1

European Health Data Spaceand digital health actions on cancer

Ioana Gligor

Head of unit European Reference Networks and

Digital Health, DG SANTE

Ceri Thompson, DrPH

Deputy Head of unit, DG CNECT

eHealth, Well Being and Ageing

A European Health Data SpaceOBJECTIVES

SCOPE & EXPECTED IMPACT

Use of health data

(primary)

• Access and control of patient over their data & exchange

of health data (incl. cross-border) for healthcare provision

• Digital health services and products (including telehealth

and m-health);

Re-use of health

data

(secondary)

• Research, innovation

• Policy and regulatory decisions

High quality & safe

healthcare provision

Facilitated research &

innovation Data-enabled policy-

making

Timely and simplified exchange of and access to health data

MEANS

Legal / Governance Quality of data Infrastructure Capacity building

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EHDS: What are the problems?

Use of health data for healthcare

(primary)

Re-use of health data

(secondary)

Sharing of healthdata for healthcare

• Limited control to and access to patients

• Repeated tests and high costs

• Insufficientexchange of healthdata

• Limited interoperability between health care providers

Single market for digital health products and

services

• Uneven national legislative frameworks

• Uneven quality / interoperability frameworks

• Uneven proceduresfor prescriptions, reimbursement, liability

Access to healthdata for research, innovation, public

health policy making

• Low re-use of health data

• Cumbersome cross-border access to health data

• Fragmented digital infrastructures

Artificial Intelligence

• Limited provision of data for training of AI

• Difficulties for regulators to evaluate

• AI algorythms

• Uncertainty on AI liability in health

Cross-border healthcareDirective

GDPR

Data Governance Act

AI regulation

4

EHDS: Articulation with EU regulatory framework

EHDS

- health data for healthcare

- Control of patients over

their health data

- Use of data for research,

policy making, regulatory

decision

- Provision of tele-health

and m-health, including

cross-borders

- Clarifying use of AI in

health

1a. Use of data for healthcare

Primary use of health data (EHDS 1/MyHealth@EU)

5

6

Access to health data in digital format

Today, a large number of EU citizens and healthcare professionals

cannot access health data in a digital format. Data are often available

in paper, or only a limited set of data categories are available in digital

format.

Interoperable health data

Tools and infrastructure

Health data is collected in such a way, that the format is different

everywhere. This makes it impossible to understand the meaning of

health data in different contexts. Therefore, interoperability standards

are required to promote wider use and understanding.

Member States organise health data access through different means.

Some member states have patient or professional portals at the level

of healthcare provider, region or nation, while others have apps or

personal data space solutions. Also, registries of who should have

access are also local, regional or national solutions.

• Main challenges relate to adoption, deployment and integration of digital

health (particularly true in cross border settings)

• Important elements

• Control of patients over their own health data, including tele-health/m-health

• Use of cross-border infrastructure for health data exchanges (My@HealthEU)

• Support assessments and guidance on assessment criteria (in collaboration with HTA

bodies, medical devices etc.)

Digital health (tele-health and m-health)

Reimbursement Interoperability Labelling/certificationData privacy and

liability

EHDS1: rules: Commission Recommendation on a

Electronic Health Record Exchange Format

Common technical specifications (baseline)

Initial health information domains:

• patient summaries

• ePrescriptions

• laboratory reports

• medical images and reports

• hospital discharge reports

Interoperability specifications

• HL7 CDA

• DICOM

• IHE profiles

Incremental and selective approach

• adopting, refining, and maintaining the specifications of the European EHR exchange format

EHDS1: MyHealth@EU: cross-border exchange of patients’ data

patient summaries and ePrescriptions: 7 MS live, 15 MS in 2021 > 2021: images, laboratory results, discharge reports; access of patients to their health data

2. Use of data for research, policy making and AI

Secondary use of health data

10

Secondary use of data in the EHDS

Health data from patients

and healthcare professionalsReuse of health data by

researchers, policy-makers

and industry

Rules, protocols, infrastructure

and governance

Granting researchers, policy-makers and industry access to health data across

borders in an interoperable, digital format

Other research data

Targets

2021: Pilot infrastructure

2025: EU-wide infrastructure

Testbed (proof of concept)

Governance

IT and data infrastructure

Demonstrator

Cross-country ecosystem

Secondary use of health data

Pilot project EHDS2: motivation

EU4HEALTH

Inception Impact Assessment:

https://ec.europa.eu/info/law/better-regulation/have-your-

say/initiatives/12663-A-European-Health-Data-

Space-

Public consultation (3 May – 26 July

2021)

Impact Assessment(Q3 2021)• Study on Assessment of the EU

Member States’ rules on health data in the light of GDPR (Q1 2021)

• Study on regulatory gaps, including evaluation D. 2011/24/EU, digital health services, AI (Q2 2021)

• Studies to support the Impact Assessment (Q3 2021)

• JA TEHDAS 2021

Consultation EDPS

Legalproposal (Q4

2021/Q2 2022

13

EHDS: next steps

National level investments

• National funds

• RRF

• ERDF

• ESF+

• InvestEU

EU level investments

• EU4Health

• DEP

• Horizon Europe

14

Budget

A new EU state of the art platform for innovators to pilot technologies that target

cancer, and demonstrate the power of AI and digital technologies to beat cancer

European Cancer Imaging Initiative

Combining and focusinginitiatives on the

development of resources for innovators

Enabling the next generation of

diagnostics and treatment for

cancer patients

• Anonymised patient cancer

imaging available to innovators

• Testing and experimentation

facility supported by dedicated

Digital Innovations Hubs for

health

• Engaging with

stakeholders across the

ecosystem of hospitals,

researchers and innovators

• Support on regulatory

aspects of AI

H2020 projects portfolio: cancer imagingChaimeleon EuCanImage ProCancer-I Incisive Primage

