ERDR Competition�Who, Why, How and What

AI advocates www.dilaw.fi

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To enable individuals to access, generate, process and transmit more granular health data

Researchers need the individual-level genome data and the linked phenotypic trait data to reveal exactly how genetic variation plays out in disease.

ERDR: Who, Why, How and What?

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Data altruism, will it work?

Experience so far: yes, depends on trust

80 years of

blood donations in Europe

High motivation of patients to share their data

15 million donors in EU¹

91% of people willing to share their data²

¹ https://health.ec.europa.eu/blood-tissues-cells-and-organs/blood_en

² https://www.pfizer.com/news/articles/what_if_you_could_donate_your_data_for_research

Registry

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Systemic data altruism success story

1955

1961

1966

1989

1993

1997

Foundation

Biological�mechanism

Drug development�program

Care Center

Today

FDA approval

(Pulmozyme^®)

The Cystic Fibrosis Foundation case

CF Foundation

Capital: 4.5B USD�for continued R&D

Could ERDR be the European equivalent at scale?

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Data Governance Act enables�Data Altruism in the EU

2023

Data Governance Act

Individual Patients’

Data Donations

Health Data

Synthetic Data

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EHDS Creates Common Rules�for Health Data in the EU

2025

European Health Data Space

Individual’s Right to Access Personal Health Data Free of Charge

Health Data

Single-source

Harmonised Data

for Research Use

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ERDR Foundation

Article 16. Data Governance Act

Article 16

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General requirements for registration �In order to qualify for registration, �the data altruism organisation shall:

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(a) be a legal entity constituted to meet objectives of general interest;

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(b) operate on a not-for-profit basis and be independent from any entity that operates on a for-profit basis;

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(c) perform the activities related to data altruism take place through a legally independent structure, separate from other activities it has undertaken.

Open questions on structure

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Legal structure?

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Board composition?

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Location(s)?

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Long-term funding?

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Role in EU Health Data Infrastructure?

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Human resources?

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Member states + �Third countries

300m patients

EU Member states�30m patients

FIN-EST�360k patients

What should we do with the data

to prepare it for research use?

Data collection

Data engineering

Data science

Use cases

MyData Principles

FAIR Principles

Fit for Research

Depersonalization�Anonymisation

Digital Twins

Synthetic Data

Integration - Annotation

Privacy Preserving ML

Data Tables

Research & Development

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Ideal Registry

Different perspectives, different needs

longitudinal - representative

comprehensive

perfect data coverage

up-to-date - structured variables

easy access to data

linkable with other registers

Researcher

ethical - safe - secure

reliable - equitable - sustainable

Public

transparency - accessibility

scalability - replicability

interoperability - security

confidentiality

Authorities

SITRA / Gaia-X

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Core principles of the Gaia-X model:   

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• Decentralised solutions: build to support independent data structures 
• Standardisation: jointly agreed data structure and naming 
• Interoperability: can connect, access, and exchange data between different dataspaces 
• Discoverability: ensure that the data can be found in and between data spaces 
• Accessibility: automated access management and open for all to join 
• Common rules and shared principles: clear, fair and transparent rules and governance for all participants 
• Traceability: all transactions are recorded and logged  
• Business value: unlock, create and capture the new business value at the ecosystem level 
• European data protection legislation: meet or exceed the regulatory requirements  
• Usability: simple, easy and user friendly 

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• Automated regulation: the software code is readable by machine to comply automatically 
• Compliance as code: the software code prevents the user from deviating from an otherwise agreed code 

Principles to live by

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Rulebook: What should the data governance model be?

ECHA

MyData�Registry

Data Altruism Organisation

Central Control

Trust-based

Public interest

For profit

CoRDS

National BioBanks

ERNs

DeSci

GARD

Global Commission

CFF

dbGaP / EGA

23 and Me

Genomics England

To build trust and enable individual freedom as a regulated entity

PPP

FINDATA

Recap: 20 Years from Human Genome Project

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What’s next?