Dear user,

in accordance with article 13 of the Privacy Code and article 14 of EU Regulation no. 679/2016 (below the EU Regulation) through this we provide you with information about the procedures and purposes of processing your data collected through our registry.

1. Data controller and data protection officer

The Group of Relative Betasarcoglycanopathies ETS (GFB ETS) and the Stem Cell Laboratory, led by Dr. Yvan Torrente, have promoted the described study, each one for its area of ​​competence and, in accordance with the responsibilities under standards of good clinical practice (DL 211/2003), will process your Personal Data, especially your health and medical history and other sensitive data, solely for the registration and implementation of the Quality Project.

The processing of your personal data is essential for carrying out the Study; any refusal will not allow you to participate in the trial.

You can contact the Data Protection Officer by sending an email to: volbeat@libero.it

VOLA BEATRICE GFB ETS President

2. Data processing

a) Personal Data: Personal Data, such as name, date of birth, gender and place of residence, are collected and stored separately from the clinical data stored in the registry or from the quality of life data collected in the Quality Project. . These dara are never expressed in the registry/Quality Project, but are replaced by automatically created pseudonyms so that they cannot be traced back to the patient's identity. With the exception of the persons mentioned in section 4, no user of the registry / Quality Project will be able to link the identity of the patient to the data collected and recorded in the registry / project.

b) Data related to the registry: the registry will collect different clinical data related to its pathology and its evolution. For more information, see the third part of this document "Patient Information".

c) Data of the Quality Project: the project will collect the data of the questionnaires that will be administered.

d) Data on biological samples: the registry also contains information on the biological samples collected, especially on the muscle biopsies performed, type, date of collection and immunohistochemical characteristics.

The doctor who will follow you during the trial will ensure your anonymity, treating your common and personal data differently from identification data (personal data) so that it is not possible to associate them with your person,

transforming them anonymously. For this reason, the study director will give you, at the beginning of the study, a code to be identified during the following stages of the study itself. Your data, the important ones for the study, except your name, will be registered, processed and stored together with that code and with all the clinical data related to your health. Only the doctor and authorized persons will be able to match this code with your name.

3. Purpose of treatment

Personal data and data that may reveal genetic information, provided by you or collected by authorized third parties, are collected and processed for the following purposes:

• Prevention of certain diseases;

• Healing and therapy of the relatives of the interested party;

• Therapy or prevention programs (trial);

• Diagnosis of genetic diseases (diagnostic test);

• Diagnosis of pathologies described in the national registry of rare diseases;

• Prenatal diagnosis;

• Genetic screening;

• Prevention of genetic pathology in high-risk populations;

• Prevention of pathologies described in the national and/or regional registry of rare diseases;

• Statistical, medical and biomedical research;

• Trial of drugs for clinical use;

• Studies on the human genome;

• Transplantation of organs and tissues.

The confidential data provided may be processed in other registries for the purpose of assisted procreation, electronic provision of health services in relation to the database or supply of goods, epidemiological investigations, detection of mental, infectious and disseminated diseases, organ transplants and tissues and monitoring of health spending. .

4. Processing methods

Personal data is processed by the Data Controller in accordance with the principles of legality, correctness and transparency.

The processing of your personal data is carried out through the following operations: collection, registration, organization, structure, storage, consultation, adaptation or modification of datas, use, dissemination, communication, extraction, comparison, interconnection, restriction, suppression and destruction.

Your data will be processed by computer and non-computer tools and will be stored in paper files at the GFB ETS site and electronic databases and will be disseminated strictly anonymously, for example through scientific journals, statistics and scientific conferences.

The data controller will process personal data which will be stored for the period necessary for the purpose of the processing and then deleted, unless further requested.

The interested parties will not be identified during the registration query and their personal data will be protected by a cryptographic system. Identification is authorized only to the LGMD 2C-2D-2E registry and Quality Project Manager and to those in charge of informing the user following the need for processing.

5. Access to data

Your data may be made accessible, for the purposes specified in article 2, to the following recipients:

• You, at any time you wish, can access information about you that is in the Quality registry/project by contacting the doctor who has included you in the Quality registry/project. In addition, your doctor could explain the meaning of the recorded data, in case of doubt.

• Your doctor and his team will have access to your clinical data.

• Doctors of the Dino Ferrari Center: the data stored in the registry could be accessible to researchers and doctors for scientific studies. Any data that may be exported will be given a new pseudonym and cannot be linked to your identity.

• Second opinion: the personal data (or part of it) of a specific person may be transmitted in special cases for a special purpose. The data will be transmitted only temporarily.

• Researchers (only after a precise evaluation of the request for access to the LGMD 2C-2D-2E / Quality Project scientific registry): if researchers from other institutes request a consultation of the LGMD 2C-2D-2E / Quality Project registry in Para find suitable patients for specific clinical studies, the scientific committee of the Registry / Quality Project will decide whether or not to allow access to the data and its transmission. Here too, the possibly transmitted data will be anonymised again and thus cannot be traced back to the identity of the patient. In addition, your data may be transmitted anonymously to companies or third parties (Sponsors / Promoters of clinical studies or external companies acting on their behalf also in Countries outside the European Union, even if in joint projects with individuals, public entities ( local, national and international level) research organizations or companies, associations, foundations, non-profit organizations or associations, clinical laboratories, National Health Service organizations, doctors and medical personnel, pharmaceutical companies) that carry out a research activity that require access to the registry.

• Administrator: the data collected in the registry / Quality project will be visible to the administrator of the computing resources used for the registry. This will happen only if a task needs to be completed and will be logged.

• Public entities: for the fulfillment of legal obligations, and before the judicial authority, in case of formal request. The Ethics Committee and the Italian and foreign Health Authorities may see your data, collected in your original medical documents, solely to verify the procedures of the Study and the accuracy and correctness of the data collected, taking all necessary precautions to guarantee its confidentiality, identity and within the limits of the applicable regulations, with special respect to the principles of correctness, accuracy, relevance and integrity of the treatment (art.11 D.Lgs. 196/2003 - Personal Data Protection Code).

All authorized parties are required to keep the information confidential. All data publication will be anonymous.

The full list of all third-party controllers, who were able to see your Data while working with the Controller, is located on the foundation seat and can be viewed on request.

6. Rights of the interested party

Pursuant to and for the purposes of article 13 of Regulation no. 2016/679 / EU and current national legislation on privacy. You have the right to obtain: access to personal data, suggestions on the forms, purposes and approaches of treatment and the request for data restrictions, oppositions or portability, correction and deletion, in accordance with the limits and customs of the Regulation. You have the right to object to the processing of your personal data, in whole or in part, for legitimate reasons.

At any time, you can stop participating in the Study, without providing a justification. No further data about you will be collected and only the collected data will be used, without altering it for the purpose of the research.

You have the right to file a claim with the competent authority referred to in article 77 of the Regulations.

You can exercise the aforementioned rights and the right to withdraw consent by writing to the Controller Mrs. VOLA BEATRICE President Gruppo Familiari Beta-sarcoglicanopatie ETS, at the email address volbeat@libero.it

EXPRESSION OF CONSENT