Continua Health AllianceContinua Health Alliance

AALAAL

Chuck ParkerExecutive DirectorExecutive DirectorThe Continua Health Alliance

11/16/2009

The Continua Health Alliance Mission

11/16/2009 2

Remote Patient Monitoring

• Market influence and implementation• Use case Driven• Interoperability

A h– Approach– Constraining– ProtocolProtocol

• Market and Political drive

11/16/2009 3

Remote Patient Monitoring: Standards

• Continua founded to organize and push market in one direction direction.

• Structure (Working groups) is to model real-world Use Cases from industry and healthcareCases from industry and healthcare.

• Process then deconstructs requirements and selects best industry standardsbest industry standards

• Then vet processes and fill holes either with direct work within SDO’s or add definitions and refinements

• Ballot and then publish program and guidelines

• Strongest Value of Continua though is the Certification program for interoperability of devices

11/16/2009 4

Guidelines Certification Recognizable Logo

11/16/2009 5

Ecosystem Development

D l R C ifi i Test and certification tools

Right to use certified logo upon Web-based environment

(repository collaboration tools)

Developer Resources Certification

Right to use certified logo upon completion of successful

certification

(repository, collaboration tools) Reference source code

Market Intelligence Collaboration Plugfests participation

Participation in RFP MatchMaker program

Access to market research data Access to pre-publication drafts of

the design guidelines

Market Intelligence Collaboration

Unlimited participation in Continua quarterly summits, town hall

meetings, and education seminars

the design guidelines Internal and external education and

training

Monday, November 16, 2009

Remote Patient Monitoring

• Market influence and implementation• Use case Driven• Interoperability

A h– Approach– Constraining– ProtocolProtocol

• Market and Political drive

11/16/2009 7

Continua Use Cases

• To organize its work, Continua segmented the market in three large use cases:three large use cases:

A i I d d lAging Independently• An adult child helping their elderly parents

age gracefully in their own home.• Basic life monitoring as appropriate (ADL)

Health & Wellness Disease Management

• Basic life monitoring as appropriate (ADL)

Health & Wellness• Weight loss• Fitness• Email / chat / video

Disease Management• Vital sign monitoring

(RPM)• Medication reminders and

• Appt scheduling• Personal Health Records

compliance• Trend analysis and alerts• Connect with family care

i

11/16/2009 8

givers

V2 Use Case DevelopmentM1: Decompose UC into requirements M2: Select Standards M3: Identify gaps between

standards and requirements

E i E itExitSuccessful review (E2E Arch, TWG, UCWG)

ExitSuccessful TWG Ballot, BOD approval

ExitTWG, UCWG presentation

UCWG) approval

M4: Develop Guidelines

M5: Create Test Procedures and complete review

M6: Update Test Tool

9

ExitTWG review and ballot

ExitSuccessful TCWG review

ExitPass Tool Test

V2 Use Cases Underway

PAN Device Health

Se

DeviceInterf

Electric H

Application Hosting Device

PAN DeviceWAN Device

HealthRecordDevice

Physical Activity Monitor

Medication Monitor ervice (W

e (PAN)

rface

Health Re

Electrocardiogram (ECG)

Insulin Pump WAN

) Inter

Ne

ecord (XHLAN Device Low Power Radio

rface

twork (LA

Interface

HR

) InterfaPortable XHR AN)

e ace

Fi l li k i d d ti it

Portable XHR Media Extension

V1 Extensions (e.g., Multiple

10

Final link in end-end connectivitydevice users, enhanced device authentication)

Remote Patient Monitoring

• Market influence and implementation• Use case Driven• Interoperability

A h– Approach– Constraining– ProtocolProtocol

• Market and Political drive

11/16/2009 11

V 1 Interoperability Standards - Protocol

Pulse

PC

Oximeter

Pulse /Blood Pressure

• 11073-10404 = Pulse Oximeter• 11073-10406 = Pulse / Heart Rate• 11073-10407 = Blood Pressure• 11073-10408 = Thermometer

PersonalHealth SystemWeight

Scale

Blood Pressure• 11073-10415 = Weighing Scale• 11073-10417 = Glucose • 11073-10441 = Cardiovascular Fitness Monitor• 11073-10442 = Strength Fitness Equipment• 11073-10471 = Independent Living Activity

Cell PhoneGlucoseMeter

11073 10471 Independent Living Activity• 11073-10472 = Medication Monitor

Cardiovascular and Strength

Fitness Monitor Bluetooth Medical Device Profile Specification Set Top BoxIndependent

Living Activity

Medication

Device Profile Specification

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AggregatorMonitor USB Personal Healthcare Device Class Specification

