Legal · Terms of use
Terms & Conditions
These Terms govern your access to and use of OtoSensAI — an AI-assisted tympanic membrane image classification tool operated by Voxmedai Healthtech Pvt Ltd. Please read them in full before creating an account or uploading any image.
| Field | Detail |
|---|---|
| Version | 2.0 |
| Effective date | To be confirmed |
| Operator | Voxmedai Healthtech Pvt Ltd |
| Registered office | C-3/387, Vishal Khand-3, Gomtinagar, Lucknow, Uttar Pradesh — 226010 |
| Governing law | India · Courts at Lucknow |
| Regulatory framework | Medical Devices Rules 2017 · DPDPA 2023 & DPDP Rules 2025 · IT Act 2000 |
| Website | otosensai.online |
1.Acceptance of these Terms
By creating an account, uploading an image, or otherwise accessing the OtoSensAI mobile application, website, or related services (together, the "Service"), you ("you," "User") agree to be bound by these Terms & Conditions ("Terms") and our Privacy Policy, which is incorporated by reference. If you do not agree, you must not use the Service.
The Service is operated by Voxmedai Healthtech Pvt Ltd ("Voxmedai," "we," "us," "our"), a company incorporated in India, with its registered office at C-3/387, Vishal Khand-3, Gomtinagar, Lucknow, Uttar Pradesh — 226010. OtoSensAI is a product operated by Voxmedai.
If you are using the Service on behalf of a hospital, clinic, or other institution, you confirm that you have the authority to bind that institution to these Terms, and "you" refers to both you individually and that institution. Institutional use additionally requires a signed Data Processing Agreement with us.
2.Definitions
| Term | Meaning |
|---|---|
| "Image" / "Content" | Any endoscopic or otoscopic photograph of a tympanic membrane, and any accompanying clinical notes, uploaded to the Service. |
| "Classification Output" | The label, probability score, or ranked category list the AI model generates for an uploaded Image. |
| "Reviewer" | A qualified ENT faculty member affiliated with OtoSensAI who reviews Images and Classification Outputs for quality assurance. |
| "Personal Data" / "PII" | Any information that identifies, or could reasonably be used to identify, a natural person — for example, name, date of birth, contact details, government ID numbers, or facial images. |
| "Data Principal" | The individual to whom Personal Data relates, as defined under the DPDPA, 2023. |
| "Data Fiduciary" | Voxmedai, as the entity determining the purpose and means of processing Personal Data collected through the Service. |
| "De-identification" | The automatic removal of metadata, filenames, and identifiers at the point of upload, before storage, such that the retained Image is no longer Personal Data. |
3.What OtoSensAI is — and is not
OtoSensAI is an AI-assisted image classification tool that analyses uploaded tympanic membrane images and returns a Classification Output, which is subsequently reviewed by a Reviewer for quality assurance.
OtoSensAI is not a substitute for medical diagnosis, examination, or treatment.
It does not establish a doctor–patient relationship.
Its outputs are screening and decision-support information only — never a diagnosis.
Any decision about diagnosis, treatment, referral, or further investigation must be made by a licensed medical practitioner following an in-person or tele-consultative clinical examination — not on the basis of the Service alone.
4.Regulatory status
OtoSensAI is regulated as a software medical device under India's Medical Devices Rules, 2017, as administered by the Central Drugs Standard Control Organisation (CDSCO).
| Field | Detail |
|---|---|
| Approval | CDSCO market approval — pending Market approval has not been granted. The Service currently operates under CDSCO Form MD-13, Licence No. SW/MD/MD-13/2026/000004207 — a licence to manufacture for the purpose of test. See the Test-Period Disclaimer. |
| Device class | As determined at approval Class B under the current test licence. |
| Approved use | Screening and clinical decision-support aid, subject to independent clinical judgement |
| Manufacturer | Voxmedai Healthtech Pvt Ltd |
The Service is a decision-support aid. It is not approved as a standalone diagnostic device, and no Classification Output may be treated as a diagnosis. We will update this section, and notify Users, if our regulatory classification or approval status changes.
This section describes the intended use at approval. Until market approval is granted, the Test-Period Disclaimer governs: outputs are "not a diagnosis, not a clinical finding, and not authorised decision-support," and no output may be used to direct, delay, alter, or escalate the management of any patient.
5.Who can be an end user
The Service is designed for two categories of User:
- Non-ENT medical practitioners — general physicians, family doctors, or other clinicians seeking an AI-assisted second opinion on a tympanic membrane image before referral.
- Patients and general members of the public — individuals uploading their own tympanic membrane image for informational screening purposes.
