Intended Use
2 min
Document Information
- Document Version: 2.0 (Revised)
- Original Date of Issue: 2026-02-26
- Date of revision: 2026-05-28
- Product Name: Autoscriber
- Product Type: Administrative Software / AI Documentation Assistant
- Regulatory Status: Not Applicable (Not a medical device under EU MDR 2017/745)
- Provider: Autoscriber B.V., High Tech Campus 6a, 5656 AE Eindhoven, The Netherlands ([email protected])
Intended Use
Autoscriber is an ambient AI-powered documentation assistant designed to streamline administrative workflows for healthcare professionals. The software captures spoken dialogue during consultations and structures it into draft clinical notes (e.g., SOAP summaries) for integration into Electronic Health Record (EHR) systems.
Regulatory Boundaries:
- No Medical Purpose: Autoscriber is strictly an administrative support tool. It does not diagnose, treat, monitor, or provide clinical decision support or therapeutic recommendations.
- Human-in-the-Loop: All generated text is a preliminary draft. The healthcare professional retains sole clinical responsibility and must review, edit, and approve the documentation before saving it to the patient's permanent record.
System Requirements & Deployment
- Deployment: Software-as-a-Service (SaaS) via standalone web application or direct EHR integration.
- Hardware/Software Requirements: A stable internet connection, a functional microphone, and a compatible web browser (Chrome, Safari, or MS Edge).
Cybersecurity & Data Protection
Autoscriber is hosted within a secure cloud infrastructure utilizing encrypted data transmission protocols. The system is compliant with healthcare data security standards (ISO 27001 and NEN 7510). Access is restricted to authorized users via secure authentication mechanisms.
Product Limitations & User Precautions
- Accuracy & AI Characteristics: Due to the inherent limitations of Automated Speech Recognition (ASR) and Natural Language Processing (NLP), there is a risk of transcription errors, omissions, or AI hallucinations. Users must thoroughly verify all text.
- Environmental Dependencies: System performance and text accuracy can be negatively impacted by loud background noise, poor microphone quality, multiple overlapping speakers, or unstable internet connectivity.
- System Availability: In the event of temporary network or software service interruptions, users must revert to standard manual documentation procedures.