PRIVACY NOTICE

MyReco® Mobile Application

1. Who is Alira Health S.r.l.?

Alira Health is an international patient-centric and technology-enabled advisory firm whose mission is to humanize healthcare.

We provide a suite of integrated services designed to help healthcare and life sciences organizations innovate and grow, impacting the patient experience and ushering in a new standard of care.

The MyReco® platform - which includes the MyReco® app and MyReco® dashboard - is tailored for information capture in clinical studies, to improve patient experience while providing improved workflow for clinical sites and high-quality Real-World Evidence for our customers.

When using MyReco®, Alira Health can be qualified differently.

Alira Health is directly responsible for the processing of your information for the following activities:

  • Providing and ensuring the correct functioning of the App;
  • Handling requests and complaints;
  • Contractual relationship management;
  • App security and functionality;
  • Information analysis to improve the product.

    Alira Health acts as a sub-contractor under the instructions of its customers, for all the information processed in the context of the clinical trial.

    All information relating to the information process has been provided to you in the Informed Consent Form (ICF) and all your questions have been answered by the Principal Investigator before ICF signature . However, please refer to the clinical trial team for any questions related to this process.

    This Notice therefore only provides information for Processing where Alira Health is Controller.

  • 2. Why this Notice?

    The protection of personal information is a priority for Alira Health as protecting your information means protecting you.

    This is the reason we process your information securely and with the utmost prudence, respecting your rights and ensuring maximum transparency.

    Please read this notice carefully before you start using MyReco®, as it is important to us that you know how we process your information.

    Please note that this notice does not apply to the processing of your clinical information collected during the clinical trial.

    If you have any questions about these matters, you may contact the clinical trial team or you may refer to the ICF given to you during the enrolment process.

    3. How is my privacy protected?

    We consider the careful and secure processing of your personal information to be of the highest importance and we are committed to:

  • Explain to you clearly what information we process and why, before we collect it;
  • Collect only the personal information which is necessary for our purposes;
  • If required by law, ask your consent before collection and elaboration of your information;
  • Take all appropriate security measures to protect your personal information (we demand the same commitment from suppliers who process personal information on our behalf);
  • Respect your rights regarding the personal information we process;
  • Comply with the Personal Information Protection and Electronic Documents Act (S.C. 2000, c. 5) (PIPEDA);
  • Answer all your questions regarding the way we process your personal information.

  • 4. What information do you collect and what do you do with it?

    In the frame of the clinical trial, we may have to collect several types of personal information from and about you including information that falls within the categories listed below. In addition, we have provided you with examples of personal information that we may collect that corresponds to such categories.

    Category Examples
    Demographic, socio-economic and health information Unique personal identifier, age, national origin, gender (including gender identity and gender expression), marital status, education, employment, military or veteran status, medical or health insurance information, race, color, ancestry, religion, sexual orientation, medical condition, sex (including pregnancy, childbirth and other related medical conditions), mental disability, genetic information

    Collectively, the information described above and any other personally identifying information we may collect from and about you shall be referred to as “personal information.” We may collect personal information:

  • Directly from you if, and when, you provide it to us, including when you interact with the mobile app (“App”) and when you complete your patient diaries and questionnaires; and
  • From the clinical trial sponsor or contract research organization (CRO).

    In the frame of our App management, we also process:

    Category Examples
    Internet or other electronic network activity Information regarding user’s interaction with the application. At connection time:
    • Device ID;
    • Time zone;
    • Activation code.
    • The personal information we collect is used to enable us to perform the following activities:

    • A. Providing and ensuring the correct functioning of the App

      MyReco® needs to collect some information about you in order to function and thus allow you to participate in the clinical trial through this App. For this purpose, first, you will be asked to enter the activation code that the clinical trial team has provided you in order to create your account and offer you tailored content (for instance, showing you content in your local language and relevant to your disease).

      The initial information required for your login and the information collected to run our application is collected by Alira Health based on the Terms and Conditions (T&Cs), the contract, you have agreed to for using MyReco®.

      Once your account has been activated, you can start interacting with the chatbot, and filling in your diary and questionnaires with information about your health and lifestyle.

      B. Handling requests and complaints

      We process your information in order to provide you with assistance and support, to fulfill your requests, and to respond to complaints or questions you ask us via the App, by email or by other means.

      We may do so based on the T&Cs, the contract, you have agreed to for using MyReco® and based on our legitimate interest. We consider that we have a lawful interest in answering your requests. We understand that the processing of this information is also beneficial to you to the extent that it enables us to assist you adequately and answer the queries raised.

      For complaints or questions about the clinical study, please contact your clinical trial team.

      C. Contractual relationship management

      We use your information to notify you of changes to the T&Cs or this Privacy Notice, or changes to App functionality. We may do this based on the consent you have explicitly provided while agreeing to the T&Cs of MyReco®.

      D. Post-market surveillance: App security and functionality

      Alira Health created MyReco®. Canadian law, and the good privacy practices for developing mobile apps issued by the Canadian Privacy Commissioner, require Alira Health, as the manufacturer of MyReco®, to collect and analyze proactively the app usage in order to identify any need to proceed immediately with corrective or preventive actions.

