Todd Cooper, CoChair IHE PCD

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IHEPatient Care DeviceDomain
IHE Europe 2006 - Changing the Way Healthcare
Connects IHE Presentation at the World of Health
IT show, October 2006

• Todd Cooper, Co-Chair IHE PCD
• Andrea Poli, University of Trieste, Italy

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Proven Standards Adoption Process
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IHE Organizational Structure Multi-Domain
Multi-National
IHE Domain-related Planning and Technical
Committees
Global DevelopmentRadiology,IT
Infrastructure,Cardiology,Lab, etc.
contribute
Participants
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IHE 2006 Nine Active Domains
Close to 200 vendors involved world-wide, 6
Technical Frameworks 51 Integration Profiles,
Testing at Connectathons Demonstrations at major
conferences world-wide
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IHE Patient Care Device (PCD)
In June, 2005, The American College of Clinical
Engineering (ACCE) was appointed the Domain
Sponsor for Patient Care Devices by IHEs
principal sponsors, ACC, HIMSS, and RSNA.

• A Clinical Engineer is a professional who
  supports and advances patient care by applying
  engineering and managerial skills to healthcare
  technology. Founded in 1991, ACCE is the
  professional college of Clinical Engineers
  throughout the US.
• (www.ACCEnet.org)

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IHE Patient Care Device (PCD)
Why patient care devices?

• For every connected IT Device in the hospital,
  there are 4 Patient Care Devices that are not
  connected
• There are over 1500 Patient Care Device
  manufacturers and over 3500 Make-Model
  combinations
• The typical 200 bed hospital contains 1,000s of
  Patient Care Devices
• that are constantly changing with
  updated/upgraded technology and require
  interoperability too?!

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IHE Patient Care Device (PCD)
One Patient Many Devices
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IHE Patient Care Device (PCD)
REALITY CHECK Patient Care Devices are quite
unique

• Many devices are used in multiple clinical
  contexts, with acquired data having different
  implications depending upon the clinical setting.
  
• Many devices provide signals or critical alarms
  that have direct significance to patient safety
  and well being in real-time, and should be
  accorded appropriate priority in the system.
• Many devices are portable, meaning that
  connectivity must include wireless portions,
  direct network connections, and Internet links,
  all with hacker and virus risks, too.
• Many devices provide data that should be
  automatically and accurately incorporated
  directly into the information stream that feeds
  the emerging Electronic Health Record (EHR).

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IHE Patient Care Device (PCD)
HIMSS Survey IHE pre-2005 Annual Conference
results

• Survey of all IHE Users
• Over 50 of those surveyed said patient care
  devices should be the next area developed for IHE
  

• In Summer 2005, HIMSS conducted a supplemental
  Patient Care Device survey, which allowed us to
  drill down to the detailed issues and
  priorities
• IHE-Europe survey placed Medical Devices behind
  Pharmacy Pathology

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IHE Patient Care Device (PCD)
2005 Summer Survey Results

• Highest priority devices for integration are
  Vital Signs Monitors, Blood Gas Analyzers (POC),
  and Infusion Pumps
• Highest priority departments are ICU, Emergency,
  OR/Anesthesia, and Lab (POC)
• Highest technology priority is Enterprise Wide
  Sharing
• Highest priority for clinical application is EHR
  or CIS integration followed by Improved
  Management and Decision Support
• Highest perceived barrier is Lack of Standards.
  Fear of Litigation not a concern
• Users are willing, on average, to pay a premium
  to achieve IHE compliance with the expectation
  of a lower overall cost of ownership!

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IHE Patient Care Device (PCD)
Key Benefits of PCD Interoperability

• Heterogeneity Multiple manufacturers multiple
  device modalities coexisting over a shared
  infrastructure
• Semantic Interoperability ( comparability)
  shared terminology and data models, interpret
  data based on the clinical context, compare
  information from different healthcare facilities,
  and interrogate systems across enterprises and
  regions.
• Real-Time Availability ability to provide data
  in a time frame appropriate to the physiologic
  function being measured, displayed or affected
  (controlled), typically milliseconds to seconds.

