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The Engine for a Plug-and-Play WorldContinua Health AllianceAugust 20130What is Personal Connected Health?

Communications & health devices deployed or enabled by healthcare organizations to collect/share individual patient physiologic & Quality of Life (QOL) dataUnlike telehealth, allows providers & patients to employ data & communications independently, at their convenience non linearExamples of PCH: Remote home monitoring programs in chronic disease or independent aging; Employer sponsored wellnessPCH allows providers and patients to:Use technology to collect data conveniently and securelyCommunicate more frequently with little manual interventionEffectively monitor and better understand personal health data

1Drivers for Personal Connected HealthPressure on Healthcare Requires New Models of CareSource: DB Research 2010Aging population in industrial countries leads to increase of age-related diseases

Care of elder highly correlated to development of population

Demographic ChangeIncrease of Chronic DiseasesHigh Health Care ExpensesProvision of healthcareWorldwide rise of chronic diseases

Compounding impact on expenses due to growing number of chronically ill children

Chronic and long-term illnesses account for 75% of health care expenses

Decreasing # of regional hospitalsReduction in hospital bedsDeclining care by general practitionersHousing situation and lack of transportation affect access to careDeclining access to quality care for many people with disease

Accelerated increase of chronic diseasesContinuous riseof health care cost for payers and patientsInsufficient number of working population to finance the health care systemSlide 2

Lets get back to the challenges of Diabetes. A little outlook to what we are looking at today and in the in the near future. The bottom line here is that the changes in the population and with the dramatic increase of diabetes we face an ever growing mountain of health care cost. This is compounded by a declining access to quality health care in industrialized countries and inadequate health care systems in emerging markets.We need new models of and new business models for the near future to maintain the quality of care. Benefits of Personal Connected HealthPatient/ConsumerRemain/return to home QOL, time & cost savingsNew awareness of health status creates understanding & engagement Automatic nature allows for ease of use and better retentionImproved collaboration with health care provider Avoidance of unnecessary office and/or ER visits

ProviderAutomatic updates & alerts on patient status Data can be trusted coming from device rather than patientImproved triage capability & preservation of physician resources for most serious casesMaximal time for preventive action Ideal for chronic diseases management3

Example 1:Example 2:Other ExamplesCell phones and ATM networks use interoperable devices, systems and servicesthey are connected and capable of inter- communicating

Benefits:

Ease of useFreedom of choiceUser satisfactionQualityInnovationDifferentiationScalabilityCompetitiveness Cost (Development, TCO, deployment)

Value of InteroperabilityWhy interoperability?Humans have an intrinsic desire towards simplification, consolidation, organization, efficiency and reduction of redundancies.Most of us want to have neat, organized home.

I want one cell phone that works around the globe independent of my provider. Especially in telecom I want freedom of choice iPhone vs. Android vs. maybe WindowsWhy having 5 remote controls for my home entertainment system? Look at the space it needs, the clutter on my couch, my table. Not to speak of all the different batteries I need.Digital photography without download to a computer doesnt make sense. I want to share my pictures, send them to friends, family. What about x-ray pictures when did you get an email from your doctor sharing the latest x-rays of your broken arm with you?I want money where ever I go. The times are unsafe enough. I dont want to carry large amounts of cash if I want to buy a piece of furniture or when Im on vacation.Im annoyed that my $200 heart rate monitor for indoor cycling does communicate with my bike computer on my streetbike. It gives me calories burned, but it doesnt hook up with my bathroom scale

And more and more do we want to share among these systems: I want to see my pictures on my 50 flat screen TV and my cell phone and share my bank account information with my computer, getting rid of paper statements. And so on.

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Continua Health AllianceThe Engine for a Plug-and-Play World International non-profit industry organization enabling end-to-end, plug-and-play connectivity of personal health devices, systems and services in Personal Connected Health200+ members: technology, medical device,telecom, health tech service & healthcareindustry leaders5What We DoDevelop and publish Design Guidelines that combine & apply existing standardsCertify products, systems and services for compliance with Continuas Design GuidelinesPromote favorable operating climate for PCH through advocacy & coordinationCreating a global market for personal connected healthConnect leading technology developers, innovators and healthcare organizations 6How Were DifferentOnly organization convening global technology standards in Personal Connected Health (PCH)

Uniquely focused on end-to-end, plug-and-play connectivity to advance the PCH ecosystem

Wide based consortium of Healthcare, Device manufacturers, and Governmental bodies developing Guidelines for deployments

