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argenx BV (“argenx”), a biopharmaceutical company based in Belgium, is sponsoring the MyRealWorld™ MG Study (the “Study”) assisted by its third-party vendor, Vitaccess Limited (“Vitaccess”, “we” or “us”). The goal of the Study is to improve argenx’s understanding of the experience of individuals living with myasthenia gravis (“MG”).
argenx and Vitaccess are both subject to the European Union General Data Protection Regulation 2016/679 (“GDPR”) in their access and/or use of your personal data provided through the MyRealWorld™ MG App. In implementing the Study on behalf of argenx, Vitaccess will collect, store and analyse personal data of participants as a subcontractor of argenx.
This notice provides information to participants (referred to as "you") about how and why we use your personal data in relation to our services to argenx.
We may update this notice from time to time. It was last updated on .
2. About Vitaccess and argenx
Vitaccess Limited is a company registered in England and Wales with company number 10642948. We act as a data processor for the Study based on argenx's instructions regarding our collection and use of your data from our app and technology. In limited circumstances, we may ourselves determine how your personal data are used – see section 3.3.
We have appointed a Data Protection Officer, who is responsible for overseeing the use of personal data by Vitaccess. You may contact the Data Protection Officer with questions or concerns about our use of your data. Contact details for Vitaccess are set out in section 10.
argenx BV is a company incorporated in Belgium with company number 0818.292.196 and address Industriepark-Zwijnaarde 7, 9052 Zwijnaarde, Belgium. It acts as a controller for the purposes of data protection laws, meaning that it determines how and why your data are to be collected and used by Vitaccess, and instructs Vitaccess accordingly. Contact details for argenx are set out in section 10
3. What data we collect and how we use it
3.1. Data collected for registration
You may download the app from Android or iOS app stores. When you install the app, you will be asked to register with us and provide us with information to enable us to assess your eligibility for participation in the Study.
Once you have completed this information, if you are eligible to participate in the Study, you will be able to create a username and password for the app. We will also assign you with a respondent ID, which we will use for administrative purposes. If you are not eligible to participate, we will let you know, and will remove your details from our systems within a reasonable period – see section 7
3.2. Data collected during the Study
You will be asked to enter personal information and data into the app as part of the Study.
As such, the data you enter into the app will be transferred into a database, de-identified and aggregated by Vitaccess before it is shared with authorized recipients. This means that your name and other personally identifiable information will be removed from the data before it is shared. Authorized recipients of the data include argenx, the Study Investigator, Veritas IRB (except Alberta and Newfoundland and Labrador), and other qualified parties using the data for research purposes. See section 4.
Vitaccess will have a key which allows us to re-identify you if needed, but this key will only be used in exceptional circumstances, for example if a clinician has identified a health risk for a particular patient arising from the Study.
The data collected during the Study will be used by argenx and authorized recipients to better understand current treatments, identify new topics for research, improve MG research design, and ultimately, improve patient care. argenx will use the data you provide for research purposes and may also publish aggregated data from this Study and present it at scientific meetings.
3.3. Sharing your information with other participants and viewing other participants’ data
The app may provide you with features that allow you to share some of your personal data with other participants. If you consent to display or share disease-related data with other study participants or users of the app, we ask that you regularly review and set your sharing options. If you view or receive information about other participants or users of the app, please respect the privacy of such individuals and the confidentiality and sensitivity of their data.
3.4. Other uses of the data you share
Your personal data is used for Study purposes but may also be used by us on behalf of argenx:
- to monitor your use of the app, in order to check that it is being used appropriately, and for the purposes of administration and maintenance of the app and our systems;
- to improve app functionality; and
- to assist argenx in protecting or enforcing its legal rights, or complying with applicable laws (including data protection laws).
Vitaccess may, in limited circumstances, use your personal data for our own business purposes. These purposes include protection of our software and intellectual property (and other rights and responsibilities in relation to the app and our technology), administering our technology and our relationship with argenx, and maintaining appropriate records relating to the same.
3.5. Special categories of data: health data
The activities described previously involve collection and use of special categories of data (also known as “sensitive data”), including the following:
- information about MG and your condition. This is fundamental to the Study, so this information is collected and used by us throughout the course of the Study and the features provided to you.
4. Sharing your data with other parties
In addition to argenx and Vitaccess, these additional parties will have access to your de-identified data as described below:
4.1. Scientific Advisory Board
The Scientific Advisory Board is an advisory body established to protect participants’ interests and provide advice on research-related requests to access data in the database. The Scientific Advisory Board will generally only access and use the data, which is de-identified and aggregated by Vitaccess, from the database. If the Scientific Advisory Board needs to contact you personally, it would obtain independent ethics approval to do so.
4.2. Veritas IRB and other accrediting agencies
Veritas IRB and Newfoundland and Labrador Health Research Ethics Board are the bodies which have approved the Study for the purposes of ethics requirements and may review the study activities to confirm it is being conducted appropriately. As part of this review, Veritas IRB may access the database. In general, Veritas IRB will only access and use de-identified and aggregated data.
