Clinical Safety Statement

BrainSynex is not classified as Software as a Medical Device (SaMD) under the UK Medicines and Healthcare products Regulatory Agency (MHRA) guidance. The platform functions as a digital wellness and self-reflection tool, rather than a product intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.

Any AI-generated insights, vocal biomarker analysis, or journal pattern summaries provided by the platform are informational only and do not constitute clinical evidence or a medical opinion.

BrainSynex does not and cannot replace consultation with a qualified healthcare professional. All outputs from the platform are intended to support self-reflection and care team conversations. They are not a substitute for in-person clinical assessment by a GP, psychiatrist, psychologist, or any other licensed professional.

BrainSynex follows a structured clinical risk management approach aligned with NHS Digital best practices:

• Hazard identification: Systematic review of AI output accuracy, potential for user misinterpretation, and escalation pathways for high-risk indicators.
• Risk analysis and evaluation: Each identified hazard is assessed for severity and likelihood, with mitigations documented and reviewed quarterly.
• Risk control: Where the platform identifies possible elevated risk (for example, from voice biomarker flags or journal sentiment), it provides guidance to seek professional support — it does not offer diagnostic conclusions.
• Post-deployment monitoring: Feedback from users and care teams is reviewed to identify emerging safety concerns and update disclaimers accordingly.

Users should be aware of the following limitations when interpreting platform outputs:

• AI-generated journal summaries are derived from natural language models and may not reflect the nuance of a clinical interview.
• Vocal biomarker analysis is experimental and has not been validated against clinical diagnostic standards. It should be treated as exploratory, not definitive.
• Self-reported metrics (mood, anxiety, sleep) depend on user input accuracy and do not capture the full clinical picture.
• Trend visualisations show recorded data over time and may not represent clinical trajectories or account for external factors.
• No automated decision-making is used for clinical purposes. No diagnostic thresholds or treatment recommendations are generated by the system.

The named Clinical Safety Officer (CSO) for BrainSynex is:

The CSO is responsible for reviewing clinical safety incidents, maintaining the risk management file, and ensuring compliance with this statement.

BrainSynex is designed to be compatible with the NHS DCB0129 standard (Clinical Risk Management: Its Application and Implementation from Health IT Systems) where deployed in a care setting. This includes:

• Maintaining a clinical risk management file that is reviewed and updated regularly.
• Appointing a qualified Clinical Safety Officer responsible for clinical risk management.
• Ensuring that all clinical risk controls are documented and that incidents are recorded and investigated.

Note: Full DCB0129 compliance certification is in progress and will be published once completed. This statement will be updated accordingly.

If you have concerns about the clinical safety of BrainSynex, or wish to raise a formal complaint: