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Dr.Axis — Medical Disclaimer

Dr.Axis is a clinical reference tool for licensed HCPs — not a medical device, not a substitute for clinical judgment. Function-level regulatory status is pending counsel confirmation.

Last updated: 2026-08-29
⚠ Draft — for internal review. Not legal advice.

Dr.Axis — Medical Disclaimer

Status: DRAFT v2 — aligned with Legal/Regulatory README v10.1. For internal team review. Not legal advice.
Must be reviewed by qualified legal counsel and a regulatory/medical advisor before publication.
Last updated: 2026-08-29

Document control

FieldValue
Document ownerDr.Axis legal/medical
Version0.1 (DRAFT)
Effective date[to be set at publication]
Review cycleAnnual, or upon material change in clinical content
Languages (target)English, French, Arabic
Public URLhttps://draxis.app/legal/medical-disclaimer

1. Nature of the Service

Dr.Axis is a physician-facing clinical calculation and reference application developed by Hajti Group / Nuraxis AI. It is the go-to-market flagship of the broader Nuraxis AI platform. It provides:

  • Deterministic clinical calculations — formula-based outputs from clinician-entered inputs (e.g., SOFA, GRACE, PESI, RCRI, APACHE II).
  • Clinical reference / protocol display — published protocols and guidelines, clearly sourced.
  • Drug dosing and adjustment references.
  • An antibiotic-suggestion tool provided as a labeled educational demonstration (deterministic, not AI).
  • Secure messaging between verified professionals (planned, not yet implemented).

Dr.Axis is not the full Nuraxis AI platform. The full platform (continuous multimodal patient monitoring, RoboCam bedside layer, early deterioration detection) is a separate regulatory track — see the master Legal/Regulatory README, Section 0.

The Service is not a medical device, a diagnostic instrument, or a substitute for independent professional clinical judgment.

2. No medical advice

Nothing in the Service constitutes:

  1. Medical advice — personalized recommendations for a specific patient.
  2. A diagnosis — identification of a disease or condition.
  3. A treatment plan — a prescription or course of therapy.
  4. A substitute for clinical judgment — the independent assessment of a qualified physician.

Calculator outputs, drug doses, and antibiotic suggestions are reference values generated by published formulas. They must be interpreted by a qualified physician in the full clinical context of the individual patient, including history, examination, investigations, and local protocols.

3. No warranty on clinical accuracy

While Dr.Axis ports clinical formulas from peer-reviewed sources and audits them for fidelity to the original publications, we provide the Service "as is" and make no warranty that:

  • Calculator outputs are correct for every patient.
  • Drug doses are appropriate for every patient (e.g., renal adjustment, interactions, allergies).
  • Antibiotic suggestions are appropriate for the local epidemiology and antibiogram.
  • Content is up to date with the latest clinical guidelines.

Clinical references evolve. The user is responsible for consulting the current literature and local protocols.

4. EU MDR positioning

Dr.Axis's regulatory status is function-specific and pending counsel confirmation — it is not positioned as universally exempt from medical-device regulation. Classification is determined from actual functionality, intended purpose, clinical claims, user population, outputs, level of automation, and role in diagnosis, monitoring, prediction or treatment decisions.

US FDA — Function-Level Assessment

Dr.Axis is assessed function-by-function under FDA's Clinical Decision Support Software guidance (January 2026). Each function (deterministic calculations, reference display, Q&A function) is assessed separately against the four Non-Device CDS criteria (21st Century Cures Act §520(o)(1)(E)) and the enforcement-discretion pathway. No function is presumed to qualify for Non-Device CDS treatment or enforcement discretion until confirmed by qualified regulatory counsel.

EU MDR / MDCG 2019-11 Rev.1

Whether Dr.Axis qualifies as Medical Device Software (MDSW) is assessed primarily against its manufacturer-defined intended purpose and actual functionality, per MDCG 2019-11 Rev.1 (June 2025). The fact that Dr.Axis displays published guidance, exposes calculation inputs/formulas, and requires clinician validation may support a non-MDSW position for particular functions, but does not by itself establish that conclusion.

