Term & Conditions

Summary (not a substitute for the full Terms)

• Who we are: DataClever is a MedTech and digital health engineering firm. We build data pipelines, signal processing and machine learning algorithms, AI agents, and regulatory evidence for healthcare and medical device companies.
• Website vs. projects: These Terms govern your use of dataclever.ai and its forms. Paid engagements are governed by a signed Statement of Work (SOW) or Master Services Agreement (MSA), which prevails on commercial terms.
• No patient data through our forms: Never send protected health information (PHI) or patient data through our contact or newsletter forms. We accept PHI only under a signed Business Associate Agreement (BAA) through a secure channel we provide.
• Not medical advice: Our website, insights, and deliverables are engineering and technical work. They are not medical advice, diagnosis, or a guarantee of FDA clearance.
• Disputes: California law, individual arbitration in Orange County, California, after a 60-day informal resolution period.

1. Acceptance and Scope

1.1 These Terms and Conditions (“Terms”) govern your access to and use of dataclever.ai, its subpages, forms, newsletters, and related content (the “Website”), and apply to professional services, software, AI agents, and deliverables we provide (the “Services”) unless a signed agreement states otherwise. The Website and Services are operated by [DataClever legal entity name, e.g., DataClever AI LLC], a [State] [entity type] (“DataClever,” “we,” “us,” or “our”).

1.2 By browsing the Website, submitting a form, subscribing to our communications, or engaging our Services, you agree to these Terms and to our Privacy Policy, which is incorporated by reference. If you act on behalf of a company, hospital, research institution, or other organization, you represent that you are authorized to bind it, and “you” refers to that organization.

1.3 Order of precedence. If these Terms conflict with a signed MSA, SOW, BAA, Data Processing Addendum (“DPA”), or Non-Disclosure Agreement (“NDA”) (each, an “Agreement”), the Agreement controls for the matters it covers. A BAA always controls for the handling of PHI.

1.4 If you do not agree to these Terms, do not use the Website or Services.

2. Eligibility

2.1 The Website and Services are intended for business and professional users, including medical device manufacturers, digital health companies, healthcare providers, researchers, and investors. They are not directed to patients or consumers seeking care.

2.2 You must be at least 18 years old and able to form a binding contract. The Website is not intended for children under 16, and we do not knowingly collect their personal information.

2.3 You represent that you are not located in, or a national of, a country subject to U.S. embargoes, and that you are not on any U.S. government restricted-party list. You will comply with applicable export control and sanctions laws.

3. Website Forms and Communications

3.1 Forms we operate. The Website includes (a) the “Let’s Talk About Your MedTech AI Challenge” contact form, which collects your full name, email, country, professional role, and area of interest; and (b) a newsletter subscription form, which collects your email address. We use this information to respond to your inquiry, qualify and scope a potential project, send the communications you requested, and maintain business records, as described in our Privacy Policy.

3.2 Do not submit health or confidential information through forms. Website forms are not designed to receive PHI, patient data, physiological recordings, clinical notes, trade secrets, source code, or unpublished regulatory documents. Do not include such information in any form field or unsolicited email. If you need to share it, ask us first; we will put an NDA and, where required, a BAA in place and provide a secure transfer method.

3.3 Unsolicited information. Information you send before an NDA is signed is not treated as Confidential Information under Section 9, except personal information, which we handle under our Privacy Policy. We may already be working on similar ideas, and receiving your inquiry does not restrict our independent work.

3.4 Accuracy. You agree that the information you submit is accurate and belongs to you or that you are authorized to share it. Do not submit another person’s contact details without their permission.

3.5 Newsletter and marketing emails. By subscribing, you consent to receive DataClever insights, case studies, and service updates. Each marketing email will identify DataClever, include our physical mailing address, and contain an unsubscribe link, consistent with the U.S. CAN-SPAM Act. You may unsubscribe at any time; we will honor requests within 10 business days. Transactional and project emails may continue while you have an active engagement.

