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eDiary privacy policy

1. Introduction

Salvia BioElectronics (hereinafter: “Salvia’’ or “we/our’’ is a medical device company pioneering neuromodulation therapies for migraine. Salvia is currently in a clinical stage of development, and as part of this, Salvia has developed the Salvia eDiary app (hereinafter: ‘’eDiary’’ or ‘’our app/app’’).

We understand that your privacy is important to you and that you care about how information relating to you (“Personal Data”) is used. Salvia is committed to ensuring the privacy and security of the Personal Data it processes and to protecting your privacy rights in accordance with our obligations under applicable Privacy and Data Protection laws.

This Privacy Statement explains how Salvia handle’s personal data that is collected through or in connection with our app. For information about your personal data that we collect from other sources you can refer to the Privacy Statement available in our website.

2. When do we collect your data?

This Privacy Statement informs you how we collect, use, disclose, and process your personal data in our role as a Data Controller when you:

  • When you voluntarily download and install the app on your device.
  • Every time you use the eDiary app
  • Contact us in relation to the use of our eDiary.

3. What Personal Data do we collect and how do we collect data about you?

We only collect information from you when you provide it to us, for instance when you use the eDiary or you contact us in relation to our app.

  • First and/ or  last name when you voluntarily decide to share this with us directly or indirectly by the use of your email address.
  • Subject ID: provided to you by the site where you are enrolled to participate in one of our clinical trials.
  • Email address
  • Medical data: headache occurrence, duration, severity and applied acute treatment.
  • Usage statistics:  The data relates to the country or region where the app was downloaded and installed. This information does not necessarily link to you as an individual.
  • Complaint and communication data: information related to the use of our app that you may have logged with Salvia regarding the use of the app.  For example, date and nature of the complaint or question.

Please note that sharing name or last name is optional, the data you input in our app is only linked to your subject ID.

4. Purposes and legal grounds for processing

We process your personal data for certain purposes, described below. Under the applicable Privacy and Data Protection laws, we are only allowed to process your personal data for such purposes if we can rely on one or more of the legal grounds for processing, as described below:

      
Purpose Legal ground
For use in clinical trials. To document headache occurrence, duration, severity and applied acute treatment. This information is linked to your Subject ID and is analysed for the purpose of the clinical trials.
  • To comply with a legal obligation incumbent on us. For example, to handle complaints, or report adverse events as required by the governing European medical devices and clinical trials laws and regulations;
  • For our legitimate interest in providing and managing a service and managing our business.
  • Based on your specific and explicit consent;
  • If it involves the processing of health related data, for a task carried out in the public interest in conjunction with a public interest in the area of public health, such as ensuring high standards of quality and safety of medical devices on the basis of the governing European medical devices and clinical trials laws and regulations (and others applicable).
If you contact us regarding the use of our app, we might use your data to communicate with you in relation to your request or complaint.      
         
  • Based on your consent when providing us the information;
  • Legitimate Interest: our legitimate interest in fulfilling your requests and communicating with you.
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To allow you to share the data input in the app with the site or to the email address you decide to include. Please note that our app is not cloud based, the only way to access the data you input in our app is when you decide to share it by email.      
         
  • Based on your specific and explicit consent.
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To measure the use and effectiveness of our app and to improve its functionality.      
         
  • Based on your specific and explicit consent (where required).
    •        
  • Legitimate interests: our legitimate interest in providing well-functioning applications related to our products and efficient and innovative tools for the development of clinical trials.
    •  
 
Complying with legal obligations.      
         
  • To comply with a legal obligation incumbent on us. For example, to handle complaints, or report adverse events as required by the governing European medical devices and clinical trials laws and regulations
    •        
  • If it involves the processing of health-related data, for a task carried out in the public interest in conjunction with a public interest in the area of public health, such as ensuring high standards of quality and safety of medical devices on the basis of the governing European medical devices and clinical trials laws and regulations (and others applicable).
    •  
 

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5. Who do we share your personal data with?