Regardless of category, every User acknowledges and accepts the limitations described in Sections 3 and 18.
Participation is limited to enrolled investigators and delegated staff named on the approved protocol, at the sites named in the test licence. See the Test-Period Disclaimer.
6.De-identification and personal information
Personal Data must not appear in any Image, filename, or note. Responsibility for ensuring this is allocated as follows.
| Task | Responsibility | How |
|---|---|---|
| Strip EXIF and all image metadata | Voxmedai — automatic | Enforced in the upload pipeline before the Image is written to storage |
| Discard the original filename | Voxmedai — automatic | Replaced with a generated identifier at ingestion |
| Reject non-conforming uploads | Voxmedai — automatic | Format and size validated server-side |
| Frame the shot to exclude faces and identifying marks | You | Capture technique — see the Medical Image Guidelines |
| Keep names, IDs, and contact details out of the notes field | You | The notes field accepts clinical description only |
You must not upload, embed, or transmit Personal Data through the Service. This includes patient or user names and initials; dates of birth or ages tied to an identifiable record; medical record numbers, hospital IDs, insurance numbers, or Aadhaar or other government ID numbers; contact details placed in notes or captions; and any facial image or other identifying body part captured incidentally alongside the tympanic membrane.
Where the Image is of a patient other than yourself, you confirm that you have obtained appropriate clinical consent for AI-assisted analysis. We may remove any Image found to contain Personal Data, and may suspend accounts that repeatedly breach this rule.
7.Ownership and licence to your images
You retain ownership of the Images you upload. By uploading, you grant Voxmedai a worldwide, royalty-free, sub-licensable, non-exclusive licence to store, reproduce, process, analyse, and display your Images for the purposes of:
- generating a Classification Output;
- enabling Reviewer assessment;
- improving and training the underlying AI model, subject to Section 8;
- maintaining service quality, security, and technical support.
This licence survives deletion of your account only in respect of Images already de-identified and incorporated into aggregated training datasets, as described in Sections 8 and 12.
8.Use of images for AI model training
Improving the classification model is a core purpose of the Service. Your consent to it is sought separately from your acceptance of these Terms.
At registration you are asked separately whether your de-identified Images may be used to train and improve the classification model. This is a distinct choice, not part of accepting these Terms.
You may decline and still use the Service in full.
You may withdraw your consent at any time in Settings, with the same ease as giving it.
Withdrawal stops all future use of your Images and removes them from the training dataset. Images already incorporated into a trained model cannot be extracted from it — see Section 12.
9.Data we collect
| Category | Examples | Purpose |
|---|---|---|
| Account data | Email address, hashed password, account type | Login, authentication, communication |
| Content data | De-identified tympanic membrane Images, clinical notes | Classification, review, and model training where consented under Section 8 |
| Usage data | App interactions, timestamps, feature usage, session duration | Product improvement, troubleshooting |
| Device data | Device type, OS version, app version, approximate IP-based location | Security, compatibility, fraud prevention |
We do not intentionally collect, and you must not submit, any Personal Data beyond your account email.
10.How your data is used
- To generate and display a Classification Output on upload;
- To route the Image and Output to a Reviewer for quality assurance;
- To train and improve the AI model, where you have consented under Section 8;
- To operate, secure, and maintain the Service;
- To communicate with you about your account, updates, or support requests;
- To meet our materiovigilance obligations under the Medical Devices Rules, 2017;
- To comply with applicable law, including lawful requests from regulators or courts.
We do not sell your Personal Data to third parties. We do not use your data for advertising.
11.Human review by ENT faculty
Reviewers are qualified ENT faculty affiliated with the platform. When you upload an Image:
- The Classification Output is shown to you instantly, generated by the AI model;
- The Image and Output are separately queued for Reviewer assessment;
- Reviewer feedback, where provided, is offered for quality assurance and education connected to the Service, and does not constitute a formal medical opinion, prescription, or diagnosis.
You consent to your uploaded Image and its accompanying details being visible to Reviewers as part of the standard operation of the Service.
Review is not real-time and may take several days. You must never wait for it before seeking care.
Where a Reviewer identifies a finding suggesting urgent or serious pathology, we will attempt to contact you at your registered email within one working day, advising you to seek in-person specialist assessment promptly.
This is a safety measure, not a diagnosis, and not a service you may rely upon. Absence of contact never indicates absence of pathology.