3.6 Response times. Statements such as “we will reply within one business day” are service goals, not contractual commitments.

3.7 Electronic communications. You consent to receive notices and agreements electronically. Electronic signatures and records satisfy any legal writing requirement where permitted by law, including the U.S. E-SIGN Act.

3.8 Cookies and third-party tools. The Website uses cookies and third-party technologies such as web fonts, form processing, analytics, and embedded video. See our Cookie Policy for details and choices.

4. Professional Services and Engagements

4.1 Services. We provide data engineering, physiological signal processing, machine learning and deep learning development, custom AI agents and automation, validation and verification support, and regulatory strategy support (collectively, “Services”), as described on the Website and defined in an Agreement.

4.2 No obligation until signed. Website content, pricing ranges, conversations, and proposals are not offers. No engagement exists until both parties sign an SOW or MSA that defines scope, deliverables, timeline, fees, and acceptance criteria.

4.3 Engagement models.

4.4 Published price ranges. Ranges shown on the Website (for example, typical hourly rates or project ranges) are indicative estimates in U.S. dollars, based on typical engagements. Your price is the one stated in your signed SOW. Hourly R&D estimates are good-faith projections, not caps, unless the SOW sets a not-to-exceed amount.

4.5 Change requests. Changes to scope, data sources, requirements, or regulatory pathway require a written change order. A change may adjust fees, timeline, or both. Fixed fees cover only the scope defined in the SOW.

4.6 Client responsibilities. You will provide timely access to data, documentation, devices, personnel, and decisions reasonably needed. Delays caused by missing inputs extend the timeline and may increase fees.

4.7 Acceptance. Deliverables are accepted on the earlier of written acceptance or 10 business days after delivery without a written notice of material nonconformity with the SOW’s acceptance criteria. We will correct reported nonconformities within a reasonable period.

4.8 Payment. Unless the SOW states otherwise, invoices are due within 30 days, in U.S. dollars, exclusive of taxes, wire fees, and pre-approved expenses. We may suspend work on overdue accounts after 10 days’ written notice. Late amounts may accrue interest at 1% per month or the maximum allowed by law, whichever is lower.

4.9 Independent contractor. DataClever is an independent contractor. We control the means and methods of our work and may use qualified personnel and subcontractors, including our engineering team in Cali, Colombia, who are bound by written confidentiality and data protection obligations.

4.10 Non-solicitation. During an engagement and for 12 months after, neither party will directly solicit for employment the other party’s personnel who worked on the engagement, except through general job postings.

5. Health Data, Privacy, and Security

5.1 PHI only under a BAA. Where our Services involve PHI as defined under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”), the parties will sign a BAA before any PHI is shared. We act as a business associate (or subcontractor business associate) and handle PHI only as the BAA permits.

5.2 De-identified data preferred. Where the project allows, you will provide data de-identified under HIPAA’s Safe Harbor or Expert Determination method, or a limited data set under a data use agreement. You are responsible for the de-identification you perform and for having the rights, consents, IRB approvals, and authorizations needed to share data with us.

5.3 Your role. As between the parties, you (or your customer) are the covered entity, data owner, or controller of Customer Data and are responsible for patient notices, consents, and the lawful basis for processing. “Customer Data” means data, signals, recordings, records, files, and materials you provide.

5.4 Our safeguards. We maintain administrative, physical, and technical safeguards appropriate to the data, including access controls, encryption in transit and at rest where supported, audit logging, and least-privilege access. Specific security commitments are defined in the BAA, DPA, or SOW. Statements on the Website such as “HIPAA-aware” or “supports HIPAA compliance” describe our design approach; they are not a certification, and compliance remains a shared responsibility.

5.5 State health privacy laws. Where applicable, we will support your obligations under U.S. state laws covering consumer health data, including the California Consumer Privacy Act as amended by the CPRA, the California Confidentiality of Medical Information Act, and Washington’s My Health My Data Act. Website forms do not collect consumer health data.

