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ISO/IEEE 11073IEEE, EMB, S2E Standards Opportunities for Medical Devices and Healthcare Informatics

Presentation to IEEE S2E ExCom, 31 July 2008:The 21st Century Healthcare Informatics Industry

& IEEE’s leadership roles and opportunities

Elliot B. SloaneVillanova University

EMBS AdCom, IEEE 11073 SponsorChair, IEEE’s Healthcare Industry Segment Initiative (’03-’05)

Presentation developed with input and permission from Todd Cooper, President of Breakthrough Solutions, IEEE 11073 Chair, and ISO TC 215 Chair

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ISO/IEEE 11073BioBrief: Elliot Sloane, PhD, CCE

Dual Clinical Engineering and Information Technology “Citizenship!” • 32+ Years of CE and IT/IS Industry and Academic Expertise

– Initially, Vice President, ECRI Institute – 15 years, CIO & COO• World’s largest medical device research, testing, standards, and education agency

– Then, Vice President, MEDIQ/PRN – 10 Years, COO & CTO • Medical device & drug distribution, service, and manufacturing

– Since 2000, Information Systems faculty at Villanova University School of Business, near of Philadelphia.

• Teaching, research and publishing in health informatics.• #12 undergraduate Business School in US (Business Week)

• Member and Officer in CE/IT/MIS Societies since 1980– IEEE EMBS Board of Directors since 2003; Member of IEEE SA

• Senior Member IEEE, member since 1974.– Board of Directors ANSI HITSP committee– Co-chair International IHE Board of directors representing HIMSS, and co-

chair of the IHE Patient Care Device Domain.– Past-President, American College of Clinical Engineering

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ISO/IEEE 11073

What is a medical device?

• According to FDA, it is “any product (or portion of a product) that affects a patient’s diagnosis or therapy of”

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ISO/IEEE 11073Important Update for IEEE standards

activities/opportunities

In a recent 2008 FDA proposed ruling data communication or storage devices or networks that merely transmit or store patient data will

become “medical devices” • e.g., This might be an opportunity to introduce

IEEE S2E standards into life-critical healthcare applications, because formal validation is required.

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ISO/IEEE 11073

What standards govern medical devices in the US?

• Unlike Europe the FDA has NO written federal/state standards for medical devices!– FDA chooses to regulate quality and safety by

pre-market screening and post-market surveillance.

– The furthest FDA goes is to provide a few “guidance documents” for manufacturers.

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ISO/IEEE 11073What standards really govern medical

devices in the US?

• AAMI, an industry association, develops consensus clinical, technical, and safety standards for specific medical devices like IV Pumps. – Now “importing” European standards from IEC and

other sources.

• IEC 60601 and some ISO standards cover European medical devices– Some of those standards include “smart” functions such

as intelligent alarms, but not the transmission of data.

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ISO/IEEE 11073What standards really govern medical devices?

• IEEE 11073 committees develop most of the medical information standards(a.k.a. medical informatics standards) related to nomenclature, structure, and transmission of data between medical devices and/lr computer systems used for medical care.– Medical image data standards are handled by DICOM, but

realtime waveform data like heart rhythms are not yet addressed there.

• Following approval, IEEE 11073 standards are presented for ISO balloting and approval, to make them visible for widespread global adoption.

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ISO/IEEE 11073What else is a “medical device?”

• Strong movement now occurring inside/outside government to include “consumer health/medical devices” such as heart monitors used with treadmills as non-regulated, but still partially valid, sources of medical data.– Low cost products suit Medicare plans to reduce costs

• Allows people to purchase many products for their medical care at Costco, BJs, and Wal-Mart for own “basic” medical care at home.

• HHS plans use “telemedicine” to leverage these low cost devices.

– IEEE 802.x (Zigbee, Bluetooth, Wi-Fi, Wi-Max), USB devices, laptops, disk drives, PDAs, etc, will acquire new liabilities when used in such applications.

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ISO/IEEE 11073 “Industry” (e.g., Intel, Microsoft, etc) is leading this

effort to create standards for this new class of “consumer health/medical devices” and associated communication, storage, and computing accessories.

ContinuaAlliance.org is the group leading that effort.– Continua Alliance is beginning to build out their

standards as a subcommittee within IEEE 11073.– Intel HAS achieved FDA 510K approval for one

consumer product this July! (http://www.healthnewsdirect.com/?p=372)

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ISO/IEEE 11073• How big is the healthcare market in the US?