Can hand off data to EHR, PHR, HIE or to local apps run by consumers all with same infrastructure and devices7Standards Incorporated in Continua Design Guidelines

Sensors11073PAN

TransportEHRs

Continua End-to-End Architecture Includes these standards, and more8

Development Life Cycle Submission of ideasUse Case developmentUse Case Commenting Open processBallotingUse Case sponsorshipDecomposition into Work ItemsGap AnalysisGuidelines DevelopmentGuidelines Commenting Open ProcessBallotingApprovalTestingPublic Release & Comment PeriodUse CasesRequirementsStandardsGuidelinesContinua Annual Process: Developing Design GuidelinesDeveloped annually to include new technologies 9Continua Architecture Enabling PCH at the Interface

HealthRecordNetwork(HRN) InterfacePersonal DeviceWeight ScalePulse OximeterIndependent Living Activity

Cardio / Strength

MedicationAdherenceGlucose MeterPulse /Blood Pressure

Thermometer

Physical Activity

Peak Flow

Electrocardiogram

Insulin PumpAggregationManagerPersonalAreaNetwork(PAN) Interface

WideAreaNetwork(WAN) Interface

TelehealthServiceCenter

HealthRecords/NetworksEHRPHRNHINHIEWiFi, 2G, 3G & 4G

New Technologies in current release Hdata, Restful components, bi-directional data exchange and Oauth. (Working with HL7 to complete these)10Continua Certification Continua Certification signifies compliance with global industry standards, and is proven to decrease time to market and reduce development costs:Lower Design Costs: saves US$ 40,000-$80,000 in development costs per device*Faster to Market: decreases integration time from three months to just three weeksIncreased Efficiency: quicker, less expensive integration to EMR or HIE platforms*Source: PricewaterhouseCoopers

11Continua Certification, contd.Certified devices guaranteed for forward/backward compatibility with all Continua-ready productsSame-use devices are interchangeableEasy to expand or add new programs/products with plug-and-play

Health Records Network interface is standardized Consolidated CDA document. Interoperability shown at HIMSS,IHE ConnectaThons and directly with NIST.

12International Activity Hubs: Continua Adoption & Work Groups

UK (NHSWorcestershire)Japan WGDenmarkSingaporeSE Asia WGAustralia WGIndia WGBrazil WGAbu Dhabi= Adopting Continua= Continua Work GroupUS Veterans Administration

US WGJapanEU WGA volunteer army, driven by members. Frequent F2F meetings to help drive us forward.13Where Were Going: Globally Scalable Products & ServicesNational adoptions by Denmark, SingaporeRegional adoptions by Abu Dhabi, NHSCommercial deployment in Japan Becoming a global standardAccepted as a Work Item by the International Telecommunications Union (ITU), the oldest international telecommunications standards organizationComprised of 193 national governments and 700 private companies and organizationsScheduled for completion in early 2014 Driving government adoptionEx: Continua Connects showcase events14Continua Design Guidelines on Track to Become Global Health Standard in the ITU

The International Telecommunications Union (ITU) is the oldest United Nations organizationITU-T is dedicated to produce timely, stable, worldwide standardsThe ITU-T is comprised of 200 national governments and 700 private companies and organizationsContinua Design Guidelines accepted as ITU-T SG16 Work Item Approval: start in Nov 2013 & complete in early 2014

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VALUE OF CONTINUA GUIDELINESSource: PricewaterhouseCoopers*Figures based on actual experience, **Estimates

Time12 weeks**incl. 30 days for connectivityMan-weeks(1 FTE per company)72**Non-Continua2 weeks*incl. 3 days for connectivity12*ContinuaBring down deployment time down to 1/660 man-weeks or $139k savedInteroperability assured quality because each company could focus on their module in D-CAP

$166k**$27k**DISASTER CARDIOVASCULAR PREVENTION NETWORK (D-CAP)Target: 1,500 survivors of Great East Japan earthquake living in evacuee camps, two conditions that put them at risk for cardiac events Tech Objectives: Determine comparative time/cost of implementing Continua-certified devicesMethod: RPM for pts identified as high risk (400 pt), using devices previously certified by Continua Tech Providers: A&D (Automatic blood pressure monitors), Alive Inc. (Gateway firmware), Ryoto Electro Corp. (data server), Panasonic (PC), Toppan Forms (Patient ID Cards), Intel (Project coordination)Evidence of Cost & Time-to-Market Advantages Using Continua DGs: Japan Disaster Cardiovascular Prevention Network (DCAPS)16Continua Health AllianceThe Engine for a Plug and Play WorldChuck Parker, Executive DirectorEmail: chuck.parker@continuaalliance.org