5.6 International processing. We are headquartered in Orange County, California, and operate an engineering hub in Cali, Colombia. Customer Data may be processed in the United States, in Colombia, or in cloud regions you approve. We process data from Colombia in line with Colombian Law 1581 of 2012 and its regulations, and we use appropriate transfer safeguards. PHI will not be stored or accessed outside the United States unless your BAA or SOW expressly permits it.

5.7 Security incidents. We will notify you of a confirmed security incident affecting your Customer Data without undue delay and within the timeframe in the BAA or DPA, and in any case within the period required by law.

5.8 Return and deletion. At the end of an engagement, we will return or securely destroy Customer Data as stated in the Agreement, except copies we must keep by law, which remain protected under these Terms.

6. Clinical, Regulatory, and AI Disclaimers

6.1 Not medical advice. Website content, insights, case studies, and our communications are for general information for professional audiences. They are not medical advice, diagnosis, or treatment, and do not create a provider–patient relationship. If you are a patient, consult a qualified healthcare provider.

6.2 Engineering services, not a manufacturer. Unless an Agreement says otherwise, DataClever is not the legal manufacturer, sponsor, or regulatory submitter of any device, software as a medical device (SaMD), or clinical decision support tool. You remain responsible for intended use, design controls, quality management system, labeling, clinical evaluation, risk management, regulatory submissions, post-market surveillance, and the final decision to release any product.

6.3 No guarantee of regulatory outcomes. Terms such as “FDA-ready” or “regulatory-ready” mean work prepared to support a submission, including documentation, traceability, and validation evidence. They do not guarantee FDA clearance or approval, CE marking, or any other regulatory decision, timeline, or outcome. Past results, including products that received clearance, do not predict future results.

6.4 Clinical use requires validation and oversight. Algorithms, models, and AI agents we build (including agents for triage, chart review, prior authorization, clinical notes, or reports) are tools to support qualified professionals. They must not be used to make clinical or coverage decisions without appropriate validation in the intended setting, human review, and any required regulatory authorization.

6.5 AI outputs. AI and machine learning outputs are probabilistic and may be inaccurate, incomplete, biased, or outdated. You must review and validate outputs before relying on them, especially in clinical, safety, regulatory, or patient-facing contexts. Model performance can change with data, devices, populations, and care settings.

6.6 Third-party AI providers. Some Services use third-party models or cloud platforms (for example, AWS or Microsoft Azure). We use them under agreements that, where PHI is involved, include a BAA, and we do not permit them to train general-purpose models on your identifiable data. We will identify subprocessors on request or in the DPA.

6.7 Training on your data. We will not use your Customer Data to train models for other clients or for our own products without your written consent. We may use aggregated, de-identified operational metrics (for example, runtime or error rates) to maintain and improve our tools.

6.8 High-risk uses. Any use of deliverables in life-supporting, emergency, or autonomous treatment contexts requires an Agreement that expressly covers that use.

7. Intellectual Property

7.1 Website content. The Website, including text, graphics, the DataClever name and logo, agent names and characters (such as Sama, Linky, Kardy, Senty, and Describa), illustrations, and code, is owned by DataClever or its licensors. You may view and share Website pages for informational purposes. You may not copy, scrape, republish, or create derivative works from it without our written permission.

7.2 Deliverables. Unless the SOW states otherwise, upon full payment we assign to you our rights in deliverables created specifically for you under that SOW (“Deliverables”), such as project-specific code, trained model weights, reports, and documentation.

7.3 Background IP. We keep all rights in tools, libraries, frameworks, agent architectures, signal processing methods, know-how, and templates we owned before or develop independently of an engagement (“Background IP”). To the extent Background IP is embedded in a Deliverable, we grant you a perpetual, non-exclusive, royalty-free license to use it as part of that Deliverable.

