Joint Action addressing differences in national General Data Protection Regulation (GDPR) implementation in the health sector, including the European Health Data Space and the health data use

Martin DorazilDG SANTE ERNs and Digital Health

“We need to make the most of the potential of e-

health to provide high-quality healthcare and

reduce inequalities. I want you to work on the

creation of a European Health Data Space to

promote health-data exchange and support

research on new preventive strategies, as

well as on treatments, medicines, medical

devices and outcomes. As part of this, you

should ensure citizens have control over their

own personal data.”

Mission letter of Stella Kiyriakides

Commissioner for Health

EHDS – why?

As part of this, you should ensure citizens have control over their own personal data.”

I want you to work on the creation of a European Health Data Space to

promote health-data exchange

support research on new preventive strategies,

as well as on treatments, medicines, medical devices and

outcomes.

“We need to make the most of the potential of e-health to provide high-quality healthcare and reduce inequalities.

What?

Use of health data for:

• Better healthcare

• Better policy making

• Better research and innovation

How?

3 pillars of action:

• Data governance and rules

• Data quality and interoperability

• Infrastructure and technology

European Health Data Space

Quality of Data InfrastructureGovernance

Better Research

and Innovation

Better Policy

Making

Better

Healthcare

Legislative and

non-legislative

measures on

governance and

rules for primary

and secondary use

of data, respecting

GDPR (data for

healhcare, policy

making, reserach

and innovation)

AI framework (incl

AI&liability)

Uptake and

develop the

EHRxF

FAIR-ification of

health data for

primary and

secondary use

MyHealth@EU

ERN-CPMS

1+mil genomes

Access of regulators

to data

Linking repositories

in MS, including

data permit

authorities,

registries and other

databases

Images database

Research

infrastructures

Matrix of the EHDS

Joint Action on EHDSObjectives:

• Technical support for the development of guidelines on the use of medical information for public health and research

• Preparatory work towards the European Health Data Space, by developing proposals for governance model and options for data-sharing, data quality and data infrastructure

• Support the EU, the national authorities and medical community to agree on semantic interoperability guidelines (e.g. data sets, data models, vocabularies), ways of data anonymization, adhering to the FAIR principles

• Support the EU, national authorities and the IT community to agree technical interoperability guidelines (e.g. architecture, message exchange protocols – patterns - profiles, and building blocks)

The results of the JA may feed into future legislative or non-legislative framework for the European Health Data Space

1. EHDS - governance• Preparatory work: Workshops & study on primary and secondary use of health data (2020: 29 Jan, 11 Mar, 29 Apr)

– Mapping of GDPR implementation

– Governance structures for secondary use of health data

– Access of regulators to health data

Study on regulatory gaps in cross-border digital healthcare (to be launched in Q1 2020)

– Digital services: telehealth/m-health

– AI – liability, regulators, rules, needs, standards

– Evaluation of article 14 of Directive 2011/24 (eHealth Network)

1. EHDS Governance: JA contribution

• Options for a Data Governance model for the European Health Data Space, complementing the European Data Spaces horizontal framework (also taking into account the mapping on GDPR)

• This should also include functions and responsibilities of the relevant actors

• Options for guidelines on using health data for research and policy making;

• Options for guidelines on Ethical, Legal and Social issues in the European Health Data Space;

• Options for Economics models focused on the sustainability of European Health Data Space.

[Code of Conduct for secondary use of health data to be externalized from the JA in a separate action]

2. EHDS: Data quality and semanticinteroperability

• Commission recommendation on

Electronic Health Record Exchange Format

• Making data Findable Accessible,

Interoperable and Reusable (FAIR principles)

2. JA contribution on data quality

• Options for a Data Quality framework encompassing

semantic interoperability and FAIR principles relevant for the

EHDS: mapping, metadata, vocabularies, data models

– Electronic health records (taking into account EHRxF)

– Registries

• Anonymization and pseudomisation techniques

• Use of synthetic data

3. EHDS: Infrastructure and technology

• What is being done: – MyHealth@EU– ERN– 1+ million genomes initiative– Existing research infrastructure

• New projects: – Upscale of MyHealth@EU– Use of data for policy making, research and innovation

3. Infrastructrure: JA contribution

• Options for an Infrastructure architecture

and technical interoperability

guidelines/agreements to enable European

Health Data Space services

JA budget

• EUR 1 500 000

– [Code of Conduct to be supported

outside the JA]

Thank you!

DigitalSingleMarket@DSMeu

EU_Health@EU_Health

DG Health and Food Safety

http://ec.europa.eu/health/ehealth/policy/index_en.htm