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Additional information and Power MatrixContinua Health Alliance18Open Source Opportunities: Assisting to Develop the PCH industryThe Alliance is working with OpenHealthTools.org to publish Open Source code covering all Continua end-to-end interfacesThe Open Health Personal Connected Health Project will become a hub for the software and tools used to build the ecosystem, and stimulate innovation among entrepreneurs and studentsThe following components are now available from Continua on OpenHealthTools.org:WAN IEEE-20601 Encoder implementation, written in JavaWAN Sender & Receiver implementation, written in JavaBinary Object package of the core WAN implementation suitable for Mobile implementations, written in JavaWAN Encoder and Sender Android Example , written in Java

19Industry Trade Groups Promotional & Policy SupportRegional Adoption

Global Certification

Global Adoption

Unique Role: Coordination With Key Industry Partners & Liaisons 20Metrics for MaturityBreadth of Support: HIGH- 200+ organizations participating from industry and healthcare; Use Cases sponsored by members; IEEE training; SDO relationships; regional WGsStability: HIGH- Initial Guidelines developed 7 years ago; built on existing standards; new functionality, updates each annual release; Lifecycle defined and stable with corrections built in multiple times/yearContinuity: HIGH- Design Guidelines based on existing standards but extend their value and practical application by defining architecture for a solution that does not otherwise exist; this rationale is outlines in the Guidelines and Lifecycle documents; 7 yrs. In existence; Guidelines incorporate 13 standards setsDegree Interop. Among Non-Coord. Implementations: HIGH- Ability to accomplish non-coordinated implementation is integral to Continuas Guidelines as they are designed for blind plug-and-play capability and forward/backward compatibility. Multiple, non-coordinated implementations have taken place.Adoption of Spec: LOW-MOD- Low in US but mandated in 5 countries (Denmark, Singapore, Japan, UK, UAE) at regional or natl levels; adoption anticipated to increase generally and govt implementations will drive Continua compliat design; major mobile operators have joined & interest up in this segment; expect market segments will be more fully representedSDO Context: HIGH- Guidelines built on established, existing standards (i.e., ISO, IHE, HL7, etc.) in close cooperation with publishing SDOs. On track for ratification by ITU by late 2013 or early 2014.21Metrics of Maturity for Underlying TechBreadth of Support: HIGH- Active board members & WGs in multiple regions of the world; strong relationsihps with SDOs and standards coordinating bodies; broad base of support in industry, government, academia; training for 11073/PHD standards underlying Design Guidelines; new Open Source initiative anticipated to attract developersStability: HIGH- All Guidelines in place & have been in production for 7+ yrs; annual updates incorporate minor changes to core standards in accordance with underlying standards sets; new functionality added to respond to industry changes, norms; no historical crises; oldest implmentation 3+ years agoDegree Interop. Among Indpt Non-Coord. Implementations: HIGH- Guidelines designed for blind plug-and-play as part of its fundamental mission -- thus, non-coordinated implementations are integral to the purpose and value of the Guidelines; 5+ non-coordinated implementations and interoperability is established for the entire standard between at least 2 implementationsAdoption of Spec: LOW-MOD- Low in US but mandated in 5 countries on regional or natl basis; pilots and programs implemented in compliance with Continua's Guidelines, i.e., remote monitoring of earthquake survivors following the Great Japan earthquake of 2011; health prevention programs in several cities in Japan; a "live" endurance exercise study among cyclists with/without type 1 diabetes. Adoption happening among the intended stakeholders; Platform Support: HIGH- Guidelines developed to provide user-friendly, end-to-end connectivity between devices, services, and systems across multiple platforms and settings; more than 90 diverse devices and services already certified for compliance with Continua's Guidelines; the Guidelines supply multiple platforms with end-to-end, plug-and-play functionality, with minimal additional effort;Maturity of Tech. within Lifecycle- TRL9 - The technology has existed for many years; most devices defined under Continua's Guidelines have been defined for interoperability for 3 years; technologies are in their final form and many have been proven through successful mission operations22Attributes of Market AdoptionInstalled HC User Base: LOW- Installed healthcare user base is low, but anticipated to rise due to planned government (health ministry) rollouts in Denmark, Singapore and Abu Dhabi.Installed User Base Outside HC: LOWFuture Projections & Anticipated Support- 5 countries require standards at a natl or regional level; Continua is in discussions with other governments as well; there is interest in Continua's work within US agencies - i.e., the U.S. Department of Defense (TATRC) and the VA; mobile operators are showing increased interest (i.e., China Mobile, Verizon, Orange)...this is anticipated to positively impact the installed user base and drive new interest. Other govewrnmental bodies that are a part of Continua are Canada HealthInfoway; TicSalut in Spain, NHS in UK, Ministry of Health Holdings (MOHH) Singapore; MedCom Denmark; and several US Healthcare entities.

