1September, 2005 What IHE Delivers

Todd Cooper, Co-Chair IHE PCDTodd Cooper, Co-Chair IHE PCD

Andrea Poli, University of Trieste, ItalyAndrea Poli, University of Trieste, Italy

IHEIHEPatient Care DevicePatient Care Device

DomainDomain

IHE Europe 2006 - IHE Europe 2006 - Changing the Way Healthcare ConnectsChanging the Way Healthcare Connects

IHE Presentation at the World of Health IT show, October 2006IHE Presentation at the World of Health IT show, October 2006

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Proven Standards Adoption ProcessProven Standards Adoption Process

Document Use Document Use Case Case RequirementsRequirements

Document Use Document Use Case Case RequirementsRequirements

Identify available Identify available standards (standards (e.g. HL7, e.g. HL7, DICOM, IETF, OASIS)DICOM, IETF, OASIS)

Identify available Identify available standards (standards (e.g. HL7, e.g. HL7, DICOM, IETF, OASIS)DICOM, IETF, OASIS)

Develop Develop technical technical

specificationsspecifications

Develop Develop technical technical

specificationsspecifications

Testing at Testing at ConnectathonsConnectathonsTesting at Testing at ConnectathonsConnectathons

IHE IHE DemonstrationsDemonstrationsIHE IHE DemonstrationsDemonstrations

Products Products with IHEwith IHEProducts Products with IHEwith IHE

Timely access to Timely access to informationinformationTimely access to Timely access to informationinformation

Easy to integrate Easy to integrate productsproductsEasy to integrate Easy to integrate productsproducts

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IHE Organizational StructureIHE Organizational StructureMulti-Domain & Multi-NationalMulti-Domain & Multi-National

IHE Organizational StructureIHE Organizational StructureMulti-Domain & Multi-NationalMulti-Domain & Multi-National

Participants

contribute

Global Development:Radiology,IT Infrastructure,Cardiology,Lab, etc.

Delegates

IHE Europe

IHE North America

IHE Asia/Oceania

Regional &NationalDeployment

supervises reports

IHE (International) Strategic Development Committee

SponsorCo-Chairs

Global

Interoperability

IHE Domain-related Planning and

Technical Committees

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Electronic Health Record

Cardiology

Laboratory

Radiology

Oncology

Future

Domains

IHE

IT Infrastructure

17 Integration Profiles

7 Integration Profiles

7 Integration Profiles

1166 IInntteeggrraattiioonn PPrrooffiilleess

Patient Care Coordination

4 Integration Profile

Patient Care

Devices

Pathology

Eye Care

IHE 2006 – Nine Active Domains IHE 2006 – Nine Active Domains Close to 200 vendors involved world-wide,Close to 200 vendors involved world-wide, 6 6 Technical Frameworks Technical Frameworks

51 Integration Profiles, Testing at Connectathons51 Integration Profiles, Testing at ConnectathonsDemonstrations at major conferences world-wideDemonstrations at major conferences world-wide

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

In June, 2005, The American College of Clinical In June, 2005, The American College of Clinical Engineering (ACCE) was appointed the Engineering (ACCE) was appointed the Domain Domain

SponsorSponsor for Patient Care Devices by IHE’s for Patient Care Devices by IHE’s principal sponsors, ACC, HIMSS, and RSNA.principal sponsors, ACC, HIMSS, and RSNA.

A A Clinical EngineerClinical Engineer is a professional who is a professional who supports and advances patient care by supports and advances patient care by

applying engineering and managerial skills applying engineering and managerial skills to healthcare technology. Founded in to healthcare technology. Founded in

1991, ACCE is the professional college of 1991, ACCE is the professional college of Clinical Engineers throughout the US. Clinical Engineers throughout the US.

