Terms of Use

AI4MEDIMAGING, SA
AI4CMR — Terms of Use
Version 1.2 · September 2026

Related document: AI4CMR Data Processing Agreement — Global Edition v1.1 (incorporated by reference). English version authoritative; translations for reference only. Version 1.2 supersedes version 1.1 (July 2026) for all Access Plans activated or renewed on or after its effective date.

1. Scope and acceptance

1.1 These Terms of Use (“Terms”) constitute a legally binding agreement between the user (“User”) and AI4MEDIMAGING, SA, a company incorporated under the laws of Portugal (“AI4MEDIMAGING”), governing access to and use of the AI4CMR software, a certified Software as a Medical Device (SaMD) provided exclusively as a cloud-based service (“Service”), under any of the access plans described in Section 3 (“Access Plans”).

1.2 The User accepts these Terms, and the Data Processing Agreement referred to in Section 6, by any of the following acts, whichever occurs first: (a) ticking the acceptance box when requesting a Trial; (b) ticking the acceptance box in the checkout workflow when purchasing a Physician Pack; or (c) accessing or using the Service in any manner. Acceptance is recorded by AI4MEDIMAGING together with the version of the Terms accepted, the date and time, and the account identifier.

1.3 If the User acts on behalf of an institution or legal entity, the User warrants having the authority to bind that entity to these Terms. In that case, references to “User” include both the individual and the represented entity, which are jointly and severally responsible for compliance.

1.4 The Service is offered exclusively to qualified healthcare professionals and to healthcare institutions, research organisations and companies acting through such professionals. The Service is not offered to consumers or to patients, and no patient may open an account or upload their own studies.

2. Regulatory status and intended use

2.1 AI4CMR is a Software as a Medical Device developed and commercialised exclusively by AI4MEDIMAGING, SA. The Service is certified in the following territories:

TerritoryCertificationRegulationClass
European UnionCE MarkingEU MDR 2017/745Class IIa
United StatesFDA 510(k)21 CFR Part 820Class II
United KingdomUKCA MarkingUK MDR 2002Class IIa
BrazilANVISARDC 185/2001Class II

2.2 The Service is intended exclusively for use by qualified healthcare professionals as a quantitative analysis support tool for Cardiac Magnetic Resonance (CMR) imaging studies. AI4CMR analyses only CMR images — it does not process, analyse or support Computed Tomography (CT), X-ray, ultrasound or any other imaging modality.

2.3 AI4CMR is a clinical decision support tool. It does not replace the clinical judgement of the healthcare professional responsible for the diagnosis or treatment of the patient. All clinical interpretations and decisions remain the sole responsibility of the qualified clinician. The instructions for use, labelling and regulatory information of the Service are made available within the Service and on the AI4CMR website, and the User undertakes to read them before clinical use.

In territories where AI4CMR does not hold active regulatory certification, access to the Service is limited to non-clinical scientific research purposes (“Research Only”). Use for diagnosis, screening or guidance of treatment of real patients is expressly prohibited in uncertified territories. AI4MEDIMAGING may restrict the purchase or activation of Access Plans by territory.

3. Access Plans

3.1 The Service is made available under the following Access Plans. The commercial conditions in force (prices, number of study credits, validity) are those published on the AI4CMR website at the time of activation or purchase.

Access PlanNatureDuration / validityStudy uploadStudy retention (Section 5)
TrialFree, non-clinical evaluation of the Service on fictitious demonstration studies pre-installed by AI4MEDIMAGING for testing and demonstrating its features7 calendar days from activation of the Trial accountNot available — the User cannot upload any studyNot applicable — no User data is uploaded; the Trial account and all its contents are deleted at the end of the Trial
Physician Pack 1Prepaid credit for the analysis of one (1) study1 month from purchaseAvailable, within the credits purchasedEach study deleted 30 days after upload
Physician Pack 10 / 50 / 100Prepaid credits for the analysis of 10, 50 or 100 studies12 months from purchaseAvailable, within the credits purchasedEach study deleted 30 days after upload, irrespective of the remaining validity of the Pack

