1. e-Health Industry Expectation
Document No:
GSC(14)18_035
Source:
CHA
Contact:
Michael J. Kirwan
Agenda Item:
5.3
e-Health Industry Expectation
July 22nd, 2014

2. Technical Operations Director
Personal Connected Health Alliance Empowering individuals to better manage their health
Michael J. Kirwan
Technical Operations Director
PCHA and Continua
May 2014

3. Empowering Individuals to Better Manage Their Health
The world is moving to a focus on linking individuals with interoperable, personalized health solutions that meet their lifestyle needs.

4. Advantages of Personal Connected Health
Consumers are not just linking health data to the Providers any longer
Potential to transform human health and healthcare delivery, and to reduce global disparities in healthcare access
Adds motivation and inspiration to health self-management by taking advantage of support networks in social media and other online forums
Capable of reducing the impact of chronic disease, which is responsible for the greatest portion of healthcare expenditures
Ability to shift from treatment focus to preventive care by making health self-management a part of everyday life
Allows us to enjoy life longer outside of traditional healthcare

5. Engaging Consumers at Every Stage of Life
…and Providing Links to Family, Friends, Social Networks & Providers
Health and Relief
Pharma

6. PCH Creates an Information- and Inspiration-Rich Environment for Health Improvement
Consumers become engaged in health self-management
Links to social networks become a source of positive reinforcement
A secure line of communication is established between providers and caregivers outside the exam room
Consumer-collected data can enrich healthcare for individual patients and patient populations
Better use of resources, reduced cost, improved clinical outcomes…and health management incorporated into everyday life

7. The Goal: Improve Lifestyle Choices, Health
= Non Modifiable Contributors to Disease
= Modifiable Contributors to Disease
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

8. Envisioning A Better Way: Weight Loss
Wearable trackers to monitor calories burned through activity
Apps for diet/nutrition advice and caloric intake, on smart phone and/or computer
Social networking for inspiration and competition (i.e., Jenny Craig, Biggest Loser), using online forums such as Facebook

9. Envisioning A Better Way: Gaming
Wearable trackers to monitor specific activity
New sensors to enable 3d tracking and movements
Already in use for Rehabilitation and Diagnostic purposes
Can be utilized to stimulate inactive or cognitive impaired individuals
Interoperability allows for this data to be collected by healthcare team

10. Envisioning A Better Way: Management of Rare & Serious Diseases
Disease-based forums (web, social media) for peer advice on treatment options and experience
Connectivity to providers via provider portal, for expert advice during diagnosis, treatment and follow-up Apps to find a clinical trial
PCH-enabled studies that use sensors, trackers and/or remote monitoring for data accuracy and patient convenience

11. Envisioning A Better Way: Care of Special Populations
Individual and online gaming for children/teens with chronic diseases
Apps to support connection to people with communication disorders, such as autism
Wearable sensors and wireless monitoring for elderly living independently
Remote monitoring by healthcare providers to augment parental care of a sick child or aging parent
Social networking for caregivers, i.e., Facebook book, online chat with the ability to share sensor data

12. Envisioning A Better Way: Clinical Trials
Direct involvement of the individual in the trial
Evaluate patient populations
Accelerate patient recruitment
More efficient and effective management of clinical trails, data collection and reporting
Better quality, more reliable data
Get new drugs to market faster

13. Envisioning A Better Way: Interoperability
Compliance with global industry standards 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
Forward/backward compatibility: longevity of devices
Easy to expand or add new programs/products with plug-and-play

14. Architecture to Enable PCH
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
Aggregation
Manager
Telehealth
Service
Center
Health
Records/
Networks
WiFi, 2G, 3G & 4G
PHR
EHR
Personal
Area
Network
(PAN)
Interface
Wide
Area
Network
(WAN)
Interface
Health
Record
Network
(HRN)
Interface
NHIN
HIE

15. Envisioning A Better Way: Adoption
UK (NHS
Worcestershire)
Japan WG
Denmark
Singapore
SE Asia WG
Australia WG
India WG
Brazil WG
Middle East
= Adopting Continua
= Local Work Group
US Veterans
Administration
&
US Department of Defense
US WG
Japan
EU WG