(www.ACCEnet.org)(www.ACCEnet.org)

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

Why patient care devices?Why patient care devices? For every connected IT Device in the hospital, there For every connected IT Device in the hospital, there

are 4 Patient Care Devices that are are 4 Patient Care Devices that are notnot connected connected

There are over 1500 Patient Care Device There are over 1500 Patient Care Device manufacturers and over 3500 Make-Model manufacturers and over 3500 Make-Model combinationscombinations

The typical 200 bed hospital contains 1,000’s of The typical 200 bed hospital contains 1,000’s of Patient Care Devices Patient Care Devices

……that are constantly changing with that are constantly changing with updated/upgraded technology … and require updated/upgraded technology … and require interoperability too?!interoperability too?!

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)One Patient – Many DevicesOne Patient – Many Devices

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

““REALITY CHECK” –REALITY CHECK” –Patient Care Devices are quite unique …Patient Care Devices are quite unique …

Many devicesMany devices are used in multiple clinical contexts, with are used in multiple clinical contexts, with acquired data having acquired data having different implicationsdifferent implications depending upon depending upon the clinical setting. the clinical setting.

Many devicesMany devices provide signals or provide signals or critical alarmscritical alarms that have that have direct significance to direct significance to patient safetypatient safety and well being in and well being in real-timereal-time, , and should be accorded appropriate priority in the system. and should be accorded appropriate priority in the system.

Many devicesMany devices are are portableportable, meaning that connectivity must , meaning that connectivity must include include wirelesswireless portions, direct network connections, and portions, direct network connections, and Internet links, all with “hacker and virus” Internet links, all with “hacker and virus” risksrisks, too. , too.

Many devicesMany devices provide data that should be provide data that should be automaticallyautomatically and and accurately incorporatedaccurately incorporated directly into the information stream directly into the information stream that feeds the emerging Electronic Health Record (that feeds the emerging Electronic Health Record (EHREHR). ).

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

HIMSS Survey IHE pre-2005 Annual HIMSS Survey IHE pre-2005 Annual Conference results:Conference results:

In Summer 2005, HIMSS conducted a supplemental Patient In Summer 2005, HIMSS conducted a supplemental Patient Care Device survey, which allowed us to “drill down” to the Care Device survey, which allowed us to “drill down” to the detailed issues and priorities…detailed issues and priorities…

* IHE-Europe survey placed Medical Devices behind Pharmacy & Pathology* IHE-Europe survey placed Medical Devices behind Pharmacy & Pathology

• Survey of all IHE Users Survey of all IHE Users

• Over 50% of those Over 50% of those surveyed said patient surveyed said patient care devices should be care devices should be the next area developed the next area developed for IHE for IHE **

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

2005 Summer Survey Results2005 Summer Survey Results:: Highest priority devices for integration areHighest priority devices for integration are Vital Signs Vital Signs

MonitorsMonitors, , Blood Gas Analyzers (POC),Blood Gas Analyzers (POC), and and Infusion PumpsInfusion Pumps

Highest priority departments areHighest priority departments are ICU, Emergency, ICU, Emergency, OR/AnesthesiaOR/Anesthesia, and , and Lab (POC)Lab (POC)

Highest technology priority isHighest technology priority is Enterprise Wide SharingEnterprise Wide Sharing

Highest priority for clinical application isHighest priority for clinical application is EHR or CIS integrationEHR or CIS integration followed byfollowed by Improved Management and Decision SupportImproved Management and Decision Support

Highest Highest perceivedperceived barrier is barrier is “Lack of Standards.”“Lack of Standards.” – Fear of – Fear of Litigation not a concernLitigation not a concern

Users are willing, on average, to pay a Users are willing, on average, to pay a premium to achievepremium to achieve IHE IHE compliance … with the expectation of a compliance … with the expectation of a lower overall cost of lower overall cost of ownershipownership!!

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

Key Benefits of PCD Interoperability: Key Benefits of PCD Interoperability: HeterogeneityHeterogeneity – Multiple manufacturers + multiple device – Multiple manufacturers + multiple device

modalities coexisting over a shared infrastructure modalities coexisting over a shared infrastructure

Semantic InteroperabilitySemantic Interoperability ( comparability) – shared ( comparability) – shared terminology and data models, interpret data based on the terminology and data models, interpret data based on the clinical context, compare information from different clinical context, compare information from different healthcare facilities, and interrogate systems across healthcare facilities, and interrogate systems across enterprises and regions.enterprises and regions.

Real-Time AvailabilityReal-Time Availability – ability to provide data in a time – ability to provide data in a time frame appropriate to the physiologic function being frame appropriate to the physiologic function being measured, displayed or affected (controlled), typically measured, displayed or affected (controlled), typically milliseconds to seconds.milliseconds to seconds.

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

SO, WHAT IS HAPPENING IN THIS DOMAIN?SO, WHAT IS HAPPENING IN THIS DOMAIN?

In September, 2005, the PCD gathered In September, 2005, the PCD gathered 60 60 vendors, purchasers, providers, and vendors, purchasers, providers, and

regulatorsregulators in Washington D.C. for 2 days to in Washington D.C. for 2 days to explore the value propositions, explore the explore the value propositions, explore the

scope and mission of the domain, and begin scope and mission of the domain, and begin the process of use case development. the process of use case development.

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IHE Patient Care Devices (PCD)IHE Patient Care Devices (PCD)

The PCDThe PCD Business CaseBusiness Case

What outcomes of IHE-PCD Domain will What outcomes of IHE-PCD Domain will create real, tangible value for the participants create real, tangible value for the participants

(i.e., What is the “(i.e., What is the “Value PropositionValue Proposition” or, “Why ” or, “Why should we do this, and why now?”)should we do this, and why now?”)

Nothing durable can be accomplished Nothing durable can be accomplished with a project like this UNLESS there with a project like this UNLESS there are are clear rewards for all stakeholdersclear rewards for all stakeholders (economic, safety, quality, etc.). (economic, safety, quality, etc.).

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IHE Patient Care Devices (PCD)IHE Patient Care Devices (PCD)

Key Stakeholders with Business Cases that Key Stakeholders with Business Cases that are driving the PCDare driving the PCD

Stakeholders presently fall into four general Stakeholders presently fall into four general categoriescategories

VendorsVendors who sell devices or services who sell devices or services

PurchasersPurchasers who buy devices - Providers who buy devices - Providers (Clinicians) who use devices(Clinicians) who use devices

RegulatorsRegulators and and GovernmentGovernment who represent who represent the public goodthe public good

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

PCD PCD StakeholderStakeholder Value Propositions: VendorsValue Propositions: Vendors

SimplifySimplify product development process product development process

Spend time Spend time innovatinginnovating rather than doing rather than doing infrastucture work infrastucture work

Facilitate clinical decision support - innovation - Facilitate clinical decision support - innovation - added functionaliityadded functionaliity

Reduce regulatoryReduce regulatory impact/work impact/work

Improve patient safety - Improve patient safety - reduce liabilityreduce liability - make - make operations easier - device awareoperations easier - device aware

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

Value Propositions for Purchaser and Provider:Value Propositions for Purchaser and Provider: Integrity of dataIntegrity of data – automatic population of all – automatic population of all

information systems – reducing medical errors information systems – reducing medical errors

Automated systems Automated systems saves time for clinicianssaves time for clinicians

Improves Improves agilityagility of enterprises to meet varied of enterprises to meet varied patient loadspatient loads

Improved Improved life-cycle costlife-cycle cost of ownership of ownership

Automates clinical Automates clinical data capturedata capture for EHR for EHR

Access to patient data across devices and systems Access to patient data across devices and systems so custom communication interfaces can be so custom communication interfaces can be eliminated. eliminated. Allows for best of breedAllows for best of breed

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IHE Patient Care Devices (PCD)IHE Patient Care Devices (PCD)Value Proposition for Government and Value Proposition for Government and

Regulatory StakeholdersRegulatory Stakeholders Value lies in easing regulators’ tasks by industry Value lies in easing regulators’ tasks by industry

adoption and implementation of adoption and implementation of uniform specificationsuniform specifications..

For example one Business Case statement for For example one Business Case statement for government and regulatory stakeholders is: “IHE PCDD government and regulatory stakeholders is: “IHE PCDD can can simplify the approval processsimplify the approval process for medical devices for medical devices and related clinical information systems.”and related clinical information systems.”

