Instructions for Use

Intended Purpose

Rhazes Scribe is software intended to assist healthcare professionals with clinical documentation. It transcribes the audio of a clinician-patient encounter and structures the transcribed content into a draft clinical note, which the clinician reviews, edits as necessary, and approves before it is used or exported.

Rhazes Scribe does not diagnose, treat, monitor, predict, or provide clinical decision support. It does not generate clinical alerts, perform medical coding, or infer diagnoses or other clinical facts that were not stated during the encounter. All generated content is draft documentation until the clinician approves it. The clinician remains fully responsible for the content of the clinical record.

Indications for Use

Rhazes Scribe is indicated for use by qualified healthcare professionals to produce draft documentation of clinician-patient encounters conducted in person or remotely. It is not indicated for any specific disease, condition, or patient population and may be used across clinical specialties and care settings where the clinician conducts the encounter and holds responsibility for the resulting record.

The software has no direct contact with the patient and does not act on the patient. The patient is the subject of the recorded encounter only.

Rhazes Scribe is not restricted to particular spoken languages. Transcription accuracy varies with language, accent, terminology, and audio quality; the clinician's review of the draft is the control for this (see "Warnings and Precautions").

Functionality

Rhazes Scribe receives live or recorded clinician-patient encounter audio captured through a compatible device and converts the spoken content to text. It processes the transcript to organise information stated during the encounter into an editable, structured draft clinical note. The healthcare professional reviews, corrects, and approves the draft before it is incorporated into the medical record; the software does not independently infer unstated clinical facts or provide diagnostic, treatment, alerting, or clinical decision-support outputs.

The functions provided through the clinician web application and the clinician mobile application are:

• Secure sign-in to an authorised user account.
• Creation of an encounter session and, where available, association with the patient or encounter context.
• Recording of encounter audio using the device microphone, or upload of an existing audio recording where supported.
• Secure upload of the audio to the Rhazes service, with automatic resume of interrupted uploads.
• Transcription of the audio into text.
• Structuring of the transcript into a draft clinical note using a controlled note template.
• Display of upload, transcription, and draft-generation status.
• Presentation of the transcript for review and correction, with the ability, where available, to locate the part of the transcript that supports a given part of the draft note.
• A text editor for correcting, deleting, inserting, and formatting draft note content.
• Explicit clinician approval of the note, recorded with the user, note version, and time of approval.
• Export or transfer of the approved note, for example by copying, downloading, or transferring it to a connected electronic health record where that integration has been enabled by the organisation.
• An audit trail of access, editing, approval, and export events.

Rhazes Scribe also does not provide monitoring, risk prediction, medical coding, clinical audit, web search, or reasoning over patient data held elsewhere. Any other Rhazes platform features that a user may have access to are outside the scope of Rhazes Scribe and of these instructions.

Device Compatibility Requirements

Rhazes Scribe requires a supported computer or mobile device, a functioning microphone for encounter-audio capture, an authorised user account, and a stable internet connection. No specialised client hardware or specified minimum local storage capacity is required.

For browser access, use Chrome, Edge, Safari, or Firefox in the latest or previous major version on a supported desktop or mobile device. JavaScript and cookies must be enabled, and the browser must support Service Workers and HTTPS network access.

For mobile access, use iOS 16.4 or later or Android 7.0 (API level 24) or later with HTTPS network access. Microphone permission is required to record encounter audio. Supported file-access permission is required only when uploading an existing recording.

The mobile application is not yet released. Until it is, Rhazes Scribe is used through the web application only, and the mobile requirements above apply from the release in which the mobile application becomes available.

An active network connection is required to upload encounter audio, receive transcription and draft-note processing status, review and approve draft documentation, and export approved content. Rhazes Scribe does not support offline creation, editing, approval, or export of notes. Cached static pages or application assets may remain visible during a connection interruption, but encounter audio, transcripts, draft notes, approved notes, patient identifiers, and export content are not available for offline use.

Use Rhazes Scribe only with supported browser, operating-system, microphone, EHR, and service configurations.

Intended Users

Licensed healthcare professionals, including physicians, nurses, and allied health professionals, and medical scribes or documentation staff working under the supervision of the responsible healthcare professional. Review and approval of a note is reserved to the responsible healthcare professional. Users access the software through an account provided or authorised by their organisation. Patients do not directly interact with the software.

Contraindications

There are no known contraindications for Rhazes Scribe when used as intended.

Accessories

No accessory devices are required.