16. PCH: Why Now? Consumer market is exploding
more than 97,000 mobile health apps are currently available;
each day the top 10 apps generate up to 4 million free and 300,000 paid downloads
New regulations and incentives transforming healthcare delivery, putting consumers at the center of their care
the Affordable Care Act features comprehensive health insurance reform to improve the quality and patient access to care in the US
Meaningful Use Stage 3 to address population health
Governments around the world demonstrating significant interest in adopting personal connected health (ex: Denmark, Norway, UK, UAE, Singapore)
the UK’s 3million lives initiative changing care delivery using connected health tools for citizens with chronic conditions
Globally, healthcare in crisis and world population aging

17. PCHA: An Historic Collaboration Continua Health Alliance, mHealth Summit & HIMSS
Global plug-and-play interoperability Design Guidelines and Product Certification program
Unmatched industry education, thought leadership and networking
International leadership in hospital-based health technologies
Worldwide presence to promote local, regional and national public policy, advocacy and market development

18. PCHA Mission
Generating greater awareness, availability and access to plug-and-play, consumer-friendly personal health technologies to empower individuals to better manage their health and wellness, anywhere at any time.

19. 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

20. The Time is Now
PCHA will coordinate stakeholders in PCH and maintain a ‘consumer first’ position
It’s about the individual
The technology is available
Consumers are demanding it
Nations are implementing it
We can’t afford to miss this opportunity
The Market will not grow until we reach interoperable solutions

21. Get Involved with PCHA! http://www.mhealthsummit.org/subscribe
Web:

22. Thank You

24. Case Examples

25. Denmark’s National Action Plan for Telemedicine
Scope
Secure collection, transmission, storage of personal health data from patients’ homes to healthcare providers across the country
Sharing of medical documents & images
Management of health records, medical appointments, etc.
Objectives
Ensure end-to-end, plug-and-play connectivity of personal health devices; establish interoperability standards
Ensure personal health devices & services easy to deploy, secure & convenient for patients & providers
Reduce acute care stays
Enable elderly to live home independently
Develop chronic disease management programs
Expand use of telemedicine
ESPO is UK's largest public sector professional buying organization,

26. Denmark: Centralized Approach to Standards Adoption
Mandated national compliance with interoperability standards (Continua)
Pros:
National healthcare IT conformity supports large-scale population health and creation of cost, operational efficiencies
Limited systems integration issues during rollout and subsequent changes in technology
Cons: limited regional, local influence over standards development; currently fewer choices in devices
ESPO is UK's largest public sector professional buying organization,

27. UK Dept of Health: 3millionlives (3ML) Campaign
Based on evidence from the Whole System Demonstrator Programme (6,000+ person telehealth/telecare study)
Goals
Improve lives of 3ML people with long term conditions, social care needs
Develop market, remove barriers to delivery (5 yrs)
Create environment to support uptake
Public/private cooperation to simplify procurement and commissioning processes for telehealth, telecare at scale
Put NHS and UK industry at the forefront of telehealth, telecare globally
Promote benefits of telehealth and telecare services to patients

28. 3ML: Regional Approach to Standards Adoption
All personal health device providers must comply with CEN ISO/IEEE 11073
Contracting occurs on a local basis
NHS Worcestershire County and East Shires Purchasing Organization have voluntarily adopted Continua
Pros: localities maintain maximal control (device selection, cost)
Cons: healthcare IT infrastructure likely to require significant integration to achieve end-to-end interoperability at a national scale
ESPO is UK's largest public sector professional buying organization,

29. Catalonia, Spain: Regional Approach
Population covered by universal healthcare with a mix of public/private providers
Health Ministry funded ICT organization (TicSalut) coordinates standards, integrates health and social welfare systems
100% of hospitals use EHRS; 70% have mobile tools
Device integration primarily based on Hl7 standards

30. Opportunities & Challenges for Big Data
Adopt common standards for PHRs to enable data aggregation, tracking from multiple consumer devices
A starting point for big data, especially in decentralized markets
Agree upon type, definition and format of personal health data relayed from consumer devices to a medical records system
Ex: Health Records Network
Challenges
Retail and home devices need common standards to enable consumer plug and play
Clinical workflow impact complicates standards adoption
End-to-end standards adoption

31. Personal Connected Health Alliance (PCHA)
An alliance and collaboration focused on the vision of person-centered health and health care with a mission to deliver interoperable personal health solutions that foster independence and empower people to better manage their health and wellness from anywhere; at anytime.  
Global Access &
Leadership
Interoperability &
Ecosystem Enablement
Thought Leadership &
Industry Connection
Design guidelines enabling vendors to build interoperable platforms and health and wellness services.
Product certification program with consumer-recognizable logo signifying the promise of interoperability across certified products.
Collaboration with government regulatory agencies to provide methods for safe and effective management of diverse vendor solutions
Working with leaders in the health care industries to develop new ways to address the costs of providing personal telehealth systems.

