SmartNotes Supplementary Terms

These SmartNotes Terms are supplementary to the Core Terms and apply where You buy SmartNotes from Us. They form part of the Agreement. If there is any conflict between these SmartNotes Terms and the rest of the Agreement, these SmartNotes Terms prevail to the extent of that conflict. Where a capitalised word is used in these terms but is not defined here, it has the meaning given to it in the Core Terms.

About SmartNotes (intended purpose)

SmartNotes is a mobile application for healthcare professionals working in mental health and community health settings. It runs on workplace-authorised iOS and Android devices and captures clinical notes and summaries during or after a consultation. Clinician and patient speech are transmitted to an AI system located outside the UK, which converts them into clinical notes and summaries that are then downloaded to the app for review, editing and approval by the clinician before being added to the patient's record in the Rio Electronic Patient Record (EPR) system.

The system is intended for English-language consultations only, between a single authorised health professional and a single patient aged 18 or over (or, where applicable, the patient's adult parent, guardian or helper). Intended users include doctors, nurses, community workers and allied professionals in mental health, community health, hospitals, clinics and appropriate external settings such as the patient's home.

Limitations. The system may not function in noisy environments. Where the quality and/or content of audio recordings does not meet SmartNotes' internal requirements, this will be flagged to the user and to Rio EPR, and neither clinical notes nor summaries will be produced.

1. Definitions

AI Content — any output generated by SmartNotes from Audio Data.

AI Services — any features within SmartNotes that are powered by, use, or incorporate artificial intelligence, machine learning, or large language models.

Audio Data — voice recordings captured during clinical consultations.

Clinical Documentation — progress notes and assessment forms generated through SmartNotes.

Healthcare Professional — Your authorised clinical staff permitted to use SmartNotes.

Prompts — any inputs, queries or instructions provided to SmartNotes' AI Services, including Audio Data and template selections.

SmartNotes — Access Rio Smart Notes, a Class I medical device under the UK Medical Devices Regulations 2002.

Validation Process — the mandatory clinician review and approval of all AI Content before submission.

2. Medical device classification and regulatory compliance

2.1 SmartNotes is a Class I medical device under the UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended), intended solely to assist with clinical documentation. It does not provide clinical decision support, diagnostic or therapeutic recommendations, monitor physiological processes, or replace clinical judgement. We maintain technical documentation as required by the regulations.

3. AI technology and limitations

3.1 Technology. SmartNotes uses Microsoft Azure OpenAI Service within Our secure environment to transcribe speech and structure documentation.

3.2 No warranty. The AI Services are provided 'as is'. We make no warranties about their accuracy, completeness or reliability. AI Content may contain errors and requires human validation.

3.3 Mandatory validation. No AI Content may be used without completing the Validation Process. You acknowledge that AI outputs may be inaccurate and that similar outputs may be generated for other users.

4. Acceptable use

4.1 You must not:

(a) use SmartNotes for clinical decisions without following the Validation Process;

(b) attempt to discover, extract or reverse-engineer the underlying AI models, algorithms, weights or system components of SmartNotes;

(d) generate harmful, illegal or discriminatory content;

(e) present AI Content as human-generated, or remove any indicators that content was AI-generated;

(f) submit requests designed to overload, test the limits of, or disrupt the AI Services;

(g) record without required consent; or

(h) use the AI Services to generate, process or distribute content that :

is illegal, harmful, abusive, discriminatory or offensive

infringes third-party intellectual property rights

contains malware, viruses or malicious code

breaches any applicable law or regulation.

4.2 Violations. We may immediately terminate or suspend Your use of SmartNotes if, in Our commercially reasonable opinion, We believe You have breached any provision of this section 4.

5. Clinical safety and validation requirements

5.1 Validation. You must ensure Healthcare Professionals complete the full Validation Process for every document, reviewing all sections and explicitly approving content before submission.

5.2 Training. All users must complete mandatory SmartNotes training covering proper use, AI limitations and validation requirements.

5.3 Compliance. You will comply with all applicable laws, including data protection, anti-discrimination, healthcare regulations and professional standards.