Warnings and Precautions

1. Review and approval required. Rhazes Scribe generates AI-produced draft documentation that may contain omissions, transcription errors, incorrect speaker attribution, unsupported text, or misplaced information. A qualified clinician must independently review, correct, and explicitly approve the complete draft before it is exported, signed, filed in the medical record, used for coding or billing, shared, or otherwise relied upon.
2. Not for clinical decision-making. Rhazes Scribe is an administrative documentation aid only. It does not diagnose, treat, cure, mitigate, or prevent disease and does not provide clinical decision support, alerts, recommendations, or inferred diagnoses. Do not use its output as the sole basis for patient care or clinical decisions.
3. Verify critical content. Pay particular attention to patient identity, diagnoses, medications, allergies, doses, units, dates, times, laterality, negations, speaker attribution, and follow-up instructions. Correct or remove any ambiguous, inaccurate, incomplete, or unsupported content before approval.
4. Obtain consent where required. Confirm that applicable patient notice, consent, and authorisation requirements have been met before recording. Ensure that all participants are aware when recording is active and stop recording if consent is withdrawn or recording is not permitted.
5. Maintain adequate audio quality. Background noise, overlapping speech, distance from the microphone, poor microphone quality, accents, speech patterns, and interruptions may reduce transcription accuracy. Check unclear or inaudible passages against your own recollection of the encounter and document manually any information that cannot be verified.
6. Use only supported configurations. Use only supported browsers, devices, microphones, templates, and EHR integrations, and keep the operating system and browser up to date. Rhazes Scribe accepts any spoken language, but transcription accuracy differs between languages and is lower for less widely spoken languages, strong regional accents, and encounters that switch between languages; review the draft with particular care in these cases. Unsupported vocabulary, workflows, or transfer destinations may result in unusable or inaccurate draft content.
7. Verify the patient, encounter, and destination. Before recording, confirm the selected patient and encounter. Before export, confirm the patient identity, encounter, author, date and time, destination record, field mapping, formatting, and transferred content. Do not approve or export content associated with the wrong patient or encounter.
8. Respond safely to interruption or failure. Network, service, storage, synchronisation, or EHR integration interruptions may delay processing or produce incomplete output. Follow the message displayed and your organisation's downtime procedure, use an approved alternative documentation method when necessary, and do not approve or export an affected draft until its completeness and integrity have been verified.
9. Protect access and confidentiality. Use only an authorised account and an organisation-approved secure device and network. Do not share credentials, leave an active session unattended, or permit unauthorised persons to access patient audio, transcripts, or draft notes. Log out when finished.
10. Report suspected integrity or security issues. Stop using the affected session if content appears corrupted, unexpectedly modified, duplicated, inconsistent, or associated with another patient or organisation. Preserve relevant information and report the issue through your organisation's incident process and to Rhazes support at support@rhazes.ai.
11. Do not attempt to override safeguards. Do not enter spoken, pasted, or imported instructions intended to alter system behaviour, bypass approved features, generate recommendations, or infer information that was not stated during the encounter.

Adverse Events

There are no known or anticipated side effects associated with the use of Rhazes Scribe as intended. Rhazes Scribe is a software-only administrative aid and does not directly interact with the patient or provide diagnosis, treatment, monitoring, or clinical decision support.

Any incident involving Rhazes Scribe, including an error in generated content that could have led or did lead to harm, should be reported as described under "Notice to the User".

Installation

Rhazes Scribe is cloud hosted and does not require installation of server software, a local database, or specialised hardware at the healthcare facility. Before first use, the user must hold an authorised account. Accounts are created by invitation from the user's organisation or by registration approved by Rhazes AI Ltd.

For browser use, open https://clinician.rhazes.ai in a supported current browser, sign in, and allow microphone access when prompted if audio recording will be used. The application may optionally be installed as a progressive web application using the browser's standard installation function; this is optional and does not enable offline Scribe operation. Updates are applied automatically on the server; refresh the page if prompted.

The mobile application is not yet released. When it is, obtain and install it only through the distribution channel specified by Rhazes AI Ltd. (the Apple App Store or Google Play), then sign in and grant the required microphone and network permissions. A stable HTTPS internet connection is required to upload audio, receive transcripts and draft notes, review and approve documentation, and export approved content.

Before the first clinical encounter, confirm that the user can sign in, select the correct organisation or workspace, access the intended Scribe functions, and record or upload a short test audio sample.

The installed software version is shown on the Settings page of the application. Quote this version when contacting support.

Training Required

No formal or specialised training is required to use Rhazes Scribe. Before first use, users should review the Instructions for Use and the onboarding materials available within the application. These materials explain how to start and stop a recording, generate a draft clinical note, review and edit the draft, approve or export the note, protect patient information, and obtain technical support. Users must understand that Rhazes Scribe is an administrative transcription aid and that the clinician remains responsible for verifying the accuracy and completeness of each draft before it is used in the clinical record.

Security

Access to Rhazes Scribe is restricted to authenticated users. Role-based, least-privilege permissions and tenant- and patient-level access controls limit access to encounter audio, transcripts, draft notes, approved exports, and administrative functions. Clinical information is encrypted in transit using TLS and encrypted at rest. Security-relevant and clinical-documentation events are recorded in protected, timestamped audit logs.

Rhazes Scribe is hosted in an isolated cloud environment with network filtering, intrusion monitoring, vulnerability management, automated encrypted backups, and recovery controls. EHR transfers use approved interfaces, bind data to the confirmed patient and encounter, validate transfer content, and require authorised user approval before the note is committed to the medical record.

Users must keep credentials confidential, use only organisation-approved and secured devices and networks, sign out when finished, and promptly report suspected unauthorised access or other security incidents to their organisation's administrator or to Rhazes support at support@rhazes.ai.

Instructions

Technical Assistance

If you experience technical difficulties with Rhazes Scribe, contact Rhazes AI Ltd. at support@rhazes.ai, using the support channel provided within the application, or via the website rhazes.ai. Include your organisation name, the Rhazes Scribe software version, the device and browser used, the date and time of the issue, and a description of the problem and any displayed error message. Do not include patient-identifiable information in a support request unless Rhazes AI Ltd. specifically instructs you to provide it through an approved secure channel.

Release Date

The release date of these instructions is stated at the top of this document and corresponds to the software release to which they apply. Superseded versions are withdrawn from this address.

Additional Information

Rhazes Scribe is placed on the market as a Class I medical device under Regulation (EU) 2017/745 (the Medical Device Regulation). The software is developed and maintained under the quality management system of Rhazes AI Ltd.

Notice to the User

In the case of any serious incident that has occurred in relation to the use of Rhazes Scribe, report it immediately to the manufacturer at support@rhazes.ai and to the competent authority of the Member State in which you are established.