Functional Scope & User Governance Documentation

1. Product Overview & Scope of Use

Lyrebird Health is an AI-powered documentation assistant designed to support healthcare professionals in creating clinical and administrative documentation during healthcare encounters. 

The system is intended to:

• Capture spoken interactions during consultations when activated by the clinician
• Convert speech to text 
• Generate draft documentation
• Assist with preparation of administrative materials such as letters, reports, referrals, forms, and summaries
• Support documentation workflows within electronic medical record (EMR) systems

Lyrebird is intended solely as a productivity and documentation aid. It does not independently analyse clinical data to generate new diagnoses or treatment recommendations.

Lyrebird does not:

• Diagnose medical conditions
• Provide clinical decision support
• Recommend treatments
• Perform patient monitoring
• Trigger clinical actions
• Replace professional judgement

The system operates only under clinician supervision and requires review before any use.

2. Non-Medical Device Statement

Lyrebird Health is not intended to be used for medical purposes as defined under applicable medical device regulations.

Specifically, Lyrebird:

• Does not analyse patient data to guide diagnosis or treatment
• Does not provide clinical interpretations or risk stratification
• Does not generate medical advice
• Does not control or influence therapeutic decisions
• Does not perform calculations that determine clinical management

Lyrebird functions as a documentation support tool similar to dictation or transcription software.

3. Clinical Safety Statement

Although not a medical device, Lyrebird is designed with patient safety as a priority.

Safety characteristics include:

• Outputs are drafts only
• Mandatory human review prior to use
• No autonomous operation
• Not configured to perform clinical analysis, interpretation, or reasoning
• No direct patient interaction

Potential risks relate to documentation accuracy rather than clinical judgement. These risks are mitigated through clinician verification.

Lyrebird must not be relied upon as the sole source of clinical documentation without review.

4. Risk Management Summary

Lyrebird Health maintains a structured risk management approach appropriate for software handling health information.

Identified Risks and Mitigations

Inaccurate transcription or summarisation
- Clinician review required before use

Omission of relevant information
- Draft status emphasised; editing required

Misinterpretation of speech
- User editing tools available

Privacy or confidentiality breach
- Security controls and access restrictions

Over-reliance on AI outputs
- Clear usage guidance provided

Technical failure or downtime
- Alternative documentation methods remain available

Risk controls are reviewed periodically as part of ongoing product management.

5. Human Oversight Description

Lyrebird operates entirely under human control. 

Oversight mechanisms include:

• Activation initiated by the clinician
• Ability to pause or stop at any time
• Review and editing prior to use
• Approval required before saving to records
• Option to discard outputs

Clinicians remain fully responsible for:

• Accuracy of documentation
• Clinical decisions
• Patient care
• Compliance with professional standards

Lyrebird does not produce final clinical records independently.

6. Data Governance Description

Lyrebird processes sensitive information in accordance with applicable privacy and data protection requirements.

Data Handling Principles

• Processing limited to documentation purposes
• Access restricted to authorised users
• Secure transmission and storage
• Confidentiality protections applied
• Compliance with relevant privacy laws

Audio Processing

• Speech may be processed in real time to generate text
• Temporary processing may occur as needed
• Audio retention (if any) depends on configuration and legal requirements
• Final documentation resides within the healthcare provider’s systems

Lyrebird Health does not use patient information for unrelated purposes without appropriate authorisation.

7. Patient Awareness and Consent

Healthcare providers using Lyrebird should follow local requirements regarding patient notification.

Where applicable:

• Patients should be informed that a documentation tool is in use
• Consent should be obtained when required
• Patients may decline use
• Care must not be affected by refusal

Responsibility for consent processes rests with the healthcare provider.

8. Post-Market Monitoring Plan

Lyrebird Health monitors system performance and safety on an ongoing basis.

Activities include:

• User feedback collection
• Incident reporting processes
• Performance monitoring
• Security monitoring
• Regular review of identified risks

If issues are identified, actions may include:

• Software updates
• User guidance updates
• Corrective measures
• Notifications to affected users

9. Instructions for Use (IFU)

Intended Users

Lyrebird is intended for use within clinical settings by:

• Registered healthcare professionals
• Authorised clinical staff
• Administrative staff under supervision

Use by unqualified individuals for clinical purposes is not permitted.

Basic Operation

1. Clinician activates the system
2. Speech is captured during the interaction
3. Draft documentation is generated
4. Clinician reviews and edits content
5. Approved text may be transferred to records

User Responsibilities

Users must:

• Verify accuracy before use
• Edit content as required
• Ensure completeness
• Maintain confidentiality
• Follow organisational policies

Limitations

Lyrebird may:

• Mishear or misinterpret speech
• Produce incomplete drafts
• Require editing for clarity
• Not capture all relevant details

Outputs must not be used without review.

Situations Where Use May Be Inappropriate

Use may be unsuitable where:

• Patient consent cannot be obtained (if required)
• Privacy cannot be ensured
• Audio quality is poor
• Clinician cannot review outputs
• Immediate care takes priority

System Availability

Lyrebird is software-based and may experience interruptions.
Alternative documentation methods should be available.

10. Compliance with Laws and Professional Standards

Users must comply with:

• Applicable healthcare regulations
• Privacy legislation
• Professional obligations
• Organisational policies

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