Intended Use

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 (support\@autoscriber com) 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