12.Data retention and deletion
| Data | Retention | On deletion request |
|---|---|---|
| Account data (email, login records) | While your account is active, plus a reasonable period thereafter for legal, audit, and security obligations | Deleted within 30 days, subject to statutory retention |
| De-identified Images not yet used in training | While your account is active | Deleted within 30 days |
| De-identified Images already incorporated into a trained model | Indefinitely, as part of the model development record | Cannot be individually retrieved or removed from a trained model |
| Vigilance and audit records | Statutory period under the Medical Devices Rules, 2017 | Retained — mandatory regulatory record |
Images are de-identified automatically at the point of upload, before storage, so that what reaches the training pipeline is no longer Personal Data.
Once a de-identified Image has been used to train a model, it cannot be extracted from that model. This is a technical characteristic of machine learning, not a policy choice. You are told this before you give training consent under Section 8, not afterwards.
Withdrawing consent removes your Images from the training dataset and stops all future use. It cannot reach back into a model already trained.
13.Security safeguards
We implement technical and organisational measures appropriate to the sensitivity of the data we hold, including:
- Encryption of data in transit (TLS) and at rest;
- Role-based access controls limiting who can view raw Images and account data;
- Authentication safeguards on all accounts;
- Automatic de-identification at ingestion, per Section 6;
- Minimum-necessary access to Images and account data;
- Audit trails of access to, and modification of, stored data;
- Periodic security review of infrastructure and access logs;
- Workforce training on data-handling practices for anyone with backend access.
13.1 Breach notification
On becoming aware of a personal data breach, we will give immediate initial intimation to the Data Protection Board of India and to affected Data Principals, followed by detailed particulars within 72 hours, in accordance with the DPDP Rules, 2025.
No system is completely secure. You acknowledge that no method of transmission or storage is guaranteed to be secure, and that we cannot warrant absolute security.
14.Hosting and cross-border data transfer
Your data is stored on servers located in location — to be confirmed, operated by hosting provider — to be confirmed. Where data is transferred outside India, we take steps to ensure it receives a comparable standard of protection, consistent with the DPDPA and applicable government notifications on cross-border transfer.
15.Territorial scope
The Service is offered in India only, to Users located in India, under Indian regulatory approval. Access from outside India is not offered and is not supported.
- Registration requires confirmation of Indian residence.
- We may geo-restrict access to give effect to this Section.
- We do not target, market to, or offer the Service to users in the European Union, the United Kingdom, or the United States.
A medical device approval is territorial. Approval granted by CDSCO authorises the Service in India and confers no authorisation in any other jurisdiction.
16.Your rights under the DPDPA and our Grievance Officer
As a Data Principal under India's Digital Personal Data Protection Act, 2023 and the DPDP Rules, 2025, you have the right to:
- Obtain a summary of the Personal Data we hold about you and the processing activities carried out;
- Request correction or updating of inaccurate or incomplete Personal Data;
- Request erasure of your Personal Data, as set out in Section 12;
- Withdraw consent at any time — including training consent under Section 8 — with the same ease as giving it. Withdrawal does not affect processing lawfully carried out beforehand;
- Nominate another individual to exercise these rights on your behalf in the event of death or incapacity;
- Lodge a complaint with our Grievance Officer, and thereafter with the Data Protection Board of India if unresolved.
| Grievance Officer | Detail |
|---|---|
| Name | To be confirmed |
| Designation | To be confirmed |
| To be confirmed | |
| Postal address | To be confirmed |
We will acknowledge grievances within a reasonable period and aim to resolve them promptly.
17.Adverse events and materiovigilance
As manufacturer, we are responsible for detecting, assessing, and reporting device malfunctions and adverse events under the Medical Devices Rules, 2017. Please report any suspected misclassification with clinical consequence, malfunction, or adverse event to us as soon as practicable, using the contact details in Section 26.
| Step | Timeline | Owner |
|---|---|---|
| You report a suspected misclassification, malfunction, or adverse event | As soon as practicable | User |
| We acknowledge and open a vigilance record | Within 24 hours | Safety lead |
| Initial triage and severity assessment | Within 72 hours | Safety lead |
| Report to MvPI / CDSCO where reportable | Per Medical Devices Rules, 2017 | Voxmedai |
| Root cause analysis and corrective action | Within 30 days of triage | Voxmedai |
| Field safety notice or service suspension if warranted | Immediately on determination | Voxmedai |
18.Limitations, warranties, and liability
The Service is decision-support, never a diagnosis.
Classification accuracy varies with image quality, lighting, positioning, and pathology not visible in a single photograph. The model may miss conditions that are present, and may suggest conditions that are not present.
You must always seek in-person evaluation by a qualified ENT specialist for any diagnosis, treatment, or medical decision. Do not delay seeking medical care because of a result shown on the Service.
