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Recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data

Published by European Data Protection Board

General Data Protection Regulation GPDR International Transfers of Data

These recommendations provide
exporters with a series of steps to follow, potential sources of information, and some examples of
supplementary measures that could be put in place.

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Guidelines 07/2020 on the concepts of controller and processor in the GDPR

Published by European Data Protection Board

Controller Processor General Data Protection Regulation GPDR

The main aim is to clarify the meaning of the concepts and to clarify the different roles and the distribution of responsibilities between these actors.

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EDPB Document on response to the request from the European Commission for clarifications on the consistent application of the GDPR, focusing on health research

Published by European Data Protection Board English

EC Consultation General Data Protection Regulation GPDR

In its guidelines (currently in preparation and due in 2021) on the processing personal data for scientific
research purposes, the EDPB will elaborate further on these issues while also aiming to provide a more
comprehensive interpretation of the various provisions in the GDPR that are relevant for the processing of personal data for scientific research purposes.

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Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (better known as Oviedo Convention) (Article 10)

Published by Council of Europe

Biomedicine Human Rights Patients

It is a framework Convention aiming at protecting the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.

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Recommendation CM/Rec (2016)6 of the Committee of Ministers to member States on research on biological material of human origin

Published by Council of Europe

Biological Materials of Human Origin Biomedical Research Genetics Rights

Member States should protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity, the right to respect for private life and other rights and fundamental freedoms with regard to any research activity governed by this recommendation.

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Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Health-related Research Involving Humans. 2016.

Published by Council for International Organizations of Medical Sciences (CIOMS)

Biobanking Clinical Trials Epidemiological Studies Observational Research

The Working Group decided to broaden the scope of the 2002 Guidelines from “biomedical research”
to “health-related research”. The Working Group considered biomedical research too narrow since that
term would not cover research with health-related data.

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Guidelines 01/2021 on Examples regarding Personal Data Breach Notification

Published by European Data Protection Board English

Data Breach General Data Protection Regulation GPDR Security

This document is intended to complement the Guidelines WP 250 and it reflects the common experiences
of the SAs of the EEA since the GDPR became applicable. Its aim is to help data controllers in deciding how
to handle data breaches and what factors to consider during risk assessment.

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Guidelines 05/2021 on the Interplay between the application of Article 3 and the provisions on international transfers as per Chapter V of the GDPR

Published by European Data Protection Board English

General Data Protection Regulation GPDR International Transfers of Data

Aims at clarifying this interplay between Article 3 and the provisions of the GDPR on international transfers in Chapter V in order to assist controllers and processors in the EU in identifying whether a processing constitutes a transfer to a third country or to an international organisation and, as a result, whether they have to comply with the provisions of Chapter V of the
GDPR.

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Guidelines 04/2021 on codes of conduct as tools for transfers

Published by European Data Protection Board English

General Data Protection Regulation GPDR International Transfers of Data

The aim of these guidelines is to specify the application of Article 40-3 of the GDPR relating to codes of conduct as appropriate safeguards for transfers of personal data to third countries in accordance with Article 46-2-e) of the GDPR.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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Recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data

Guidelines 07/2020 on the concepts of controller and processor in the GDPR

EDPB Document on response to the request from the European Commission for clarifications on the consistent application of the GDPR, focusing on health research

Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (better known as Oviedo Convention) (Article 10)

Recommendation CM/Rec (2016)6 of the Committee of Ministers to member States on research on biological material of human origin

Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Health-related Research Involving Humans. 2016.

Guidelines 01/2021 on Examples regarding Personal Data Breach Notification

Guidelines 05/2021 on the Interplay between the application of Article 3 and the provisions on international transfers as per Chapter V of the GDPR

Guidelines 04/2021 on codes of conduct as tools for transfers

International Sharing of Personal Health Data for Research