3.2 Trial. The Trial is a free, time-limited evaluation of the Service, granted at AI4MEDIMAGING’s sole discretion following review of the Trial request. The Trial account gives access exclusively to a fixed set of fictitious demonstration studies pre-installed by AI4MEDIMAGING solely for testing and demonstrating the features of the Service (“Demonstration Studies”). The Trial User cannot upload, import, transfer or otherwise introduce any study, image or patient data into the Service, and agrees not to attempt to do so by any means. The Demonstration Studies are fictitious: they do not correspond to any real patient or real clinical examination, are the property of AI4MEDIMAGING, may not be downloaded, copied, redistributed or used for any purpose other than evaluating the Service, and the results generated from them have no clinical value and shall not be used in the care of any patient nor relied upon as evidence of the clinical performance of the Service. One Trial per person and per institution is permitted unless AI4MEDIMAGING agrees otherwise in writing. AI4MEDIMAGING may modify, limit, suspend or terminate the Trial, or any Trial account, at any time and without notice or liability. At the end of the Trial period the account is deactivated and all its contents, including any results, edits or annotations made by the User on the Demonstration Studies, are permanently deleted. The Trial creates no obligation for either party to enter into a paid Access Plan.

3.3 Physician Packs. A Physician Pack is a prepaid, non-transferable bundle of study credits for use by a single named healthcare professional through a single account. One (1) credit is consumed each time a study is submitted for analysis and the analysis is completed by the Service. Changes to parameters, re-computation of results or editing of the analysis of an already processed study do not consume additional credits. A study whose analysis fails for reasons attributable to the Service is re-credited automatically or upon request; a study rejected because it is not a supported CMR study, is corrupted, incomplete or does not comply with the Service documentation does not entitle the User to any re-credit or refund. Credits not used within the validity period of the Pack expire automatically and are non-refundable. Credits cannot be transferred between accounts or converted into money. Purchasing an additional Pack (“top-up”) adds credits to the same account; each Pack keeps its own validity period.

3.4 The features available under each Access Plan are those described on the AI4CMR website at the time of purchase. AI4MEDIMAGING may change the composition, features or prices of Access Plans for the future at any time; changes do not affect Packs already purchased during their validity period.

4. Usage restrictions

The User agrees not to use the Service for any purpose other than those expressly provided in Sections 2 and 3, and specifically agrees not to:

  • Use the results generated by AI4CMR as the sole basis for a clinical decision, diagnosis or therapeutic prescription, without validation by a qualified healthcare professional;
  • Use results generated from Demonstration Studies, or any result generated under a Trial, in the care of a patient or in any clinical, regulatory or scientific publication without AI4MEDIMAGING’s prior written consent;
  • Process patient studies in territories where AI4CMR is not regulatorily approved for clinical use, except within the scope of duly approved research protocols;
  • Upload, or attempt to upload, any study or patient data under a Trial account, or upload under any Access Plan data that the User is not legally entitled to process through a third-party cloud service;
  • Share credentials, allow more than one individual to use a personal account, sublicense, resell, lend or in any way make the Service or its credits accessible to unauthorised third parties;
  • Attempt to reverse engineer, decompile, disassemble, scrape, benchmark for competitive purposes, or access the source code, models or infrastructure of the Service, or use automated tools to access the Service other than through interfaces expressly provided by AI4MEDIMAGING;
  • Submit false, synthetic or fabricated data not corresponding to real medical studies, with fraudulent intent or for unauthorised testing purposes;
  • Circumvent any access control, credit accounting, retention, deletion or feature gating mechanism implemented by the Service, or use the Service as a storage, archiving or transfer service;
  • Use the Service in violation of any applicable law, including rules on the protection of personal data, professional secrecy and medical device regulation;
  • Facilitate or assist any third party in performing any of the above.

5. Storage, retention and deletion of studies

5.1 Fixed 30-day retention per study. Every study uploaded to the Service, together with the analysis results and reports generated from it, is retained in the User’s account for thirty (30) days counted from the moment of upload, and is then automatically, permanently and irreversibly deleted, as detailed in Section 9 of the Data Processing Agreement. This retention cycle is a fixed, non-configurable design feature of the Service and applies identically to all Access Plans that allow uploads.

5.2 Retention is independent of plan validity. The validity period of an Access Plan (for example, 12 months for Physician Packs 10, 50 and 100) determines only the period during which the User may submit studies for analysis and consume credits. It does not extend the retention of any study. For the avoidance of doubt, a study uploaded on the first day of a 12-month Pack is deleted 30 days after that upload, even though the Pack remains valid for a further 11 months.

