Who is responsible for the study?
The entity responsible for the study is MX LABS OÜ Branch in Estonia, Lõõtsa tn 8a, 11415 Tallinn, Estonia, hereinafter referred to as MX LABS – a technology company specializing in the use of signal analysis methods and artificial intelligence for non-contact estimation of physiological parameters.
The people handling the study conduct it on behalf of MX LABS.
Who can participate in the study?
You must be at least 18 years of age to participate in the study. Participation is voluntary. You can opt out of participating in the study at any time.
Description of the study: Before starting the study, you will be asked to complete the linked questionnaire. As a study participant, you will be subjected to multiple measurements with the tested product in different scenarios, i.e. using various devices with a camera (phones, tablets and laptops) in a sitting position (at the table) or lying down (on a couch). You will be asked to read the SHEN.AI Vitals Instructions for Use before taking measurements.
Processing of personal data in the study:
In connection with the examination, we will process your personal data including: age, sex, weight, height, medical education (if applicable), information on smoking (if applicable), skin phototype, type of beard (if applicable), make-up (if applicable) ), whether there is hand tremor, health information constituting the basis for exclusion (the same as in the linked questionnaire), i.e. preventing measurement or related to disease, as well as measurement results and recorded measurement signals, which will primarily include: measurement of pressure, pulse, oxygenation and the record of blood pulsations on the face (obtained by remote photoplethysmography), as well as the image of the face recorded in a video recording during the measurements.
Providing personal data in order to carry out measurements is voluntary. The basis for the processing of your personal data is consent, which you can withdraw at any time. Withdrawal of consent does not affect the lawfulness of the processing that was made on the basis of consent before its withdrawal.
Withdrawal of consent will result in the destruction of records, if any, in connection with the study and the deletion of the participant’s data.
We will process the personal data that we collect in the study only until the end of the research project and the end of the data archiving period (up to 10 years).
Your data may be made available to third parties only to the extent justified by the purposes of the study, i.e. representatives of research units or experts to the extent necessary to analyze or verify the results of study measurements and to assess their impact of various factors on the operation of the Shen.AI Vitals software. In each case, we will oblige the data recipients to maintain data confidentiality and comply with the data processing rules set out in MX LABS.
If you qualify to participate in the study, you will receive full information about participation in the study and the processing of personal data of study participants before the study begins.
Processing of personal data provided in the questionnaire
Who is the data controller:
The controller of your personal data provided in the questionnaire is MX LABS OÜ Branch in Estonia, Lõõtsa tn 8a, 11415 Tallinn, Estonia.
You can contact the controller at any time by writing to the e-mail address: data@mxlabs.ai.
Scope, purpose and time of personal data processing:
Through the questionnaire, we collect your basic data: identification (name), demographic (date of birth, gender), anthropometric (height, weight) and contact: (e-mail, telephone number). Based on the answers given to the questions in the questionnaire, we will also process your health data.
Providing data is voluntary, but necessary to qualify for participation in the study.
We will process the collected personal data in order to:
- initial assessment of your application in terms of qualification for the study and – in the case of positive verification of the application, for contact related to confirmation of participation in the study;
- potentially qualifying you for the next editions of the study or similar studies and communication related to the confirmation of participation in further studies.
If you qualify to participate in the study, you will receive full information regarding the processing of the clinical trial participant’s personal data before the start of the study.
Also on the basis of the above personal data, we will identify you in the event of a request to us for the exercise of rights related to the protection of personal data.
Personal data will be processed only until the end of the recruitment of study participants, i.e. no longer than 30 June 2024, and in the event of consent to participate in subsequent editions or similar studies – no longer than for a period of 10 years.
In no case will your personal data be processed for longer until you object to the processing of personal data.
We may share your data to third parties only to the extent justified by the purposes of qualification for the study, i.e. from the category of research units or experts conducting the study. In each case, we will oblige the recipients of the data to maintain data confidentiality and comply with the data processing rules set out in this clause.
Basis for data processing and your rights:
The basis for the processing of your personal data is your consent, which you can withdraw at any time. Withdrawal of consent does not affect the lawfulness of data processing until consent is withdrawn.
You can also request the deletion or limitation of the processing of your data at any time. You also have the right to access, rectify or transfer your data.
If you believe that your rights have been violated, you have the right to complain to the appropriate supervisory authority. In Poland, this authority is the President of the Personal Data Protection Office.
If you intend to use the above rights or reporting any questions or comments, you can also contact directly our data protection officer Stalmach Szczeszek Kancelaria sp.j., (contact person: Piotr Szczeszek), at the e-mail address: dpo@stsk.pl.