Todd Cooper President and Founder, Breakthrough Solutions Inc. [email protected]
Co-Chair of the American College of Clinical Engineering (ACCE) IHE-PCD Domain Task Force
HIMSS 2006 IHE Interoperability Showcase
The New IHEPatient Care Devices (PCD) Domain:
Business Cases and “Warp Speed Ahead” to
Patient Care Device Interoperability!
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 2
The IHE-Patient Care Devices (IHE-PCD) Domain
Integrating the Healthcare Enterprise Patient Care Devices (IHE-PCD) Domain
Helping to fulfill the general IHE Vision:
“Providers and vendors working together to deliver interoperable
health information systems within and between enterprises and
settings”
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 3
The IHE-Patient Care Devices (IHE-PCD) Domain
BioBrief: Todd Cooper 25+ Years of Software Engineering & Medical Device Expertise •Founder and President of Breakthrough Solutions, a
medical device connectivity component software & consulting firm
•International Medical Technology Standards Leader–Chair, IEEE EMBS 1073 Medical Device Communication
Standards–Convenor, ISO TC215 WG7 Health Informatics – Devices–Co-chair, HL7 Health Care Devices SIG–Board Member, ANSI/HIMSS Health I.T. Standards Panel
(HITSP)
•Member of the American College of Clinical Engineering, and Co-Chair of this IHE Patient Care Devices Domain
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 4
The IHE-Patient Care Devices (IHE-PCD) Domain
In June, 2005, The American College of Clinical Engineering (ACCE) was appointed
the Domain Sponsor for Patient Care Devices by IHE’s 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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The IHE-Patient Care Devices (IHE-PCD) Domain
What do we mean by 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 economic, regulatory, and other rewards for the stakeholders.
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The IHE-Patient Care Devices (IHE-PCD) Domain
HIMSS Survey IHE pre-2005 Annual Conference results:
• Further, 56% said they’d pay more for IHE-compliant products!
• So, in Summer 2005, HIMSS conducted a supplemental Patient Care Devices survey, which allowed us to “drill down” to the detailed issues and priorities…
•Over 50% of those surveyed said patient care devices should be the next area developed for IHE
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 7
The IHE-Patient Care Devices (IHE-PCD) Domain
Summer Survey Question re: Devices: How important is it for each device listed to become integrated under the IHE?• Highest priority devices are Vital Signs Monitors, Blood Gas
Analyzers (POC), and Infusion Pumps
0
1
2
3
4
5
6
7
8
9
10
1
Vital Signs Monitors
Infusion Pumps
Ventilators
Anesthesia systems
Dialysis
Point of Care - Glucometers
Point of Care - Blood GasAnalyzers
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The IHE-Patient Care Devices (IHE-PCD) Domain
Departments: Rate each department in terms of the benefit from implementation of IHE
• Highest priority departments are ICU, Emergency, Surgery, and Lab (POC)
0
2
4
6
8
10
12
1
ICU
Surgury
Anesthesia systems
ED
Pharmacy
Oncology
Point of Care - Lab
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The IHE-Patient Care Devices (IHE-PCD) Domain
Technologies: Which technological areas are most important for patient care device integration?• Highest priority technology is Cross Enterprise Sharing
0
1
2
3
4
5
6
7
8
1
Security
RF Wireless
CommonTerminology/Data
Quality of Service Mgt.
Cross Enterprise Sharing
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 10
The IHE-Patient Care Devices (IHE-PCD) Domain
Applications: Which clinical applications would you like to see IHE target?
0
2
4
6
8
10
12
14
16
18
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The IHE-Patient Care Devices (IHE-PCD) Domain
Barriers: What do you see as the biggest barriers to IHE integration of patient care devices?• Highest perceived barrier is “Lack of Technology Standards.”
0
1
2
3
4
5
6
7
8
Expense/Cost Lack ofTechnologyStandards
VendorEntrenchment
Fear of Litigation
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The IHE-Patient Care Devices (IHE-PCD) Domain
Cost: Would you buy IHE compliant devices over non compliant, at equal price?
Yes
Don't Know
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 13
The IHE-Patient Care Devices (IHE-PCD) Domain
Premium: How much of a premium would you pay for IHE compliance?
0
1
2
3
4
5
6
7
None < 5% 5% 10% 15% Over 15%
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The IHE-Patient Care Devices (IHE-PCD) Domain
“REALITY CHECK”Patient Care Devices are quite unique, e.g.,
• Many devices are used in many clinical contexts, filling roles in one context that may be very different in another setting.
• In the arena of interoperability, which cannot be separated from the IHE requirements for connectivity, many of the signals and information from the devices – such as life-critical alarms -- have direct significance to patient safety and well being in real-time, and should be accorded appropriate priority in the system.
• Since many of the devices are portable, means of connectivity will of necessity include wireless portions, direct network connections, and Internet links, all with “hacker and virus” risks, too.
• Most PCD’s provide data that should be automatically and accurately incorporated directly into the information stream that feeds the emerging Electronic Health Record (EHR).
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 15
The IHE-Patient Care Devices (IHE-PCD) Domain
Who are the key Stakeholders with Business Cases that are driving this NOW?
