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The use of personal data for health-related research and demonstrating compliance with the GDPR

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ISC, 27th April 2017

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RAND Study on Value of Health Data

Types of value: core messages

The benefits of health data fall into 3 core categories

For R&D and innovation

For pharmacovigilance and

public health

For health care delivery and

health systems more widely

Source : RAND Europe

Creating supportive health data ecosystems: key findings

1. Collaboration

and coordination

(independencies in

value capture)

2. Public

acceptability

5. Workforce

capacity

4. Data quality and

interoperability

3. Data protection

regulation

Source: RAND Europe

Key Benefits of Health Data

Health service planning, demand management, commissioning,Pharmacovigilance, HTA, reimbursement

R&D efficiencies, improved responseTo patient need, rational reimbursement,New industries - analytics

New types of analysisStronger evidence baseFor funding

Improved decision-makingPatient self-managementCPD

More Personalised careEmpowerment to engage in decision-making

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Who should be responsible for shaping datagovernance arrangements?

How do we align approaches to consent andreuse?

If there are choices/trade-offs to be made toensure public acceptability of uses of data, whichconsiderations are most important to patients?

BBMRI code of conduct:

• GDPR implementation is complex

• GDPR is not alone in the EU’s plans for digital

• Code approach is a good basis for collective engagement and external accountability endorsed by the Commission

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Here’s the question

• Recitals 33,34,53,159,161

• Articles1,4,5,6,9,13,14,15,16,17,18,19,20,21,22,32,34,89

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…and the answer

• Recitals 33,34,53,159,161

• Articles1,4,5,6,9,13,14,15,16,17,18,19,20,21,22,32,34,89

• Recitals and articles in the GDPR which provide some latitude to Member States to shape the GDPR in relation to research

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type status relevance

GDPR Legislation In effect 5/18

Research provisionsVBOCInternational data transfers

***

******

E-privacy Legislation Adopted1/17

Transmission of information

*

IMI Do-it Stakeholdersolution

Minimum consent standards

***

EMA disclosure policy

Policy Technical standards **

standards development

Stakeholder solutions

Various initiatives

Anonymisation, consent, pseudonymisation

***

Personal Data

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type status relevance

Building a European digital economy

consultation Concludes Q2 2017 – normally followed by legislative proposals

Free movementOwnershipAccessLiabilityData portablity

**********

Non-personal data

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Type Status relevance

SANTE-CONNECT JTF Expert group Launched 2/17

M-health code Code of conduct Under review Code for apps developers

*

E-Health network

European Reference networks

Investment –being launched

Exchange of data on rare disease

**

Member state health data initiatives

Normally to advance public health

*

Council of Europe Political/policyguidance

On-going Research ethics and data protection

**

OECD health data governance

Political/policyguidance

Policy frameworkadopted 1/17

Comprehensive framework forgovernance

***

Health Data

Reasons for exploring a cross-sectoral code

• The GDPR provides for the use of codes in implementing the GDPR

• Health Data is a multiple source/multiple user environment

• The Commission has indicated the importance of the “representativeness” of codes

• External accountability

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