IHE-PCD accelerates the fulfillment of key clinical IHE-PCD accelerates the fulfillment of key clinical requirements for requirements for EfficacyEfficacy, , EfficiencyEfficiency, and , and SafetySafety in the in the emerging Electronic Health Record programs that have been emerging Electronic Health Record programs that have been mandated by President Bush and Health and Human mandated by President Bush and Health and Human Services leadership.Services leadership.

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

IHE-PCD CharterIHE-PCD Charter

The Patient Care Device Domain is The Patient Care Device Domain is concerned with Use Cases in which at concerned with Use Cases in which at least one actor is a regulated patient care least one actor is a regulated patient care device. The PCD coordinates with other device. The PCD coordinates with other IHE clinical specialty based domains such IHE clinical specialty based domains such as IHE RAD and IHE LAB.as IHE RAD and IHE LAB.

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

IHE-PCD Domain Vision StatementIHE-PCD Domain Vision Statement

The IHE Patient Care Device Domain (IHE PCD) is the nexus for The IHE Patient Care Device Domain (IHE PCD) is the nexus for vendors and providers to jointly define and demonstrate vendors and providers to jointly define and demonstrate unambiguous interoperability specifications, called profiles, unambiguous interoperability specifications, called profiles, which are based on industry standards, and which can be which are based on industry standards, and which can be brought to market. brought to market.

IHE-PCD profiles:IHE-PCD profiles:

1. 1. improve patient safetyimprove patient safety and clinical efficacy, and clinical efficacy,

2. 2. optimize healthcare delivery costoptimize healthcare delivery cost by improving by improving

efficiency, reliability, and operational flexibility for efficiency, reliability, and operational flexibility for

healthcare providers,healthcare providers,

3. 3. enable innovative patient careenable innovative patient care capabilities, and capabilities, and

4. 4. expand the international marketplaceexpand the international marketplace for patient care for patient care

device vendors.device vendors.

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

IHE-PCD MissionIHE-PCD Mission

The IHE Patient Care Device Domain will apply The IHE Patient Care Device Domain will apply the proven, Use Case driven IHE processes to:the proven, Use Case driven IHE processes to:

DeliverDeliver the technical framework for the IHE-PCD the technical framework for the IHE-PCD domain profiles;domain profiles;

ValidateValidate IHE-PCD profile implementations via IHE-PCD profile implementations via Connectathons; and Connectathons; and

DemonstrateDemonstrate marketable solutions at public trade marketable solutions at public trade shows.shows.

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

PCD Roadmap…PCD Roadmap…

Year 1:Year 1: Enterprise sharing of Patient Care DataEnterprise sharing of Patient Care Data Patient & Device ID Binding to Device (deferred)Patient & Device ID Binding to Device (deferred) Initial device classes – Initial device classes – vital sign monitorsvital sign monitors, ,

infusioninfusion pumpspumps, , ventilators ventilators … and possibly … and possibly othersothers

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

Year 2++Year 2++ Home healthHome health Emergency CareEmergency Care Real-time data archiving and communicationReal-time data archiving and communication PCD Alarm Management + smart alarms & interlocksPCD Alarm Management + smart alarms & interlocks Medication ManagementMedication Management Device Control (e.g., Hospital Bed–Blood Pressure Device Control (e.g., Hospital Bed–Blood Pressure

Coordination)Coordination) Mobile, enterprise-wide, reliable vital signs monitoringMobile, enterprise-wide, reliable vital signs monitoring … … many more!many more!

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

2006 Development Schedule:2006 Development Schedule: Planning Committee decision:Planning Committee decision: mid-Januarymid-January Issue Public Comment version: Issue Public Comment version: June 2006June 2006 Public Comment Due:Public Comment Due: July 2006July 2006 Issue Trial Implementation version: Issue Trial Implementation version: August 8, 2006August 8, 2006 IHE Connectathon: IHE Connectathon: January 2007January 2007 HIMSS Demo: HIMSS Demo: February 2007February 2007

Next Face-to-Face:Next Face-to-Face:

2006-10-31 Oak Brook Illinois U.S.A.2006-10-31 Oak Brook Illinois U.S.A.