– Roughly $2 trillion/year in 2006– Projected to reach $4 trillion, or 25% GDP, by

2015.– IOM/National Academies of Engineering report

in 2005 gave these facts:• Waste is estimated by government at 30-40%• Errors are running at 2-3 Sigma levels• Medical errors are killing 70-100,000 patients each

year

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ISO/IEEE 11073The global solution perceived for spiraling medical

costs?Medical Informatics

Since the current trends are unsustainable; US and worldwide governments are “changing the game” by building National Healthcare Information Networks (NHINs), essentially bring eCommerce and automated manufacturing tools and techniques to healthcare.

– The US NHIN Program launched in 2004– Second pilot projects under way in 2008– Funding to physicians and hospitals in tax incentives and payment

bonuses will begin in late 2008 – Participation will remain voluntary, BUT, all payments for non-

NHIN-participants will be cut off in 4-5 years AND data-mining will be used to cull out (i.e., fire) underperformers

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ISO/IEEE 11073• How is the US NHIN being created?

– The ANSI Healthcare Technology Standards Panel (HITSP) is given a portfolio of annual informatics projects at the beginning of each year.

• HITSP has over 350 associations now, spanning government, vendor, SDO, and other stakeholders.

• The HITSP Board has about 15 elected members.– Todd Cooper (an IEEE SA delegate) was elected to the

Board by the SDOs because of his medical device and informatics expertise.

– Because of my own medical device, informatics, and patient safety background, and the fact that I co-chair the International Integrating the Healthcare Enterprise (IHE) organization, I was elected to the Board by the SDOs as well.

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Chairman of the ANSI/HITSP Board: Dr. John Halamka, CMIO of Harvard

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ISO/IEEE 11073How many IEEE standards have been incorporated in the US NHIN so far?

• The first are being added to this year’s drafts – Medical device-related tasks were deferred by the

HHS until 2008, which delayed IEEE 11073, and– Despite the fact that the meetings are open, free, and

are mostly conducted by teleconference, and despite repeated requests from Todd Cooper and myself, nobody from any IEEE standards committees except 11073 has participated since 2004

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ISO/IEEE 11073Will IEEE’s involvement change?

• Yes, for the 11073 standards

• Maybe for the huge battery of relevant IEEE standards that SHOULD be considered.– S2E has finally stepped forward to at least consider

bringing the library of software engineering and verification and validation standards into the ANSI/HITSP discussion

– We are trying to mobilize IEEE 802.x or various quality, genomics, security/encryption, and other IEEE standards leaders…

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ISO/IEEE 11073What’s involved?

• HITSP panels do not write primary standards. • HITSP committees do their best to identify all

relevant potential standards• HITSP committees do their best to interpret the

advantages and disadvantages of all available standards– They post their findings and recommendations for

internal and then public review• The bottom line: whoever shows up or speaks up

gets to vote, and the earlier, the better!– Committee and subcommittee leaders are volunteers

who are voted in mostly due to their willingness to do the work.

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HITSP TC Existing Constructs

C35 - Lab Result Terminology

C36 - Lab Result Message

C37 - Lab Report Document

T18 - View Lab Result From Web App

C39 - Encounter Message

C41 - Radiology Result Message

TP49 - Sharing Radiology Results

C48 - Encounter Document

C32 - Summary Docs Using CCD

C28 - Emergency Care Summary Document

C34 - Patient Level Quality Data Message

C38 - Patient Level Quality Data Document

T42 - Medication Dispensing Status

TP43 - Medication Orders

C19 - Entity Identity Assertion

C25 - Anonymize

C26 - Nonrepudiation of Origin

T15 - Collect and Comm Security Audit Trail

T16 - Consistent Time

T17 - Secured Communication Channel

T24 - Pseudonymize

TP20 - Access Control

TP30 - Manage Consent Directives

C44 - Secure Web Connection

T29 - Notification of Document Availability

T31 - Document Reliable Interchange

T23 - Patient Demographics Query

T33 - Transfer of Documents on Media

TP13 - Manage Sharing of Documents

TP14 - Send Lab Result Message

TP21 - Query for Existing Data

TP22 - Patient ID Cross-Referencing

TP50 - Retrieve Form for Data Capture

C47 - Resource Utilization

T40 - Patient Eligibility Verification

TP46 - Medication Formulary and Benefits Information

Security Privacy & InfrastructureCare Management & Health Records Administrative & Finance

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HITSP 2008 TC Project Plan OverviewRED indicates potential IEEE Standards Opportunities

TC 2008 Use Case Work 2006/2007 Carry-over Work Provider • Consultations and Transfer of

Care

• Personalized Healthcare

• IS01 Lab EHR

• IS04 Emergency Responder EHR

• IS07 Medication Management

Consumer • Remote Monitoring (11073)

