Empowering individuals to better manage their health. PCHA - Confidential Continua ‘Now” Webinar Oct 30, 2014 Kelvin Lim – Roche Diagnostics, Continua TCWG Chair Michael Kirwan – PCHA/Continua Technical Operations Director Raul Gonzalez – AT4 wireless, Continua Certification Expert (CCE) Brian Hedegaard – Delta, Sr. Consultant

Empowering individuals to better manage their health. PCHA - Confidential Agenda Overview: PCHA & Continua Continua Standards: Benefits Status of Continua’s International Developments Case-Study: Denmark Continua Membership Benefits and Incentives Questions & Answers / References

Empowering individuals to better manage their health. PCHA - Confidential Personal Connected Health Alliance (PCHA) PCHA is a first-of-its-kind collaboration between Continua, mHealth Summit and HIMSS, focused on engaging consumers with their health. Mission - Making health and wellness a convenient part of daily life through personal connected health technologies.

Empowering individuals to better manage their health. PCHA - Confidential PCHA, why now? Globally, healthcare in crisis and world population aging Governments around the world demonstrating significant interest in adopting personal connected health: Denmark, UK, Abu Dhabi, Singapore New regulations and incentives transforming healthcare delivery, pushing consumers to the center of their care Consumer market is exploding: +97k mobile health apps are available, each day the top 10 apps generate up to 4M free and 300k paid downloads

Empowering individuals to better manage their health. PCHA - Confidential Education Advocacy IOP Standards and Certification Public Policy: Global Reach, Global Presence Areas of Focus

Empowering individuals to better manage their health. PCHA - Confidential PCHA Strategic Initiatives Promoting education and awareness through events and outreach to all stakeholders Facilitating adoption of global industry standards for user-friendly interoperability between devices; privacy and security – Publishing annual Continua Design Guidelines for end-to-end, plug-and-play interoperability; certifying products – Ratified by ITU as global standard for PCH technologies Defining the path to market by advocating for appropriate regulation and promoting investment Supporting governments and health ministries seeking connected health solutions Operating in nations around the globe to promote market development

Empowering individuals to better manage their health. PCHA - Confidential PCHA Momentum PCHA will coordinate stakeholders in Personal Connected Health ecosystem and maintain a “consumer first” position: – It is about the individual – The technology is available – The consumers are demanding it – Nations are deploying and using it – We cannot afford to miss this opportunity The Market will not grow until we reach interoperable solutions!!!

Empowering individuals to better manage their health. PCHA - Confidential Industry Liasons Promoter Members Continua Members 160+ Members

Empowering individuals to better manage their health. PCHA - Confidential Agenda Overview: PCHA & Continua Continua Standards: Benefits Status of Continua’s International Developments Case-Study: Denmark Continua Membership Benefits and Incentives Questions & Answers / References

Empowering individuals to better manage their health. PCHA - Confidential Continua End-to-End Architecture Health Record Network (HRN) Interface Health Exchange Personal Area Network (PAN) Interface Consumer Wide Area Network (WAN) Interface Health Exchange EHR PHR NHIN HIE WiFi, 2G, 3G & 4G Personal Device Weight Scale Pulse Oximeter Independent Living Activity Cardio Strength Medication Adherence Glucose Meter Pulse / Blood Pressure Thermometer Physical Activity Peak Flow ECG Insulin Pump Aggregation Manager Telehealth Service Center Cloud Service Health Records Networks More Coming!!

Empowering individuals to better manage their health. PCHA - Confidential Architecture Benefits Full End-to-End Architecture: – Observed Measurements travel from the Medical Device to Health Record – Data keeps the accuracy, the semantic and the patient identification Flexible Architecture: – It can me adapted to most common Use Cases. From personal wellness applications to remote patient monitoring. Publicly Available Standards: – Continua Design Guidelines are publicly available for free – Underlining Standards and specifications selected by Continua are open and publicly available – Continua Design Guidelines have been adopted by United Nations through ITU-T as official global standard (H-810).

Empowering individuals to better manage their health. PCHA - Confidential Architecture Benefits Enables the Interoperability: – Continua Design Guidelines add constraints to underlying standards to clarify them and reduce available options in order to enable the interoperability – Continua Certification Program and Plugfests empowers the interoperability and the Continua Logo recognition by the end user Development Costs Reduction: – Open standards without royalties – Reference Stack, Example Applications ant Certification Test Tool available for free for Continua Members Deployment Costs Reduction: – Avoid proprietary and captive solutions – Option to select different vendors. Multiple choices, Lower Prices and Second Sources.

