Continua ‘Now” Webinar Oct 30, 2014

1. Continua ‘Now” WebinarOct 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

2. Agenda • Overview: PCHA & Continua • Continua Standards: Benefits • Status of Continua’s International Developments • Case-Study: Denmark • Continua Membership Benefits and Incentives • Questions & Answers / References

3. 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.

4. PCHA, whynow?

5. Areas of Focus

6. PCHAStrategicInitiatives • 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

7. PCHAMomentum • 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!!!

8. Continua Members http://bit.ly/continua-members 160+ Members PromoterMembers IndustryLiasons

9. Agenda • Overview: PCHA & Continua • Continua Standards: Benefits • Status of Continua’s International Developments • Case-Study: Denmark • Continua Membership Benefits and Incentives • Questions & Answers / References

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

11. 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).

12. 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.

13. InteroperabilityBenefits • LowerDesignCosts: Save 40k – 80k USD* in developmentcosts per device** • FastertoMarket: Decreaseintegration time from 3 monthstojust 3 weeks* • IncreaseEfficiency: Quicker, lessexpensiveintegrationwithHeath Records • More Robust and ReliableCommunication: Highercustumersatisfaction • Forward/Backwardcompatibility: Longevity of devices • EasytoExpand: Add new productswithplug-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

14. Example: JapanEarthquake 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

15. Example: JapanEarthquake 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 • Continua Non-Continua Time Bring down deployment time down to 1/6 2 weeks*incl. 3 days for connectivity 12 weeks**incl. 30 days for connectivity  Man-weeks(1 FTE per company) 60 man-weeks or $139k saved $166k** 12* $27k** 72** • Interoperability assured quality because each company could focus on their module in D-CAP • *Figures based on actual experience, **Estimates • Source: Time and Cost Savings of Using Continua’s Design Guidelines – A PwC Survey

16. DevelopmentSupport Design Guidelines Webinars Trainings Certification Program Demo Optys CCEs Resources: CESL mCESL Test Tool Plugfests Logo Enforcement

17. Certification Program Certification Goal Assurance that a device has been designed to meet the requirements of the Continua Design Guidelines. Guidelines Select connectivity standards and publish Guidelines for strict interoperability. Certification and Logo Recognizable logo signifying the promise of interoperability with other certified products.

18. Scope of Certification Program

19. Agenda • Overview: PCHA & Continua • Continua Standards: Benefits • Continua International Developments • Case-Study: Denmark • Continua Membership Benefits and Incentives • Questions & Answers / References

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

21. ITU-T - H.810 2012: • 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

22. Americas • Food and Drug Administration (FDA) • Continua working closely with the FDA on several fronts (Regulatory, Specification and Certification Guidance). • Veterans Affairs (VA) • Continua working closely with the VA on time-stamping (ensuring a consistent time-line for remote monitoring). • The US Model (Medicare/Medicaid) evolving • Fosters innovation via incentives based on meaningful achievements. • Launching innovation into the health information exchange • 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.

23. US model through incentives • The US (Medicare/Medicaid) fosters innovation via incentives based on meaningful achievements. Healthcare providers have objectives they must achieve to get incentive payments. http://www.healthit.gov/providers-professionals/how-attain-meaningful-use http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/Beginners_Guide.pdf

24. Asia Pacific • Progress in many Countries becoming significant • China • Taiwan • Singapore • India • Japan • S. Korea • 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.

25. Europe/Middle-East/Africa • ITU-T • Continua and ITU-T contributions continue. • Many active and new programs • Continua working closely EU countries ensuring Guidelines recognition within RFPs and Tenders. • Nordic countries engagement • Continua recognized now by many countries. • 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.

26. mHealth Grand Tour (for diabetes) • Charity event for diabetes in September, including a showcase for mHealth and an opportunity to highlight mHealth’spotential 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.

27. EU Nordic Countries

28. Call to Action – Be a part of History • Membership • Join now and experience • Certification • Certify your devices • Contribution • Create: Empower and influence future Guidelines

30. Agenda • Overview: PCHA & Continua • Continua Standards: Benefits • Status of Continua’s International Developments • Case-Study: Denmark • Continua Membership Benefits and Incentives • Questions & Answers / References

31. Case-Study: Denmark

32. Case-Study: Denmark • Facts in brief • Population 5.5 mio • Single Government • 5 Regionswith local government • Responsiblefor: • Hospitals • GP’s • 93 municipalities • Responsiblefor: • Nursinghomes • Home care • Taxbasedhealthcaresystem • Somepaymentonpharmaceuticals • Numeroustelemedicinprojects / pilots • Estimatedconcurrentprojects – 1 pr. 11000 citizens. • Fewsuccesses – in production

