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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

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

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)

European Diversity…

…in terms of life expectancy

Eurostat statistics database

European Diversity…

…in terms of population health status

OECD data

Prevalence estimates of diabetes, adults aged 20-79 years, 2013 USA = 9,3%

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)

European Diversity…

…in terms of healthcare activities

OECD data

European Diversity…

…in terms of equipment

OECD data

European Diversity…

…in terms of expenditures

OECD data

European Diversity…

…in terms of type of financing

OECD data

European Diversity… …but universal coverage for basic healthcare

OECD data

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

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

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

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)

Private Insurances main models in EU: o  Complementary insurance: additional coverage on top of the public coverage (France) o  Duplicate: faster access to care or larger choice of providers (Spain) o  Exceptions: Netherlands is only covered by a complex system of private insurers only / Germany

is mixing private non-profit (almost public) and for-profit insurers

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

Resources

European Connected Health Alliance (ECHAlliance) www.echalliance.com mHealth code of conducthttps://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 regulationhttps://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

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