V 1 Data Standards - Syntactical

Healthcare Provider

LabsDisease

Management Service

CDA/CCD-based Personal Health Monitor (PHM)

Specification

Home-based Remote Patient Monitoring

Service

Patient Monitoring (RPM) System Electronic

Health Record System

PatientXDR Transport Specification

Vital Sign Devices

EHR / PHR

V1 Interoperability - Semantic

• Use of HL7 and SNOMED CT for semantic understandingunderstanding

V 2 will have further implementation and conditional • V 2 will have further implementation and conditional understanding

11/16/2009 14

Interoperability in Three-tier Approach

• Continua constrains the outputs at the device level. (PAN interface)(PAN interface)– Reduces device overhead and intelligence requirements

Reduces power requirements– Reduces power requirements– Reduces development time– Reduces connection complexity Reduces connection complexity

• Intelligence is at the Hub / ManagerIntelligence is at the Hub / Manager– Understands what it is communicating with– What data to expectp– May issue commands to send certain data

11/16/2009 15

Continua Reference Device Classes(with real-world examples)( p )

ApplicationHosting Device

PAN “Adapter” Device:

PANDevice

to represent a device as aPAN Device in the

Continua ecosystem

LAN

LAN “Sharing” Device:to represent a device as a

LANDevice

LAN Device in the Continua Ecosystem

WANDevice

Health RecordDevice

16

V1 Certification Process

SDO TransportCertificate

ContinuaCompliance

ContinuaCertificationCertificate Compliance

Testing

Test

Certification& Logo

Test Test Plans

Test Report

MembersMembers

TCWG Test Lab

TestSuites

Test Admin

Logo

Remote Patient Monitoring

• Market influence and implementation• Use case Driven• Interoperability

A h– Approach– Constraining– ProtocolProtocol

• Market and Political drive

11/16/2009 18

Working Group Structure

BoardOf Over 1 400 membersDirectors Over 1,400 members

participatingin the various

VTMAdministration

ExecutiveDirector

Working Groups

Use CaseWG

TechnicalWG

Test & Certification

WG

Employer HR Benefits

WG

Marketing WG

Regulatory WG

PolicyStrategy

WG

Expert Group S b PR & Australia EU Japan LatinA i U.S. U.S.

11/16/2009 19

Expert GroupNHS, AAFP,ATA, AHA…

Sub-Committees

PR & Marketing

agency

AustraliaPolicyWG

EUPolicy

WG

JapanPolicyWG

AmericaPolicyWG

U.S.PolicyWG

U.S.PayerWG

RPM market now: Current Participants

• Continua membership shows across the board interest both from supply and demand sides:both from supply and demand sides:– Medical devices

Governmental Agencies– Governmental Agencies– Health care providers– Health insurersHealth insurers– Fitness– PharmaPharma– Telecommunications– IT– Integrators– Applications (PHR, EHR, desktop)

11/16/2009 20

RPM market in the future

• The individual / home as the hub

• Convergence consumer / healthcare

• Consumer health / PHRs fitness - sometimes with bli i tipublic incentives

• Support public health and corporate wellness programs

• Rewards for keeping people healthy

• Greater integration among wellness, health and social care

• Best-of-breed plug and play

• Increased connectivity, evolutionary, scalable, service

11/16/2009 21

Increased connectivity, evolutionary, scalable, service driven offerings

End-to-end demo – Vancouver 2009

Device InterfaceDevice Manager

XHR InterfaceSender ReceiverWAN

EHR

PHRBased upon proposed

protocols for Continua WAN EHR

Glucose MeterRoche Accu-Chek 360

IP networkxHR

Web i

Pulse Oximeter

Disease management

platform

A d id b d G C ll

Wi-fi or 3G

services

LNI Android-based G1 Cell phone 20601 manager

Thank You

Thank you!a you!

Chuck ParkerChuck ParkerExecutive Director

admin@continuaalliance.org

www.continuaalliance.org

11/16/2009 23

Remote Patient Monitoring

• Additional Content

11/16/2009 24

Remote Patient Monitoring:enablers & drivers

Health Cost BurdenNational Action

Increasing costs of the old model of health care become a national crisis

Economic pressures force nations to demand new 

health solutions

ConnectedPersonal Health

New KnowledgeA new path to personal 

wellness, citizen productivity, and 

sustainable health costs

New Knowledge

Modifiable lifestyles are key drivers for population health and disease sustainable health costs