You may contact Veritas via this contact form or Newfoundland and Labrador Health Research Ethics Board at: email@example.com, if you would like to speak with someone unrelated to the Study, have questions, concerns, or complaints regarding the study, or have questions about your rights as a research participant. If you do so, Veritas IRB or Newfoundland and Labrador Health Research Ethics Board will use your personal data to assist you with your query.
4.3. Study Investigator
The Study Investigator is Dr Mark Larkin, the CEO of Vitaccess. His role is to ensure the Study is conducted appropriately and completed within the agreed period. The scope of data shared with the Study Investigator will be determined by argenx – please contact argenx for further information. The Study Investigator will generally only access and use de-identified data.
4.4. Users of the research portal, publications and presentations
Aggregated and de-identified information arising from the Study will be used to help researchers understand what treatments works for MG and what does not, which will improve the treatments that are offered to patients in the future. Access to the research portal by third-party researchers will be overseen by the Scientific Advisory Board.
These details may also be presented at conferences and published in peer-reviewed journals by argenx – please contact argenx for further information about this.
4.5. Your clinical team
We do not share your personal data with your physician or clinical team, though you may choose to share your personal data with them within the app.
4.6. Our technology service providers
Our technology service providers may handle your data. They act as sub-processors on behalf of argenx (but appointed by us), meaning that argenx remains primarily responsible for how they use your data, and we pass on our responsibilities as a processor to such providers within our agreements and arrangements with them. Our providers (as of the date of this notice) provide platforms on which we store your data, and assist us and argenx to analyse and pseudonymize your data.
4.7. Other parties
We may also share your data, where required, with legal authorities or regulatory bodies. For example, other accredited agencies investigating matters related to the appropriate conduct of this Study.
argenx is responsible for determining any additional disclosures of your personal data, outside the scope of Vitaccess's involvement. You should contact argenx directly for more information about this – see contact details in section 10.
5. Consents and legal basis for use of your data
We need your consent for the collection, use, and disclosure of your information. If you chose not to consent, which is your right, to your data being used for any specific activity (or withdraw any consent previously given) you may not be able to participate with that activity.
We will collect, use, and disclose your data as described in this Privacy Notice. We also may (on behalf of argenx or directly, where required) collect, use or disclose personal data as is necessary to comply with a legal obligation, such as where law enforcement authorities require us or argenx to do so, or to address rights of individuals under data protection laws.
6. International data transfers
As the Study is an international project, your data may be transferred to a different country to that in which you are based. This may include:
- transfers to argenx in Belgium;
- transfers to Veritas IRB in Canada;
- transfers to Vitaccess in the UK; and
- transfers to Vitaccess's technology providers, whose data systems may be located either within the US, the UK or the European Union.
In all cases, where data is transferred to providers based outside the UK or the European Union, we will check that appropriate safeguards are in place to protect your data to a similar standard as under UK and Belgian law.
7. How long do we retain your information?
We will retain your personal data for as long as required for the purpose of the Study.
If you are discontinued or withdraw from the Study after we have collected information about you, no new study data about you will be collected by Vitaccess. However, all your data that have been collected to date will remain within the study database. If you prefer that your data be removed from the study database, Vitaccess can be contacted using the contact details in section 10. Note that your information may still included in aggregated and de-identified datasets which have already been collated and used for research purposes.
We may also continue to maintain records relating to you (such as your name, contact details, communications with you, and information about how you used the app):
- for argenx's or our record-keeping purposes, including to comply with its or our legal obligations and to defend its or our legal rights; and
- where requested by argenx, to assist with app improvement and development.
8. Security of your data
You will be able to select a password to access your MyRealWorld MG account. We recommend you use a strong password of at least twelve characters, including one upper and one lower case letter, one special character and one number.
You are also advised to enable a password-protected screen lock from your device's Settings menu.
Your data entries within the app are encrypted before being sent to our systems and information within the study database is de-identified.
If you would like any further information about our information security measures, please contact us or argenx using the contact details at section 10.
9. YOUR LEGAL RIGHTS
In accordance with data protection laws, you have a right:
- to obtain a copy of the personal data we hold about you, together with other information about how we and argenx process it;
- to withdraw any consent which you have given relating to our use of your data;
- to request changes to inaccurate or incomplete data, and, in some circumstances, to request that we erase or restrict our use of your data;
- to receive a copy of personal data that you have provided to us or have us send those data to another party; and
- not to be subject to a decision based solely on automated processing, which significantly affects you, unless additional legal requirements are met.
Note that there are certain limitations and exemptions to these rights that may be applied depending on the circumstances.
Please contact Vitaccess (see section 10) to make requests to exercise these rights (specifying what you are requesting), or if you would like further information about them.
10. Vitaccess and argenx contact details
- For general queries about the Study:
- For data protection queries to argenx:
- For data protection queries to Vitaccess:
Data protection officer
2 Lower Mortlake Road
Richmond, Greater London, England