TERMS OF USE AND PRIVACY NOTICE
PART I: TERMS AND CONDITIONS OF USE
Please read this document carefully in its entirety before using the services offered by the TrAIcorder medical device. These services are managed by Ad Astra Innovation & Design s.r.l., with registered office at Via Carlo Goldoni no. 8, 10092, Beinasco (TO), Italy, VAT no. IT01213580317, hereinafter referred to as the "Controller" or "Ad Astra".
1. General Information and Acceptance
By selecting the "I ACCEPT" buttons, you declare that you have read, understood and accepted these Terms of Use and the Privacy Notice, undertaking to comply with them legally. You also declare that you have full legal capacity to enter into this agreement in your own name. By selecting "I DO NOT ACCEPT", you reject these Terms in their entirety and will not be authorised to use the device services.
2. Age Requirements and Limitations of Use
Minimum age: 18 years of age or older. Should it emerge or be established that the user is under 18 years of age, access to the services will be immediately interrupted.
Business/B2B use: If use is made on behalf of a company, partnership, association, healthcare entity or any other organisation, such use is not governed by these Terms for end users, but requires the execution of a separate specific commercial agreement.
3. Intended Use (EU MDR 2017/745) and Service Limits
TrAIcorder is a Class I Medical Device, compliant with European Regulation (EU) 2017/745 (MDR), intended specifically for screening and preventive guidance activities.
Value of screening: The results, measured parameters and statistical risk indices provided by the device are intended solely to carry out preliminary screening and identify potential risk factors.
Diagnostic limitation: Screening does not constitute and does not replace a definitive medical diagnosis, prognosis or therapy. The results indicate a statistical probability and not absolute clinical certainty.
Medical consultation: The user is expressly invited to share the generated reports with a medical professional for any diagnostic evaluation, clinical assessment or therapeutic decision.
Use in emergencies: TrAIcorder must not be used in emergency situations or in the presence of acute symptoms. In such cases, the user must immediately contact emergency services or a healthcare professional.
Non-replacement of clinical devices: TrAIcorder does not replace certified diagnostic devices, laboratory tests, medical examinations or clinical measurements carried out by healthcare professionals.
Measurement conditions: To obtain a reliable measurement, the user must remain still, keep their face correctly positioned, ensure adequate lighting and follow the instructions displayed on the device. Movement, insufficient light, incorrect positioning or unsuitable environmental conditions may compromise the quality of the result.
4. Algorithmic Functioning and Use of Artificial Intelligence
Signal acquisition: TrAIcorder uses facial detection technology to identify specific regions of interest, mainly the forehead and cheeks. Variations over time in the red, green and blue colour channels are extracted from these areas and used to reconstruct a remote photoplethysmographic signal.
Nature of processing: The algorithms produce estimates and indicators intended solely for preliminary screening. Automated processing does not make diagnoses, prescribe treatments or adopt therapeutic or legally binding decisions concerning the user.
Variability of results: Estimates may be influenced by signal quality, environmental conditions, user movement, lighting, individual characteristics and the accuracy of the medical history data entered.
5. Amendments to the Terms of Use
The provider reserves the right to amend these Terms to comply with regulatory requirements or to update the software. Material changes will be notified to the user at least 3 days in advance. Use of the services after that period constitutes acceptance of the changes. If the user does not intend to accept the new Terms, they must cease using the device.
6. User Obligations and Conditions of Use
Accuracy of information: To access the service, the user must provide accurate, truthful, up-to-date and complete medical history and demographic data. In the event of manifestly false, inaccurate or incomplete data, the Controller may suspend or interrupt access.
Strictly personal use: It is prohibited to allow third parties to use the service with one’s own data. The user is solely responsible for their access credentials.
Inactivity and Removal: The Controller reserves the right to remove or limit access to the device if it is not used for more than 6 months, in accordance with the principle of data minimisation.
System security: The user undertakes not to compromise or breach the security and integrity of Ad Astra's systems or those of third parties hosting the services; to avoid unauthorised access; and not to transmit malware, viruses or harmful files.
Intellectual property: All content, software, trademarks, patents and technologies relating to TrAIcorder services are the exclusive property of Ad Astra or its licensors. Reverse engineering of the software is strictly prohibited, except within the strictly mandatory limits permitted by law. All rights are expressly reserved.
7. Disclaimer of Warranties and Limitation of Liability
Use at the user's risk: Use of the TrAIcorder device/solution and of any integrated third-party applications takes place at the user's sole risk.
Limits of warranties: To the maximum extent permitted by applicable law, Ad Astra and its suppliers disclaim any implied warranty or condition of merchantability, fitness for particular purposes or absence of interruptions, bugs, viruses, errors, loss or destruction of data.