Enabling Technology

Telehealth devices, 

Perspective Shift

From treatment of disease to proactive nurturing 

personalized biometrics, device interoperability

11/16/2009 25

p gof personal wellness

Technology Out Paces Biology

Our evolution cannot support our current sedentary high-fat activities

26Private and Confidential, Oregon Medical Laboratories

Goal: Realize Peak Health Potential

• Goal – Experience peak health potential throughout life for a high quality of life at minimal

costs• Reality

– Average individual is experiencing much less of full health potential than expected at a high financial & quality of life cost

• Cause

Ti

• Cause– Adverse health events such as stress, poor nutrition, inactivity… are causing the

population to fall away from their peak health potential

Time Peak Health Potential Line

Max

Unpredictable E /A id

Min

Health

ealt

h

Actual Health Experience

Poor nutrition, inactivity,

Event/Accident

Cost

s Expectations

nH

e

Non-modifiable & Unpredictable Health

Experienceact v ty, Stress…

xC

11/16/2009 27

Min

Modifiable & Predictable Health

DeathDeath

Ma

Adapted from Oregon Medical Labs

RPM Market: The Need

• The challenge:

Al t h lf f ll A i 133 illi l i 2005 h t l t – Almost half of all Americans – 133 million people in 2005 – have at least one chronic condition, and the medical care costs of people with chronic diseases consumes more than 75 percent of US medical care costs (CDC)

– Up to 60% of all medication prescribed is taken incorrectly, or not at all (National Council on Patient Information & Education).

National Health Expenditures, Aggregate and Share of Gross

Domestic Product (GDP),

Source: Employee Benefit Research Institute estimates from Centers for Medicare and

1960-2017

estimates from Centers for Medicare and Medicaid Services and U.S. Department of Commerce. Last Updated: January 6, 2008

11/16/2009 28

RPM Market: the Need for Transformation

• The area of telehealth/home health monitoring is predicted to grow very rapidly, from a $3B market in 2009 in North America and Europe to very rapidly, from a $3B market in 2009 in North America and Europe to an estimated $7.7B in 2012 (Data Monitor, 2007)

• Number of telehealth subscribers worldwide will increase to 55.5 million by 2016, representing a forecast CAGR of almost 72%, (InMedica, 2008)

• There is increasing evidence to support the value of remote monitoring There is increasing evidence to support the value of remote monitoring for patients with chronic diseases, including: – 35-56% reduction in mortality; – 47% reduction in risk of hospitalization; – 6 days reduction in length of hospital admission and – 65% reduction in office visits; 65% reduction in office visits; – 40-64% reduction in physician time for checks and – 63% reduction in transport costs

11/16/2009 29

(Cleland et al 2005; Lee R, Goldberg et al, 2003; Scalvini S et al., 2001; Elsner et al, 2006; Van Ginneken et al 2006)

Address 60-80% modifiable Adverse Health

• Many diseases can be broken 91% Diabetes 83% Heart Diseaseydown into non-modifiable and modifiable contributors

• Non-modifiable contributors– Age, gender and genes

69% Cancer

• Modifiable contributors– Lifestyle choices

• Today, poor lifestyle choices increasingly are the largest

Actual Goal

contributors to common adverse health outcomes Non-modifiable Contributors to Disease

Modifiable Contributors to Disease

11/16/2009 30

Hu et al. Diet, lifestyle and the risk of type 2 Diabetes in women. NEJM 2001 Sep 13;345(11):790-7.Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000; 343: 16–22

RPM Market: the Market Segments

Multiple providers / service oriented

WeightScale

Device /Systems / Sensors

Biometrics Testing

Wellness Management/Support

Systems Glucose Meter

HRA/Health Administrative

Assistant

Blood-Presser Cuff

SpirometerCholesterol HDL/LDL

Weight

Blood-Pressure

Triglycerides

Bio-metric/BehavioralResponses

Fitness

PersonCentered

Fitness Equipment

Pulse

PressureBlood Sugar

Lung Air Volume

Fitness, nutrition, stress management…

Pulse Oximeter

P d t

Resting Heart Rate

Body Fat %

B d F t

Wellness Center

Diseasemanagement

Healthcareprovider

Gait analysis

Information Systems Medication

Tracking

Pedometer Body Fat Analyzer

PHR/PHA

ActivityHub

gservice

analysis

11/16/2009 31

ClassesFamilycare

givers

Elderlymonitoring

services

Continua Use Cases

• Disease management market: – evolve the current models of care; chronic and post-acute– connect patients, families and healthcare providers to the right

information at the right time– more informed decision-making

empowering people to take a more active role in their own care– empowering people to take a more active role in their own care– e.g.: Northern Ireland, West Lothian (UK); AOK Cardio Integral (DE)– mostly led by public healthcare administrations; statutory health insurers

11/16/2009 32

Continua Use Cases

• Health and wellness market:– health conscious and worried well– fitness and lifestyle trackers, PHRs– employer programs and occupational health (HRA)– national public health programs, screening

