document3

Continua Health Alliance:Advancing Information Technology in

the Personal Health Solutions Ecosystem

By Chuck Parker, Executive Director, Continua Health Alliance

Conflict of Interest DisclosureChuck Parker, Executive Director,

Continua Health Alliance

Has no real or apparent conflicts of interest to report.

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Technology Out Paces Biology

Private and Confidential, Oregon Medical Laboratories

Our evolutionary ability to store fat cannot support our current sedentary high-calorie activities

2/24/2010 4

Remote Patient Monitoring

Objectives:• What is Continua?• Market influence and implementation• Use case driven• Interoperability

– Approach– Constraining– Protocol

• Market and political drive

2/24/2010 5

The Continua Health Alliance Mission

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Connected Healthcare Monitoring Market

• The challenge:– In England 15.4 million people, including 60 percent of those over age 60, suffer from

a long-term condition. LTCs account for 72 percent of all inpatient bed days, 65 percent of all outpatient appointments and 52 percent of all GP appointments. LTCs consume 69 percent of England’s primary and acute care budget (NHS England)

– 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)

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

2/24/2010 7

Need for Transformation

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

• Number of connected health 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 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; – 40-64% reduction in physician time for checks and – 63% reduction in transport costs

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

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Realize Peak Health Potential

Time Peak Health Potential Line

Min

Hea

lth

Max

Non-modifiable & Unpredictable Health

Modifiable & Predictable Health

Actual Health Experience

Poor nutrition, inactivity, Stress…

Unpredictable Event/Accident

DeathDeath

• 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

– Adverse health events such as stress, poor nutrition, inactivity… are causing the population to fall away from their peak health potential

Max

Cost

s

Min

Health Expectations

Adapted from Oregon Medical Labs

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• Many diseases can be broken down into non-modifiable and modifiable contributors

• Non-modifiable contributors– Age, gender and genes

• Modifiable contributors– Lifestyle choices

• Today, poor lifestyle choices increasingly are the largest contributors to common adverse health outcomes

Address 60-80% modifiable Adverse Health

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

Actual Goal

Non-modifiable Contributors to Disease

Modifiable Contributors to Disease

91% Diabetes 83% Heart Disease

69% Cancer

2/24/2010 10

Remote Patient Monitoring: enablers & drivers

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2/24/2010 12

Remote Patient Monitoring: Standards

• Continua founded to organize and push market in one direction

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

• Process then deconstructs requirements and selects best 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

2/24/2010 13

Guidelines → Certification → Recognizable Logo

Industry competitors could discuss without Anti-trust

Unified Political drive to encourage adoption

Single voice for industry

Access to market research dataAccess to pre-publication drafts of

the design guidelinesInternal and external education

and training

Test and certification toolsRight to use certified logo upon

completion of successful certification

Web-based environment (repository, collaboration tools)

Reference source codePlugFests

Ecosystem Development

Wednesday, February 24, 2010

Developer Resources

Market Intelligence Safe Environment

Certification

2/24/2010 15





2/24/2010 16

Continua Domains

• Continua segmented the market in three large Domains:

Health & Wellness• Weight loss• Fitness• Email / chat / video• Appt scheduling• Personal Health Records

Disease Management• Vital sign monitoring

(RPM)• Medication reminders and

compliance• Trend analysis and alerts• Connect with family care

givers

Aging Independently• An adult child helping their elderly parents

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

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Domain 1: 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– e.g.: Northern Ireland, West Lothian (UK); AOK Cardio Integral (DE)– mostly led by public healthcare administrations; statutory health insurers

2/24/2010 18


• 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– 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 programs

2/24/2010 19


• 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

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PC

PersonalHealth System

Cell Phone

Set Top Box

Aggregator

V 1 Interoperability Standards - Protocol

WeightScale

PulseOximeter

Independent Living Activity

Cardiovascular and Strength

Fitness Monitor

MedicationMonitor

GlucoseMeter

Pulse /Blood Pressure

USB Personal Healthcare Device Class Specification

Bluetooth Medical Device Profile Specification

• 11073-10404 = Pulse Oximeter• 11073-10406 = Pulse / Heart Rate• 11073-10407 = Blood Pressure• 11073-10408 = Thermometer• 11073-10415 = Weighing Scale• 11073-10417 = Glucose • 11073-10441 = Cardiovascular Fitness Monitor• 11073-10442 = Strength Fitness Equipment• 11073-10471 = Independent Living Activity• 11073-10472 = Medication Monitor

V 1 Data Standards - Syntactical

Home-based Remote Patient Monitoring

(RPM) System

Vital Sign Devices

Patient

Electronic Health Record

System

EHR / PHR

Labs

Healthcare Provider

Disease Management

Service

XDR Transport Specification

CDA/CCD-based Personal Health Monitor (PHM)