• Patient Provider Secure Messaging

• IS03 Consumer Access via Media

• IS05 Consumer Access via Network

Population • Public Health Case Reporting

• Immunization and Response Management

• IS02 Biosurveillance

• IS06 Quality

Security, Privacy & Infrastructure

• Remote Monitoring• Patient Provider Secure Messaging

• IS03 Consumer Access via Media

• IS05 Consumer Access via Network

• IS06 Quality

• TN900 Security and Privacy and 19 existing constructs

• TN900 Security and Privacy and 19 existing constructs

Care Mgmnt & Health Records

• TBD • 15 existing constructs

Administrative and Finance • TBD • 3 existing constructs

NOTE: 11073 is stretched to cover soley the medical device issues!

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ISO/IEEE 11073ISO/IEEE 11073 Tutorial for IEEE EMBS - 2003-09-17

The 11073 standards are pretty simple, and constitute a Medical Device Data Language (MDDL):

i.e., the Semantics needed to communicate a device’s application status and control information.

Device Data & Services1073.1.x

Consists of three main components: Nomenclature (1073.1.1.1) Domain Information Model (DIM)

(1073.1.2.1) Device Specializations (1073.1.3.x)

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ISO/IEEE 11073Major vendors, including Draeger/Siemens, GE, and Philips are already well advanced in a “Rosetta Project” that maps each vendor’s proprietary data standards to the IEEE 11073 standard “Reference ID,” as shown below:

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“IHE International” is a major underlying NHIN framework, with global governance processes

Scope ofScope ofIHE InternationalIHE International

GovernanceGovernance

Nations/regions Nations/regions establish establish

separate but separate but consistent consistent governance governance

modelsmodels

BoardOperations Committee

IHE International Board

Liaison Organizations

Liaison Organizations

Operations Committee

Marketing and Communications

Committee

Marketing and Communications

Committee

Testing and Tools

Committee

Testing and Tools

CommitteeDomain Planning & Technical

Committees

Domain Planning & Technical

CommitteesDomain

Planning & Technical

Committees

Domain Planning & Technical

CommitteesDomain

Planning & Technical

Committees

Domain Planning & Technical

Committees

Domain Coordination Committee

Domain Coordination Committee

Domains Development Activities

National Deployment Committee

National Deployment Committee

National Deployment Committee

National Deployment Committee National

Deployment Committee

National Deployment Committee National

Deployment Committee

National Deployment Committee

Regional Deployment Committee

National Deployment Committee

National Deployment Committee National

Deployment Committee

National Deployment Committee National

Deployment Committee

National Deployment Committee

Regional Deployment Committee

Regional Deployment Activities

Advisory Panel

EmpowermentEmpowerment

IEEE SHOULD play a role in IEEE SHOULD play a role in IHE’s Infrastructure IHE’s Infrastructure

Committees in order to Committees in order to have GLOBAL impact.have GLOBAL impact.

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International Adoption of IHE

FranceUSA

Germany

Italy

JapanUK

Canada

Korea

Taiwan

Norway

Holland

SpainChina

Yea

r 1

(199

9)

Yea

r 2

(200

0)

Yea

r 3

(200

1)

Yea

r 4

(200

2)

Yea

r 5

(200

3)

Yea

r 6

(200

4)

Yea

r 7

(200

5)

Yea

r 8

(200

6)

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Growth in IHE Domains

Radiology (18)

IT Infrastructure for Healthcare (17)

Cardiology (7)

Laboratory (6)

Radiation Oncology (1)

Patient Care Coordination (5)

Patient Care Devices (1)

Quality

Eye Care (3)

VeterinaryEndoscopyPathologyPharmacy

Ye

ar

1

(19

99

)

Ye

ar

2

(20

00

)

Ye

ar

3

(20

01

)

Ye

ar

4

(20

02

)

Ye

ar

5

(20

03

)

Ye

ar

6

(20

04

)

Ye

ar

7

(20

05

)

Ye

ar

8

(20

06

)

Ye

ar

9

(20

07

)

• Over 250 vendors involved world-wideOver 250 vendors involved world-wide• 12 Technical Frameworks12 Technical Frameworks• 48 Integration Profiles48 Integration Profiles

•Testing at “Connectathons” world-wideTesting at “Connectathons” world-wide• Demonstrations at major conferences world-wideDemonstrations at major conferences world-wide

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IHE Interoperability Showcases demonstrate working systems by leading COMPETING companies:

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IHE PCD in the HIMSS 2007 and 2008 Interoperability Showcase

