EU MDR Intended Purpose and Product Limitations
This document specifies the operational framework, intended use, and limitations of the Emothy software. It was developed based on the system's design assumptions, the Security-by-Design concept, legal requirements (GDPR, HIPAA, AI Act), and the concept of Embedded Ethics in the field of medical artificial intelligence.
- Intended Use
The Emothy system is an advanced analytical software whose primary purpose is to automate the process of creating clinical documentation for mental health professionals. The system achieves this through:- Intelligent transcription of therapeutic session recordings along with automatic diarization (speaker recognition).
- De-identification (anonymization) of sensitive personal data within texts. Clinical content analysis within defined therapeutic modalities (e.g., cognitive-behavioral, psychodynamic).
- Generation of standardized notes and session summaries, supporting the specialist in monitoring the therapeutic process.
- Intended Users
The system has been designed for mental health specialists—professionals possessing appropriate qualifications. Target users include:- Psychotherapists
- Psychologists
- Psychiatrists
- Mental health clinics and centers (within therapeutic teams).
- Psychology students and trainees at psychotherapy schools (as an educational and supervision-support tool).
- Target Group (Patients)
The tool is used to analyze sessions conducted with a wide group of patients:- Age demographic and mental state: The system analyzes sessions with both adults and children, regardless of the severity of their problems or mental state.
- Expert decision-making: Emothy does not assess the patient's capacity to participate in therapy. The sole evaluation of the patient's condition – including making the decision to continue psychotherapy, refer to a psychiatrist, or refer to a psychiatric hospital (e.g., to an inpatient ward) – rests entirely with the qualified specialist (the system user).
- Contraindications and Technical Limitations
Due to the specific nature of AI technology and the current regulatory stage, the system has the following limitations:- Regulatory status (Lack of MDR certification): At the current stage of development, Emothy is not a medical device within the meaning of directives or regulations (MDR). It functions solely as analytical and administrative software, although its development ultimately aims toward medical certification (ISO and MDR).
- Susceptibility to errors (AI Hallucinations): The applied artificial intelligence models may occasionally generate inaccurate results, miss emotional nuances, or create so-called “hallucinations” (information inconsistent with the actual course of the recording).
- Input data quality: The effectiveness of transcription and analysis is strictly dependent on the audio quality of the uploaded file (background noise, overlapping voices).
- No intervention in crisis situations: The system is not intended for real-time monitoring of patients in life-threatening conditions or for crisis management.
- Scope of User Responsibility
The Embedded Ethics approach imposes specific obligations on system users. Using the Application does not relieve the specialist of their professional responsibility:- Absolute verification: The user is required to verify and authorize every generated transcript and note before incorporating them into the patient's medical records.
- Decision-making autonomy: Final diagnostic decisions, treatment planning, and therapeutic interventions belong exclusively to the human professional. Uncritical reliance on AI results (so-called automation bias) is unacceptable.
- Privacy and consent: It is the user's duty to obtain informed consent from the patient to record the session and to inform them about the use of artificial intelligence tools for data analysis (transparency required by GDPR and the AI Act).
- Explicit Disclaimers (What Emothy does NOT do):
- Diagnosis: Emothy DOES NOT make medical or psychiatric diagnoses. Emothy DOES NOT qualify patients for treatment.
- Therapist replacement: Emothy DOES NOT conduct therapy, DOES NOT provide advice, and DOES NOT replace the therapeutic relationship.
- Suggesting pharmacotherapy: Emothy DOES NOT analyze indications for medication use and DOES NOT generate prescriptions.
- Use of patient data for AI training: Emothy DOES NOT use patient content (transcripts, audio) to train general language models of external providers.
FAQ
EU MDR Intended Purpose and Product Limitations
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Emothy supports mental health specialists by offering innovative tools for transcription, analysis, and generation of clinical notes to improve patient care.
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