Di b P i DEHKO (FI) b li d d – e.g.: Diabetes Prevention DEHKO (FI); metabolic syndrome – mandatory HRA (JP); 10K Steps a Day; Nike Plus; Google Health; MS HealthVault; Dossia

– mostly privately driven; a few national programsmostly privately driven; a few national programs

11/16/2009 33

Continua Use Cases

• Ageing independently market: – residential care, independent living facilities, individual homes– support ADL, fall detectors, bed occupancy, medical reminders, …– personal emergency response services– e.g.: Tunstall, Philips Lifeline, GE Quiet Care – driven by a mix of social care providers, group housing, individual

subscribers

11/16/2009 34

Remote Patient Monitoring

• Additional Technical Content

11/16/2009 35

Continua E2E Reference Topology(with real-world example devices overlaid)

Embedded Apps Could subsume PAN interface and expose WAN interface

PAN

Application Hosting Device

PAN Device WAN DeviceHealthRecordDevice

WA

N-Interface

xHAN

-Interfa

e RN-InterfaaceLA

N-Inte

aceLAN Device

erface

36

PAN Interface IEEE PHD State MachineDisconnected

Transport connect indication Transport disconnect indication

• Agent states shown, Manager is similar

Connected

AssociatedDisassociatingassocRelReq

• Configuration state transmits all static

Operating+entry / TxAssocRelReqq

RxAssocAbortTxAssocAbort

RxAssocRelRsp

RxAssocRelReq/TxAssocRelRsp

data one time for efficiency

Unassociated

RxAssocAbort

TxAssocAbort

RxAssocRelReq/TxAssocRelRsp

Configuring RxConfigEventReportRsp(accepted-config)

• Operating state is where measurements are transmitted

assocReq

RxAssocAbortO

p

RxAssocRsp

Waiting Approval

are transmitted

Associating

OrTxAssocAbort

TxAssocRsp(rejected)

RxAssocRsp(accepted)

TxConfigEventReportReq

RxConfigEventReportRsp(unsupported-config)

+ entry / TxAssocReq RxAssocRsp(accepted-unknown-config)

Sending Config

WAN Interface Goals

• Minimal Payload Translationh d d h– Keep the device readings consistent with PAN (e.g.,

same nomenclature)Mi i l P l d T f ti• Minimal Payload Transformation– Manager should not be forced to deal with the

complexity of transformations from one payload model complexity of transformations from one payload model to another

• Support for all 3 Continua Domains• Support for all 3 Continua Domains– Health and Fitness, Aging Independently, and Disease

ManagementManagement• Extensibility• Minimize divergence of standards• Minimize divergence of standards

WAN Recommendations

• HL7 v2.6 messages using IHE PCD-01I i i ll i d IEEE 11073 20601 d 104 – Initially constrained to IEEE 11073-20601 and 104xx nomenclature for personal health devicesCan be extended to support IEEE 11073 10101 – Can be extended to support IEEE 11073–10101 terminologies and core components of the-10201 information model for clinical devices10201 information model for clinical devices

• Web Services transport based on WS-I Basic Profile– Work with HL7 WS-I and IHE ITI on furtherWork with HL7, WS I, and IHE ITI on further

Web Service Profiles– TLS for SecurityS o Secu ty

• Define placeholder for alarm, alert, control, and command messages but defer message contents for later versionsg g

WAN Proposed Protocol Stack

40Device Intermediary Remote Monitoring Management System

Personal Telehealth

Health & Wellness• Weight loss

FitnessBLOOD-

PRESSURE

IMPLANTPULSE

OX

Healthy

• Fitness• Email / chat / video• Appt scheduling• Personal Health Records

DigitalHome

Cell Phone

PEDOMETER

PRESSURECUFF

yfamily

Disease Management• Vital sign monitoring (RPM)• Medication reminders and

PCHOME AUTOMATION

& CONTROL

FITNESSEQUIPMENT

• Medication reminders and compliance

• Trend analysis and alerts• Connect with family care

Eld l

Personal Health SystemMEDICATIONTRACKING

Internet

ygivers

Aging Independently• An adult child helping their

Elderly

Weight lossWeight lossand fitnessand fitness

hihiHealthcareHealthcare

P f i lP f i l

PersonalPersonalHealthHealth

RecordsRecords

• An adult child helping their elderly parents age gracefully in their own home.

• Basic life monitoring as DiseaseDisease

managementmanagementserviceservice

11/16/2009 41

coachingcoaching ProfessionalsProfessionalsg

appropriate (ADL)serviceservice

FamilyFamilycare giverscare givers