32. Clint McClellan
PCHA Organization

33. PCHA Structure, Governance and Services
Personal Connected Health Alliance LLC
Continua Council
Up to 15 members elected from Promoters
Promoters Contributors Developing Companies
Participants:
mHealth Council
Single Member LLC with HIMSS as sole Equity Holder
Operating agreement defines constitution & duties
Board of Managers:
- Sets strategy
- Defines objectives & organization
- Plans budget
Up to 15 Managers elected from Continua Promoter Participants Current board carries over into BoM
5 Managers appointed by HIMSS
Exec. Vice President represents LLC
1 Manager represents in HIMSS WW
Operational sub-structure
Operating agreement defines duties
Council manages:
Guideline development / releases
Certifications
Working groups
Events & content
Up to 15 Members elected from Continua Promoter Participants
Director acts as COO
Similar in many rights to a Shareholder in a for-profit corporation.
Vision and Mission stays unchanged
Brand will continue unchanged
WG’s structure are the same
WG’s charters & processes remain
Membership dues and benefits stay intact
Current Continua members will become PCHA participants automatically 33

34. Small Changes
We are dropping the Health Alliance portion of Continua Health Alliance – now referred to as Continua
Marketing-wise – We refer to Continua as …a Founding member of PCHA…
Continua name still represents the Guidelines and Certification
Continua logos to remain the same and integrated into the PCHA logo

35. Website Changes New PCHAlliance.org website
Continua website will remain separate as we have specific functionality to maintain membership and voting processes.
Continua site undergoing a phased approach to integrate with PCHAlliance look and feel.
Adding new features
Comment section
Online request for Guidelines

36. Past Events What: mHealth Summit Europe When: May 6 – 8, 2014
Where: Messe, Berlin
Info:
Continua was a supporting organization
Speakerships
What: Continua Spring Summit
When: May 8 – 10, 2014
Where: Berlin, Germany
First co-located mHealth Summit and Continua Summit

37. Past Events What: eHealth Forum 2014 When: May 12 – 14, 2014
Where: Anthens, Greece
Info:
-Continua was a supporting organization
What: mHealth Summit Middle East
When: May 28 – 29, 2014
Where: Abu Dhabi
Info:
First Continua Connects Event
Continua was a supporting organization

38. Continua Summer Summit
Save the Date!
Continua Summer Summit
August , 2014
Montreal, Canada

39. Upcoming Events July - JWG visit (Chuck and JWG Chair)
August - Shanghai Bluetooth event
Sept – HIMSS AsiaPac mHealth event
Sao Paulo mHealth event
Oct – Partners Connected for Health
Dec – 7-10 mHealth Summit DC
9-12 Continua Summit

41. mHealth Summit Components
400 Exhibiting Companies
Intelligent Medical Home Pavilion
Startup Showcase
Comprehensive Sponsorship Program
Targeted Pre-conference and Co-located Events
5 Keynotes Delivered by Industry Leaders
3-Day Core Conference Program
2-day, Co-located Global mHealth Forum
Continua Technology/Interoperability Showcase
Continua Member Summit