Specification

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Use Case Development

M1: Decompose UC into requirements

ExitSuccessful review (E2E Arch, TWG, UCWG)

M2: Select Standards

ExitSuccessful TWG Ballot, BOD approval

M3: Identify gaps between standards and requirements

ExitTWG, UCWG presentation

M4: Develop Guidelines

ExitTWG review and ballot

M5: Create Test Procedures and complete review

ExitSuccessful TCWG review

M6: Update Test Tool

ExitPass Tool Test

V1.5 (Spring 2010)

• Advanced Medication Monitor

• Peak Flow Monitoring Device

• Upload Health Information on the WAN

• Sneaker-Net xHR Interface

• Insulin Pump Monitor Device

• Errata from V 1

• Low Power Radio

V2 (Winter 2010)

• Clinical Coding for HRN

• ECG and Respiration Monitoring

Device

• Physical Activity Monitoring Device

• Ultra-Low-Power Body Area

Network

• Low-Power LAN

• Clinical Coding for xHR

• Device and Patient Authenticity

• Controlled Information Sharing

• Disease Management Multiple Users

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Service (WA

N) Interface

Netw

ork (LAN)

InterfaceD

evice (PAN)

Interface

Electric Health R

ecord (XH

R) Interface

Application Hosting Device

LAN Device

V2 Use Cases Underway

PAN DeviceWAN Device

HealthRecordDevice

Physical Activity Monitor

Medication Monitor

Electrocardiogram (ECG)

Insulin Pump

Final link in end-end connectivity

Portable XHR Media Extension

Low Power Radio

V1 Extensions (e.g., Multiple device users, enhanced device authentication)

2/24/2010 24





2/24/2010 25

Working Group Structure - Internal

BoardOf

Directors

Use CaseWG

TechnicalWG

Test & Certification

WG

WellnessSolutions

WG

VTMAdmin

Expert Group

NHS, AAFP,ATA, AHA…

Sub-Committees

PR & Marketing

agency

Marketing WG

Regulatory WG

PolicyStrategy

WG

AustraliaPolicyWG

EUPolicy

WG

JapanPolicyWG

LatinAmericaPolicyWG

U.S.PolicyWG

ExecutiveDirector

More than 2,000 membersParticipating in the various

Working Groups

Testing and

CertificationLab

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V1 Interoperability - Semantic

• Use of HL7 and SNOMED CT for semantic understanding

• V 2 will have further implementation and conditional understanding

2/24/2010 27

Interoperability in Three-tier Approach

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

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

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

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Continua Reference Device Classes

WANDevice

LANDevice

PANDevice

ApplicationHosting Device

Health RecordDevice

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

LAN Device in the Continua Ecosystem

PAN “Adapter” Device:to represent a device as a

PAN Device in theContinua ecosystem

V1 Certification Process

SDO TransportCertificate

TestSuites

ContinuaCompliance

Testing

Test Plans

ContinuaCertification

& Logo

Logo

Test Report

Members

TCWG Test Lab

Test Admin

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Working Group Structure - External

BoardOf

Directors

Use CaseWG

TechnicalWG

Test & Certification

WG

WellnessSolutions

WG

VTMAdmin

ExpertGroup

NHS, AAFP,ATA, AHA…

Sub-Committees

PR & Marketing

agency

Marketing WG

Regulatory WG

PolicyStrategy

WG

AustraliaPolicyWG

EUPolicy

WG

JapanPolicyWG

LatinAmericaPolicyWG

U.S.PolicyWG

ExecutiveDirector

More than 2,000 membersParticipating in the various

Working Groups

Testing and

CertificationLab

2/24/2010 32

RPM market in the future

• Personal Connected Health • The individual / home as the hub• Convergence consumer / healthcare• Mobile health / Personal Health Records

fitness - sometimes with public incentives• Rewards for keeping people healthy• Greater integration among wellness, health

and social care• Best-of-breed plug and play • Increased connectivity, evolutionary,

scalable, service driven offerings

Health App Growth iTunes

Parks Associates- All Rights Reserved

End-to-end demo – Vancouver Q2 2009

Device InterfaceDevice Manager

XHR InterfaceSender Receiver

EHR

PHR

Pulse Oximeter

Glucose Meter

Disease management

platform

Roche Accu-Chek 360

LNI Android-based G1 Cell phone 20601 manager

WAN

Wi-fi or 3G

IP network

Web services

xHR

Based upon proposed

protocols for Continua WAN

2/24/2010 35

RPM market now: Current Participants

• Continua membership shows across the board interest both from supply and demand sides:– Medical devices– Governmental Agencies– Fitness– Pharma– Health care providers– Health insurers– Telecommunications– IT– Integrators– Applications (PHR, EHR, desktop)

Promoter Members

Open Open InternationalInternational

More Than More Than 228 Member 228 Member Companies!Companies!