5.4 Clinical responsibility. Healthcare Professionals retain full professional responsibility for documentation accuracy and patient care.

5.5 Patient consent. You must obtain appropriate consent before recording consultations and follow organisational consent policies.

5.6 Risk management. You must conduct local clinical risk assessments per DCB0160:2018 and promptly report safety incidents.

6. Data privacy and security

6.1 No model training. Your customer data, Prompts, Audio Data and AI Content are not used to train or improve the underlying AI models unless You give explicit written consent.

6.2 Audio Data handling. Audio Data is stored locally on devices during processing; is automatically deleted after successful submission of validated Clinical Documentation; and is retained for a maximum of 7 days in accordance with the NHS Records Management Code of Practice.

6.3 Data retention. Prompts and AI Content are retained for 30 days for security and quality purposes, after which they are automatically deleted unless longer retention is required by law.

6.4 Data minimisation. SmartNotes processes only the minimum data necessary for clinical documentation and does not retain Audio Data beyond operational requirements.

7. Intellectual property

7.1 Your content. You retain all rights to Your customer data, Audio Data and Prompts. We claim no ownership of Your inputs to the AI Services.

7.2 AI Content. Subject to Your rights in the underlying customer data, You own all AI Content generated specifically for You. However, You acknowledge that:

similar outputs may be generated for other users with similar prompts,

AI Content may not be unique or proprietary

We retain rights to aggregated, anonymous insights derived from usage patterns.

7.3 Feedback. We may use any feedback You provide about SmartNotes or the AI Services without restriction to improve Our products and services.

8. Clinical risk management

8.1 Risk awareness. You acknowledge receipt of Our Clinical Safety Case Report and Hazard Log, which identify potential clinical risks and the control measures implemented.

8.2 Local risk assessment. You must conduct appropriate local clinical risk assessments to DCB0160:2018 standards, considering

integration with Your existing clinical workflows;

training and competency requirements for Healthcare Professionals; and

local governance and quality-assurance processes.

8.3 Incident reporting. You must promptly report to Us any incidents involving SmartNotes that may affect patient safety or clinical care quality.

9. Limitation of liability - clinical use

9.1 Clinical decision limitation. Our liability does not extend to clinical decisions made by Healthcare Professionals using information generated by SmartNotes, whether or not that information has been properly validated. You acknowledge that failing to follow the mandatory Validation Process is misuse of SmartNotes, and You will indemnify Us against any claims arising from such misuse.

9.2 Medical device liability. Our liability in connection with SmartNotes as a medical device is subject to the limitations set out in the Agreement. These limitations apply to all claims, whether based on defects, patient harm or otherwise, except to the extent applicable law prevents such limitation.

9.3 Indemnity. You will indemnify, defend and hold Us harmless from all claims, losses, damages, costs and expenses (including reasonable legal fees) arising from or related to:

(a) any breach of the prohibited uses in section 4;

(b) any failure to complete the mandatory Validation Process under clauses 3.3 and 5.1;

(d) any clinical safety matters under clauses 5.4 and 5.6;

(e) any consent and privacy violations under clauses 5.5 and 6; and

(f) any third-party intellectual property infringement claims.

9.4 Risk assumption. You assume all risks associated with AI-powered clinical documentation, including transcription errors and technology failures.

10. Term and termination

10.1 These SmartNotes Terms continue for as long as Your SmartNotes licence(s) continue, in accordance with the Agreement.

10.2 We may suspend or terminate Your access to the AI Services immediately if You breach these SmartNotes Terms.

11. General

11.1 Updates. We may update SmartNotes and these SmartNotes Terms. We will give 30 days' notice of material changes where practicable. Any mandatory safety updates may require immediate implementation.

11.2 Compliance priority. Where compliance with medical device regulations conflicts with general commercial terms, regulatory compliance takes precedence.

11.3 Geographical limitations. Because SmartNotes is a Class I medical device under the UK Medical Devices Regulations 2002, it can only be sold and used within Scotland, England and Wales.