the digital health society · empowered citizens and adequate data availability at the point of...

The Digital Health SocietyWebinar 2nd October 2017

Welcome & introduction

Ain AAVIKSOODeputy Secretary General for E-services and Innovation

at Ministry of Social Affairs of Estonia

Brian O’CONNORChair at ECHAlliance

EU Presidency 2017-II (Estonia) Platform to createthe desired meaning for e-health

Ain Aaviksoo, MD MPH

deputy secretary general for e-services and innovation (CIIO)

04.07.2017

Free movement of data in healthcaremakes difference through hitting the triple aim

Increased access and safety in healthcare can be achieved through empowered citizens and adequate dataavailability at the pointof care

Sustainability of health systems will be supported by value-based approach.

New economic opportunities, jobs and investment will be created using data-driven health care innovation.

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Health data should be used securely, not to be secured from being used!

Digital Society Recipeof Three

Datagovernance

Techno-logy

Legalframework

eHealth focus areas for Estonian EU presidency

1. The right of citizens to control the processing of their health data comfortably and electronically should be realized in practice

2. Wider use of health data for research and innovation

EU General Data Protection Regulation facilitates betteruse of personal data

Privacy means that

personal data

should not be secured

from being used, but

to be used securely

© C

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yrig

ht

Digital Health Society

eHealthTallinn2017.ee | #eHealthTallinn | @eHealthTallinn2017

eHealth highlights of Estonian EU Presidency (July-Dec 2017)

✓ Tallinn Stakeholder Declaration on eHealth

✓ Task Forces ja Commitments on large impact cross-border activities

High level eHealth Conference„Health in the digital society

Digital society for health“

October 16-18, 2017 | Tallinn

EU Council Conclusionsby Health Ministerson eHealth

✓ Task Forces to deliver action commitments- 4 in operation- 1 in preparation

Digital Health Society -

✓ Digital Health Society Tallinn Declaration

✓ Sustained energy to support large-scale digitalhealth implementation in Europe

building future with EVERYBODY in the same room

Estonian EU Presidency in support of digitaltransformation of healthcare for European citizens

The Digital Health Society

The Declaration The Task Forces The Event

The DHS Declaration

Consultation process from 4th of July to 31st of August

125+ inputs from across Europe

Contributors = multi-stakeholders group(policy-makers, patients groups, industry, academics, healthcare professionals, insurers…)

Release of new version: 10th October

Co-signature by the contributors and all interested stakeholders

Information and contact: http://echalliance.com/?page=digitalhealthsociety

http://echalliance.com/?page=digitalhealthsociety

The DHS Task ForcesConvergence roadmap on interoperability standards and Digital Tele healthcare

protocolLed by Erik GERRITSEN, Secretary General of the Ministry of Health of Netherlands

Citizen-controlled data governance & Data DonorsLed by Angela Brand, Professor at Maastricht University

Legal framework facilitating the free flow and the 2nd use of health dataLed by Bleddyn REES, Digital health expert and lawyer at Osbourne Clarke

Digital transformation & change management in health and social care

organisationsLed by Richard CORBRIDGE, CIO Health Service Executive and CEO of eHealth Ireland

Task forces are now open to contributions

Organisations and individuals are invited to propose

tangible actions & projects to progress on these topics

PRESENTATIONS TASK FORCES

TASK FORCE 2

DATA DONORS &

CITIZEN-CONTROLLED DATA GOVERNANCE

FOR SECONDARY USE

Where we are I/II

Technical solutions & tools: e.g.

• Bitcoin/Blockchain

• Artificial Intelligence (AI)

• European Open Science Cloud

• Integrated Health Care Enterprise (IHE) Standard

Political committment & tools:e.g.

• “citizen-centered” approaches

• Health in All Policies (HiAP)/Health in All Politics

• X-Border Healthcare Directive

TF2 – Data Donors & Citizen-controlled data governance

for secondary use

Where we are II/II

European frameworks & principles:e.g.

