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Privacy Policy of the miPROLEPSIS Lite Application

1. Introduction

We consider privacy a matter of utmost importance and in this policy, we present the principles to which we adhere to and the measures implemented to ensure the lawful processing, security and protection of the personal data processed through the use of the miPROLEPSIS Lite application (app), developed and maintained by WELLICS Ltd. We remain committed to complying with all relevant EU and national legislation regarding the protection of personal data and the "rights and freedoms" of the data subjects, in accordance with the General Data Protection Regulation (GDPR).

To this end, we have developed and implement this Privacy Policy and any other necessary policies and procedures regarding the processing and protection of personal data which regulates the use of the miPROLEPSIS Lite app. This applies to all processing operations on the personal data of the end users of the app.

Moreover, we hereby provide the end users with the necessary information regarding the collection, use, sharing, retention and general processing of their personal data. At the same time, we provide information about their rights and how to exercise them properly and in accordance with the GDPR.

We remain at the end users’ disposal in order to provide them with any information within the framework of our compliance with the current European and national legislation on the protection of personal data, as applicable, and the applicable regulatory directives related to the management of personal data, guaranteeing a secure environment for the processing of end users’ data.

For the purposes of this policy, clinical partners are considered the following entities, participating in the iPROLEPSIS project:

i. THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD (UOXF), established in UNIVERSITY OFFICES, WELLINGTON SQUARE, OXFORD OX1 2JD, United Kingdom.

For the purposes of this policy, technical partners are considered the following entities, participating in the iPROLEPSIS project:

i. WELLICS Efarmoges erevnas kai Pliroforikis Monoprosopi I.K.E., PIC 885409696, established in Esperidon 18, Acharnes 136 74, Greece,

ii. NETCOMPANYSA, PIC 999702371, established in RUE NICOLAS BOVE 2B, Luxembourg 1253, Luxembourg,

iii. Aristotelio Panepistimio Thessaloniki, PIC 999895692, established in KEDEA building, Tritis Septemvriou, Aristotle University Campus, Thessaloniki, 54636, Greece,

iv. Ainigma technologies, PIC 892135579, established in Kapeldreef 60, Leuven 3001, Belgium,

v. Ethniko Kentro Erevnas kai Technologikis Anaptyxis, pic 998802502, established in Charilaou Thermi road 6 km, Thermi Thessaloniki 57001, Greece.

2. Personal data collected

2.1 Personal data includes any information in paper or digital form that may lead either directly or in combination with other information (indirectly) to the unique identification of a natural person.

2.2 For the purpose of provision of the services of the miPROLEPSIS Lite application during the study, the following categories of personal data will be collected from the data subjects, through either direct insertion or automated collection through the use of optionally paired personal wearables by well-known wearable vendors.

i. Personal identification number (Participant ID) that will be automatically assigned during the onboarding process. During onboarding, the participant’s name, surname and email address are collected exclusively for eligibility verification, electronic informed consent, account creation and authentication purposes. These identifiers are stored separately within the authentication system and are not used during the study analyses, where only the Participant ID is used,

ii. Name, surname and email address (processed exclusively during participant onboarding and authentication and stored separately from the study dataset)

iii. photos of hands and feet,

iv. mobile device accelerometer and gyroscope data

v. Wearable-derived health and activity metrics (where available)

a. Sleep duration

b. Sleep score

c. Steps

f. Ex ercise minutes

d. Heart rate variability

e. Resting heart rate

vi. Keystroke dynamics data (see section 3)

vii. Joint pain existence manual declaration

viii. Responses to study questionnaires

2.3 Most of the personal data listed in section 2.2 constitutes special categories of personal data under Article 9 of the GDPR, as they relate to the health status or physical condition of the study participants. These data are processed solely for the purposes of conducting the iPROLEPSIS study and on the basis of the participant's explicit informed consent.  The concept of special categories of personal data includes personal data concerning racial or ethnic origin, political opinions, religious or philosophical beliefs or trade union membership, genetic or biometric data, data concerning the health, sexual life or finally, sexual orientation of an individual.