Investments in User Training: LOW- While we must rate this "low", the category is in some ways not applicable. Continua certified devices are typically designed for consumers and are easy to use - training is not necessary for such devices.Complexity of Specification: HIGH- Guidelines designed for easy implementation and reference code is available. Can be devolved into smaller parts and is already intentionally broken into four subsections, devices, hubs, WAN, and Health Records interface. Can certify in one area only or all.Quality & Clarity of Specifications: HIGH- Clear and defined specifications. Highly specific (components clearly defined and underlying standards applied and limited in a highly specific manner). Semantics are precisely defined, terminology is unambiguous within the Guidelines23Attributes of Market Adoption - contd.

Specification of Modularity: HIGH- Guidelines and reference architecture broken into 5 logical parts of an end-to-end system, including interfaces for PAN, LAN, WAN-Sender, WAN Receiver, and HRN (health records network), which clearly align well to business issues that can be solved via connectivity, i.e., interoperability from consumer to physician and health recordSeparation of Concerns: HIGH- Continua's Design Guidelines address the need for end-to-end, plug-and-play connectivity in personal connected health. While its Design Guidelines incorporate 13 different standards sets, no underlying standard accomplishes an end-to-end solution in personal connected healthEase of Use of Specification: MOD- There is some complexity due to mixing of standards, but the Design Guidelines are broken into logical portions. Navigation links are indexed and available for subsections. Further refinement of the Guidelines will be available in 4Q 2013 in partnership with ITU and disseminated into 6 languagesDegree to which Spec Uses Familiar Terms to Describe Real-World Concepts: HIGH- Guidelines are designed for easy implementation, with terminology and general language that can be easily understood; requirements and objectives are well explainedRuntime Coupling: HIGH- Reference code is available to create virtual connections and overall Guidelines are designed for open interoperabilityDegree of Optionality: LOW- Interoperability requires limited optionality - Guidelines are well defined and limited; optionality exists to fulfill and support the required implementation use cases24

Metrics for Ease of Operation

Comparison of Targeted vs. Actual Scale of Deployment: LOW- Continua's Guidelines are designed for large-scale implementations (millions); while implementations have not reached that scale, there are cities in Japan deploying Continua compliant mobile phones for resident mhealth programs Number of Operational Issues Identified in Deployment: MOD- Process for incorporating improvements and bug fixes cycles several times each yearDegree of Peer-Coordination of Tech Experts Needed: HIGH- Process work has already taken place with experts. Ease of use is well defined and the standards reduce optionality. Tough decisions have already been made by the industry to create single interoperability standards. Only limited or sporadic technical support is needed.Operational Scalability (impact of addiing a single node): HIGH- The overall system is designed for blind plug-and-play meaning you can connect any device without knowing specifics and customizations; therefore, the addition of nodes has little ot no additional ipacts to operatioal effort or complexityFit to Purpose: HIGH- Continua's Guidelines define an end-to-end solution in personal connected health, therefore applicability of the Guidelines to any PCH use case is somewhat inherent; however, Continua works with SDOs to ensure that underlying standards are appropriately limited and fully applicable to each use case when necessary25Attributes of Intellectual PropertyOpenness: HIGH- All underlying standards are open; also, Guidelines are available to public free of charge following a testing period; additionally, an Open Source initiative is underway to make all components available, via Openhealthtools, to emerging innovators, students, universities, etc.Accessibility and Fees: HIGH- We make Guidelines available for free - see above - there are no fees for accessing the Guidelines or referenced specifications and no coasts to use standards and standard documentationLicensing Policy: HIGH- Fees are only required to certify devices according to Continua's Guidelines; the Guidelines and referenced specifications are available free of chargeCopyrights: HIGH- Rights are held by Continua . All members must abide by Bylaws and RAND licensing requirements of BylawsPatents: MED-HIGH- Bylaws specifically designed to eliminate patent issues. Any identified patents required to operate on RAND model. Contributors to standards agree to reasonable, non-discriminatory (Rand) terms for their contributed materials. Some code already released as Open Source for samples & modeling. Members have available the entire Source Code library that enables rapid prototyping without further royalties. Further components of code will be released as Open Source in the future.26