Empowering individuals to better manage their health. PCHA - Confidential Interoperability Benefits Lower Design Costs: Save 40k – 80k USD* in development costs per device** Faster to Market: Decrease integration time from 3 months to just 3 weeks* Increase Efficiency: Quicker, less expensive integration with Heath Records More Robust and Reliable Communication: Higher custumer satisfaction Forward/Backward compatibility: Longevity of devices Easy to Expand: Add new products with plug-and-play Source: Personal Connected Health Alliance: Applications to Diabetes Care * Source: Time and Cost Savings of Using Continua’s Design Guidelines – A PwC Survey ** Continua Members survey estimates factor 3-5 cost savings potential for certain devices

Empowering individuals to better manage their health. PCHA - Confidential Example: Japan Earthquake of 2011 The Disaster Cardiovascular Prevention Network (D-CAP) was developed to remotely monitor the blood pressure of evacuees in campsites, with a goal to prevent cardiac events in survivors identified as “high risk.” 400 people with elevated cardiac risk were enrolled in D-CAP program D-CAP registrants received electronic identification cards and were encouraged to measure their own blood pressure at automated stations within the evacuation camp. The data were sent via wireless communication to a data server and relayed to Jichi Medical University, about 200 kilometers away. Clinicians monitored the data and alerted on-site physicians by phone of any significant developments. The system was deployed in just two weeks Source: Building the Case: Interoperability in Disaster Recovery

Empowering individuals to better manage their health. PCHA - Confidential Example: Japan Earthquake of 2011 Interoperability problem Continua guidelines allowed for a quick RPM solution during the Great East Japan Earthquake. Disaster Cardiovascular Prevention Network (D-CAP) was developed to remotely monitor the blood pressure of evacuees in Campsites without hospital infrastructure. Interoperability was guaranteed because the six companies involved were Continua members. Devices: 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) Value of Continua guidelines *Figures based on actual experience, **Estimates Source: Time and Cost Savings of Using Continua’s Design Guidelines – A PwC Survey 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**

Empowering individuals to better manage their health. PCHA - Confidential Development Support Design Guidelines Certification Program Plugfests Logo Enforcement Resources: CESL mCESL Test Tool CCEs WebinarsTrainings Demo Optys

Empowering individuals to better manage their health. PCHA - Confidential Certification Goal Assurance that a device has been designed to meet the requirements of the Continua Design Guidelines. Certification Program Guidelines Select connectivity standards and publish Guidelines for strict interoperability. Certification and Logo Recognizable logo signifying the promise of interoperability with other certified products.

Empowering individuals to better manage their health. PCHA - Confidential Scope of Certification Program Data / Protocol (i.e PHD) Testing conformance to data and messaging standards. Transport Testing conformance to transport specification and interoperability at the transport level. Interop Testing conformance to Continua Interoperability Guidelines

Empowering individuals to better manage their health. PCHA - Confidential Agenda Overview: PCHA & Continua Continua Standards: Benefits Continua International Developments Case-Study: Denmark Continua Membership Benefits and Incentives Questions & Answers / References

Empowering individuals to better manage their health. PCHA - Confidential Worldwide Continua/PCHA Adoption UK (NHS Worcestershire) Japan WG Denmark Singapore SE Asia WG Australia WG India WG Brazil WG Abu Dhabi = Adopting Continua = Local Work Group US Veterans Administration US WG Japan EU WG US Department of Defense Taiwan = Continua Test Labs and Certification Experts (CCEs).