2.4 The personal data collected will be stored in a pseudonymised form. Personal identifiers (such as name, surname and email address) are collected exclusively during the onboarding and authentication process and are stored separately from the study dataset. Throughout the study, participants are identified within the research dataset only through their unique Participant ID. Clinical partners retains the information necessary to re-identify participants where required for the conduct of the study, whereas technical partners process only pseudonymised data.

miPROLEPSIS Lite keyboard: Alongside the miPROLEPSIS Lite application, the miPROLEPSIS Lite keyboard is installed and the user is requested to enable it as the default keyboard. It can be disabled through the device settings and, when it is enabled, collects the following information:

Variable

Description

downtime

Timestamps corresponding to the moment keys were tapped down

uptime

Timestamps corresponding to the moment keys were released

pressure

Normalised (0-1) maximum pressure applied for each key tap

longPress

Flag denoting whether a key was long pressed

distance 

Relative distance between keys tapped

downtimeDelete

Timestamps corresponding to the moment delete key was tapped down

uptimeDelete

Timestamps corresponding to the moment delete key was released

downtimeSpace

Timestamps corresponding to the moment space key was tapped down

uptimeSpace

Timestamps corresponding to the moment space key was released

numDels  

Number of times the backspace/delete key was tapped

isSoundOn

Flag denoting whether sound feedback is on

isVibrationOn

Flag denoting whether vibration feedback is on

vibrationDuration

In case of vibration, its duration

keyboardScale

Scale of the keyboard (portrait or landscape)

startTime

The time the typing session started

endTime

The time the typing session ended

currentLanguage

Keyboard language

currentAppName

Classify the typing category between a message and a search

currentCountry

Ensure the processing of data that are collected from EU countries

currentIMIE

Detect a change of mobile phone device

The deletion of the miPROLEPSIS Lite application from the user’s mobile phone uninstalls the keyboard as well permanently. It is noted that no text typed by the user is captured, collected, or processed by the miPROLEPSIS Lite keyboard.

3. How do we collect personal data?

3.1 During the use of the app and depending on the personal data, the project partners collect the personal data through the following means:

i. Through direct insertion of the personal data from the end users themselves in the miPROLEPSIS Lite app. This included direct upload of information or photos, for instance in the case of providing any information requested, taking photographs or performing the touchscreen typing dynamics test.

Automatically through the use of the optionally paired personal wearables of the participants. The collection of wearable data is subject to the transfer of the data of the end users’ wearables via a dedicated back-end integration with the vendors available under this integration, APIs. Participants need only select their wearable vendor from the dedicated wearable pairing screen and authenticate with their personal accounts on the vendors’ portals. During their authentication process targeting their vendors' portal, they are free to select the data collection scope (namely the high-level data categories their vendor collects and processes). When the authentication and scope selection process is successful, wearable data begin to be received by the back-end integration offered. Participants may freely choose to unpair their wearables, at which point miPROLEPSIS no longer has access to or receives the participants' wearable data.

4. Processing of personal data

The envisaged processing operations on the personal data of the users are the following:

i. Collection of personal data directly from the end users or automatically through the use of the app.

ii. Storage of personal data on the iPROLEPSIS data management infrastructure and the premises of the clinical and technical partners of the iPROLEPSIS project. Through this repository, specific technical partners’ representatives will be granted access to personal data for the purposes mentioned below.

iii. Curation and harmonisation of personal data by technical partners.

iv. Processing for the purpose of validation of the function of the iPROLEPSIS framework by technical partners. The end user’s personal data will be used in order to test the functionality of the iPROLEPSIS framework and identify any potential issues that may affect its operations. Publication of some of the results of the studies being conducted as a result of the iPROLEPSIS project to Open Science repositories, with the personal data being anonymised before the publications may take place. An internal committee has been created in order to ensure that privacy is respected in the case of publications.