42. Global mHealth Forum

43. Past Keynotes and Executive Spotlights

44. Past Sponsors

50. Emerging Markets Incentive
BoD Approved!
Emerging Markets Incentive
This emerging markets incentive qualifies new members from either a developing region or from a small company.
Developing Region
Small Company
A company may qualify by being a company originating out of a defined Developing Area (OECD GDP of less than $15K per Capita).
A company may qualify if:
less than 20 full-time employees (in all company divisions).
Less than $4M annual gross revenues.
Less than $4M in total assess (as indicated on balance sheet).
The membership process is as follows:
1. Submit signed membership application and questionnaire
2. Submit signed form confirming the requirements listed above
3. Receive approval from the Continua Board of Directors
4. Submit membership payment
Contact Continua Administration for more details.
Qualifying Benefits
Company pays only $1000 for their first year, $2,500 for their second and full Contributor costs in their third year of Continua membership.
Company receives one free listing fee (subject to the listing fee only and excludes the testing fee).
Company may participate in Continua Plugfests and Continua Connects (subject to existing fees).
Company in the Developing Region category will receive all Contributor membership benefits except they are limited to a maximum of 2 participants at each Summit. Leadership roles are also not available to this category.
To sign-up, please contact Continua Administration.

51. Certification Incentives for New Members
BoD Approved!
For New Members
If you join Continua between now and December 31, 2014, you get:
All existing benefits of Continua membership (CESL code, free Test Tool, matchmaking, etc.).
PLUS –
Free certification within first year of Continua membership.
Notes Regarding this Certification Incentive:
Only one offer per company/subsidiary.
Covers certification for one device specialization and one transport. Additional device specializations/transports follow typical fees.
Does not cover retest fee.
The deadline refers to the date company is ready for certification (device is at Test Lab, certification application has been received and approved). Actual test completion date is dependent on Test Lab volumes.
Join Now

52. University Member Incentive
BoD Approved!
University Member Incentive
This incentive qualifies new members from a College or University who contribute resources back to Continua.
For a limited time period only, until December 31st, 2014, a College or University may join Continua for as little as $1000 (a $5,500 savings)!
A College or University may qualify for this incentive by stating their goal or intent for the use of their Continua membership in what they can contribute back to Continua. Contribution possibilities may vary but a few examples may be as follows:
Provide research for Continua, i.e., similar to what may be required as part of a request for grant.
Become reviewers of Continua’s test tools, guidelines and documents, providing inputs based on their use and understanding of the industry requirements.
Use Continua’s tools to demonstrate complete End-to-End Plug-n-Play interoperability.
Create educational materials that incorporates the key technical or business concepts of Continua while utilizing them in daily teaching activities.
Many other possibilities exist, just provide your ideas for contributing back to Continua.
Access to Continua’s membership portal is available to the College or University staff only.
Please note that Continua’s Bylaws, due to intellectual property rights, do restrict educational entities from participating in the Technical Working Group (TWG), the Use-case Working Group (UCWG), gaining access to draft Continua Design Guidelines and in certifying devices. Each university would need to be nominated by two Continua Board members and to sign an agreement with Continua.
Qualifying Benefits
College or University pays only $1000 annually for Contributor Level Membership.
College or University will have full access to Continua CESL and Test Tools.
College or University may participate in Continua Plugfests and Continua Connects (subject to existing university fees).
College or University will receive all Contributor membership benefits except they are limited to a maximum of 2
participants at each Summit. Leadership roles are also not available to this category.
Join Now
To sign-up, please contact Continua Administration:

53. Adopter Member Incentive for Self-Certifying your Device or Service
Approved by Continua Council, Need PCHA BoD Approval
Adopter Member
Incentive for Self-Certifying your Device or Service
Companies can receive a significant savings on membership and certification if they join Continua as an Adopter member and self-certify an Agent or Service within their first year of membership.
Qualifying Benefits
Company pays only $1000 for their first two years, then $3,000 for their third year. At the fourth year and beyond, Company selects to either continue paying for Adopter level at $3000 and pay for tools, meetings, Plugfests, and testing - or move to the annual Contributor membership fee ($6,500).
Company receives one free listing fee (subject to the listing fee only and excludes the testing fee).
Company may participate in Continua Plugfests and Continua Connects (subject to current posted fees).
Notes on Adopter Membership
Access to CESL libraries will require fee or upgrade to Contributor membership.
Access to draft Guidelines or to internal Working Groups is not allowed.
Additional fees may be required for participation in Showcases and Demo centers.
Join Now
To sign-up, please contact Continua Administration:

54. Continua Test Labs http://www.at4wireless.com/
Basingstoke, UK
Korea
Herndon, VA, USA
Beijing, China
Berkshire UK
Malaga, Spain
Taipei, Taiwan

55. Thank you!