Empowering individuals to better manage their health. PCHA - Confidential ITU-T - H : – In 2012, the World Telecommunication Standardization Assembly adopted Resolution 78 – “Information and communication technology applications and standards for improved access to e-health.” – That same week, the Global Standards Symposium expressed the need for ITU to take a leading role in the e-health field by building on its collaboration with the World Health Organization (WHO) to create a global, open environment for the development and promotion of e- health standards. 2013: – In December 2013, the International Telecommunication Union (ITU), the United Nations’ specialized agency for information and communication technologies (ICTs), announced the adoption of Continua’s Design Guidelines for interoperability under Recommendation ITU-T H.810. – International standards avoid costly market battles over preferred technologies, and for companies operating in emerging markets, create a level playing field with regard to market access. Through economies of scale, global ICT standards can reduce costs for manufacturers, operators and consumers, and are also an essential aid to developing countries building their infrastructures and promoting economic dev. 2014: – Continua contributes entire test suite to the ITU. Test suites were consented in July. – H.810 converted in to 6 different languages. 2015: – Continua working toward further contributions with ITU moving forward (DG 2015 and other materials, etc.). Source: Building the Case: Developing the Global Ecosystem for Personal Connected Health

Empowering individuals to better manage their health. PCHA - Confidential Americas 1.Food and Drug Administration (FDA) Continua working closely with the FDA on several fronts (Regulatory, Specification and Certification Guidance). 2.Veterans Affairs (VA) Continua working closely with the VA on time-stamping (ensuring a consistent time-line for remote monitoring). 3.The US Model (Medicare/Medicaid) evolving Fosters innovation via incentives based on meaningful achievements. Launching innovation into the health information exchange 4.New Membership Level Continua adds a New Adopters Membership, significantly reducing membership fees and listing fees. Lowering the barriers of entry to all countries, all organizations.

Empowering individuals to better manage their health. PCHA - Confidential The US (Medicare/Medicaid) fosters innovation via incentives based on meaningful achievements. Healthcare providers have objectives they must achieve to get incentive payments. US model through incentives

Empowering individuals to better manage their health. PCHA - Confidential Asia Pacific 1.Progress in many Countries becoming significant China Taiwan Singapore India Japan S. Korea 1.New Membership Level Continua adds a New Adopters Membership, significantly reducing membership fees and listing fees. Lowering the barriers of entry to all countries, all organizations.

Empowering individuals to better manage their health. PCHA - Confidential Europe/Middle-East/Africa 1.ITU-T Continua and ITU-T contributions continue. 2.Many active and new programs Continua working closely EU countries ensuring Guidelines recognition within RFPs and Tenders. 3.Nordic countries engagement Continua recognized now by many countries. 4.New Membership Level Continua adds a New Adopters Membership, significantly reducing membership fees and listing fees. Lowering the barriers of entry to all countries, all organizations.

Empowering individuals to better manage their health. PCHA - Confidential mHealth Grand Tour (for diabetes) Charity event for diabetes in September, including a showcase for mHealth and an opportunity to highlight mHealth’s potential to enable active, healthy lifestyles and disease management for people with diabetes. 13-day cycling challenge from Brussels to Barcelona (2,300 kilometers). Participants included 167 cyclists from 24 countries. Sponsors: GSMA and the International Diabetes Federation European Region Technology collaborators designed and deployed a novel, end-to-end mHealth system for real-time tracking of the cyclists’ blood glucose levels, heart rate and cycling statistics. Internet followers were able to track their data, and included a back-end database that accumulated data in real time for analysis by the research team. Devices included wearable sensors, bike computers and a web portal to capture rider data.

Empowering individuals to better manage their health. PCHA - Confidential EU Nordic Countries Denmark was the 1st country to adopt Continua and make the Continua framework a fundamental part of the national reference architecture. Reference architecture officially released in June Downloaded in more than 50 countries. Norway is working toward mandating Continua compliance by 2018 Sweden recently held a large event involving industry and government. Sweden made the decision to move from pending to actively working toward Continua adoption. Finland is working on similar top-down approach as Norway with regards to Continua adoption

Empowering individuals to better manage their health. PCHA - Confidential Call to Action – Be a part of History Membership – Join now and experience Certification – Certify your devices Contribution – Create: Empower and influence future Guidelines

Empowering individuals to better manage their health. PCHA - Confidential Links to a few studies Partners HealthCare: Connecting Heart Failure Patients to Providers Through Remote Monitoring of 640 patients with chronic heart failure and COPD _Partners_case_study.pdf Centura Health at Home: Home Telehealth as the Standard of Care The Veterans Health Administration: Taking Home Telehealth Services to Scale Nationally _VHA_case_study.pdf Return on investment analysis of the VISN1 telehealth program /unrestricted/MQP_Telehealth_ROI_and_Overall_Benefit_Analysis_FINAL_VERSION.pdf Telehealth Navigating the Maze and Turning Challenges into Opportunities healthcare/online-syllabus/telehealth-pdfs/0740-cress Deployment of an mHealth Patient Monitoring Solution for Diabetes monitoring-leads-r#.Uv0cgT4piU8.twitter 3millionlives program Socio-economic impact of mHealth