5.3 Trial. The retention regime in Sections 5.1 and 5.2 does not apply to the Trial, because no study is uploaded by the User: the Demonstration Studies are provided by AI4MEDIMAGING, remain available for the duration of the Trial only, and are removed from the Trial account together with all other account contents at the end of the Trial period.

5.4 User’s duty to export. It is the User’s sole responsibility to download and preserve, within the 30-day window, any studies, results and reports required for the patient’s medical record or by applicable medical records retention law. The Service is not a medical archive, a PACS, a backup service nor a system of record. AI4MEDIMAGING has no technical ability to recover a study after its scheduled deletion and shall have no liability whatsoever for any consequence of the User’s failure to export data in time.

5.5 Expiry or termination of the Access Plan. Upon expiry of the validity period of the last valid Pack, or upon termination or non-renewal of any Access Plan, the User may no longer submit studies. Studies still within their 30-day window remain accessible for consultation and export until their scheduled deletion, unless access is terminated for breach under Section 13, in which case AI4MEDIMAGING may delete all Study Data immediately. Account Data is retained as described in Section 6.3.

6. Data protection

6.1 Data Processing Agreement

The processing of personal data contained in studies uploaded to the Service is governed exclusively by the AI4CMR Data Processing Agreement — Global Edition (“DPA”), which is incorporated by reference into, and forms an integral part of, these Terms. By accepting these Terms, the User also accepts the DPA. In case of conflict between these Terms and the DPA regarding the processing of personal data, the DPA prevails. The current version of the DPA is available on the AI4CMR website and upon request.

6.2 Summary of key data processing terms

For convenience only (the full DPA governs):

  • AI4MEDIMAGING acts as Processor (GDPR), operador (LGPD) and, where applicable, business associate (HIPAA — see the Business Associate Addendum in Annex 5 of the DPA); the User and/or their institution is the Controller;
  • Each study and its analysis results are retained in the User’s account for thirty (30) days from upload and are then automatically, permanently and irreversibly deleted, irrespective of the Access Plan and of its remaining validity;
  • Under a Trial no personal data of the User’s patients is processed, because the User cannot upload studies; the DPA applies to the Trial only in the residual manner described in its Section 1.6;
  • AI4MEDIMAGING makes no secondary use of uploaded studies: no model training, no anonymisation or de-identification, no sale or sharing of study data;
  • Study data is stored and processed exclusively within the Azure Processing Region assigned to the User’s account (Europe, North America, South America or Asia-Pacific), as detailed in Annex 4 of the DPA; the Service is only available in territories served by such a region.

6.3 Account Data

Data relating to the User and their account (identification, professional and contact details, credentials, billing, invoicing, tax identification and usage records, acceptance records of these Terms, and support communications) is processed by AI4MEDIMAGING, SA as an independent controller for account administration, billing, security, fraud prevention, regulatory traceability and legal compliance, in accordance with the AI4CMR Privacy Policy, and is not subject to the DPA. Account Data is retained for as long as required by such purposes and by applicable law (including tax and medical device vigilance obligations), including after the end of the Access Plan.

7. Account, credentials and security

7.1 Each account is personal to the individual healthcare professional identified at registration. The User is responsible for the accuracy of the information provided, for keeping credentials confidential, for all activity carried out through the account, and for notifying AI4MEDIMAGING without delay of any suspected unauthorised access. AI4MEDIMAGING may require multi-factor authentication and may suspend an account showing signs of compromise or abuse.

7.2 AI4MEDIMAGING may verify the professional status, institution and country of the User before activating any Access Plan, and may refuse, suspend or cancel an Access Plan where such information is inaccurate, cannot be verified, or where the User’s territory is not served by the Service.

8. Prices, payment, taxes and refunds

8.1 Prices of Physician Packs are those displayed on the AI4CMR website at the time of purchase, exclusive of VAT and any other applicable taxes, which are calculated at checkout on the basis of the billing country and tax identification number provided by the User. The User is responsible for providing accurate billing and tax information; AI4MEDIMAGING may issue corrected invoices and recover any tax shortfall resulting from inaccurate information. Payments are processed by AI4MEDIMAGING’s payment service provider; AI4MEDIMAGING does not store card details.

8.2 Access to a Physician Pack is activated upon confirmation of payment. All payments are final. Credits consumed and credits expired are non-refundable. AI4MEDIMAGING does not refund unused credits on request, save where mandatory law provides otherwise.