7.4 Open-source components. Deliverables may include open-source software (for example, TensorFlow, PyTorch, LangChain, or LangGraph), which is governed by its own license. We will identify material open-source components on request.

7.5 Customer Data. You keep all rights in your Customer Data. You grant us a limited license to use it only to perform the Services under the applicable Agreement.

7.6 Client names, logos, and case studies. Names and logos of companies shown on the Website are trademarks of their respective owners and appear to describe past work, with permission where required. Their display does not imply endorsement of DataClever. Case studies describe projects in general terms and exclude confidential details. We will not publicly name you as a client without your consent.

7.7 Feedback. If you give us suggestions about our Website or Services, we may use them without obligation to you, but we will not disclose your Confidential Information in doing so.

8. Acceptable Use of the Website

You agree not to:

• violate any law or third-party right, including privacy, intellectual property, and export laws;
• submit PHI, patient data, or another person’s sensitive information through Website forms;
• send spam, automated or bulk form submissions, or false or misleading information;
• upload malware or attempt to disrupt, probe, or gain unauthorized access to the Website or our systems;
• scrape, crawl, or harvest Website content or contact information by automated means, except search engine indexing that follows robots.txt;
• use Website content to train AI models or build a competing service without our written permission;
• impersonate any person or misrepresent your affiliation with an organization.

We may block access, delete submissions, or report violations to authorities.

9. Confidentiality

9.1 Each party will protect the other’s non-public information that is marked confidential, or that a reasonable person would understand to be confidential (“Confidential Information”), with at least reasonable care, and use it only to evaluate or perform an engagement. A signed NDA or MSA controls if it conflicts with this Section.

9.2 Confidential Information excludes information that is or becomes public without breach, was already known, is independently developed, or is rightfully received from a third party. Disclosure required by law is permitted with prompt notice where lawful.

9.3 These obligations last five (5) years after disclosure. Trade secrets stay protected for as long as they remain trade secrets, and PHI stays protected as the BAA and law require.

10. Third-Party Services and Links

The Website may link to or embed third-party services such as LinkedIn, YouTube, Google Fonts, cloud providers, and form or analytics tools. Their terms and privacy policies govern your use of them. We are not responsible for third-party content, availability, or practices.

11. Warranties and Disclaimers

11.1 Services warranty. We will perform Services in a professional and workmanlike manner consistent with generally accepted industry standards. Your remedy for a breach of this warranty, reported within 30 days of delivery, is re-performance of the nonconforming Services or, if we cannot re-perform, a refund of the fees paid for them.

11.2 Disclaimer. EXCEPT AS STATED IN SECTION 11.1 OR IN AN AGREEMENT, THE WEBSITE, SERVICES, DELIVERABLES, AND AI OUTPUTS ARE PROVIDED “AS IS” AND “AS AVAILABLE.” TO THE MAXIMUM EXTENT PERMITTED BY LAW, DATACLEVER DISCLAIMS ALL OTHER WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, ACCURACY, CLINICAL EFFICACY, AND REGULATORY ACCEPTANCE.

11.3 We do not warrant that the Website will be uninterrupted or error-free, or that Website content is complete or current.

12. Limitation of Liability

12.1 TO THE MAXIMUM EXTENT PERMITTED BY LAW, NEITHER PARTY WILL BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR FOR LOST PROFITS, REVENUE, DATA, OR GOODWILL, EVEN IF ADVISED OF THEIR POSSIBILITY.

12.2 DATACLEVER’S TOTAL LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS, THE WEBSITE, OR THE SERVICES WILL NOT EXCEED THE FEES PAID TO DATACLEVER UNDER THE APPLICABLE SOW IN THE 12 MONTHS BEFORE THE EVENT GIVING RISE TO THE CLAIM. FOR USE OF THE WEBSITE ALONE, THIS LIMIT IS US $100.