Empowering individuals to better manage their health. PCHA - Confidential Agenda Overview: PCHA & Continua Continua Standards: Benefits Status of Continua’s International Developments Case-Study: Denmark Continua Membership Benefits and Incentives Questions & Answers / References

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark Facts in brief – Population 5.5 mio – Single Government – 5 Regions with local government Responsible for: – Hospitals – GP’s – 93 municipalities Responsible for: – Nursing homes – Home care Tax based healthcare system – Some payment on pharmaceuticals Numerous telemedicin projects / pilots – Estimated concurrent projects – 1 pr citizens. – Few successes – in production

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark Wish to have a fully connected healthcare system – Multiple systems exchanging data across sectors – standardised interfaces Patient empowerment – Self management Creating the market – New Super Hospitals – Closing older hospitals 20% reduction in hospital beds Increased distance to rural areas TELEMEDICINE SOLUTION REQUIRED

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark – Action plan Action plan for dissemination of Telemedicine (2012)

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark – Reference architecture – Downloaded by apx. 50 countries

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark – the uptake Continua based 2 Tenders for products Project name: TeleCare Nord (OpenTele) Apx COPD patients Cross sector cooperation Project name: KIH (Clinical Integrated Homemonitoring) (OpenTele) Pregnants without complications (300) Bowel disceases (250) COPD (280) Hospital controlled Project name: Next Step Citizen Home Monitoring COPD Video consultation Cross sector cooperation Project name: KIH (Clinical Integrated Homemonitoring) (OpenTele) Pregnants with complications (160) Diabetes (180) Hospital controlled

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark – Status Infrastructure implementation in progress – Solutions deployed High focus on interoperability – Device – System – systems High focus on interoperable device – but lacks products More products needed to create the market for Continua certified devices – Legislative requirement for tenders Survey coming up! Device typeNumber of Continua certified devices (March 2014) CE Mark Glucose monitor6 6 !6 ! Blood pressure monitor5 Aggregation unit (eg. AHD)21 Pulse oximeter5 Weight scale6 Reference systems38

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark – Activities Center of Integrated Care – Permanent Plugfest – Large scale test – ~5000 users Mockup, Care home, Hospitals and GPs – Innovation and test in real world settings - Realitylabs An easy way in to co-developments Standard model for developing and testing Screening and match-making A model for business partnerships Pre-testing in lab Knowledge sharing and facilitation of progress Reality Labs Initiatives driven by user needs Testing directly within daily operations Documentation and certification Training, development of competency and implementation

Empowering individuals to better manage their health. PCHA - Confidential Case-Study: Denmark – The market place Denmark alone is a small country- 5.5 mio –Technology accustomed population Measured by the number of smartphones and tablets pr. Capita – it’s a big country –High degree of co-evolution (PPP) –Great test market –More tenders (on continua certified products) coming up –Reimbursement on devices ( Eg. Diabetes treatment) Free of charge (White list): Glucose monitor, sticks, insulin pens/pumps, needles User payment(Limited): Insulin, special devices Nordic movement towards Continua –August 2014, Norwegian report recommends Continua certificate to become mandatory by –Sweden and Finland actively moving towards adoption –Total population of 28 million

Empowering individuals to better manage their health. PCHA - Confidential Agenda Overview: PCHA & Continua Continua Standards: Benefits Status of Continua’s International Developments Case-Study: Denmark Continua Membership Benefits and Incentives Questions & Answers / References

Empowering individuals to better manage their health. PCHA - Confidential Continua Roadmap Health Record Network (HRN) Interface Health Exchange Personal Area Network (PAN) Interface Consumer Wide Area Network (WAN) Interface Health Exchange EHR PHR NHIN HIE WiFi, 2G, 3G & 4G Personal Device Weight Scale Pulse Oximeter Independent Living Activity Cardio Strength Medication Adherence Glucose Meter Pulse / Blood Pressure Thermometer Physical Activity Peak Flow ECG Insulin Pump Aggregation Manager Telehealth Service Center Cloud Service Health Records Networks Already supported