Accelerating the lab to market

transition of AI tools for cancer

management

A EU cancer image platform linked

to biological and health data for

next-generation AI and precision

medicine in oncology

An AI Platform integrating

imaging data and models,

supporting precision care

through prostate cancer’s

continuum

A multimodal AI-based toolbox

and an interoperable health

imaging repository for the

empowerment of imaging analysis

related to the diagnosis, prediction

and follow-up of cancer

PRedictive In-silico Multiscale

Analytics to support cancer

personalized diaGnosis and

prognosis, Empowered by

imaging biomarkers

Setting up an EU-wide

structured repository for

health imaging data as a

distributed infrastructure to

be openly reused in AI

experimentation for cancer

management.

Building a highly secure,

federated and large-scale

European cancer imaging

platform, populated with new

data from 25 000 subjects

and cross-linked to biological

and health repositories

through the European

Genome–phenome Archive.

Establishing a validated

AI Platform integrating

imaging data and models

to support precision care

and clinical decision

making for prostate

cancer treatment

Establishing a pan-European

federated repository of

medical images; developing

and validating an AI-based

toolbox to enhance existing

cancer imaging methods;

developing an automated,

machine learning-based

annotation mechanism.

Establishing a cloud-

based platform to support

decision making for

clinical management

based on the use of

novel imaging

biomarkers, in-silico

tumour growth simulation

and machine-learning

based translation into

predictors for Clinical End

Points

Lung, breast, colorectal

and prostate cancer

Colorectal, breast cancer Prostate cancer Lung, breast, colorectal and

prostate cancer

Neuroblastoma and

Diffuse Intrinsic Pontine

Glioma

BD2 Decid

e

Big Data and models for personalized Head and Neck Cancer decision support

Decision Support System linking population-specific epidemiology and behavioral data, patient-specific genomic, pathology, clinical and imaging data with big data techniques against Head and Neck Region Cancers

Bounce

Supporting clinical decision making for

breast cancer

building a decision-support system for breast cancer patients to establish

a predictive model of patient outcomes

iPC

Supporting clinical decision making for paediatric cancers using virtual-patient models – iPC

addressing paediatric cancers through in-silico avatars to provide personalized diagnostics and recommended treatment options

H2020 projects portfolio: decision support systems

CAPABLE• CAncer PAtients Better Life

Experience - A cancer patient coaching system combining AI and Big Data for predictive models

ONCORELIEF• A digital guardian angel

enhancing cancer patient’s wellbeing and health status improvement following treatment

LifeChamps• A collective intelligence

platform to support cancer champions

ASCAPE• Artificial Intelligence

Supporting Cancer Patients across Europe

FAITH• A Federated Artificial

Intelligence solution for moniToring mental Health status after cancer treatment

BD4QoL• Big Data Models and

Intelligent tools for Quality of Life monitoring and participatory empowerment of head and neck cancer survivors

CLARIFY• Cancer Long Survivors

Artificial Intelligence Follow Up

PERSIST• Patients-centered

SurvivorShIp care plan after Cancer treatments based on Big Data and Artificial Intelligence technologies

QUALITOP• Monitoring QoL after cancer

ImmunoTherapy - an Open smart digital Platform for personalized prevention and patient management

Call H2020-SC1-

DTH-01-2019:

Big data and

Artificial

Intelligence for

monitoring

health status

and quality of

life after the

cancer

treatment

35 000 000 EUR

H2020 projects portfolio: quality of life

Pilot project: Develop Artificial Intelligence for diagnosis and treatment of paediatric cancer – EU4Child project

Objectives

• Support the development of multi-national approaches to facilitate capturing

data on paediatric cancer from multiple sources

• Build a multi-stakeholder network to explore the applications of Artificial

Intelligence technologies in paediatric cancer

• Develop a state-of-the-art report to help understanding the challenges, needs

and gaps in capturing data on paediatric cancer across the EU/EEA,

developing a framework to find solutions to bridge existing gaps

• Pave the road to a one-stop shop European point of access for integrated

healthcare and research data platforms that collate clinical data

• Create a multi-stakeholder network to connect and facilitate the exchanges

and dissemination of best practices in clinically relevant Machine-Learning

and Artificial Intelligence technologies between all relevant stakeholders

Financed under the EP programme ‘Pilot

Projects and Preparatory Actions’

1 000 000 EUR available, 2 years

EU4ChildRecently launched

Digital twins

Health in Digital Europe (WP 2021/22)

Data spaces

Genomics

Cancer Imaging

Testing and Experimentation

Facilities

TEF

for

Health

Cybersecurity and trust

Support to the health sector

Accelerating best use of

technologies

Cloud, data and Artificial Intelligence

Uptake of digital solutions in Health and

Care

An ecosystem for digital twins in healthcare

€20m

1st call

48mo

€18m

2nd call

36mo

€1m

1st call

24mo

€5m

1st call

24mo

€30m; 2nd call;

48-60 months€10m; 2nd call;

up to 24 months

… plus activities under advanced skills; benefits through HPC and cloud infrastructures; European Digital Innovation Hubs…

Subject to adoption of the DIGITAL programme

Thank you

© European Union 2021

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