Contributor Members

7 Layers AG24eight, LLCAdvanced Digital InstituteAir ProductsAlcatel LucentAlereAllion Test Labs, Inc.All Medicus Co., Ltd.American Heart AssociationAnalog DevicesAnalogic CorporationAndago Ingenieria s.l.AppsHub, Inc.ASE Consulting LimitedAstraZenecaAT4 WirelessAT&T MobilityAttrezzature Medico Sanitarie SRLAuthentidate Holding Corp.AViTAAwarepointBiancaMedBiocomfort Diagnostics GmbH BIOSPACE Co., Ltd.Bluegiga Technologies OyBoston ScientificBroadcom CorporationBrunel UniversityBXI Health Systems, LLCCambridge Consultants Ltd.Canada Health InfowayCardiff UniversityCEA - LETI

Centre for Global eHealth InnovationCerner CorporationChiptech LimitedChristus HealthChunghwa Telecom Co., Ltd.ConnectBlue ABContinuity HealthConvergence Wireless, Inc.CSR plcCYPAK ABDellDELTADenso CorporationDossia ConsortiumDuodecim Medical PublicationsDynastream Innovations Inc.eflow Inc.Elbrys NetworksEmber CorporationEmpirica GmbHEricsson Nikola Tesla d.d.ETRIEuroTech, Inc.Fairbanks ScalesFitLinxxFlextronics Design SRLFrance Telecom R&D, LLCFreescale Semiconductorfrog design, inc.Frontline Test EquipmentFujitsu Limited

GenerationOne, Inc.GlaxoSmithKlineGoogle Inc.Hill-RomHitachi, Ltd.Holst Centre (IMEC)Home For Life SolutionsHoMedicsHoneywell HomMed LLCHosiden CorporationHospira, Inc.HTCI2BC – Insitute of Innovation for Human WellbeingiFoundry Systems Singapore Pte LtdiMetrikusIndustrial Technology Research InstituteInfineon TechnologiesINFORSON Co., Ltd.Innomed Medical Zrt.Innovation Centre ScotlandInstitute for Infocomm ResearchInstitute of BiomedicalInsung Information Co., Ltd.InterComponentWare, Inc.Intramed A/SKai Sensors, Inc.KDDIKorea Electronics Technology InstituteLaird TechnologiesLamprey Networks, Inc.LAXTHA Inc.

Contributor Members Continued

• Product Development Technologies (PDT)

• Proskauer Rose LLP• Proximiti Communications, Inc.• Red Embedded Design• Renesas Technology America• ResMed Corp.• RF Technologies• RMD Networks• RTEmd• Ryoyo Electro Corporation• Sagemcom• Sensor Technology & Devices Ltd• Shimmer Research• SHL Telemedicine• Shorewood Packaging• Sigma Designs• Silicon and Software Systems• Silicon Laboratories, Inc.• SK Telecom Americas• Smartlife Technology Ltd• Sony Electronics Inc.• SterlingTech, Inc.• Stollmann E+V GmbH• STMicroelectronics N.V.• Sumitomo Electric Networks, Inc.• Sybase iAnywhere• T-Mobile USA• TaiDoc Technology Corporation• Taiyo Yuden Co., Ltd.• Tanita Corporation• TechnoGym

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LG Electronics Inc.Lifescan LifeWatch AGLogicMarvell International Ltd.McLaren Applied TechnologiesMedApps, Inc.Medgate AGMedHelp InternationalMedixine OyMicrolife CorporationMindTree LimitedMotorolaMIR- Medical International ResearchMTI Ltd.MTS Medication TechnologiesMurata Manufacturing Co., Ltd.NEC Access Technica, LtdNestleNeusoft Medical SystemsNippon Telegraph and Telephone CorporationNordic Semiconductor ASANorth End TechnologiesNovo NordiskNuubo (Smart Solutions Tech)ON SemiconductorOregon Medical LabsOregon Scientific Inc.Orthosensor, Inc.PA Consulting GroupPfizerPolymap WirelessPrecor Fitness

Tekoa Technologies Inc.Telbios, SpATelecom Italia SpATelefonica S.A.Telehealth Solutions Ltd.TELUS Health SolutionsTextronics Inc.Toshiba Home Appliances CorporationToumaz Technology LimitedTSBTTATyco ElectronicsTynetec LtdUnitedHealth GroupUniversity of Applied Sciences Technikum WienUniversity of Miami - Miller School of MedicineValentia TechnologiesVerizonVigNet Inc.Vitaphone GmbHVivoMetrics, Inc.Vocollect Healthcare Systems, Inc.Vodafone Group Services Ltd.VTT Technical Research Centre of FinlandWaldo NetworksWelch AllynWind RiverWipro TechnologiesYellow Digital Health LabZarlink SemiconductorZeroG Wireless, Inc.Ziehm Medical LLCZyXEL Communications, Inc.

