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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
11/16/2009 12
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
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