8.3 Where a User qualifies as a consumer under mandatory law and benefits from a statutory right of withdrawal, the User expressly requests that the Service be made available immediately upon payment and acknowledges that the right of withdrawal is lost once the first study is submitted for analysis, without prejudice to a proportional refund for the period or credits not used before withdrawal, where such law so requires.

8.4 AI4MEDIMAGING may suspend access to the Service in case of non-payment, chargeback, payment reversal or suspected payment fraud, and may recover any amounts due together with reasonable collection costs.

9. Clinical responsibility, warranties and limitation of liability

9.1 The User assumes full responsibility for the clinical interpretation of results generated by the Service and for any clinical decisions arising therefrom. AI4MEDIMAGING, SA is not liable for any harm, injury, death or adverse consequence resulting from the use or misuse of the Service, including without limitation diagnostic errors, therapeutic delays or inappropriate clinical decisions.

9.2 The Service is provided “as is” and “as available”. To the maximum extent permitted by law, AI4MEDIMAGING, SA makes no warranty, express or implied, as to the accuracy, completeness or fitness for a particular clinical purpose of the results generated by AI4CMR, nor as to uninterrupted or error-free operation. The User is responsible for verifying the clinical plausibility of all outputs before acting upon them. The Trial is provided free of charge, for evaluation purposes only, without any warranty whatsoever and without any service level or support commitment.

9.3 AI4MEDIMAGING shall not be liable for: (a) any indirect, consequential, special or punitive damages, loss of profits, loss of business, loss of goodwill or loss of data; (b) any loss or unavailability of studies, results or reports resulting from the automatic deletion regime of Section 5 or from the User’s failure to export data within the retention window; (c) any damage resulting from the User’s breach of these Terms, from unauthorised access using the User’s credentials, or from the User’s hardware, software, network or internet connectivity; (d) any unavailability or degradation of the Service attributable to the cloud infrastructure provider, to scheduled maintenance, or to events of force majeure under Section 14.

9.4 In no event shall the total aggregate liability of AI4MEDIMAGING, SA to the User, on any ground whatsoever, exceed the amount actually paid by the User to AI4MEDIMAGING under the applicable Access Plan in the twelve (12) months preceding the event giving rise to liability. For a Trial, or where no amount has been paid, the total aggregate liability of AI4MEDIMAGING shall not exceed one hundred euros (EUR 100). This aggregate cap applies jointly to claims under these Terms and under the DPA. Nothing in this Section limits liability that cannot be limited or excluded under mandatory applicable law, including liability for wilful misconduct or gross negligence.

10. Indemnification by the User

The User shall defend, indemnify and hold harmless AI4MEDIMAGING, SA, its directors, employees and agents from and against any claims, proceedings, fines, penalties, damages, losses and reasonable costs (including legal fees) arising from or related to: (a) the User’s breach of these Terms or of the DPA; (b) the unlawfulness of any data uploaded by the User or of the User’s instructions; (c) any clinical decision, diagnosis or treatment made by or on behalf of the User; (d) use of the Service in territories or for purposes not permitted by Section 2 or 3, including any clinical use of results generated under a Trial; or (e) any claim by the User’s patients, institution or third parties relating to the User’s use of the Service.

11. Intellectual property

11.1 The Service, including its algorithms, artificial intelligence models, interfaces, documentation, Demonstration Studies and all elements comprising it, is the exclusive property of AI4MEDIMAGING, SA or its licensors and is protected by applicable intellectual property rights. The User does not acquire any ownership rights over the Service by entering into these Terms — only a limited, revocable, non-exclusive and non-transferable right of access for the purposes set out in Sections 2 and 3, for the duration of the applicable Access Plan.

11.2 Patient data and reports generated by the Service from studies uploaded by the User belong to the User or their institution. AI4MEDIMAGING, SA claims no ownership over clinical data submitted to or outputs generated by the Service from the User’s studies. Any feedback, suggestions or usage statistics provided by or collected from the User may be used by AI4MEDIMAGING without restriction, provided they contain no patient data.

12. International sanctions and export compliance

The User declares not being subject to economic sanctions or embargoes imposed by the European Union, the United States of America, the United Kingdom, the United Nations or any other body with relevant jurisdiction, and that the Service will not be used in violation of any applicable international sanctions regime or export control law. The User further warrants that use of the Service complies with all applicable medical device regulations in the User’s jurisdiction, including any local market authorisation requirements not expressly covered by the certifications listed in Section 2.