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IHE Patient Care Device (PCD)
SO, WHAT IS HAPPENING IN THIS DOMAIN?
In September, 2005, the PCD gathered 60 vendors,
purchasers, providers, and regulators in
Washington D.C. for 2 days to explore the value
propositions, explore the scope and mission of
the domain, and begin the process of use case
development.
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IHE Patient Care Devices (PCD)
The PCD Business Case What outcomes of
IHE-PCD Domain will create real, tangible value
for the participants (i.e., What is the Value
Proposition or, Why should we do this, and why
now?)

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

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IHE Patient Care Devices (PCD)
Key Stakeholders with Business Cases that are
driving the PCD

• Stakeholders presently fall into four general
  categories
• Vendors who sell devices or services
• Purchasers who buy devices - Providers
  (Clinicians) who use devices
• Regulators and Government who represent the
  public good

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IHE Patient Care Device (PCD)
PCD Stakeholder Value Propositions Vendors

• Simplify product development process
• Spend time innovating rather than doing
  infrastucture work
• Facilitate clinical decision support - innovation
  - added functionaliity
• Reduce regulatory impact/work
• Improve patient safety - reduce liability - make
  operations easier - device aware

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IHE Patient Care Device (PCD)
Value Propositions for Purchaser and Provider

• Integrity of data automatic population of all
  information systems reducing medical errors
• Automated systems saves time for clinicians
• Improves agility of enterprises to meet varied
  patient loads
• Improved life-cycle cost of ownership
• Automates clinical data capture for EHR
• Access to patient data across devices and systems
  so custom communication interfaces can be
  eliminated. Allows for best of breed

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

• Value lies in easing regulators tasks by
  industry adoption and implementation of uniform
  specifications.
• For example one Business Case statement for
  government and regulatory stakeholders is IHE
  PCDD can simplify the approval process for
  medical devices and related clinical information
  systems.
• IHE-PCD accelerates the fulfillment of key
  clinical requirements for Efficacy, Efficiency,
  and Safety in the emerging Electronic Health
  Record programs that have been mandated by
  President Bush and Health and Human Services
  leadership.

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IHE Patient Care Device (PCD)
IHE-PCD Charter

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

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IHE Patient Care Device (PCD)
IHE-PCD Domain Vision Statement

• The IHE Patient Care Device Domain (IHE PCD) is
  the nexus for vendors and providers to jointly
  define and demonstrate unambiguous
  interoperability specifications, called profiles,
  which are based on industry standards, and which
  can be brought to market.
• IHE-PCD profiles
• 1. improve patient safety and clinical
  efficacy,
• 2. optimize healthcare delivery cost by
  improving
• efficiency, reliability, and operational
  flexibility for
• healthcare providers,
• 3. enable innovative patient care
  capabilities, and
• 4. expand the international marketplace for
  patient care
• device vendors.

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IHE Patient Care Device (PCD)
IHE-PCD Mission

• The IHE Patient Care Device Domain will apply the
  proven, Use Case driven IHE processes to
• Deliver the technical framework for the IHE-PCD
  domain profiles
• Validate IHE-PCD profile implementations via
  Connectathons and
• Demonstrate marketable solutions at public trade
  shows.

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IHE Patient Care Device (PCD)
PCD Roadmap

• Year 1
• Enterprise sharing of Patient Care Data
• Patient Device ID Binding to Device (deferred)
• Initial device classes vital sign monitors,
  infusion pumps, ventilators and possibly others

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IHE Patient Care Device (PCD)

• Year 2
• Home health
• Emergency Care
• Real-time data archiving and communication
• PCD Alarm Management smart alarms interlocks
• Medication Management
• Device Control (e.g., Hospital BedBlood Pressure
  Coordination)
• Mobile, enterprise-wide, reliable vital signs
  monitoring
• many more!

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IHE Patient Care Device (PCD)

• 2006 Development Schedule
• Planning Committee decision mid-January
• Issue Public Comment version June 2006
• Public Comment Due July 2006
• Issue Trial Implementation version August 8,
  2006
• IHE Connectathon January 2007
• HIMSS Demo February 2007
• Next Face-to-Face
• 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 Implementation in
Europe
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Question

• After the previous lecture, a question could be
  raised through the audience
• From the Vendors perspective
• Why should I produce, test and sell PCD compliant
  devices?
• From the Healthcare Providers perspective
• Why should I ask for PCD compliant devices?