Further information regarding the processing operations will be provided in the consent forms that will be distributed to the end users before any processing operations take place. The aforementioned processing operations will be taking place on the health-related personal data, described in section 2.2 of the current policy, that will be collected during the course of the study.

5. Distinct Roles and Responsibilities

5.1 According to Article 4, paragraph 7 of the GDPR, the definition of the data controller is given, stating that "a data controller is a natural or legal person, public authority, agency, or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the data controller or the specific criteria for its nomination may be provided for by Union or Member State law."

According to the above, the clinical and technical partners are considered the (Joint) Data Controllers, are assumed responsibility, and shall be able to demonstrate compliance with the GDPR. The purposes and means of processing are defined by the grant agreement and any other project related documentation of the iPROLEPSIS project and the project partners implement the appropriate technical and organisational measures to protect the data being processed.

5.2 Additionally, according to the definition provided in Article 4, paragraph 8, "data processor" is defined as "a natural or legal person, public authority, agency or other body which processes personal data on behalf of the data controller."

Mainly, the appointed personnel of the project partners, including scientists, doctors, developers and legal representatives, are the ones executing the processing on behalf of the project partners. Agreements have been concluded between the project partners and the aforementioned personnel, outlining their responsibilities as processors, with specific reference to the nature, purpose, and duration of the processing, the types of data, and the categories of data subjects.

Under certain circumstances, other natural or legal persons may also be engaged by the project partners as processors. The project partners ensure that they collaborate exclusively with processors who provide sufficient assurances for the implementation of appropriate technical and organisational measures to meet the requirements of the Regulation and ensure the protection of data subjects' rights.

5.3 The processing by the processor is governed by a contract or other legal act subject to Union or Member State law, which binds the processor in relation to the project partners and specifies the subject matter and duration of the processing, the nature and purpose of the processing, the type of personal data and categories of data subjects, and the obligations and rights of the data controller. No third party may have access to personal data processed by the project partners without prior signing of a cooperation and confidentiality agreement with the related project partner. Compliance with data protection legislation is the responsibility of all employees processing personal data.

The processor and any person acting under the supervision of the data controllers, processes the personal data under the defined purposes and instructions set out by the data controller, unless required to do so by Union or Member State law. The processor does not engage another processor without the prior specific or general written authorisation of the project partners.

5.4 As a rule, access to the personal data of each end user will be provided to the relevant clinical partner the end user is located in or communicates with and, following the application of pseudonymisation on the personal data, to the technical partners, with the additional information that could help identify the data subjects remaining to the relevant clinical site.

6. Lawful Processing

6.1 Data processing refers to any act or series of acts carried out, with or without the use of automated means, on personal data or sets of personal data, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or any other form of making available, alignment or combination, restriction, erasure, or destruction.

6.2 A general rule in data processing is that, in principle, it is unlawful unless the conditions set forth in Articles 6 and 9 of the Regulation are met, which provide the necessary legal framework which defines the lawfulness of the processing operations on personal data.

6.3 The legal basis for processing of the aforementioned personal data for the project related purposes through the use of the app is informed consent, according to articles 9 par 2a’ and 7 of the GDPR. The end users are provided with a form, with which they will provide their consent to the processing operations on their personal data, as they are described in sections 2 and 3 of the current policy. Additionally, since the processing of the end users’ personal data is based on their previously given explicit informed consent, they have the right to withdraw from it at any time by making a relevant request to our authorised legal partner of the project via an email at legalint@diadikasia.gr

6.4 During the course of the consent provision process, the end users will be thoroughly informed regarding the processing operations, the personal data that will be processed, the purpose of the personal data processing operations, the data controllers and any potential data processors, the period of storage of the personal data and their data protection related rights and the way they could exercise them.

7. Data Subjects’ Rights & Principles of Data Collection and Processing

7.1 With this Privacy Policy, our aim is to provide the necessary information to the end users of the app about the terms of collection, processing, and transmission of their personal data by our project partners as the Data Controller or Processor. The project partners and their appropriately trained personnel adhere fully to the principles governing the processing of personal data as provided in the GDPR, namely the principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity, confidentiality, and accountability.