• Four common values and principles in EU healthcare systems: solidarity, universality,

access to good quality care, equity (“Together for Health” strategy, 2007)

• Solidarity, Subsidiarity, Proportionality (!)

• Digital Single Market (DSM) Strategy: “Access to own health data”

• Estonian Presidency: “Fifth” EU freedom -“Digitalisation/Gigabit Society”?


for secondary use

What needs to change

• Current models for governing data for better health and health care are based on an

outdated assumption of data protection and data security: This does not work for the

future!

• A good governance model is missing!


for secondary use

What we need

A Good Governance Model

• for citizen-owned and -controlled data

• allowing for both, (1) free flow of non-personal data and (2) access and re-use of data

for future known and unknown purposes

• going beyond health, health data and IT solutions for health

• understanding data as the essential part for health research, healthcare and health

improvement

• in line with e.g.

• the forthcoming EU Commission policy paper on “The Transformation of Health

and Care in the Digital Single Market”

• “Cloud Council” recommendations


for secondary use

The Solution

“A pan-European Good Governance Model putting the citizen in the driver’s

seat to make best use of technological innovations and (health) data

for individual benefit and the common good

= (Health) Data Cooperatives”

This means:

The citizen is the creator, the “natural” interpreter, the controller, the owner and

the sharer of the data for primary and secondary use for all kinds of purposes

in a trusted entity – even beyond the health sector.


for secondary use


for secondary use

Development of an European good governance model

for citizen-owned and -controlled data: within the

global context, going beyond the health sector

Definition:

A cooperative is "an autonomous association of

persons united voluntarily to meet their common

economic, social, and cultural needs and aspirations

through a jointly-owned and democratically-controlled

enterprise“.

(International Cooperative Alliance)

More at: https://mydata.org/declaration


for secondary use

Development of an European good governance model

for citizen-owned and -controlled data: within the

global context, going beyond the health sector

In line with “My Data” movement:


for secondary useWhy a cooperative model?

- Truly Bottom-up solution (citizen in the driver´s seat) and truly democratic solution

for Europe and beyond

- Can include varies types of data donors (citizens, companies, administration, etc.)

- One person = one vote

- Data can be stored in an intelligent cloud

- All over Europe established = all legal problems solved

- Citizen (human being) as the interface („super-computer“/holistic data integrator)

- Horizontal use of data/Health in all Policies (HiAP)

- Data commons/knowledge commons/commons arrangements

- Balancing personal benefit and common good

- Benefit/ incentives for provider and user (business models)

- Useful for primary and secondary use of data

- There is even a statute for a European Cooperative Society(1)

(1) „The European Cooperative Society (SCE) is an optional legal form of a cooperative. It aims to facilitate cooperatives' cross-

border and trans-national activities. The members of an SCE cannot all be based in one country. The SCE is required to unite residents from more than one EU country"

Next steps I/IIFunding & Pilots

Funding:

e.g.

• Smart cities

• European Investment Bank (EIB)

• EU Member States

• DG CONNECT and DG SANTE

• IMI


for secondary use

Next steps II/IIFunding & Pilots

Pilots:

e.g.

• “Tool box” for (Health) Data Cooperatives

• Business to business money initiatives (VKB)

• X-border implementation

• Depending on stakeholders and local needs:

• Quartier/neighbourhood management

• Hospital management

• Disease-specific self-help groups

• Social networks

• Smart city


for secondary use

Members Phase 1o Angela Brand (Maastricht University, NL) / lead

o Robert Madelin (Strategy Consultant, BE)

o Matthias Reumann (IBM Research, CH)

o Richard Bergstrom (SICPA & Hoelzle Consulting,

CH)

o Antti Poikola (Helsinki University of Technology, FI)

o Ricardo Baptista Leite (Member of National

Parliament, PT)

o Nikolaos Evangelatos (Paracelsus Medical University

Nuremberg, DE)

o Helmut Brand (Maastricht University, NL)

o Lada Leyens (swissmedic, CH)

o Peter Kapitein (Inspire2Live, NL)

Phase 2Any organisations willing to join the initial group and

commit to the roadmap defined by the TF2

recommendations

Please contact:[email protected]


for secondary use

Digital Health Society Task Force 3: Legal Framework

facilitating the free-flow & 2nd use of health data

2 October 2017

osborneclarke.com

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1. Why? (Background)

• EU has no power to harmonise national health laws.