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PCD Year 1 Profiles

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IHE PCD

Practical Aspects for PCD Practical Aspects for PCD Implementation in Europe Implementation in Europe

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Question Question

After the previous lecture, a question After the previous lecture, a question could be raised through the audience:could be raised through the audience: From the Vendors perspectiveFrom the Vendors perspective

• Why should I produce, test and sell PCD compliant Why should I produce, test and sell PCD compliant devices?devices?

From the Healthcare Providers perspectiveFrom the Healthcare Providers perspective• Why should I ask for PCD compliant devices? Why should I ask for PCD compliant devices?

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BenefitsBenefits

Theoretically speaking the PCD benefits Theoretically speaking the PCD benefits have been well explained:have been well explained: HeterogeneityHeterogeneity Semantic InteroperabilitySemantic Interoperability Real-Time AvailabilityReal-Time Availability

But practically what could be the benefits But practically what could be the benefits of PCD implementations?of PCD implementations? Two interesting examples are reported.Two interesting examples are reported.

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Vendor perspectiveVendor perspective

How PCD could help me in rationalization How PCD could help me in rationalization of my internal resources?of my internal resources?

Most telemedicine applications are delivered Most telemedicine applications are delivered by so called small-medium companiesby so called small-medium companies

They commonly assemble sensors in a They commonly assemble sensors in a package that can deliver data to a central package that can deliver data to a central managing and storage facilitymanaging and storage facility

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Waste for re-design Waste for re-design

A 10 years experience company is forced to REDESIGN its systems every time technology, interfaces and enterprise side

information system changes.

This is an extreme waste of time and resources

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SolutionsSolutions

PCD could save resources and improve business.

In a complete PCD framework, a change in In a complete PCD framework, a change in the system does not necessitate a the system does not necessitate a redesign of interfaces.redesign of interfaces.

This allows companies to focus their This allows companies to focus their expertise on device development. expertise on device development.

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User PerspectiveUser Perspective

You negotiate a full range of products from Vendor X

You negotiate each device, focusing on the best quality/cost ratio

P.

C.

D.

Choices mean saving moneyChoices mean saving money

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Vendors/Users perspectiveVendors/Users perspective

Open Standard / interoperability means saving Open Standard / interoperability means saving moneymoney

No longer Black No longer Black Box approach…Box approach…

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Clinical Engineers role in IHE Clinical Engineers role in IHE

CEs have a important role within IHE, because CEs have a important role within IHE, because they contribute, with their wide spectrum of they contribute, with their wide spectrum of knowledge, to help clinicians and administrative knowledge, to help clinicians and administrative staff in the new technology acquisition process.staff in the new technology acquisition process.

They are able to educate them toThey are able to educate them to require IHE require IHE compliance.compliance.

So CEs must be aware and trained about IHE So CEs must be aware and trained about IHE framework!framework!

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CEs Role in PCDCEs Role in PCD

CEs role in PCD domain is crucial CEs role in PCD domain is crucial because:because: CEs manage directly devices CEs manage directly devices CEs have a complete vision of devices used within CEs have a complete vision of devices used within

the Healthcare Enterprisethe Healthcare Enterprise CEs have the capability to think overgapping the CEs have the capability to think overgapping the

barriers accross clinical Specialitiesbarriers accross clinical Specialities

PCD is a multidisciplinary domain!PCD is a multidisciplinary domain!

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Health Technology Assessment and PCDHealth Technology Assessment and PCD

In 2003 Eucomed (European Medical In 2003 Eucomed (European Medical Technology Industry Association) has Technology Industry Association) has produced the HTA Europe Position Paper:produced the HTA Europe Position Paper:

"Health technology assessment for "Health technology assessment for medical devices in Europe - What has to medical devices in Europe - What has to be considered"be considered"

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Health Technology Assessment and PCDHealth Technology Assessment and PCD

Pre-assessment of new products, is Pre-assessment of new products, is considered by the position paperconsidered by the position paper

