AI Clinical Documentation Policy Template

Document Type: Policy Template
Version: 1.0
Usage: Customise for your organisation

This template provides a framework for establishing an AI clinical documentation policy. Customise the sections in [BRACKETS] for your organisation.

Review Requirements:

• Legal/compliance review before implementation
• Clinical leadership sign-off
• Staff training before rollout

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Policy Header

Policy Number: [POL-XXX]
Effective Date: [DATE]
Review Date: [DATE + 12 months]
Policy Owner: [TITLE/DEPARTMENT]
Approved By: [NAME, TITLE]

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1. Purpose

This policy establishes the framework for the use of artificial intelligence (AI) clinical documentation systems at [ORGANISATION NAME]. It ensures that AI-assisted documentation is implemented safely, ethically, and in compliance with applicable healthcare regulations.

2. Scope

This policy applies to:

• All clinical staff using AI documentation systems
• All patient encounters where AI documentation may be used
• All locations operated by [ORGANISATION NAME]
• All AI documentation vendors and systems

Exclusions: [List any excluded departments, patient populations, or scenarios]

3. Definitions

Term	Definition
AI Documentation System	Software that uses AI to transcribe, structure, and generate clinical documentation from spoken conversations
Ambient Scribing	AI technology that captures natural clinical conversations without requiring clinician dictation
Protected Health Information (PHI)	Individually identifiable health information as defined by HIPAA/Australian Privacy Principles
Business Associate	Third-party vendor that creates, receives, maintains, or transmits PHI

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4. Policy Statements

4.1 Authorised Systems

Only AI documentation systems that meet the following criteria are authorised for use:

• Approved by [IT Security/Compliance Committee]
• Covered by a signed Business Associate Agreement
• Compliant with [HIPAA/Australian Privacy Principles/other]
• Listed on the approved vendor register

4.2 Patient Consent

Consent Requirement: Patient consent must be obtained before any AI-assisted recording of clinical encounters.

Consent Process:

1. Patient is informed about AI documentation at [check-in/appointment booking/beginning of consultation]
2. Information provided includes: purpose, data captured, protections, right to opt out
3. Consent is documented in [EHR/consent system]
4. Verbal confirmation is obtained at the start of each recorded encounter

Opt-Out: Patients may decline AI documentation at any time. Staff must respect the decision, document it, and use alternative documentation methods.

4.3 Clinical Use

Appropriate Use:

• Routine clinical consultations
• Specialist appointments
• Telehealth encounters

Inappropriate Use:

• Encounters where patient has declined consent
• Psychiatric evaluations (unless specifically authorised)
• Any purpose other than clinical documentation

Clinician Responsibilities:

1. Verify patient consent before initiating recording
2. Review all AI-generated content before finalisation
3. Make necessary corrections to ensure accuracy
4. Sign off on all documentation as the responsible author
5. Report issues to [designated contact]

4.4 Data Protection

Data Type	Retention	Storage Location
Audio recordings	[Not retained / X hours / X days]	[On-device / Cloud]
Transcripts	[Until review complete / X days]	[Specify]
Final documents	Per medical record retention policy	[EHR system]
Audit logs	Minimum 6 years	[Specify]

Access Controls: Role-based access for clinicians, administrators, and compliance staff.

Data Transmission: TLS 1.2+ encryption in transit, AES-256 at rest.

4.5 Vendor Management

Required Agreements: All AI documentation vendors must have:

• Signed Business Associate Agreement
• Security assessment completed
• Annual security review

Vendor Responsibilities: Maintain security standards, notify of incidents within 24 hours, provide audit logs, not use PHI for AI training without consent.

4.6 Incident Management

Reportable Incidents:

• Unauthorised access to AI documentation
• Recording without patient consent
• Clinically significant errors in AI output
• System breaches or vulnerabilities

Reporting Procedure:

1. Report to [Privacy Officer/IT Security] within [4 hours]
2. Complete incident report form
3. Preserve relevant evidence
4. Cooperate with investigation

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5. Training Requirements

Role	Training Requirements	Frequency
Clinicians	Full system training + privacy	Before first use
Administrative	Consent process + privacy	Before first use
IT	Technical administration	Before first use

Ongoing: System updates (as released), privacy refresher (annual), competency assessment (annual)

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6. Compliance Monitoring

Audit Type	Frequency
Access log review	Monthly
Consent compliance	Quarterly
Documentation quality	Quarterly
Vendor compliance	Annual

Metrics Tracked:

• Consent rate (target >95%)
• Same-day documentation completion (>90%)
• Significant edit rate (<15%)
• Incident count (target: 0)

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7. Policy Violations

Examples: Using AI without consent, failing to review content, sharing credentials, unauthorised use.

Consequences: Additional training, suspension of privileges, disciplinary action, regulatory reporting if required.

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8. Roles and Responsibilities

Role	Responsibilities
Chief Medical Officer	Clinical oversight, quality standards
Privacy Officer	Privacy compliance, incident response
IT Security	Technical security, vendor management
Department Heads	Staff compliance, training completion
Individual Clinicians	Consent, review, accuracy

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9. Policy Review

This policy will be reviewed:

• Annually
• Following significant incidents
• When regulations change
• When new AI systems are implemented

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Appendices

Appendix A: Patient Information Sheet

[Include or reference patient-facing information]

Appendix B: Consent Form

[Include or reference patient consent form]

Appendix C: Incident Report Form

[Include or reference incident reporting form]

Appendix D: Training Curriculum

[Include or reference training materials]

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This template is provided for informational purposes. Consult with legal and compliance professionals before implementation.

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Download Formats:

• Word Document (.docx)
• PDF

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Related Resources:

• HIPAA Compliance Guide
• Patient Consent Forms
• Implementation Checklist