Improper use: Ad Astra is not liable for improper, negligent or unintended uses of the device, including measurements performed on third parties without their prior valid consent.
Cap on compensation: Without prejudice to cases of wilful misconduct or gross negligence and personal injury (which are mandatory by law), Ad Astra's total liability for any claim arising from the use or inability to use the services may not exceed the amount of any fees paid by the user in the 3 months preceding the claim.
Indemnity: The user undertakes to indemnify and hold Ad Astra harmless from any claim for compensation, legal action or expense (including legal fees) arising from a breach of these Terms or unlawful use of the services.
8. Applicable Law and Jurisdiction
Jurisdiction: The services are controlled and managed by Ad Astra in Italy. The Terms are governed and interpreted in accordance with Italian law.
Consumer forum: For any dispute arising from these Terms, where the user acts as a consumer (a natural person acting for purposes unrelated to their business activity), mandatory territorial jurisdiction lies with the court of the consumer's place of residence or domicile, in accordance with the Italian Consumer Code (Legislative Decree 206/2005).
Forum for non-consumer users: Where the user does not qualify as a consumer, the exclusive forum shall be Turin.
Access from abroad: A user accessing the services outside Italian territory is solely responsible for complying with the local laws in force in their country.
PART II: PRIVACY NOTICE ON THE PROCESSING OF PERSONAL DATA (Art. 13 GDPR)
1. Data Controller and Data Protection Officer (DPO)
Data Controller: Ad Astra Innovation & Design s.r.l., with registered and tax office at Via Carlo Goldoni no. 8, 10092, Beinasco (TO), Italy. Data Protection Officer (DPO): Mr Marco Voto, contact: privacy@traicorder.it
2. Types of Data Processed and Collection Methods
We collect your personal data necessary for the operation of the medical device through:
Common and Identification Data: Personal data (first name, surname), demographic data (sex, age) and contact data (email address, telephone number) provided at the time of any registration, completion of forms or customer support.
Special Categories of Data (Health Data): Epidemiological data, medical history information (e.g. hypertension, ongoing treatments, diabetes, asthma, allergies, smoking, cardiovascular disorders, anaemia), physiological parameters measured by the device and screening indices generated by the algorithm.
Collection methods: Through direct entry in on-screen forms, direct interactions with support or technical data flows generated by use of the software.
3. Purposes, Legal Bases and Retention Periods
The Controller processes your personal data exclusively for the purposes indicated below, within the limits of the respective legal bases under Articles 6 and 9 of the GDPR.
A) Provision of Services
Purpose: To enable use of the TrAIcorder medical device for processing physiological parameters indicative of health status and early identification of risk factors for screening purposes, by means of the optical technique of remote photoplethysmography (rPPG).
Legal bases:
For common data: Performance of the contract (Art. 6(1)(b), GDPR).
For health-related data: The data subject's explicit, freely given and informed consent (Art. 9(2)(a), GDPR), collected through the specific on-screen acceptance form before personal data are entered.
Retention period: Personal data and associated measurements are retained in the database in Italian territory until the user withdraws consent, without prejudice to overriding legal obligations related to the surveillance and vigilance of medical devices.
B) Technical Analysis, Research and Development
Purpose: Maintenance, support and audit logs. Audit log: for each consultation by a back-office administrator/operator, any reading, modification or deletion of data is recorded.
Data processed: Demographic data, generated physiological parameters and technical data (system logs, IP address, approximate geographical location).
Video Payload specifications: The video stream or images of the user's face are processed locally in real time and ARE NOT transmitted to the backend server. Actual facial images and video recordings are not saved or stored in any way.
Legal basis: The Controller's legitimate interest (Art. 6(1)(f), GDPR) connected with technological improvement and the security of the medical device, balanced by the adoption of rigorous pseudonymisation and encryption measures.
Retention period: Until completion of the technical analysis of the flow or, in the case of statistical/research purposes, following immediate and irreversible anonymisation of the data.
C) Security, Fraud Prevention and Legal Protection (Other Purposes)
Purpose: Detection of unlawful or fraudulent activities, monitoring of system operations, secure user authentication, verification of compliance with the Conditions of Use, as well as management and defence in the event of legal disputes or claims.
Legal basis: The Controller's legitimate interest in protecting its rights and the security of its systems (Art. 6(1)(f), GDPR). Compliance with legal obligations (Art. 6(1)(c), GDPR).
Retention period: For the period provided for by the ordinary limitation periods for rights (10 years for legal protection) or as required by competent authorities.