7.2 Additionally, the project partners respect, protect, and ensure the exercise of the data subjects’ rights provided in the GDPR, including:

i. “Right to be informed” regarding anything that is related to the processing of personal data (arts. 12-14 GDPR),

ii. “Right of access” to the personal data and any other information related to the data processing activities (art. 15 GDPR),

iii. “Right to rectification” of inaccurate personal data or completion of incomplete personal data (art. 16 GDPR),

iv. “Right to erasure” (“right to be forgotten”), according to which the data subject could achieve the deletion of his/her personal data under certain conditions (article 17 GDPR),

v. “Right to restriction of processing” of the personal data under certain conditions (art.18 GDPR),

vi. “Right to data portability”, according to which the data subject can receive the personal data concerning him/her, which had been provided to a controller, in a structured, commonly used and machine-readable format and transmit them to another controller without hindrance from the controller to which the personal data had been previously provided (art. 20 GDPR),

vii. “Right to object” at any time to processing of personal data concerning him/her (art. 21 GDPR),

viii. “Right to object to the automated individual decision-making, including profiling” (art. 22 GDPR),

ix. “Right to withdraw from the provided consent” freely, at any time and

x. “Right to appeal against the competent supervisory authority”.

7.3 The project partners remain at the disposal of the data subjects – end users to respond to any of their requests regarding the above and to ensure the substantial and effective protection of personal data throughout the use of the miPROLEPSIS Lite application, in compliance with the applicable European and national legislation for data protection, as well as applicable regulatory directives related to data management.

For this purpose, the end users can submit a request or exercise their rights by contacting the authorised legal partner of the iPROLEPSIS project, Diadikasia Business Consulting Symvouloi Epicheiriseon AE, via the email legalint@diadikasia.gr.

8. Minimisation, Storage, and Deletion of Personal Data

8.1 The project partners request from the end users the minimum necessary personal data, according to the data minimisation principle and as required by law, to fulfill the project related tasks. The selection of the personal data to be collected and processed is based on a selection process that was based on scientifically proven factors that affect the inflammation of the Psoriatic Arthritis disease.

8.2 Our project partners will store the personal data for as long as required by current legislation, based on the respective purpose of processing. Following their collection, the personal data will be stored in the iPROLEPSIS data management infrastructure and the premises of the clinical and technical partners of the iPROLEPSIS project. The personal data stored in the premises of each clinical partner will be the ones related to the patients located in the premises, while the ones stored by the technical partners, will be in a pseudonymised form, with the identifiers – additional information not being available to them but remaining to the relevant clinical partner.

8.3 The iPROLEPSIS data management system, offered by partner Netcompany, is hosted on Hetzner, a Public Cloud Provider (Nuremberg data center) under direct contract with Netcompany S.A., a German company which is ISO27001 certified. An agreement with Hetzner has been signed concerning availability, back-up, malware protection, encryption, etc. The information is stored in the Economic European Area. Data infrastructure will offer access only to authorised users, with authentication mechanisms and interfaces for secure data exchange with the Cloud-based back-end being implemented. Access to the iPROLEPSIS data management infrastructure is provided only to specific personnel of the clinical and technical partners by the provision of limited entry credentials.

8.4 As a general rule, the partners who will in any way process the end user’s personal data, will be deleting them following the end of the project, following a relevant personal data deletion plan. As an exception to this rule, following relevant national legal obligations, following the end of the relevant study, partner UOXF will be storing the personal data of the patients – end users for a period of 10 years but will proceed to their deletion, following a relevant request. After this, the personal data of the end users will be completely deleted by the aforementioned project partners.

9 Data Transfer to Third Parties

9.1 As a rule, our project partners do not transfer personal data to any third parties without the need for such processing operation to take place and additionally, the explicit consent of the data subjects. Respecting the principle of confidentiality, they ensure that the personal data processed is not disclosed to unauthorised individuals, taking necessary measures accordingly.

