Todd Cooper President and Founder, Breakthrough Solutions Inc. [email protected] Co-Chair of the...

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”



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



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)



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.



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



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

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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



Departments: Rate each department in terms of the benefit from implementation of IHE

• Highest priority departments are ICU, Emergency, Surgery, and Lab (POC)

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2

4

6

8

10

12

1

ICU

Surgury

Anesthesia systems

ED

Pharmacy

Oncology

Point of Care - Lab



Technologies: Which technological areas are most important for patient care device integration?• Highest priority technology is Cross Enterprise Sharing

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1

2

3

4

5

6

7

8

1

Security

RF Wireless

CommonTerminology/Data

Quality of Service Mgt.

Cross Enterprise Sharing



Applications: Which clinical applications would you like to see IHE target?

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2

4

6

8

10

12

14

16

18



Barriers: What do you see as the biggest barriers to IHE integration of patient care devices?• Highest perceived barrier is “Lack of Technology Standards.”

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1

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3

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5

6

7

8

Expense/Cost Lack ofTechnologyStandards

VendorEntrenchment

Fear of Litigation



Cost: Would you buy IHE compliant devices over non compliant, at equal price?

Yes

Don't Know



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%



“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).



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



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…



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



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



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



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



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



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!



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.



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.



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.



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.



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



Thank You!Questions – Comments?

Todd Cooper [email protected], Breakthrough Solutions

American College of Clinical Engineering (ACCE)www.ACCEnet.org

www.ACCEnet.org/IHE

Todd Cooper President and Founder, Breakthrough Solutions Inc. [email protected] Co-Chair of the...

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