D) Exclusion of Direct Marketing and Commercial Profiling
Guarantee of limitation: It is expressly guaranteed that personal and sensitive data collected through the TrAIcorder system will under no circumstances be processed for direct marketing, commercial profiling, market research or advertising communications.
4. How and With Whom We Share Your Data
The Controller does not sell or disclose your personal data to third parties for commercial purposes. Sharing takes place exclusively with:
Data Processors (Art. 28 GDPR): Providers of cloud services, IT infrastructure and calculation algorithm providers, bound by strict confidentiality and IT compliance contracts.
Authorised Personnel: Healthcare professionals, paramedics or internal technical staff of the authorised facility where the service is performed, instructed and authorised to access data through a dedicated Dashboard (protected by credentials and MFA), in compliance with professional secrecy and strict confidentiality obligations.
Competent Authorities: Judicial, governmental or health authorities (including communication to the National Health Service or the general practitioner) only in cases expressly provided for by law or on the basis of independent and specific express consent of the data subject.
Strict Pseudonymisation Measures: In the event of sharing statistical or development data with internal teams, the data are previously pseudonymised. In particular, the tax code truncation technique is applied by deleting the last 6 digits, leaving visible only aggregated and not directly identifying parameters (e.g. weight, height, sex, age, conditions declared in the medical history).
5. Storage Location and Security Measures
Location: All personal and health data collected are stored and processed within the territory of the European Union, specifically on secure cloud servers located in Italy and managed directly by the Controller. No transfer of personal data outside Italy is envisaged.
Security: Industry-standard technical and organisational measures compliant with the GDPR are implemented, including encryption of data flows in transit (SSL/TLS) and at rest, granular access control based on need, multi-factor authentication (MFA) and physical/electronic/perimeter safeguards continuously updated.
6. Tracking and Cookies
During completion of the "Medical History" form and use of the device, no third-party technical cookies, profiling cookies, or behavioural tracking and profiling services (such as Google Analytics without consent) are used.
7. Your Rights (Arts. 15-22 GDPR)
At any time, by sending a communication to privacy@traicorder.it, you may exercise the following rights:
Access and Copy: Obtain confirmation of the existence of processing and receive a structured copy of it.
Rectification: Obtain correction of inaccurate data or completion of incomplete data.
Erasure (Right to be Forgotten): Obtain removal of your data within the limits provided for by Art. 17 GDPR (the Controller will block or erase the data upon expiry of the relevant periods, except for residual contractual needs).
Restriction: Request restriction of processing in the event of disputes (Art. 18 GDPR).
Objection and Withdrawal of Consent: Withdraw consent to the processing of health data. Withdrawal entails the immediate impossibility of using TrAIcorder screening services and the start of processing of residual data in accordance with the law.
Portability: Receive your data in a structured, commonly used and machine-readable format.
Exclusion of automated decisions: The TrAIcorder device performs assisted screening but does not use user profiling or make legally relevant decisions based solely on automated processing.
Complaint: You have the right to lodge a formal complaint with the Italian Data Protection Authority (www.garanteprivacy.it).
Note: To protect data, the Controller may request appropriate proof of the requester's identity before processing the request.
8. Feedback and Reviews Policy
If the user submits comments, suggestions or feedback relating to the Services, they agree that the undersigned may use, reproduce and exploit them without restrictions, time limits or compensation, unless otherwise agreed in writing.
Important note for the User: It is strictly forbidden to include information concerning one's own health status, medical records, screening results or sensitive data of oneself or third parties in feedback. The undersigned will immediately delete any feedback containing health data whenever it becomes aware of it.
9. Links to Third-Party Websites, Apps and Services
The screening service may include links or connections to applications, websites or services operated by third parties. These third parties operate independently and are governed by their own Terms of Service and Privacy Notices. The undersigned has no control over them and disclaims any liability for losses, damages or commercial transactions carried out by the user with such third parties. The possible presence of third-party banners, advertisements or publicity does not constitute approval, recommendation or medical guarantee by the undersigned; use of such advertising information takes place at the user's sole risk.
10. Communications and Notifications to Users
The user may receive technical and administrative notifications (e.g. service changes, policy updates, availability of screening reports) through the contact details (email, SMS) provided at the time of registration. The user is solely responsible for the accuracy, updating and safekeeping of the contact details provided. The undersigned shall not be held liable for:
Any costs or charges applied by the user's telephone operator.
Loss, delay or disclosure of data resulting from the entry of incorrect, obsolete or intentionally false contact details by the user. Unauthorised access to notifications on the user's device by third parties.
Last updated: 08-2026