Access to personal data relating to you is limited. It is Salvia’s policy that persons within the organization should only have access to personal data on a need-to-know basis. Where applicable, we share your personal data in the following circumstances:

Third parties

Salvia does not share the data collected through the app with any third party. Salvia eDiary is not a cloud-based app; it only allows you to manually share the data with the site or any third party you choose to send the report to via email.
If you contact us and we need to involve third parties to process your request, we will do so. Personal data will only be disclosed if such service providers have provided sufficient guarantees to implement appropriate technical and organizational measures to protect your personal data, in accordance with this Privacy Statement and applicable law.

Salvia’s entities, affiliates

We may also share your personal data with our affiliates for purposes consistent with this Privacy Statement. Personal data may be transferred between Salvia’s Entities to ensure efficient and effective business operations and to enable the Salvia’s entities to provide information technology, legal, quality assurance, software/product development, and other support services.

Disclosures for Law Enforcement, and other Regulatory Reporting Obligations
  • We may share your personal information to ensure high standards of quality and safety of health care related to our medical devices and applications.
  • We may share personal information to comply with our legal or regulatory obligations including, but not limited to, our obligations related to adverse event reporting, pharmacovigilance, product safety and other regulatory reporting obligations.
  • Under certain circumstances, we may be required to disclose your personal data in response to valid requests by public authorities, including to meet national security or law enforcement requirements or to investigate fraud.
  • We may also disclose your personal information to third parties as necessary to investigate potential data incidents, or to protect the rights, property or safety of us, the users of our Websites, or others.
  • We may share your information with courts, law enforcement authorities, regulators, attorneys or other third parties to comply with laws and legal obligations, for the establishment, exercise, or defence of a legal or equitable claim, and to respond to law enforcement and regulatory requests.

6. International transfers of personal data

Your personal data may be transferred and processed outside of your geographical zone, and in countries that may not provide for the same level of data protection as your geographical zone. In such cases, Salvia ensures that the recipient of your personal data provides an adequate level of protection, for example by entering into appropriate processing agreements and, if necessary, standard contractual clauses or an alternative lawful data transfer mechanism. Where required by applicable law, we will only share, transfer or store your personal data outside of your jurisdiction with your prior consent.

7. Retention period

We will retain your personal data for as long as is necessary in order to fulfil the purposes for which we collected it, including any legal requirements. To determine the retention period, we take the following into account:

  • Whether we are subject to any legal obligation;
  • Whether retention is required considering our legal position (such as for statutes of limitations, litigation or regulatory investigations); and
  • The length of time that we have an ongoing relationship with you, and provide our services to you.

At the end of the retention period, we will delete your personal data or anonymized in a manner designed to ensure that it cannot be reconstructed.

8. Your rights

You, as a data subject, have the following rights with regard to your personal data:

  • The right to access your personal data;
  • The right to have your personal data rectified, corrected or updated;
  • The right to have your personal data deleted, including from any third parties where your personal data has been shared or disclosed;
  • The right to restriction of the processing;
  • The right to data portability, i.e., the right to receive your personal data in a structured, commonly used and machine-readable format, and the right to transmit those data to another controller;
  • The right to object to certain types of processing;
  • The right to withdraw your consent.

In addition to these rights, you also have the right to lodge a complaint with your local data protection authority.
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Please note that not all requests regarding your privacy rights can be completed; for example, deletion of your personal data is a right that can be limited due to Salvia’s compliance with legal obligations derived from the European medical devices and clinical trials laws and regulations. In such cases, we will inform you about this at the time of your request.
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If you wish to exercise any of your rights above, please contact us using the information in the section ‘How to Contact Us’ at the end of this Privacy Statement.

9. Changes to this Privacy Statement

We reserve the right to unilaterally change or update this privacy statement. Please make sure to check our privacy statement from time to time to read the latest version.

10. How to contact us?

If you have any questions or comments about this Privacy Statement and/or the processing of your personal data, or if you wish to exercise your rights, please reach out to our Data Protection Officer (DPO) at:

Email address: mbdpo@salviabioelectronics.com
Address: High Tech Campus 37, 5656 AE Eindhoven, The Netherlands

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