Industry Liaisons

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40

Thank You

Thank you!

Chuck ParkerExecutive Director

[email protected]

www.continuaalliance.org

2/24/2010 41


• Additional Content

2/24/2010 42

WeightScale

PersonCentered

Device /Systems / Sensors

Biometrics Testing

HRA/Health Administrative

Assistant

Classes

Information Systems

Fitness Equipment

Wellness Management/Support

Systems

Blood-Presser Cuff

Glucose Meter

Spirometer

Pulse Oximeter

Medication Tracking

Pedometer

Cholesterol HDL/LDL

Weight

Blood-Pressure

Blood Sugar

Resting Heart Rate

Lung Air Volume

Triglycerides

Body Fat %

Body Fat Analyzer

Bio-metric/BehavioralResponses

Multiple providers / service oriented

Wellness Center

PHR/PHA

Fitness, nutrition, stress management…

RPM Market: the Market Segments

ActivityHub

Familycare

givers

Elderlymonitoring

services

Diseasemanagement

service

Healthcare provider

Gait analysis

2/24/2010 43


• Additional Technical Content

WA

N-InterfaceLA

N-Interface

PAN

-Interface

xHRN

-Interface

Application Hosting Device

LAN Device

Continua E2E Reference Topology

PAN Device WAN DeviceHealthRecordDevice

Embedded Apps Could subsume PAN interface and expose WAN interface

PAN Interface IEEE PHD State Machine

• Agent states shown, Manager is similar

• Configuration state transmits all static data one time for efficiency

• Operating state is where measurements are transmitted

Disconnected

Connected

Transport connect indication Transport disconnect indication

Unassociated

Associating

+ entry / TxAssocReq

assocReq

RxAssocAbortOr

TxAssocAbort

TxAssocRsp(rejected)

Associated

RxAssocAbort

TxAssocAbort

RxAssocRelReq/TxAssocRelRsp

RxAssocRsp(accepted-unknown-config)

RxAssocRsp(accepted)

Operating

Configuring

Sending Config

TxConfigEventReportReq

RxConfigEventReportRsp(accepted-config)

Waiting Approval

Disassociating

+entry / TxAssocRelReqassocRelReq

RxAssocAbortTxAssocAbort

RxAssocRelRsp

RxConfigEventReportRsp(unsupported-config)

RxAssocRelReq/TxAssocRelRsp

WAN Interface Goals

• Minimal Payload Translation– Keep the device readings consistent with

PAN (e.g., same nomenclature)• Minimal Payload Transformation

– Manager should not be forced to deal with the complexity of transformations from one payload model to another

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

Disease Management• Extensibility• Minimize divergence of standards

WAN Recommendations

• HL7 v2.6 messages using IHE PCD-01– Initially constrained to IEEE 11073-20601 and 104xx

nomenclature for personal health devices– Can be extended to support IEEE 11073–10101

terminologies and core components of the-10201 information model for clinical devices

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

Web Service Profiles– TLS for Security

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

WAN Proposed Protocol Stack

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Device Intermediary Remote Monitoring Management System

2/24/2010 49

Personal Connected Health

Healthyfamily

Health & Wellness• Weight loss• Fitness• Email / chat / video• Appt scheduling• Personal Health Records

Internet

Weight lossWeight lossand fitnessand fitnesscoachingcoaching

HealthcareHealthcareProfessionalsProfessionals

PersonalPersonalHealthHealth

RecordsRecords

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

compliance• Trend analysis and alerts• Connect with family care

givers

Aging Independently• An adult child helping their

elderly parents age gracefully in their own home.

• Basic life monitoring as appropriate (ADL)

Elderly

DiseaseDiseasemanagementmanagement

serviceservice

FamilyFamilycare giverscare givers

DigitalHome

Cell Phone

PC

Personal Health System

PEDOMETER

BLOOD-PRESSURE

CUFF

MEDICATIONTRACKING

HOME AUTOMATION & CONTROL

FITNESSEQUIPMENT

IMPLANTPULSE

OX

Example Application


Example Application


Mobility Topics

• Interoperability standards (Continua)• Clinician acceptance (workflow, data

overload)• Policy (reimbursement, regulatory)• Liability (indemnity)• Privacy (identifiers)• Security (encryption)• Consistency of cell coverage• Cost• Business models

A Perspective on the Ecosystem


document3

Education

adult child

working group

medical care

continua health

australia

market influence

eu japanu

aging independently