• Data is very important for:

‒ the development of new health and care services & products;

‒Patient safety and quality of services;

‒ academic research, understanding, policy & innovation;

‒ whole population management & sustainable healthcare systems;

• Health data must include both health and social care data.

• Truly integrated care (both health ( primary and secondary) and social care ) is facilitated and

enabled by data.

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2. Nature of proposed legal framework

• Outside of the formal EU legal framework.

• "European Health and Care Data Convention".

• 9 Principles.

• Each region/country signatory agrees to pass any required national laws to the extent

necessary to adopt the Principles.

• Recommendation: The Digital Health Society ( DHS) considers whether the Health and Care

Data Convention should be binding or non binding on signatories.

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Objectives

• Create common legal rights and obligations for Citizens and Patients to:

− underpin and enable the flow of health and care data and 2nd use;

− strengthen Citizen trust by increasing transparency and confidentiality;

− facilitate greater use and flow of health and care data in regions/country and between

regions /countries for the tangible benefit of individuals and society driven by practical

positive use cases;

• Recommendation: DHS should review exactly what information/data should constitute a

health and care record and create a priority list of use cases both for individuals and society.

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Principle 1 – Duty to create and maintain electronic health and care

record(the "Record")

• In State funded systems there should be an obligation to create a single [aggregated]

integrated Record for every Citizen/Patient underpin and enable the flow of health and care

data and 2nd use;

• Every Record should be able to note:

− any consents or refusals ( from time to time) to share information for treatment or research;

− permissions to share information with family;

− Powers of Attorney given by the citizen/patient;

• Recommendation: DHS propose exactly what information/data constitutes a "Record".

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Principle 2 – Comply with the Law & Ethics

• All access to Records must be lawful and specifically comply with all EU (e.g. GDPR) and

national laws.

• Citizens and Patients have the right to privacy and confidentiality and for health and care

systems to keep their confidential information safe and secure.

• Health and Care workers must comply with applicable professional ethical obligations.

• Consent needs to be freely given and 'informed'.

• Recommendation: DHS considers whether "informed" needs a clear standard definition.

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Principle 3 – Access for citizens & patients

• The right for Citizens & Patients (including authorised family) to access their health and care

Records created by health and care providers (whether paper and/or electronic) free of charge.

• Recommendation: DHS considers how Principle 2 may apply to private health and care

providers or insurance based systems.

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Principle 4 – Control of the Record

• The right for Citizens and Patients to control access to their Record by anyone including health

and care professionals who will need consent to access the Record.

• Right for health and care professionals to access a Record in an emergency to treat a Patient.

• Recommendation: DHS should clarify the extent to which "implied consent" should apply, if at

all, for the treatment of Patients and the provision of care services to Citizens.

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Principle 5 – Communication and transparency

• The benefits of health data both for individuals and society need to be clearly and regularly

communicated to all Citizens and health and care workers.

• The use of data by health and care providers, researchers and public health organisations need

to be clearly explained to Citizens and Patients.

• There should be ongoing education and training for health and care workers and information for

Citizens and Patients on the use and benefits of data and Records as well as information

governance and compliance.

• Improved communication, knowledge and transparency will assist obtaining lawful consents

especially for GDPR purposes.

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Principle 6 – Research Consent

• All use of Patient or Citizen identifiable health and care data requires explicit consent .

• The use of anonymised data does not require consent.

• Recommendation: DHS considers whether Citizens and Patients should be able to sell access

to their Record if they wish.

