Transparency Portal

Reuse of health data and biological samples for research purposes

The Institute of Myology Association (Association Institut de Myologie in French, hereinafter referred to as “AIM”) contributes to the advancement of research and the improvement of knowledge about muscles and neuromuscular diseases, as well as improving patient care.

As part of its activities, AIM may reuse health data and biological samples collected from patients and healthy individuals for scientific research, evaluations, or clinical studies.

Data concerned by these reuses include the following:

  • Personal data collected during clinical trials and natural history studies sponsored by AIM and centralized in the MyoData Health Data Warehouse (HDW);
  • biological samples (fluids and tissues) and associated personal health data collected from patients by AIM’s Myobank-AFM.

 

The MyoData Health Data Warehouse (HDW)

The MyoData Health Data Warehouse (HDW) is a centralized system that enables the secure storage, organization, and use of health data. It facilitates data analysis and the development of research projects in the field of myology. These studies, based on personal health data, pave the way for new discoveries and are essential for improving knowledge, particularly in the field of rare diseases, where many questions remain unanswered.

The centralization of data, made possible by the MyoData HDW, facilitates collaboration between researchers and may ultimately lead to the development of innovative and personalized treatments.  Epidemiological and medico-economic studies, artificial intelligence-based studies, as well as patient cohort follow-up studies may also be conducted using data from the MyoData HDW.

 

Regulatory framework

The reuse of personal health data and biological samples within the context MyoData HDW is strictly regulated by:

  • General Data Protection Regulation (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC);
  • French law on data protection « Informatique et Libertés » in its latest version in force (Law No. 78-17 of January 6, 1978 on information technology, files, and civil liberties);
  • The guidelines of the French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés – CNIL) on the processing of personal data for the creation of data warehouses in the health sector;
  • Deliberation of the French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés – CNIL) No. 2018-155 of May 3, 2018, approving the reference methodology for the processing of personal data implemented in the context of research not involving human subjects, studies, and evaluations in the field of health (MR-004)
  • The certification standard for hosting personal health data (decree of April 26, 2024).

 

Your rights  

In accordance with Articles 15 to 18 and 21 of Regulation (EU) 2016/679 of April 27, 2016 on the protection of personal data (GDPR), you have the following rights:

  • Right to access your personal data (right of access): you may request from the Institute of Myology Association a copy of your personal data that it holds.
  • Right to correct your personal data (right to request the rectification) you may request that the Institute of Myology Association correct any inaccurate personal data.
  • Right to be informed (right to be informed): you have the right to be informed about research projects that are being conducted using your personal data or biological samples. To this end, a list of past and current projects conducted using MyoData HDW data is provided below.
  • Right to object to the reuse of your personal data in the Health Data Warehouse in general, or withdraw from a specific research project (right to object). The research projects conducted using MyoData HDW’s data are listed below. If you do not object to the reuse of your personal data and you subsequently change your mind, you may object at any time, without having to provide reasons. Your decision to object will apply prospectively and will not affect the research projects already conducted.

Myobank-AFM

Myobank-AFM specializes in the collection, preparation, storage, and provision of biological resources, such as human fluids and tissues, derived from surgical residues. Thanks to its medical and scientific expertise, Myobank-AFM helps researchers advance knowledge in the field of myology.

You have consented to the use of your biological samples and the processing of your personal data by AIM, and more specifically by Myobank-AFM. Accordingly, a list of past and ongoing research projects conducted using these biological samples and data is provided below.

If you wish to withdraw your consent, you may send us the completed and signed withdrawal of consent form by email at the following address: dpo@institut-myologie.org or by post to: Association Institut de Myologie, Data Protection Officer (DPO), Groupe Hospitalier Pitié- Salpêtrière Bâtiment Babinski, 47/83 boulevard de l’Hôpital, 75 651 Paris Cedex 13, France.

Please note that withdrawing your consent will only apply prospectively. Research projects already conducted on your samples at the date of withdrawal will not be affected.

 

How to exercise your rights and who to contact?

You may exercise any of the above-mentioned rights at any time. Exercising your rights does not require justification and will not affect your medical care. To exercise any of your rights, you may:

  • contact the doctor who enrolled you in the clinical trial or who is treating you at the Neuromyology Department of the Pitié Salpêtrière Hospital or at I-Motion Pediatric or Adults, who will forward your request to the Data Protection Officer (DPO) at the Institute of Myology Association;
  • submit an objection or withdraw your consent by downloading and completing the relevant form (objection form or consent withdrawl form) and sending it :
    • by email to: dpo@institut-myologie.org
    • or by post to the following address: Association Institut de Myologie, Data Protection Officer (DPO), Bâtiment Babinski, Groupe Hospitalier Pitié- Salpêtrière, 47/83 boulevard de l’Hôpital, 75 651 Paris Cedex 13, France
  • send a written message to the Data Protection Officer (DPO) of the Institute of Myology Association:
    • by email to: dpo@institut-myologie.org
    • or by post to the following address: Association Institut de Myologie, Data Protection Officer (DPO), Bâtiment Babinski, Groupe Hospitalier Pitié- Salpêtrière, 47/83 boulevard de l’Hôpital, 75 651 Paris Cedex 13, France

If you believe that your rights have not been respected or that your data is not being processed in accordance with applicable regulations, you also have the right to lodge a complaint with the French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés – CNIL).