33. Case-Study: Denmark • Wish to have a fullyconnectedhealthcaresystem • Multiplesystemsexchanging data acrosssectors – standardised interfaces • Patientempowerment • Selfmanagement • Creatingthemarket • New SuperHospitals • Closingolderhospitals • 20% reduction in hospital beds • Increaseddistance to rural areas • TELEMEDICINE SOLUTION REQUIRED

34. Case-Study: Denmark – Action plan • Action plan fordissemination of Telemedicine (2012)

35. Case-Study: Denmark – Reference architecture • Downloadedbyapx. 50 countries • http://bit.ly/1zDkaEh

36. Case-Study: Denmark – the uptake • Project name: TeleCare Nord (OpenTele) • Apx. 4500 COPD patients • Cross sectorcooperation • Continua based • 2 Tendersforproducts • Project name: KIH (Clinical Integrated Homemonitoring) (OpenTele) • Pregnants with complications(160) • Diabetes (180) • Hospital controlled • Project name: KIH (Clinical Integrated Homemonitoring) (OpenTele) • Pregnantswithoutcomplications (300) • Boweldisceases (250) • COPD (280) • Hospital controlled • Project name: Next Step Citizen • Home Monitoring • COPD • Video consultation • Cross sectorcooperation

37. Case-Study: Denmark – Status • Infrastructureimplementation in progress • Solutionsdeployed • High focusoninteroperability • Device – System – systems • High focuson interoperable device – butlacksproducts • More productsneeded to createthemarketfor Continua certifieddevices • Legislativerequirementfortenders • Surveycoming up!

38. Case-Study: Denmark – Activities 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 • Center of Integrated Care • Permanent Plugfest • Large scale test – ~5000 users • Mockup, Care home, Hospitals and GPs • Innovation and test in real worldsettings- Realitylabs Reality Labs • Initiatives driven by user needs • Testing directly within daily operations • Documentation and certification • Training, development of competency and implementation

39. Case-Study: Denmark – The market place • Denmarkaloneis 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 2018. • Sweden and Finland actively moving towards adoption • Total population of 28 million

40. Agenda • Overview: PCHA & Continua • Continua Standards: Benefits • Status of Continua’s International Developments • Case-Study: Denmark • Continua Membership Benefits and Incentives • Questions & Answers / References

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

42. Continua Roadmap Genome Iris Keratin IOP release(+6 mo. till public) Q2 2016 Q3 2014 Q2 2015 • Weight Scale (BT Smart) • SABTE • Timestamp & time sync • WAN updates • CGM C&C • Sleep Monitor • … • … • … • Insulin Pump • Remote AHD control • bGM revision • Direct for ONC • Pulse Ox. • (BT Smart)

43. CESL – ReferenceCode http://bit.ly/download-cesl

44. mCESL – ExampleAHDforAndroid http://bit.ly/download-mcesl 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

45. Continua Test Tool http://bit.ly/download-testtool Official Certification Test Tool Helps ensure you can pass all conformance tests. Recommended for internal pre-testing before going to test lab.

46. http://www.continuaalliance.org/about-continua-join/benefits-of-continua-membershiphttp://www.continuaalliance.org/about-continua-join/benefits-of-continua-membership http://www.continuaalliance.org/about-continua-join/how-to-join-continua

47. 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. http://www.continuaalliance.org/about-continua-join/new-member-incentives

48. Don’t miss! Continua Winter Summit & Plugfest December 9-12, 2014 Gaylord National Resort & Conference Center National Harbor, MD 20745 Held in connection December 7-11

49. 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. 8th, 3:45pm • Global Interoperability Update Tuesday, Dec. 9th , 2:30pm • Recent Interoperability Standards & Collaborations Wednesday, Dec. 10th, 12 Noon • Impact of Recent FDA Regulation Wednesday, Dec. 10th, 1pm • IEEE 11073 Training Wednesday, Dec. 10th, 8am • Continua Path to Certification Training Wednesday, Dec. 10th, 1pm • Continua Implementation Guides Training Wednesday, Dec. 10th, 3pm • Time-Stamping and Time Synchronization Wednesday, Dec. 10th, 1pm • Live Member Demos | MHealthSummit Interoperability Showcase™ • Interested in meeting with Continua leadership to discuss more at mHS? Contact emily@continuaalliance.org • Continua members, agenda details for the Winter Summit are available here: https://cw.continuaalliance.org/wg/members/home/2014-continua-winter-summit

50. Agenda • Overview: PCHA & Continua • Continua Standards: Benefits • Status of Continua’s International Developments • Case-Study: Denmark • Continua Membership Benefits and Incentives • Questions & Answers / References