interoperable products in Clinical Settings worldwide

IHE Improves, Safety, Quality and

Efficiency in Clinical Settings.

month 14-18

IHE Call for Proposals Opens

IHE Call for Proposals Opens

Profile Selection by Committees

month 1-5

Publish in IHE’s Product Registry

Test at IHE Connectathons

PublishedFor PublicComment

IHE Technical Framework Developed

Demonstrate at aDemonstrate at a

IHE Development Process

Page 55: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

NIST Testing Tools

HL7Message

Definitions

IEEE / Rosetta

Nomenclature

Test CaseSpecific

Assertions

Value SetConstraints

Etc.

Page 56: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

NIST Testing Tools

Page 57: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Connectathon

Page 58: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

PCD – HIMSS 2013

Page 59: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Demo - AAMI 2013Device Utilization Messaging

Combined data generates asset state: Staged In Use (Active) In Use (Idle)

Drives a clearer picture of pump utilization for better workflow and analytics.

Profile based messages relay IV pump status including: Infusing Alarming Stopped

The RTLS system uses location to interpret asset status: Cleaning Clean Staged/In Use Dirty

Page 60: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Profiles In Process

• Use Cases– Medical Device Technical Management

• Error logs• Access to device logs• Software & Hardware revisions

– Medical Device Cyber Security– Medical Device to Device Communication– Medical Device Specializations

• Pumps • Ventilators • Patient Monitors

Page 61: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Role of Healthcare Organizations

• Support the Mission of IHE-PCD– Participate in IHE-PCD– Plant the seed

• Support & request IHE Interoperability• Encourage vendors’ active IHE participation

– Purchase IHE-PCD compliant products• Request Integration Statements - printed• Specify IHE PCD compliance in RFPs• This will get the attention of vendors!

Page 62: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

IHE PCD Compliant Systems

COMPANY SYSTEM SYSTEM TYPE PCD PROFILES

Accent on Integration, Inc. (AOI) Accelero Connect® Medical Device Integration DECAmcom Messenger Alarm Manager ACM

B BraunDoseTrac Infusion Management Software Gateway software DEC, ACM, PIV

BIOTRONIK SE & Co. KG Home Monitoring Service CenterImplantable Cardiac Device Observer System IDCO

Carefusion CGW Gateway DECCerner CareAware iBus Device Connectivity Platform DEC

EpicEpicCare Inpatient and associated modules EMR/EHR DEC, PIV,IDCO

GE HealthCare CARESCAPE Gateway Gateway DECHospira Hospira MedNet Infusion pump gateway PIViMDsoft MetaVision Suite CIS, AIMS DECiSirona DeviceConX Medical Device Integration DECMindray DS USA, Inc. eGateway HL7 Gateway ACM, DECMindray DS USA, Inc. A5 Anesthesia machine DECNuvon VEGA™ Gateway DECOZ Systems eSP™ Interface DECPhilips Emergin IntelliSpace Event Management Alarm Manager ACM

Philips HealthcarePhilips IntelliVue and Philips IntelliBridge SC200

Monitoring central station and gateway DEC

ScottCare ScottCare OneView SysrtemImplantable Cardiac Device Observer System IDCO

St. Jude Medical, Inc. Merlin.net MN5000Implantable Cardiac Device Observer System IDCO

Surgical Information Systems SIS Periop CIS, EHR, AIMS ACM, DECWelch Allyn Connex VM Vital Signs Monitor DEC

Page 63: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Summary

• Current “Dysfunctional Interoperability” environment not optimal or sustainable

• Users and vendors need a “Functional Interoperability” Roadmap.

• Incentivize vendors, via user demand, • to offer compliant healthcare devices• IHE-PCD is making it happen!

Page 64: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Additional Resources

• IHE PCD Getting Started – Tiny.cc/PCDStart• IHE PCD User Guide – Tiny.cc/PCDHandbook• IHE web site - www.IHE.net

– PCD web site – www.ihe.net/pcd/index.cfm• IHE ftp site – ftp://ftp.ihe.net

– PCD ftp site - ftp://ftp.ihe.net/Patient_Care_Devices/

– PCD wiki –wiki.ihe.net/index.php?title=Patient_Care_Devices

Page 65: What is Interoperability? Really… AAMI 2013 June 2, 2013 J

Thank You!

John Rhoads

Philips Healthcare

[email protected]

Monroe Pattillo

Practical Health Interoperability, LLC

[email protected]