13. Term, suspension and termination

13.1 These Terms take effect from the moment of acceptance by the User and remain in force for the entire period of access to the Service, including the validity of any Pack and the 30-day retention window of any study uploaded before expiry. Access Plans have the duration set out in Section 3 and are not automatically renewed.

13.2 AI4MEDIMAGING, SA may suspend or terminate access to the Service, in whole or in part, with immediate effect and without liability, in the event of: breach of these Terms or of the DPA; suspected fraud, abuse or security risk; a request or order from a regulatory or judicial authority; withdrawal or suspension of the regulatory certification of the Service in the User’s territory; or non-payment. Upon termination for breach, any unused credits or prepaid fees are forfeited and non-refundable, save where mandatory law provides otherwise.

13.3 AI4MEDIMAGING may discontinue the Service, or its availability in a given territory or Processing Region, with thirty (30) days’ notice where reasonably practicable. In that case unused, unexpired credits are refunded pro rata as the User’s sole remedy.

13.4 Deletion of study data upon expiry or termination occurs as set out in Section 5.5 of these Terms and Section 9 of the DPA. Sections 5, 6.3, 9, 10, 11, 15 and 16 survive termination.

14. Service availability, support and force majeure

14.1 AI4MEDIMAGING uses reasonable efforts to keep the Service available and may perform scheduled maintenance, preferably outside European business hours, with notice through the Service where practicable. No service level commitment applies to the Trial or to Physician Packs. Support for Physician Packs is provided by e-mail during business hours (Lisbon time).

14.2 AI4MEDIMAGING shall not be liable for any failure or delay caused by events beyond its reasonable control, including failures of the cloud infrastructure provider, telecommunications or power, cyber-attacks, acts of authority, epidemics, strikes or natural disasters.

15. Governing law and dispute resolution

15.1 These Terms are governed by Portuguese law. Any dispute not resolved amicably within 30 days of written notice shall be submitted to the Lisbon Commercial Court (Tribunal de Comércio de Lisboa), with express waiver of any other forum.

15.2 For Users outside the European Union, AI4MEDIMAGING, SA may, at its sole discretion, propose international arbitration under the rules of the International Chamber of Commerce (ICC), with the seat of arbitration in Lisbon, Portugal, and proceedings conducted in English.

Nothing in this clause prevents a User who qualifies as a consumer under applicable law from invoking mandatory consumer protection provisions of their country of residence.

16. General provisions

16.1 These Terms, the DPA and the AI4CMR Privacy Policy constitute the entire agreement between the parties regarding the Service and supersede any prior communication. No terms of the User (including purchase orders or institutional procurement conditions) apply unless expressly accepted in writing by AI4MEDIMAGING.

16.2 If any provision of these Terms is held invalid or unenforceable, the remaining provisions remain in full force and the invalid provision shall be replaced by a valid one achieving, as closely as possible, the same economic and legal effect. Failure by AI4MEDIMAGING to enforce any provision does not constitute a waiver.

16.3 The User may not assign or transfer these Terms, any account or any credits without AI4MEDIMAGING’s prior written consent. AI4MEDIMAGING may assign these Terms to an affiliate or to a successor of its business or of the Service.

16.4 Notices to the User are validly given by e-mail to the address registered in the account or through the Service. Notices to AI4MEDIMAGING shall be sent to the contact addresses published on the AI4CMR website.

17. Amendments to these Terms

AI4MEDIMAGING, SA reserves the right to amend these Terms at any time, with 30 days prior notice by e-mail to the address registered in the account. Continued use of the Service after that period implies acceptance of the revised Terms. Previous versions are archived and available upon request. Amendments required by changes in applicable law or regulatory guidance may take effect immediately upon notification, where a 30-day notice period is not practicable. Amendments to the DPA follow the regime set out in the DPA itself.

Acceptance

By ticking the acceptance checkbox in the AI4CMR trial request or checkout workflow, or by otherwise accessing and using the Service, the User acknowledges having read and understood these Terms and the Data Processing Agreement in full and agrees to be bound by both.

Version history: v1.0 (2026) · v1.1 July 2026 · v1.2 September 2026 (Access Plans, credits, 30-day retention independent of plan validity, Trial regime, payments, indemnification).