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Benefits

• Theoretically speaking the PCD benefits have been
  well explained
• Heterogeneity
• Semantic Interoperability
• Real-Time Availability
• But practically what could be the benefits of PCD
  implementations?
• Two interesting examples are reported.

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Vendor perspective

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

• Most telemedicine applications are delivered by
  so called small-medium companies
• They commonly assemble sensors in a package that
  can deliver data to a central managing and
  storage facility

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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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Solutions

• In a complete PCD framework, a change in the
  system does not necessitate a redesign of
  interfaces.
• This allows companies to focus their expertise on
  device development.

PCD could save resources and improve business.
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User Perspective
Choices mean saving money
P. C. D.
You negotiate each device, focusing on the best
quality/cost ratio
You negotiate a full range of products from
Vendor X
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Vendors/Users perspective
Open Standard / interoperability means saving
money
No longer Black Box approach
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Clinical Engineers role in IHE

• CEs have a important role within IHE, because
  they contribute, with their wide spectrum of
  knowledge, to help clinicians and administrative
  staff in the new technology acquisition process.
• They are able to educate them to require IHE
  compliance.
• So CEs must be aware and trained about IHE
  framework!

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CEs Role in PCD

• CEs role in PCD domain is crucial because
• CEs manage directly devices
• CEs have a complete vision of devices used within
  the Healthcare Enterprise
• CEs have the capability to think overgapping the
  barriers accross clinical Specialities

PCD is a multidisciplinary domain!
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Health Technology Assessment and PCD

• In 2003 Eucomed (European Medical Technology
  Industry Association) has produced the HTA Europe
  Position Paper
• "Health technology assessment for medical
  devices in Europe - What has to be considered"

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Health Technology Assessment and PCD

• Pre-assessment of new products, is considered by
  the position paper
• But pre-assessment of ICT-based medical devices
  is inherently very difficult
• PCD can help very much the ICT-based medical
  devices pre-assessment, pushing them quickly into
  the market for a wide e-health integration

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

AND

• The Alpe-Adria Universities Initiative (ALADIN)
• The Adriatic Balcanic Ionian Cooperation on
  Biomedical Engineering (ABIC-BME)

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SSIC-HECE

• SSIC-HECE has well understood the importance of
  IHE and it has been the first school that has
  decided to offer to the future CEs some IHE
  targeted courses.
• From this year, the school has introduced PCD as
  a Teaching subject.

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Future Expectations

• Very soon in Europe there will be CEs aware about
  PCD.
• IHE-PCD community will continue to organize
  seminars and initiatives across Europe for each
  stakeholders
• SO
• We expect to have very soon some explicit
  request of IHE-PCD compliant devices

.and vendors?
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Conclusions

• Inter-European diversity (economical,
  geographical, linguistic and cultural) is huge.
• The PCD process must take care of that.
• As soon as possible a European group working on
  PCD should be born.

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

• There are still few European participants in the
  PCD development process
• There are NO European SME vendors or associations
  involved
• There are NO European providers or professional
  organizations involved

We need YOUR experience!
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IHE Web site www.IHE.net

• Frequently Asked Questions
• Integration Profiles in Technical Frameworks
  See Volume 1 of each TF for Use cases
• Cardiology
• IT Infrastructure
• Laboratory
• Patient Care Coordination
• Radiology
• Patient Care Devices
• Connectathon Result www.ihe.net/Events/connectath
  on_results.cfm
• Products Integration Statements
• Participation in Committees Connectathons

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IHE Patient Care Device (PCD)
Come and join the IHE-PCD Domain Team - see or
email any of the following PCD leaders

• Todd Cooper (t.cooper_at_ieee.org)
• Jack Harrington (jack.harrington_at_philips.com
  )
• Melvin Reynolds (MelvinR_at_AMS-Consulting.com)
• Andrea Poli (Poli_at_ssic.units.it)
• or visit us at www.ACCEnet.org/IHE

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Patient Care Devices!