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GEGE

AwareAwareGatewayGateway

Patient Monitor, Ventilator

PhilipsPhilipsIntellivueIntellivue

InformationInformationCenterCenter

Patient Monitor

Intensive Care

PhilipsPhilipsIntellivue ClinicalIntellivue Clinical

InformationInformationPortfolioPortfolio

DraegerDraegerInnovianInnovian®®

Solution SuiteSolution Suite

CapsuleCapsule

Welch AllynWelch AllynConnexConnexTMTM

Data MgmtData MgmtSystemSystem

Vital Signs Monitor

Emergency Care

LiveDataLiveData

OR –OR –DashBoardDashBoard

GE GE CentricityCentricity®®

PeriopPeriopAnesthesiaAnesthesia

DraegerDraeger

InfinityInfinityGatewayGateway

Patient Monitor, Anesthesia Sys

Perioperative Care

SpacelabsSpacelabs

IntesysIntesysClinical SuiteClinical Suite

Patient Monitor

EpicEpic

InPatientInPatient

Enterprise

PDQ/PAMServer

TimeServer

Patient Care DevicesHIMSS IHE ShowCase 2008, February 23-28

InfusionDevices

B. BraunB. BraunDoseTracDoseTracTMTM

InfusionInfusionMgmt SWMgmt SW

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ISO/IEEE 11073Is IEEE represented in IHE International?

• I am co-chair of the International Board of Directors

• IEEE 11073 members Todd Cooper, Jack Harrington, and have all been co-chairs of the IHE Patient Care Device Domain since its founding in 2002.– The Technical and Planning Committees are also

full of IEEE 11073 subcommittee members

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ISO/IEEE 11073• Progress?

– Worldwide, IEEE 11073 standards are becoming integral to all IHE International Patient Care Device “integration profiles”

• The entire IHE family of integration profiles are the largest single resource selected globally by “Ministry of Health” task forces who have been building national electronic healthcare information networks and systems since 2002 or so.

• In the US, since 2005, most of the ANSI HITSP panel members and leaders are drawn from the same pool of volunteers who have been drafting the IHE integration profiles since 1998.– Virtually all HITSP standards recommendations since

2005 have therefore been based on the IHE integration profiles.

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ISO/IEEE 11073Where is this headed in the US?• All of the State and Federal Medicare agencies, and

then all private insurers, will use the next generation of communicating, interoperable medical devices to install telemedicine as the standard of care for chronic disease and wellness care and to automate data capture for electronic health records.– Eventually, most homes will have multiple products that we,

today, categorize as “medical devices” – Unless we really mess this up, all state, federal, and home

medical devices, systems, and accessories will interoperable with the NHIN via IEEE 11073 standards.

• FDA-regulated devices for hospitals and acute will follow suit because, frankly, that makes more economic sense than inventing a separate system than the IEEE 11073 that the vendors, themselves, created!

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ISO/IEEE 11073HUGE GAPS exist?• None of the State or Federal healthcare

informatics initiatives in the US related to bootstrapping our National Healthcare Information Network have formal S2E concepts incorporated (e.g., no V&V, no formal system development processes, etc.)– Medical devices themselves have general

constraints, I do not believe that NO IEEE Standards are identified as exemplars, nor are courses offered to mfrs to expedite the adoption.

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ISO/IEEE 11073Three basic questions we have in front of us:

How large does IEEE want its role to be in 21st Century Healthcare?

How, or is, IEEE going to make that happen?

Can IEEE even afford to consider sitting on the sidelines in healthcare any longer (e.g., what if IEEE 802.x is displaced in healthcare, or IEEE

Software and Systems Engineering Standards are simply overlooked?)

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ISO/IEEE 11073One proposal:• Get the 11073 and S2E experts together to

consider formulating a presentation to ANSI/HITSP and IHE leadership.– This will have to be a high-level “gloss” that excites

and invites them to welcome the S2E expertise quickly in order to create a “fast path” to infuse the concepts into their cultures.

– Fortunately, there is a lot of overlap between ANSI/HITSP and IHE membership, though by no means complete…

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ISO/IEEE 11073ISO/IEEE 11073

    

“The young do not know enough to be prudent, and therefore they attempt

the impossible -- and achieve it, generation after generation.”

- Pearl S. Buck

They said it couldn’t be done….

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ISO/IEEE 11073THANK YOU!

???QUESTIONS?

Elliot B. Sloane, PhD, CCEebsloane@villanova.edu,

& @ieee.org, @gmail.com, @aol.com, @yahoo.com, @hotmail.com, etc.

www.homepage.villanova.edu/ebsloaneor just Google™ me!