      We use your information to ensure and improve the security of MyReco®, resolve any technical issues, and analyse and test the system performance. This also includes fraud prevention (e.g., cyber-attacks prevention), App improvement and maintenance, and taking steps to ensure the quality and security of MyReco®.

      Some of this information is collected automatically by the App, and some is collected by Alira Health via surveys or other methods.

      We can do this on the basis of our legal obligation related to Good Clinical Practice (GCP) and App security and functionality needs.

      E. Information analysis to improve the product

      Alira Health collects and processes a large amount of information, including via third-party software.

      In order to do this, MyReco® collects information such as:

    • Device information; and
    • App usage information;

      Your information will be previously anonymized and, therefore, you will not be identifiable.

      If you have any questions about the App, you can find more information in the T&Cs available in the "Profile" section of the App, or you can contact Alira Health.

      5. How long will my information be stored for?

      The information is stored only for the period necessary to achieve the purposes for which it was collected (end of clinical trial or if you withdraw your consent) and to comply with applicable laws, rules, or regulations.

      The duration of the processing of information collected for the purpose of clinical trials is not established by Alira Health but is specified in the information provided to you by the Clinical Center or the Sponsor or the CRO.

      6. Is my information safe?

      We are committed to protecting the information and personal information you share with us.

      Therefore, we take all appropriate technical and organizational measures to prevent any destruction, loss, alteration, dissemination, interference, or unauthorized access to such information, whether accidental or unlawful.

      The cybersecurity program implemented by Alira Health adheres to current industry standards and is continuously updated.

      Despite all our efforts, we need your help to protect your information and prevent others from accessing your information. For this reason, we recommend you never share your activation code with anyone and that you close the application at the end of each session.

      7. Who do you share my personal information with?

      As a principle, your information will not be communicated, disclosed, or sold to third parties.

      However, your information may be shared only:

    • To enable you to use MyReco®: in order to ensure the proper functioning of the App, we may provide access to some of your personal information to suppliers who, based on a contractual relationship, provide us with essential services such as provision of IT services and technical support. These service providers process personal information only by following our instructions in accordance with the agreements we have entered into to protect your information;
    • For the conduct of the clinical trial: Alira Health will share your coded information with the clinical trial team and with all relevant parties involved in the study;
    • If necessary, to fulfill a legal obligation: Alira Health may share your information with competent authorities if it is required to do so by an authority itself or on legal grounds, e.g. for matters concerning privacy and clinical trials.

      8. Information transfer

      Your personal information is processed in Italy, where Alira Health is headquartered, but may also be processed in countries where our employees and suppliers are based. This means that your information may be processed in other countries than your country of residence, which may not have a comparable level of protection towards personal information.

      Alira Health is committed to transferring information only to countries that provide a comparable level of security.

      In case Alira Health transfers your information outside your country of residence, this will be carried out in one of the ways permitted by PIPEDA, such as on the basis of a contract including the appropriate provisions necessary for the protection of such information in accordance with the applicable privacy legislation.

      9. What are my rights?

      According to the applicable law, you have a series of rights regarding your personal information.

      You may contact us if you wish to exercise the following rights:

    • Right to have access to your personal information and information that is subject to processing. You also have the right to request a copy of all information held about you;
    • Right of rectification: you can request the correction or updating of your information;
    • Where you have given us your consent to process your Personal Information, you have the right to withdraw your consent at any time, without prejudice to the lawfulness of the processing for which you have withdrawn your consent and we will apply your preferences going forward.

      We will reply to your requests, free of charge, as soon as possible, in compliance with applicable laws.

      Please remember that information collected in the frame of the clinical trial cannot be deleted (refer to the ICF). Please be informed that if your requests are manifestly unfounded or excessive, we may charge a reasonable fee to respond to your request or we may refuse to act on the request. If we choose not to act on your request, we will notify you of the reasons behind our decision.

      10. Authorities and complaints

      You have the right to make a complaint about the manner in which your personal information is being or has been processed, or about the management of a complaint you have submitted, by lodging a complaint to the Office of the Privacy Commissioner of Canada.

      https://www.priv.gc.ca/en/report-a-concern/

      11. Any additional doubts or questions? Contact us

      Herein we have tried to explain to you all the most important privacy aspects regarding MyReco®.

      However, if you have any other questions or wish to exercise any of your rights, as described above, please contact us.

      Alira Health S.r.l., Via Dante n. 14, 2021, Milano (MI), Italy.

      You may contact our Information Protection Officer by e-mail at: alirahealth.dpo@mydata-trust.info

      12. Updates and changes to this Notice

      We may make changes to the App and, therefore, may need to revise this Privacy Notice where necessary. If so, we will notify you through a notice on the App home page or other appropriate means of communication.

      Please remember to check this page periodically to stay informed about how Alira Health uses and protects your personal information. Your continued use of the App after we make changes is deemed to be acceptance of those changes.

      MRC-APP-PN-CA English V1.0 2022-10-21