The Engine for a Plug-and-Play World

Continua Health Alliance

August 2013

What is Personal Connected Health?

• Communications & health devices deployed or enabled by healthcare organizations to collect/share individual patient physiologic & Quality of Life (QOL) data

• Unlike telehealth, allows providers & patients to employ data & communications independently, at their convenience – non linear

• Examples of PCH: Remote home monitoring programs in chronic disease or independent aging; Employer sponsored wellness

• PCH allows providers and patients to:– Use technology to collect data conveniently and securely

– Communicate more frequently with little manual intervention

– Effectively monitor and better understand personal health data

Drivers for Personal Connected HealthPressure on Healthcare Requires New Models of Care

Source: DB Research 2010

Aging population in industrial countries leads to increase of age-related diseases

Care of elder highly correlated to development of population

Demographic Change

Increase of Chronic Diseases

High Health Care Expenses

Provision of healthcare

Worldwide 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 hospitals

Reduction in hospital beds

Declining care by general practitioners

Housing situation and lack of transportation affect access to care

Declining access to quality care for many people with disease

Accelerated increase of

chronic diseases

Continuous riseof health care cost for payers and patients

Insufficient number of working population to finance the health care system

Benefits of Personal Connected Health

• Patient/Consumer– Remain/return to home – QOL, time & cost savings– New awareness of health status creates understanding & engagement – Automatic nature allows for ease of use and better retention– Improved collaboration with health care provider – Avoidance of unnecessary office and/or ER visits

• Provider– Automatic updates & alerts on patient status – Data can be trusted coming from device rather than patient– Improved triage capability & preservation of physician resources for

most serious cases– Maximal time for preventive action – Ideal for chronic diseases management

Example 1:

Example 2:

Other ExamplesCell phones and ATM networks use “interoperable” devices, systems and services–they are connected and capable of inter- communicating

Benefits:

• Ease of use• Freedom of choice• User satisfaction• Quality• Innovation• Differentiation• Scalability• Competitiveness • Cost (Development,

TCO, deployment)

Value of Interoperability

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 Health

200+ members: technology, medical device,telecom, health tech service & healthcareindustry leaders

What We Do

• Develop and publish Design Guidelines that combine & apply existing standards

• Certify products, systems and services for compliance with Continua’s Design Guidelines

• Promote favorable operating climate for PCH through advocacy & coordination

• Creating a global market for personal connected health

• Connect leading technology developers, innovators and healthcare organizations

How We’re Different

• Only 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 devices

Standards Incorporated in Continua Design Guidelines

Sensors

11073

PAN Transport EHRs

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

Development Life Cycle 1. Submission of ideas

2. Use Case development

3. Use Case Commenting – Open process

4. Balloting

5. Use Case sponsorship

6. Decomposition into Work Items

7. Gap Analysis

8. Guidelines Development

9. Guidelines Commenting – Open Process

10. Balloting

11. Approval

12. Testing

13. Public Release & Comment Period

Use Cases

Requirements

Standards

Guidelines

Continua Annual Process: Developing Design Guidelines

Developed annually to include new technologies

Continua Architecture Enabling PCH at the Interface

HealthRecordNetwork(HRN)

Interface

Personal Device

Weight Scale

Pulse Oximeter

Independent Living

Activity

Cardio / Strength

Medication

Adherence

Glucose Meter

Pulse /Blood

Pressure

Thermometer

Physical Activity

Peak Flow

Electrocardiogram

Insulin Pump

AggregationManager

PersonalArea

Network(PAN)

Interface

WideArea

Network(WAN)

Interface

TelehealthServiceCenter

HealthRecords/Networks

EHR

PHR

NHIN

HIE

WiFi, 2G, 3G & 4G

New Technologies in current release – Hdata, Restful components, bi-directional data exchange and Oauth. (Working with HL7 to complete these)

Continua 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 weeks

–Increased Efficiency: quicker, less expensive integration to EMR or HIE platforms

*Source: PricewaterhouseCoopers

Continua Certification, cont’d.

• Certified devices guaranteed for forward/backward compatibility with all Continua-ready products

• Same-use devices are interchangeable

• Easy 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.