The Service is provided "as is" and "as available," without warranty of any kind, express or implied, including accuracy, completeness, or fitness for a particular clinical purpose, except as set out below.
18.1 What we do not exclude
We do not exclude or limit our liability for death or personal injury caused by our negligence, for fraud or fraudulent misrepresentation, or for any other liability that cannot lawfully be excluded or limited. Any provision of these Terms purporting to do so is severed to that extent.
18.2 What we do limit
- Subject to Section 18.1, and to the maximum extent permitted by law, we are not liable for indirect, incidental, or consequential loss of any kind.
- Subject to Section 18.1, our aggregate liability arising out of or relating to the Service is limited to amount — to be confirmed or the amount you paid us in the twelve months preceding the claim, whichever is greater.
- We maintain product liability insurance in respect of the Service. Details are available on request.
19.Children's data
Ear conditions commonly affect children, and we recognise that minors may be the subject of an uploaded Image even though they cannot hold an account themselves.
- Only Users aged 18 or older may register and hold an account.
- No Personal Data identifying a minor may be included, consistent with Section 6.
- We do not knowingly allow minors to independently create accounts. Any account found to belong to a User under 18 will be suspended pending guardian verification.
Under Section 9 of the DPDPA, processing a child's Personal Data requires verifiable parental consent, and tracking or behavioural monitoring of children is prohibited.
Where an Image is of a person under 18, the parent or legal guardian must complete our verifiable parental consent process before the Image is accepted. A self-declaration is not sufficient for this purpose.
Images of minors are not accepted through the Service until that process is completed.
20.Fees and subscriptions
OtoSensAI is offered free of charge for an initial period of two (2) months from the date of your account creation.
Following the free period, continued access may require a paid subscription. We will notify you in advance of the applicable pricing, billing cycle, and any change in terms before charges begin. Continued use of the Service after the free period without subscribing may result in restricted or suspended access.
Our refund and cancellation policy is published at otosensai.online and forms part of these Terms.
There is no subscription and no billing. Any subscription arrangement arises only if and when market approval is granted, and is governed by the Terms & Conditions applicable at that time. See the Test-Period Disclaimer.
21.Intellectual property
The Service — including its software, AI models, trained weights, design, trademarks (including the name "OtoSensAI"), and all associated documentation — is the exclusive property of Voxmedai and its licensors. Nothing in these Terms grants you any right to use our trademarks, branding, or underlying technology outside the ordinary use of the Service.
Classification Outputs generated for your Images are provided to you for your own reference and clinical workflow, and remain subject to the licence and liability terms above.
22.Suspension and termination
- You may stop using the Service and request closure of your account at any time.
- We may suspend or terminate your account for breach of these Terms, including breach of Section 6, misuse of Classification Outputs, or fraudulent activity.
- We will suspend the Service where CDSCO, or our own safety review, requires it.
- Sections 6, 7, 8, 12, 17, 18, and 24 survive termination.
23.Indemnity
If you are a medical practitioner or an institutional User, you agree to indemnify and hold harmless Voxmedai, its founders, Reviewers, employees, and affiliates from any claim, loss, or liability arising from: (a) your breach of these Terms; (b) Personal Data you upload in breach of Section 6; (c) any clinical decision made in reliance on the Service contrary to Sections 3 and 18; or (d) your violation of any applicable law.
This Section does not apply to Users who are consumers.
24.Governing law and dispute resolution
These Terms are governed by the laws of India. The courts at Lucknow, Uttar Pradesh have exclusive jurisdiction over any dispute arising out of or in connection with these Terms.
Nothing in this Section limits your right, as a consumer, to approach the consumer fora established under the Consumer Protection Act, 2019.
25.Changes to these Terms
We may update these Terms from time to time to reflect changes in the Service, applicable law, or our regulatory status. Material changes will be notified via the app or your registered email, with the effective date at the top of this document updated accordingly.
Where a change introduces a new purpose for processing your Personal Data, we will seek your fresh consent rather than rely on continued use. For all other changes, continued use of the Service after the changes take effect constitutes acceptance of the revised Terms.
26.Contact us
For questions about these Terms, data rights requests, or to report an issue:
| Channel | Detail |
|---|---|
| General support | support@otosensai.online — to be confirmed |
| Grievance Officer | To be confirmed — see Section 16 |
| Adverse events and safety | To be confirmed — see Section 17 |
| Registered office | Voxmedai Healthtech Pvt Ltd, C-3/387, Vishal Khand-3, Gomtinagar, Lucknow, Uttar Pradesh — 226010 |
| Website | https://otosensai.online |
© 2026 Voxmedai Healthtech Pvt Ltd — OtoSensAI · otosensai.online