12.3 Exclusions. The limits in this Section do not apply to (a) a party’s indemnification obligations, (b) breach of confidentiality or the BAA, which is capped at [two times] the fees paid in the prior 12 months unless the Agreement states otherwise, (c) gross negligence, fraud, or willful misconduct, or (d) liability that cannot be limited by law.

13. Indemnification

13.1 By you. You will defend and indemnify DataClever and its personnel against third-party claims arising from (a) your Customer Data, including your lack of rights, consents, or authorizations to share it; (b) your products, including their design, intended use, labeling, regulatory status, marketing, and clinical use of Deliverables; or (c) your violation of these Terms or law.

13.2 By us. We will defend and indemnify you against third-party claims that Deliverables, as delivered and used as authorized, infringe a U.S. patent, copyright, or trademark, or misappropriate a trade secret. This excludes claims caused by your materials, modifications not made by us, combinations with items we did not provide, or open-source components. We may modify the Deliverable, obtain a license, or refund the fees paid for the affected Deliverable. This is our sole obligation for infringement claims.

13.3 Process. The indemnified party must give prompt notice, reasonable cooperation, and control of the defense. No settlement may admit fault for the indemnified party without its consent.

14. Term and Termination

14.1 These Terms apply while you use the Website or Services. Each SOW runs for the term it states.

14.2 Either party may terminate an SOW for material breach not cured within 30 days after written notice. Unless the SOW says otherwise, you may terminate an SOW for convenience on 30 days’ written notice.

14.3 On termination, you will pay for Services performed and non-cancellable expenses incurred through the termination date. Sections on health data, IP, confidentiality, disclaimers, limitation of liability, indemnification, and dispute resolution survive.

15. Dispute Resolution and Governing Law

15.1 Governing law. These Terms are governed by the laws of the State of California, without regard to conflict-of-law rules. The Federal Arbitration Act governs Section 15.3.

15.2 Informal resolution. Before starting any claim, the claiming party will send written notice to the other and the parties will try in good faith to resolve it for 60 days.

15.3 Arbitration. Any unresolved dispute will be decided by binding arbitration administered by JAMS under its Comprehensive Arbitration Rules, before one arbitrator, seated in Orange County, California, in English. Either party may seek injunctive relief in court to protect intellectual property, Confidential Information, or PHI, and either party may bring an individual claim in small claims court. THE PARTIES WAIVE ANY RIGHT TO A JURY TRIAL.

15.4 Individual claims only. Claims may be brought only in an individual capacity, not as a plaintiff or class member in any class, collective, or representative proceeding.

15.5 Courts. If arbitration does not apply to a claim, the state and federal courts in Orange County, California have exclusive jurisdiction, and the parties consent to personal jurisdiction there.

16. General

16.1 Changes to these Terms. We may update these Terms by posting a new version with a new “Last Updated” date. Changes apply to Website use from that date and do not change a signed Agreement unless both parties agree in writing.

16.2 Entire agreement. These Terms, the Privacy Policy, and any Agreement are the entire agreement on their subject and replace prior discussions.

16.3 Assignment. Neither party may assign these Terms without the other’s consent, except to a successor in a merger, acquisition, or sale of substantially all related assets.

16.4 Force majeure. Neither party is liable for delays caused by events beyond its reasonable control, except payment obligations.

16.5 Severability and waiver. If a provision is unenforceable, the rest remains in effect. Failure to enforce a provision is not a waiver.

16.6 Export. You will not export or re-export Deliverables in violation of U.S. export laws.

16.7 Language. These Terms are written in English. Any translation is for convenience, and the English version controls.

16.8 Notices. Legal notices to DataClever go to [email protected] and our mailing address below. Notices to you go to the email in your form submission or Agreement.

17. Contact

[DataClever legal entity name] [Street address], Orange County, California [ZIP], United States Engineering hub [[email protected]] Legal and privacy: [[email protected]] Website: https://dataclever.ai