International Activity Hubs: Continua Adoption & Work Groups

UK (NHSWorcestershire)

Japan WG

Denmark

Singapore

SE Asia WG

Australia WG

India WG

Brazil WG

Abu Dhabi

= Adopting Continua

= Continua Work Group

US Veterans Administration

US WG

Japan

EU WG

Where We’re Going: Globally Scalable Products & Services

• National adoptions by Denmark, Singapore• Regional adoptions by Abu Dhabi, NHS• Commercial deployment in Japan • Becoming a global standard

– Accepted as a Work Item by the International Telecommunications Union (ITU), the oldest international telecommunications standards organization

– Comprised of 193 national governments and 700 private companies and organizations

– Scheduled for completion in early 2014 • Driving government adoption

– Ex: Continua Connects showcase events

Continua Design Guidelines on Track to Become Global Health Standard in the ITU

• The International Telecommunications Union (ITU) is the oldest United Nations organization

– ITU-T is dedicated to produce timely, stable, worldwide standards

• The ITU-T is comprised of 200 national governments and 700 private companies and organizations

• Continua Design Guidelines accepted as ITU-T SG16 Work Item – Approval: start in Nov 2013 & complete in early 2014

VALUE OF CONTINUA GUIDELINES

Source: PricewaterhouseCoopers*Figures based on actual experience, **Estimates

Time 12 weeks**incl. 30 days for connectivity

Man-weeks(1 FTE per company)

72**

Non-Continua

2 weeks*incl. 3 days for connectivity

12*

Continua

Bring down deployment time

down to 1/6

60 man-weeks or $139k saved

Interoperability 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 devices• Method: 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)

Continua Health AllianceThe Engine for a Plug and Play World

Chuck Parker, Executive DirectorEmail: chuck.parker@continuaalliance.org

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Additional information and Power Matrix

Continua Health Alliance

Open Source Opportunities: Assisting to Develop the PCH industry

• The Alliance is working with OpenHealthTools.org to publish Open Source code covering all Continua end-to-end interfaces

• The 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 students

• The following components are now available from Continua on OpenHealthTools.org:– WAN IEEE-20601 Encoder implementation, written in Java– WAN Sender & Receiver implementation, written in Java– Binary Object package of the core WAN implementation suitable for Mobile

implementations, written in Java– WAN Encoder and Sender Android Example , written in Java

Industry Trade Groups Promotional & Policy Support

Regional Adoption

Global Certification Global Adoption

Unique Role: Coordination With Key Industry Partners & Liaisons

Metrics for Maturity

Breadth of Support: HIGH - 200+ organizations participating from industry and healthcare; Use Cases sponsored by members; IEEE training; SDO relationships; regional WGs

Stability: 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/year

Continuity: 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 sets

Degree Interop. Among Non-Coord. Implementations: HIGH

- Ability to accomplish non-coordinated implementation is integral to Continua’s 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 nat’l levels; adoption anticipated to increase generally and gov’t implementations will drive Continua compliat design; major mobile operators have joined & interest up in this segment; expect market segments will be more fully represented

SDO 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.

Metrics of Maturity for Underlying Tech

Breadth 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 developers

Stability: 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 ago

Degree Interop. Among Indp’t 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 implementations

Adoption of Spec: LOW-MOD - Low in US but mandated in 5 countries on regional or nat’l 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 operations

Attributes of Market Adoption

Installed 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: LOW

Future Projections & Anticipated Support

- 5 countries require standards at a nat’l 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 Guidelines

Attributes of Market Adoption - cont’d.

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 record

Separation 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 health

Ease 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 languages

Degree 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 explained

Runtime Coupling: HIGH - Reference code is available to create virtual connections and overall Guidelines are designed for open interoperability

Degree of Optionality: LOW - Interoperability requires limited optionality - Guidelines are well defined and limited; optionality exists to fulfill and support the required implementation use cases

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 year

Degree 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 complexity

Fit 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 necessary

Attributes of Intellectual Property

Openness: 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 documentation

Licensing Policy: HIGH - Fees are only required to certify devices according to Continua's Guidelines; the Guidelines and referenced specifications are available free of charge

Copyrights: HIGH - Rights are held by Continua . All members must abide by Bylaws and RAND licensing requirements of Bylaws

Patents: 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.