Presentation for mHealth Israel about "EU Go-To-Market for Digital Health", by Julien Venne, Strategic Advisory, European Connected Healthcare Alliance, Oct, 2016

1. EU-US Digital health
Contrast & compare
www.echalliance.com / info@echalliance.com
European Connected Health Alliance
Bringing together the future of Health, Social Care & Wellness

2. Key Figures (1)
Demographics
Population
(millions)
510 319
Life expectancy
(W/M years old)
84 / 79 81 / 76
Population over 65 years old
(2012/2030)
18,44% / 25-30% 14,5% / 20%
Economy & organization
GDP
(US$ per capita)
31,821 56,066
Number of member states 28 50+1

3. Key Figures (2)
Health system resources & activities
Health expenditures (% GDP) 8,7% 16,9%
Health expenditures (US$ per capita) 2407 8745
Physicians per 1000 population 3,4 2,5
Nurses per 1000 population 8 11,1
Hospital beds for 1000 population 5,3 3,1
Average length of stay at hospital 7 5,4
Main financial burden
Chronic diseases
(75-80% costs)
Chronic diseases
(75-80% costs)

4. European Diversity…
…in terms of life expectancy
Eurostat statistics database

5. European Diversity…
…in terms of population health status
OECD data
Prevalence estimates of diabetes, adults aged 20-79 years, 2013
USA = 9,3%

6. European Diversity…
…in terms of population health status
OECD data
Obesity
EU: 1 adult on 6 was obese in 2012
USA: more than one third of US Adults (source: FRAC)

7. European Diversity…
…in terms of healthcare activities
OECD data

8. European Diversity…
…in terms of equipment
OECD data

9. European Diversity…
…in terms of expenditures
OECD data

10. European Diversity…
…in terms of type of financing
OECD data

11. European Diversity…
…but universal coverage for basic healthcare
OECD data

12. European Diversity…
No centralised decision for healthcare policies in Europe
o National health (and Digital health) strategy & priorities
o National budgets and pricing
o National market access pathways for health products/services
o National Health IT standards and interoperability framework
o Difficulties to reform
Most of EU member states are transferring decisions to REGIONS
o National strategy BUT regional priorities
o National framework but regional organisation
o National global financing but regional decisions for allocations

13. CE Marking
Health Technology Assessment
(Assessment of medical and societal values)
Pricing
(Medico-economic assessment)
Coverage Decision
Submission of a file by the company
Submission of a file by scientific
societies & and medical team
Economic Committee for Health Products
& Services
à Negotiate with the company
à Fixes Prices
Committee of Grading of Medical
Procedures
à Negotiates with Health professionals unions
à Fixes reimbursement prices and rates
Ministry of Health National Health Insurance
à Establishes list of reimbursable Medical Devices
(LPPR)
à Establishes list of reimbursable Medical
Procedures
1
2
3
Medical Device
Process
Medical Procedure
Process
180 days
EXAMPLE MARKET ACCESS FOR MEDICAL PRODUCT IN FRANCE

14. European Commission
see resources
Medical Devices (Directive 93/42/EEC)
Mobile Health
o EU mHealth Code of conduct
o Purpose limitation
o Data minimisation
o Transparency – information to the user
o Privacy by design and privacy by default
o Data subject right
o EU Guidance on mHealth assessment (160+ criteria in 7 categories)
o Usable & desirable
o Credible
o Interoperable & transparent
o Reliability & technical stability
o Safe
o Effective
o Private & secure
o mHealth prescription - example in Catalonia – Spain
Data protection
2016 new regulation & directive introducing 4 main rights for EU citizens (and obligation for companies) regarding their personal data:
o Obligation for companies to collect individual consent for data use
o Obligation for companies to communicate any cyber attack and failure in data security
o Obligation for companies to nominate a representative of the company for data protection
o Right for all EU citizen to erase all data

15. Who are the customers?
Business models are mainly fees for services or products
o Some cases of Bundled payments (chronic diseases in Germany, (experimental) France…)
o Additional digital services to private insurances contracts (market differentiation)
o Personal health budget in UK
Different targets for each topic:
o For Health: national social insurance (mainly tax-based), regional/local health trusts,
hospitals, private insurances…
o Examples
o Health IT
o Hospitals CIOs
o National ministries and regional health agencies CIOs & managers
o Private insurances…
o Chronic Diseases management solutions
o Mainly public/social insurances and institutions (covering around 90% of the
costs in most of the countries
o Some private insurances (impacted by around 10% of the costs)
o For Ageing: local authorities are purchasers supported by national funds (tax-based),
private insurances, consumers…
o For Wellness: consumers, some local authorities (tax-based)

16. EU trends
Paradigm switch: from curative to preventive
Personalised health + Big Data, AI & Data analytics
Behaviour change, through VR/AR, Gaming, …
Mobile Health
Smart cities
Ageing technologies
o Active Assisted Living (AAL)
o Silver/Longevity Economy

17. Resources
European Connected Health Alliance (ECHAlliance)
www.echalliance.com
mHealth code of conduct
https://ec.europa.eu/digital-single-market/en/news/code-conduct-privacy-mhealth-apps-
has-been-finalised
mHealth assessment guidelines
https://ec.europa.eu/digital-single-market/en/news/open-stakeholder-meeting-mhealth-
assessment-guidelines-presentations-and-survey
Medical devices regulation
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/
medical-devices_en
OECD reportshttp://www.oecd.org/health/health-at-a-glance-europe-23056088.htm

18. European Connected Health Alliance
Bringing Together the future of Health, Social Care & Wellness
www.echalliance.com / info@echalliance.com
Contact
Julien Venne, Strategic Advisor, julien@echalliance.com