EU AI Act

The EU AI Act assessment is conducted independently from the MDR assessment. Annex III high-risk classification is not assumed from the healthcare context alone — Annex III's healthcare-related examples are narrow (public-authority eligibility, insurance, emergency-call triage).

  • Dr.Axis is intended for informational and educational purposes for licensed HCPs.
  • Calculator outputs are not presented as a diagnosis or as a treatment recommendation.
  • Dr.Axis does not perform automated interpretation of patient-specific data with the purpose of providing information that can be used to make decisions about diagnosis, prevention, monitoring, prediction, prognosis, or treatment of a disease (MDR Art. 2(1) — "medical device" definition).
  • The antibiotic-suggestion tool is a labeled educational demonstration and is not intended to drive clinical decisions autonomously.

This positioning is documented in 10-regulatory-position.md. However, the final determination of MDR scope depends on the intended purpose as stated in the labeling, marketing, and user interface. A formal regulatory opinion from a qualified lawyer or Notified Body is required before any EU launch.

5. Tunisian medical ethics

Under the Tunisian Code of Medical Ethics (Law n° 94-112 of 31 October 1994):

  • The physician retains sole responsibility for medical decisions (Art. 32).
  • Medical secrecy must be respected (Art. 36).
  • Dr.Axis is a reference tool; it does not replace the physician's independent judgment.

6. Gulf regulatory positioning

  • KSA: Dr.Axis is not a "Medical Device" as defined by the Saudi Food and Drug Authority (SFDA) Medical Devices Interim Regulations (MDIR). If SFDA's scope expands to cover clinical decision-support software, Dr.Axis will seek appropriate registration.
  • UAE: Dr.Axis is not a medical device under Ministry of Health and Prevention (MOHAP) regulations. Telemedicine services are governed by Federal Law n° 4 of 2015 and the Telemedicine Standards; Dr.Axis is a reference tool, not a telemedicine service.

7. Antibiotic-suggestion tool — specific disclaimer

The antibiotic-suggestion tool is a labeled educational demonstration. It:

  • Is based on published clinical pathways and local antibiograms.
  • Does not account for the full clinical picture, local resistance patterns, drug interactions, or patient allergies beyond what is explicitly entered.
  • Must not be used as the sole basis for prescribing decisions.
  • Carries an in-app disclaimer visible at the point of use.

8. User responsibility

By using the Service, you acknowledge that:

  1. You are a licensed healthcare professional qualified to interpret the outputs.
  2. You will use the Service only as a reference, not as a sole decision-maker.
  3. You remain solely responsible for clinical decisions affecting your patients.
  4. You will verify outputs against current literature and local protocols.
  5. You will not represent Dr.Axis outputs as a substitute for clinical judgment to patients or third parties.

9. Limitation of liability for clinical use

To the maximum extent permitted by law, Dr.Axis is not liable for:

  • Clinical decisions made on the basis of Calculator outputs.
  • Patient outcomes resulting from the use or misuse of the Service.
  • Errors in clinical formulas, drug doses, or antibiotic suggestions.
  • Outdated or incomplete clinical content.

This does not affect liability that cannot be excluded under applicable law (e.g., gross negligence, willful misconduct, or mandatory consumer protection rights).

10. Reporting errors

If you identify a clinical error in a Calculator, drug dose, or content, please report it immediately to clinical@draxis.app with:

  • Calculator / drug name.
  • Inputs used.
  • Expected vs. actual output.
  • Reference source.

We will investigate and, if confirmed, correct the error and notify users of the affected Calculators.

11. Contact

  • Clinical content: clinical@draxis.app
  • Legal: legal@draxis.app
  • DPO: dpo@draxis.app

12. Acknowledgement

By using the Service, you acknowledge that you have read, understood, and agree to this Medical Disclaimer. If you do not agree, do not use the Service.