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Principle 7 – Research uses

• Do not use personal confidential information unless it is absolutely necessary.

• Use the minimum necessary personal information.

• All use of identifiable personal health and care data requires consent.

• When research is completed publish simple summaries for Patients and Citizens to show how

their data was used and the benefits the research achieved.

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Principle 8 – Duty to share health and care data.

• Maximise use of the Record for the treatment of Patients or the provision of care services to

Citizens.

• Health and Care workers have a duty to share information in the Record where appropriate for

treatment of Patients or the provision of care to Citizens. This duty can be as important as the

duty to protect Patient and Citizen confidentiality.

• Recommendation: DHS considers what guidelines are needed to permit the sharing of data in

the Record by Health and Care workers.

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Principle 9 – Safe havens

• Accreditated Safe Havens should be established for cross border European population based

research and statistical analysis, audit and service improvement.

• Safe Havens might be national health and care organisations or research institutions.

• Safe Havens could be used for data donations by Patients and Citizens.

• Recommendation: DHS considers technical solutions for Safe Havens such as federated data

bases where data never leaves national data bases or cloud solutions.

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Conclusions

• It is important to remember the Terms of Reference where to utilise existing work and the

Principles draw heavily from the UK Electronic Patients Records ( Continuity of Care) Bill 2013

and the Caldicott Principles.

• The Principles will need to be reviewed against the work of the other 3 Task Forces to see if

they need revising.

• The Principles are intended to be high level and to form the basis of more detailed work in

order to create a coherant proposal for a European Health and Care Data Convention.

Bleddyn Rees

Digital Health Society (DHS)Report from EU Task Force Four

Aim and Objectives

To produce a set of recommendations for implementing digital transformation & change management in health and social care organisations

The ultimate aim of the TF is to identify a set of methodologies and toolkits which can be used at a country/regional level or at a health and social care provider level to manage digital health change.

We have produced a report as a first step in that direction – it collates research, reports, recommendations and experiences related to digital health transformation provided by the TF4 members.

Task Force 4 Members

TFnº Surname First name Organisation email

TF4 CORBRIDGE Richard HSE / eHealth Ireland [email protected]

TF4 O'LOUGHLIN Maria HSE / eHealth Ireland [email protected]

TF4 QUINLAN Maria ARCH / University College of Dublin [email protected]

TF4 ROONEY Louise ARCH / University College of Dublin [email protected]

TF4 MCGOVERN Marcella ARCH / University College of Dublin [email protected]

TF4 BATCHELOR James University of Southampton [email protected],

TF4 BONFIGOLI Elena Microsoft [email protected],

TF4 CASEY Brendan SwiftQueue [email protected]

TF4 COLGAN Elaine MoH Northern Ireland [email protected],

TF4 CROOKS George Digital Health Institute [email protected]

TF4 DONAGHY Sean HSCNI [email protected],

TF4 GARCIA-CUYAS Francesc TicSALUT [email protected],

TF4 GRASS Étienne APHP (Paris Region hospitals) [email protected],

TF4 GRIFFITHS Andrew NHS Wales [email protected],

TF4 LUCAS Georgina NHS England [email protected],

TF4 MARTI Tino TicSALUT [email protected],

TF4 MARTINEZ Jordi TicSALUT [email protected],

TF4 MULROE Eibhlin iCorg [email protected],

TF4 ROODHOUSE Eve NHS Digital [email protected],

TF4 SMART William NHS England [email protected],

TF4 VELASCO César Vall d'Hebron Hospital [email protected],

TF4 BESCOS Cristina Phillips (telehealth) [email protected]

Methodology

Three conference calls organised by the ECH Alliance – TF4 members were presented with the overall objectives of TF4 and asked to contribute their experiences, tools and methods for managing digital health related change.

The Applied Research for Connected Health (ARCH) centre in University College Dublin collated the information provided by the task force members into a report. Further to the group conference calls, the ARCH team contacted each TF4 member individually, and had one-to-one calls to gather their key learnings related to change management.

