Issues

Dependency: the Starter Kit FAIR Data Point uses its own metadata schemas

GenomicDataInfrastructure/system-architecture#129 · opened

on Oct 13, 2026

Open point: whether the filter list of subject-level discovery is public (VII.2.2, VII.2.3)

GenomicDataInfrastructure/system-architecture#128 · opened

on Oct 13, 2026

Dependency: the Genome EDIC must be operational for the 1+MG access paths

GenomicDataInfrastructure/system-architecture#116 · opened

on Sep 28, 2026

Open point: who adopts the system architecture

GenomicDataInfrastructure/system-architecture#113 · opened

on Sep 27, 2026

Open point: when 1+MG data may be processed in the Commission's SPE (VIII.2.2)

GenomicDataInfrastructure/system-architecture#109 · opened

on Sep 27, 2026

Dependency: EHDS requirements for health data access applications (VII.3.3)

GenomicDataInfrastructure/system-architecture#106 · opened

on Sep 27, 2026

Open point: whether one dataset can be of more than one type

GenomicDataInfrastructure/system-architecture#105 · opened

on Sep 27, 2026

Open point: when a national veto applies to 1+MG cohort datasets (VII.4.7, VII.5.1)

GenomicDataInfrastructure/system-architecture#104 · opened

on Sep 27, 2026

Open point: legal basis for returning incidental findings (VIII.11.1)

GenomicDataInfrastructure/system-architecture#103 · opened

on Sep 27, 2026

Open point: repeated consent or objection for healthcare reuse and clinical trials (VII.5.3)

GenomicDataInfrastructure/system-architecture#102 · opened

on Sep 27, 2026

Open point: who informs data subjects after an access decision (VII.5.3)

GenomicDataInfrastructure/system-architecture#101 · opened

on Sep 27, 2026

Open point: review time for healthcare reuse requests (VII.4.3)

GenomicDataInfrastructure/system-architecture#100 · opened

on Sep 27, 2026

Open point: checking that a User is a licensed healthcare professional (VII.4.3)

GenomicDataInfrastructure/system-architecture#99 · opened

on Sep 27, 2026

Dependency: the HealthData@EU implementing act is still a draft

GenomicDataInfrastructure/system-architecture#95 · opened

on Sep 27, 2026

Dependency: data and metadata models from 1+MG Working Group 3 (II.1)

GenomicDataInfrastructure/system-architecture#94 · opened

on Sep 27, 2026

Open point: accreditation of 1+MG IT infrastructure providers (III)

GenomicDataInfrastructure/system-architecture#93 · opened

on Sep 27, 2026

Open point: who decides on pooling for 1+MG compliant datasets (VIII.3.4)

GenomicDataInfrastructure/system-architecture#91 · opened

on Sep 25, 2026

[page] 8.12 Types of dataset

GenomicDataInfrastructure/system-architecture#88 · opened

on Sep 25, 2026

1

Open point: who chooses between the 1+MG compliant and the 1+MG cohort path for a dataset (ADR-0002)

GenomicDataInfrastructure/system-architecture#85 · opened

on Sep 25, 2026

[page] ADR-0002 Who decides on access, per type of dataset

GenomicDataInfrastructure/system-architecture#83 · opened

on Sep 24, 2026

2

[page] 5.3.1 User Organisation registration and user management

GenomicDataInfrastructure/system-architecture#82 · opened

on Sep 24, 2026

[page] 5.3 User Organisation scope

GenomicDataInfrastructure/system-architecture#81 · opened

on Sep 24, 2026

[page] National implementation profile (template)

GenomicDataInfrastructure/system-architecture#76 · opened

on Sep 18, 2026

[page] Guide for implementers

GenomicDataInfrastructure/system-architecture#75 · opened

on Sep 18, 2026

[page] Guide for data protection officers

GenomicDataInfrastructure/system-architecture#74 · opened

on Sep 18, 2026

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Issues

Dependency: the Starter Kit FAIR Data Point uses its own metadata schemas

Open point: whether the filter list of subject-level discovery is public (VII.2.2, VII.2.3)

Dependency: the Genome EDIC must be operational for the 1+MG access paths

Open point: who adopts the system architecture

Open point: when 1+MG data may be processed in the Commission's SPE (VIII.2.2)

Dependency: EHDS requirements for health data access applications (VII.3.3)

Open point: whether one dataset can be of more than one type

Open point: when a national veto applies to 1+MG cohort datasets (VII.4.7, VII.5.1)

Open point: legal basis for returning incidental findings (VIII.11.1)

Open point: repeated consent or objection for healthcare reuse and clinical trials (VII.5.3)

Open point: who informs data subjects after an access decision (VII.5.3)

Open point: review time for healthcare reuse requests (VII.4.3)

Open point: checking that a User is a licensed healthcare professional (VII.4.3)

Dependency: the HealthData@EU implementing act is still a draft

Dependency: data and metadata models from 1+MG Working Group 3 (II.1)

Open point: accreditation of 1+MG IT infrastructure providers (III)

Open point: who decides on pooling for 1+MG compliant datasets (VIII.3.4)

[page] 8.12 Types of dataset

Open point: who chooses between the 1+MG compliant and the 1+MG cohort path for a dataset (ADR-0002)

[page] ADR-0002 Who decides on access, per type of dataset

[page] 5.3.1 User Organisation registration and user management

[page] 5.3 User Organisation scope

[page] National implementation profile (template)

[page] Guide for implementers

[page] Guide for data protection officers