• Stakeholders presently fall into four general categories
–Providers who sell equipment or services
–Purchasers who buy
–Users who consume
–Regulators and Government who represent the public good
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The IHE-Patient Care Devices (IHE-PCD) Domain
SO, WHAT IS HAPPENING IN THIS DOMAIN?
In September, 2005, the PCD gathered 60 vendors, purchasers, users, and regulators in Washington DC for 2 days to explore the value propositions and set initial priorities.
Here is what they said…
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 17
The IHE-Patient Care Devices (IHE-PCD) Domain
Business Case for the Provider (Vendor) as a stakeholder
• Value lies in the ability to attract, retain, or deepen a customer relationship
• For example “IHE PCDD will enable new market development” would be a value proposition
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 18
The IHE-Patient Care Devices (IHE-PCD) Domain
Vendor Business Case Value Propositions (e.g., ROI and other motivations):
Develop a minimum feature set Vendors can comply to - Simplify product development process -Get out of business of things that we do not do well
Spend time innovating rather than doing infrastucture work e.g cell phone (US multi std, ROW single std)
Reduce regulatory impact/work (resubmitting 510Ks)
Allow vendors to aggregate devices and create new solutions and clinical models
Improve patient safety - reduce liability - make operations easier - device aware
Facilitate clinical decision support - innovation - added functionaliity
Create "Open Source" environment to allow a greater focus on clincal rather than technical -- floats all boats"
Will be a mandate from either - customer or regulatory agency
Remove "customer" perceived technical barrier to interoperability
Customer risk mitigation
Facilitate innovation - Small companies do not have to take on enterprise integration projects
Key applications : Charting, decision support, web based, mobile (include wide area) remote access - cross vendor/cross domain integration currently restricted - open new domains to us
Provide a good communication tool between "buyer" and "seller"
Standard user interface - reduce training impact - reduce errors - patient safety
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 19
The IHE-Patient Care Devices (IHE-PCD) Domain
Business Case for the Purchaser/User Stakeholders
• Value lies in simplifying “quality” buying decision criteria
• For example “IHE PCDD will reduce the complexity of the purchase” would
be a value proposition
User stakeholders
Purchaser stakeholders
• Value lies in the benefit you derive
• For example “IHE PCDD will simplify workflow” would be a value proposition
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 20
The IHE-Patient Care Devices (IHE-PCD) Domain
Examples of Purchaser and User “Value Propositions” (i.e, ROI and other motivations):• Integrity of data – automatic population of all information
systems – reducing medical errors • Automated systems saves time for clinicians• Defined and easily accessible audit trails• Eases integration of multiple modalities into a single system;
provides one consistent view of patient data• Facilitates intelligent systems to support clinical reasoning• International standardization of systems so that
international outcomes research can be accomplished• Common and safe user authentication• Access to patient data across devices and systems so custom
communication interfaces can be eliminated. Allows for best of breed
• Reduce redundancy of testing and training
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The IHE-Patient Care Devices (IHE-PCD) Domain
User/Provider/Purchaser Benefit Examples• Improves agility of enterprises to meet varied patient
loads• Improved life-cycle cost of ownership
–Facilitates heterogeneous brand and model
deployment–May allow use of technologies over longer periods of
time, reducing the “obsolescence effect”• Vendor-provided IHE-PCD conformance statements will
ease selection decisions and reduce risks• Automates clinical data capture for EHR
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 22
The IHE-Patient Care Devices (IHE-PCD) Domain
Examples of emerging IHE-PCD Use Cases
• Enterprise sharing of Patient Care Data• Patient ID reconciliation• Real-time data archiving• Ventilator-to-X-ray synchronization• Mobile, enterprise-wide, reliable vital signs
monitoring• … many more!
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 23
The IHE-Patient Care Devices (IHE-PCD) Domain
Sample Business Cases for Government Payor 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.
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 24
The IHE-Patient Care Devices (IHE-PCD) Domain
IHE-PCD Domain Vision StatementThe IHE Patient Care Devices 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. reduce 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.
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 25
The IHE-Patient Care Devices (IHE-PCD) Domain
IHE-PCD MissionThe IHE Patient Care Devices Domain will
apply the proven, Use Case driven IHE processes to:
1. Deliver the technical framework for the IHE-PCD domain profiles;
2. Demonstrate IHE-PCD profile implementations via Connectathons; and
3. Publicly demonstrate marketable solutions at Association trade shows.
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The IHE-Patient Care Devices (IHE-PCD) Domain
IHE-PCD Scope
The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device (or is embedded within another device or Domain) which does not fall within one of the other IHE clinical specialty based domains such as medical imaging.
American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 27
The IHE-Patient Care Devices (IHE-PCD) Domain
In order to join the IHE-PCD Domain Team see or email any of the following:
• Todd Cooper ([email protected])• Emanuel (Manny) Furst ([email protected])• Jack Harrington ([email protected])• Elliot Sloane ([email protected])• Ray Zambuto ([email protected])
… or visit us at www.ACCEnet.org/IHE
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The IHE-Patient Care Devices (IHE-PCD) Domain
Thank You!Questions – Comments?
Todd Cooper [email protected], Breakthrough Solutions
American College of Clinical Engineering (ACCE)www.ACCEnet.org
www.ACCEnet.org/IHE