Privacy, ethics and legal framework

At TMH Suite, we understand that confidentiality is the cornerstone of the therapeutic relationship.

Thus, SophIA has been designed not only as a cutting-edge clinical tool, but also as a highly secure environment that meets the most stringent legal standards.

Regulatory and legal compliance

SophIA has been developed using a “privacy by design” architecture, thus ensuring strict compliance with:

●     GDPR (General Data Protection Regulation): guaranteeing access, rectification and deletion/erasure rights.

●     European Artificial Intelligence Act (August 2026): adhering to the risk and transparency levels required for support tools in the healthcare industry.

Data ownership and use

SophIA does not use your data or that of your patients under any circumstances for purposes unrelated to your own practice:

●     Exclusive ownership: The data entered belongs solely to the healthcare professional and the data subject.

●     No global training: Unlike other general-purpose AIs, SophIA does not use your clinical information to train public models or share it with third parties.

●     Isolated environments: Each healthcare professional works in an encrypted and independent environment. The AI only draws on your own interactions to adapt to your style, without ever leaving your account.

Anonymisation and technology

SophIA uses PsyPilot technology for advanced query processing, whereas information processing is carried out in a non-identifiable manner, thereby reinforcing the platform’s stringent privacy.

Recommendation: informed consent

When using SophIA in clinical practice, it is important to include a specific clause in the patient’s informed consent form, informing them of the use of AI-based support tools.

Suggested sample clause:

You may copy and adapt the following text for use in your legal forms.

“The healthcare professional may use SophIA, an external technology provider, as a technical support tool for organising, synthesising and structuring clinical information using artificial intelligence. The use of this tool is intended solely as an aid and shall under no circumstances replace the clinical consultation, professional assessment or care decision-making, which shall remain the sole responsibility of the healthcare professional in charge. The information entered into the platform shall be provided without any direct identifying patient details. All generated content shall be subject to human review prior to any clinical use.”