Empowering individuals to better manage their health. PCHA - Confidential Continua Roadmap IrisGenome Keratin Q3 2014Q2 2015Q2 2016IOP release (+6 mo. till public) CGM C&C Sleep Monitor … Insulin Pump Remote AHD control bGM revision Direct for ONC Pulse Ox. (BT Smart) Weight Scale (BT Smart) SABTE Timestamp & time sync WAN updates

Empowering individuals to better manage their health. PCHA - Confidential CESL – Reference Code Speed the adoption Reference source code Testing Prototypes Basis for Continua Test Tool Creation of reference devices for IOP

Empowering individuals to better manage their health. PCHA - Confidential mCESL – Example AHD for Android Continua Reference Device Code (Mobile) PAN - Reference Manager Application WAN - developed in C++ and JAVA. Available as an SDK and Reference Application developed for the Android Nexus platform

Empowering individuals to better manage their health. PCHA - Confidential Continua Test Tool Official Certification Test Tool Helps ensure you can pass all conformance tests. Recommended for internal pre-testing before going to test lab.

Empowering individuals to better manage their health. PCHA - Confidential Continua Membership Levels PromoterAll Contributor Member benefits + eligibility to become a Continua Council member; responsible for ratifying specifications; the selection of use cases, standards, industry technologies, and other key Working Group decisions ContributorIncludes access to all Continua technical Guidelines, use cases and technical specifications; full participation rights; voice in defining Continua's future direction AdopterSignificant savings on membership and certification; self-certify a device or service within first year of membership Developing Market Organizations from emerging economic regions or small companies UniversityProvide research, review Continua test tools, Guidelines and documents, use Continua tools to demonstrate end-to-end plug- and-play interoperability and create educational materials incorporating Continua's key technical or business concepts

Empowering individuals to better manage their health. PCHA - Confidential Certification Incentives New members: free certification testing for one device before the end of 2014 AND a free listing (Type A or Type O). Developing market: $1,000 for the first year of membership. Increase to $2,500 USD for the second year and full Contributor costs in year three. One free listing fee.

Empowering individuals to better manage their health. PCHA - Confidential Don’t miss! Continua Winter Summit & Plugfest December 9-12, 2014 Gaylord National Resort & Conference Center National Harbor, MD Held in connection December 7-11

Empowering individuals to better manage their health. PCHA - Confidential Learn More About Continua Activities at mHealth Summit Visit the Continua booth (#403) or attend one of our sessions: – Value Prop for Standardization Monday, Dec. 8 th, 3:45pm – Global Interoperability Update Tuesday, Dec. 9 th, 2:30pm – Recent Interoperability Standards & Collaborations Wednesday, Dec. 10 th, 12 Noon – Impact of Recent FDA Regulation Wednesday, Dec. 10 th, 1pm – IEEE Training Wednesday, Dec. 10 th, 8am – Continua Path to Certification Training Wednesday, Dec. 10 th, 1pm – Continua Implementation Guides Training Wednesday, Dec. 10 th, 3pm – Time-Stamping and Time Synchronization Wednesday, Dec. 10 th, 1pm Live Member Demos | MHealth Summit Interoperability Showcase™ Interested in meeting with Continua leadership to discuss more at mHS? Contact Continua members, agenda details for the Winter Summit are available here: summit

Empowering individuals to better manage their health. PCHA - Confidential Agenda Overview: PCHA & Continua Continua Standards: Benefits Status of Continua’s International Developments Case-Study: Denmark Continua Membership Benefits and Incentives Questions & Answers / References

Empowering individuals to better manage their health. PCHA - Confidential Questions and Answers

Empowering individuals to better manage their health. PCHA - Confidential References Personal Connected Health Alliance (PCHA) Continua Health Alliance Personal Connected Health Alliance: Applications to Diabetes Care Building the Case: Interoperability in Disaster Recovery Time and Cost Savings of Using Continua’s Design Guidelines – A PwC Survey Building the Case: Developing the Global Ecosystem for Personal Connected Health The mHealth Grand Tour for Diabetes – Population mHealth in Action

Empowering individuals to better manage their health. PCHA - Confidential END Kelvin Lim Michael Kirwan Raul Gonzalez Brian Hedegaard