NHS Implementation Training

1. Overview

This document provides the governance framework and operational procedures for NHS services integrating Flowen as an adjunct technology within fluency therapy pathways. It is intended for clinical leads, service managers, commissioners, and information governance (IG) leads.

Flowen is a Class I Medical Device under UK MDR 2002 (as amended post-Brexit). It delivers real-time acoustic biofeedback during self-directed fluency practice sessions and surfaces telemetry to the responsible Speech & Language Therapist (SLT) via a clinical portal.

2. Clinical Governance Framework

Flowen's clinical governance rests on four frameworks:

Organisational responsibilities

As the implementing NHS organisation, you are the Data Controller under UK GDPR. Flowen acts as a Data Processor. Your responsibilities include:

• Appointing a named Clinical Lead responsible for oversight of the Flowen deployment
• Ensuring your Information Governance team reviews and signs the Data Processing Agreement (DPA)
• Completing a Data Protection Impact Assessment (DPIA) — Flowen's standard DPIA is available as a starting point
• Adding Flowen as a data processor in your organisation's Record of Processing Activities (ROPA)
• Ensuring all SLTs using the portal complete the SLT Training Manual before enrolling patients
• Reviewing Flowen adverse event reports as part of your existing incident management process

3. Patient Eligibility & Referral Pathway

Inclusion & exclusion criteria

Referral pathway

The standard referral pathway for NHS services is:

• Step 1 — Clinical assessment: SLT confirms diagnosis, severity (SSI-4 or equivalent), and suitability per inclusion criteria above
• Step 2 — Consent discussion: SLT conducts informed consent discussion and documents in clinical notes (Flowen's in-app consent is supplementary)
• Step 3 — Patient enrolment: SLT creates patient profile in the Flowen portal and assigns initial programme
• Step 4 — App onboarding: Patient installs the Flowen app, completes in-app consent, and completes acoustic calibration with SLT guidance (first session or by phone)
• Step 5 — Active monitoring: SLT reviews telemetry weekly; responds to safety flags within timeframes defined in Section 8
• Step 6 — Review and discharge: Formal clinical review at agreed intervals (minimum 8-weekly); discharge when goals met or pathway no longer appropriate

4. Staff Roles & Responsibilities

Staff must not share portal credentials. Leavers must be removed from the portal by the Clinical Lead within 5 working days of their departure. Contact clinical@flowen.digital to remove a user.

5. Data Security & DSPT

Flowen's data security posture is designed to meet NHS DSPT requirements and is reviewed annually. Key technical controls:

• All data stored within the UK and EEA (no transfers to third countries)
• TLS 1.3 encryption in transit; AES-256 encryption at rest
• Multi-factor authentication enforced for all portal users
• Role-based access control — SLTs see only their own patients; no cross-organisational data leakage
• Penetration testing conducted annually by a CREST-certified provider; summary report available on request
• Audit logs retained for 7 years, tamper-proof
• Business continuity plan and disaster recovery tested twice annually; RTO ≤ 4 hours, RPO ≤ 1 hour

Data retention

6. Care Pathway Integration

Flowen is designed to integrate into existing NHS fluency therapy pathways, not replace them. Recommended integration points:

• Electronic Patient Record (EPR): Flowen PDF progress reports should be filed in the patient's EPR at each formal review. Flowen does not integrate directly with SystmOne or EMIS at this time.
• Waiting list management: Flowen can be used during active waiting periods to maintain patient engagement, with appropriate consent and clinical oversight.
• Discharge to self-management: Patients can continue to use the app on a self-managed basis after discharge, subject to a revised consent discussion. The SLT's active monitoring obligation ends at discharge.
• Group therapy: Flowen can complement group fluency programmes. Each patient requires an individual enrolment and responsible SLT.

7. Audit & Reporting

The Clinical Lead receives a monthly summary report by email covering:

• Number of active patients and session volume
• Mean session completion rate across the service
• Safety flags raised and resolution status
• Adverse event count (including zero-count confirmation)

For commissioner reporting, a quarterly outcome summary can be generated on request. This covers aggregate telemetry trends only — no individually identifiable data — and is formatted to support NHS outcome reporting frameworks.

8. Escalation & Incident Reporting

All incidents involving Flowen should be logged in your organisation's own incident management system (e.g. Datix) in addition to any notification to Flowen. This is required for your DSPT obligations.

9. Key Contacts