9.2 In the context of processing of the end users’ personal data, it may be necessary to transfer the personal data to the project partner of iPROLEPSIS located in the United Kingdom. In this case, we inform the end users that such transfer is considered secure since the United Kingdom’s legal framework for data protection has been deemed adequate by the issuance of an adequacy decision by the Commission, according to article 45 of the GDPR. No transfers of personal data will be taking place to the clinical partner located in Israel.

9.3 In any case, the project partners categorically state that they will not transfer the personal data collected during the use of the miPROLEPSIS Lite app to any third parties for their direct use for promotional purposes (marketing) or any other purpose, not related to the iPROLEPSIS project.

10. Security

10.1 The secure processing of the end users’ personal data is of utmost importance to us. Our project partners take all appropriate organisational and technical measures to ensure the confidentiality, integrity, and availability of the personal data collected under this Policy.

10.2 The project partners acknowledge the purposes described in the grant agreement or any other official documentation of the iPROLEPSIS project, determine the means of processing according to the aforementioned project related purposes and implement the appropriate technical and organisational measures to protect the data being processed. The project partners and any third parties collaborating with them on the processing of personal data, have already fully understood and complied with this policy. No third party can access personal data processed by the project partners without signing a cooperation and confidentiality agreement.

10.3 In compliance with the applicable European and national legislations on the protection of personal data, our project partners have appropriately trained and educated their staff, follow appropriate security policies, and use appropriate technical and operational tools, such as anonymisation (whenever applicable), pseudonymisation, data encryption, and continuous and targeted staff training.

10.4 for the Within the framework of the "risk-based approach," which is a novelty of the GDPR, the project partners implement the necessary measures on a case-by-case basis, both primarily preparatory and during processing, to ensure the integrity and security of the end users’ personal data. Some of the measures we have taken as a project partners to ensure the integrity and security of data include the commitment of the partners with confidentiality clauses, the identification, restriction and recording of individuals (physical or electronic) with access to databases, personal data, files, etc., conduction of access policies, protocols and measures to secure storage and access control, especially special categories of personal data that will be stored in the iPROLEPSIS data management infrastructure.

11. Actions in Case of a Data Breach event

11.1 Despite our project partners’ efforts to ensure the integrity and security of the end users’ personal data, the rapid development of technology may lead to the emergence of new, unforeseen methods that could result in malicious loss, misuse, alteration, or destruction of their personal data. While our project partners cannot absolutely guarantee the security of the personal data in every unforeseen situation, they do guarantee vigilance and effective management of potential risks, always in collaboration with the competent authorities, beyond the security measures already taken.

11.2 According to Article 33 of the GDPR, the data controller shall notify, without undue delay and, if feasible, within 72 hours of becoming aware of the personal data breach, the supervisory authority as per Article 55, unless the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons. When notification to the supervisory authority is not made within 72 hours, it shall be accompanied by a justification for the delay. If it is not possible to provide the information simultaneously, it may be provided gradually without unjustified delay.

11.3 Additionally, according to Article 34 of the GDPR, if the personal data held in the project partners’ records are breached in a manner that may pose a high risk to the end users’ freedoms and rights, we have the corresponding obligation to inform them without undue delay, as provided for in the applicable General Data Protection Regulation (GDPR).

12. Contact

If you have any questions or comments regarding this Privacy and Personal Data Protection Policy, the measures taken by our project partners to protect your personal data or you wish to exercise any of your rights as a data subject, please contact the authorised legal partner of the iPROLEPSIS project, Diadikasia Business Consulting Symvouloi Epicheiriseon AE, via the email: legalint@diadikasia.gr.

13. Validity of the Privacy and Personal Data Protection Policy

This Policy was published by the Project partners on 10/08/2026 and is subject to periodic improvement and revision. For this purpose, we encourage end users to periodically review this Policy to stay informed about how we manage the end users’ personal data.

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