But pre-assessment of ICT-based medical But pre-assessment of ICT-based medical devices is inherently very difficultdevices is inherently very difficult

PCD can help very much the ICT-based PCD can help very much the ICT-based medical devices pre-assessment, pushing medical devices pre-assessment, pushing them quickly into the market for a wide them quickly into the market for a wide e-health integratione-health integration

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From 15 years, SSIC-HECE and its network offer a Multi Level From 15 years, SSIC-HECE and its network offer a Multi Level Education process for students and PROFESSIONISTS in Education process for students and PROFESSIONISTS in Clinical Engineering all across and outside EuropeClinical Engineering all across and outside Europe

The Alpe-Adria Universities Initiative (ALADIN)

The Adriatic Balcanic Ionian Cooperation on Biomedical Engineering (ABIC-BME)

ANDAND

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SSIC-HECESSIC-HECE

SSIC-HECE has well understood the SSIC-HECE has well understood the importance of IHE and it has been the importance of IHE and it has been the firstfirst school that has decided to offer to the school that has decided to offer to the future CEs some IHE targeted courses.future CEs some IHE targeted courses.

From this year, the school has introduced From this year, the school has introduced PCD as a Teaching subject.PCD as a Teaching subject.

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Future ExpectationsFuture Expectations

Very soon in Europe there will be CEs Very soon in Europe there will be CEs aware about PCD.aware about PCD.

IHE-PCD community will continue to IHE-PCD community will continue to organize seminars and initiatives across organize seminars and initiatives across Europe for each stakeholders Europe for each stakeholders

SO SO

We expect to have very soon some explicit We expect to have very soon some explicit request of IHE-PCD compliant devicesrequest of IHE-PCD compliant devices

…….and vendors?.and vendors?

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ConclusionsConclusions

Inter-European diversity (economical, Inter-European diversity (economical, geographical, linguistic and cultural) is geographical, linguistic and cultural) is huge. huge.

The PCD process must take care of that. The PCD process must take care of that.

As soon as possible a European group As soon as possible a European group working on PCD should be born.working on PCD should be born.

This group should feedback This group should feedback requirements into profiles that requirements into profiles that address European needs address European needs

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ConclusionsConclusions

There are still few European participants There are still few European participants in the PCD development processin the PCD development process

There are NO European SME vendors or There are NO European SME vendors or associations involvedassociations involved

There are NO European providers or There are NO European providers or professional organizations involvedprofessional organizations involved

We need YOUR experience!We need YOUR experience!

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IHE Web site:IHE Web site: www.IHE.netwww.IHE.net Frequently AskedFrequently Asked QuestionsQuestions

Integration Profiles in Technical Frameworks: Integration Profiles in Technical Frameworks: See Volume 1 of each TF for Use casesSee Volume 1 of each TF for Use cases

CardiologyCardiology IT InfrastructureIT Infrastructure LaboratoryLaboratory Patient Care CoordinationPatient Care Coordination RadiologyRadiology Patient Care DevicesPatient Care Devices

Connectathon Result: Connectathon Result: www.ihe.net/Events/connectathon_results.cfmwww.ihe.net/Events/connectathon_results.cfm

Products Integration StatementsProducts Integration Statements

Participation in Committees & ConnectathonsParticipation in Committees & Connectathons

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IHE Patient Care Device (PCD)IHE Patient Care Device (PCD)

Come and Come and join the IHE-PCD Domain Teamjoin the IHE-PCD Domain Team - - see or email any of the following PCD leaders:see or email any of the following PCD leaders:

Todd Cooper Todd Cooper ((t.cooper@ieee.orgt.cooper@ieee.org))

Jack Harrington Jack Harrington ((jack.harrington@philips.comjack.harrington@philips.com))

Melvin ReynoldsMelvin Reynolds (MelvinR@AMS-Consulting.com)(MelvinR@AMS-Consulting.com)

Andrea Poli Andrea Poli (Poli@ssic.units.it)(Poli@ssic.units.it)

… … or visit us at or visit us at www.ACCEnet.org/IHEwww.ACCEnet.org/IHE

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… … Patient Care Devices!Patient Care Devices!