Within the European region TF4 members have been involved several key research programmes which have explored the specifics of change management as it relates to digital health specifically. These have provided valuable insight for the TF4 report, allied with other individual task force member contributions.

Key Findings

• The key fundamentals of money, technology and people need to be in place to support any digital health implementation.

• These three fundamentals have a range of components which need to be considered from a macro, organisational, and individual perspective.

Key Findings

• Digital health implementations are often large-scale transformation projects.

• Organisational readiness for change must be assessed at the outset so that necessary supports and resources can be identified where needed.

• Best-practice project management tools are needed at the organisational level to ensure that the project can be successfully scoped and delivered.

• Learning cycles (e.g. Plan, Do, Study, Act) can assist in refining and spreading the change.

Key Findings

PRESENTATIONS TASK FORCES

Action group preparing for a new DHS Task Force”Cross-country European Health Data Cooperation Network”

Marie Rønde

Head of Secretariat

Danish Ministry of Health

Focus of DHS Task Force 5

• The scope of Task Force 6 – as outlined by the Estonian Ministry of

Social Affairs – is to create a partnership of EU Member States

supporting the secondary use of health data especially for

research and development purposes in the interest of patients.

• The purpose is to respond to the challenges of identifying and

accessing relevant health data across the diverse infrastructure,

data governance and legal frameworks of MS.

• It is relevant in an era of precision medicine to enable a secure

and transparent secondary use of health data on a European level

Objectives and Initiatives

Given diversity in MS infrastructure and legal frameworks, a gradual

phased approach is proposed. A first step would include:

1. Analysis of barriers and opportunities for further enabling of access

to health data for secondary use across MS - focusing on health

challenges that MS cannot overcome independently

2. Health Care Data Overview: Suggests establishment of a common

overview of available data across MS, including information on

standards, access, infrastructure, governance and legal framework

3. Mapping of MS’ initiatives that aim at enabling secondary use of data.

The purpose is to facilitate sharing of valuable learnings and innovative

solutions across MS.

Formation Process and Governance

Formation of DHS Task Force 5:

1. Involving MS with specific interest in working towards the

purposes and objectives presented in the concept note

2. Discussing the concept note at the the conference “Health in

the Digital Society. Digital Society for Health”

3. Revising and specifying the objectives and initiatives

4. Forming a Health Data Cooperation Network of interested MS

Governance of DHS Task Force 5:

• To push Task Force initiatives forward, it is proposed to assign

the responsibility to an existing EU agency (e.g. the EU

eHealth Network) with support from the European Commission

3 mantrasBuilding citizen-driven demand in eHealth

eHealth supporting the value driven and

sustainable health and social services

eHealth as a driver of innovation and

economic development

3 tracks

70+ high-level speakers

700+ attendees

From Europe, USA, Australia,

Canada, India, China…

www.ehealthtallinn-2017.ee

HEALTH in the DIGITAL

SOCIETY

DIGITAL SOCIETY for HEALTH16-18 October 2017, Tallinn

#eHealthTallinn

http://www.ehealthtallinn-2017.ee/

Programme TRACK 01

❮ CITIZENS, PROFESSIONALS & SOCIETY ❯

TRACK 02

❮ DIGITAL INFRASTRUCTURE, DATA & TECHNOLOGIES ❯

TRACK 03

❮ THE ENABLING ENVIRONMENT ❯

Check & Download the full programmehttp://www.ehealthtallinn2017.ee/ehome/252892/560942/

www.ehealthtallinn-2017.ee

http://www.ehealthtallinn2017.ee/ehome/252892/560942/

Next Steps, Sustainability &

ConclusionsAin AAVIKSOODeputy Secretary General for E-services and Innovation

at Ministry of Social Affairs of Estonia

Brian O’CONNORChair at ECHAlliance

Thank [email protected]

mailto:[email protected]

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