Introduction
The Medily AI assistant is designed exclusively for educational and research purposes during its pre-clinical benchmarking beta phase. This document provides a comprehensive explanation as to why Medily AI is not classified as a medical device nor to be used in clinical practice. Our goal is to clearly articulate the limits and intended uses of the AI to ensure that users understand its proper applications and the regulatory stance. The Medily AI assistant does not provide any real-time diagnostic or therapeutic recommendations for patient care and is not suitable for making clinical decisions
Intended Use and Scope
Medily AI is specifically intended for:
- Educational Purposes: Demonstrating the potential applications of artificial intelligence in medicine to students, educators, and researchers.
- Research Demonstrations: Acting as a platform for testing and validating AI algorithms without any real-world clinical applications.
Definition of a Medical Device by MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) defines a medical device as any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for any of the following specific medical purposes:
- Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap.
- Investigation, replacement, or modification of the anatomy or of a physiological process.
- Control of conception.
Why Medily AI is NOT a Medical Device
Medily AI does not meet the criteria outlined above for several key reasons:
1. Non-Medical Purpose
Medily AI functionalities are confined to:
- Educational Simulations: Offering demonstrations of AI capabilities without the intention of real-world application.
- Research Testing: Executing algorithms in a controlled, sandbox environment where the results are purely hypothetical and not intended for clinical use.
2. No Clinical Application or Influence
- Simulation Only: Medily AI outputs, including detailed clinical scenarios and diagnostic suggestions, are strictly used in simulated environments. The data generated is entirely hypothetical and designed for academic purposes only.
- Non-Influence on Real Clinical Decisions: The AI’s diagnostic suggestions and management plans are not intended for use in actual clinical settings, and explicit disclaimers are provided to reinforce this point.
- No Handling of Real Patient Data: Throughout its beta phase, Medily AI does not deal with or process any real patient data. All data used should be simulated or anonymized for the purpose of research and education.
- Educational Simulations: Offering demonstrations of AI capabilities, including simulated clinical scenarios, that are strictly hypothetical and not intended for any real-world patient care or medical decision-making
3. Transparency in Usage
Medily AI does not support, encourage, or allow any of its outputs to be used in real patient care. All outputs are purely academic in nature and should be used strictly for educational and research purposes.
To maintain full transparency, Medily AI includes explicit disclaimers:
- Affirming that the assistant is for educational and research demonstration purposes only.
- Emphasizing that it should not be used to make any clinical or medical decisions.
These disclaimers are intended to prevent any misunderstanding regarding the anticipated use of the AI assistant.
4. Clear Disclaimers and Usage Limitations
All users are explicitly informed that the AI’s outputs are entirely hypothetical and must not be applied to real patient care or medical decision-making under any circumstances. Misuse of the platform for clinical purposes will result in immediate termination of access without refund, and such cases may be reported to relevant authorities if necessary.
Medily AI’s platform includes prominent disclaimers that:
- Clearly state its purpose is for educational and research demonstration only.
- Emphasize that it should not be used for making real clinical or medical decisions.
- Highlight that any medical advice provided by the AI is purely hypothetical and based on simulated data.
Conclusion
Based on the outlined parameters and intended uses, Medily AI does not classify as a medical device. Medily AI is designed purely for educational and research demonstration purposes, aimed at promoting a better understanding of AI applications in the medical field.
We are committed to continuously monitoring Medily AI’s compliance status with MHRA and other regulatory guidelines, especially if any future developments or changes in the AI’s intended use occur.
Medily AI is strictly restricted for use by healthcare professionals, researchers, and students for educational and research demonstration purposes only. It is not intended for real-world clinical application or decision-making. We have an internal complaints procedure to address any misuse of Medily AI outside of its intended compliance and use. If you are aware of anyone using Medily AI inappropriately, please report the activity to our regulatory team at [email protected].
Contact Information
For inquiries related to regulatory compliance or to report suspected misuse of Medily AI, please contact our regulatory team directly at [email protected].
Thank you for your understanding and support in ensuring a clear and transparent usage of Medily AI.
This document is intended for public information purposes as of 14/08/2024.