NHS ICB Procurement for Digital Therapeutics

Overview

Flowen is a regulated digital therapeutic platform for fluency disorders (stammering, cluttering, and neurogenic fluency disorders). It delivers real-time neural biofeedback and speech coordination training using evidence-based techniques aligned with RCSLT clinical guidance on fluency therapy.

Flowen has been designed for NHS commissioning from the ground up. It complies with DCB0129 Clinical Safety Standard, aligns with NHS Digital's Digital Technology Assessment Criteria (DTAC), and is built on UK data residency infrastructure compliant with UK GDPR and the Data Security and Protection (DSP) Toolkit requirements.

DTAC Alignment

The Digital Technology Assessment Criteria (DTAC) is the NHS England framework for assessing digital health tools before procurement. It covers five domains: clinical safety, data protection, technical assurance, usability, and interoperability.

Clinical safety — DCB0129

Flowen is developed and maintained in compliance with NHS England's DCB0129 Clinical Safety Standard for health IT systems. The standard mandates:

• Appointment of a Clinical Safety Officer (CSO) with appropriate clinical and technical qualifications
• A Clinical Safety Case Report (CSCR) documenting hazard identification, risk assessment, and mitigations
• A maintained and monitored Hazard Log
• Defined clinical risk management processes
• Incident reporting and response procedures

All DCB0129 documentation is available on request. Our Clinical Safety Officer can be reached at clinical@flowen.digital.

Data security — UK GDPR & DSP Toolkit

Flowen processes personal health data as a data controller (for direct-access users) and data processor (in clinical deployment models). Our data governance framework includes:

A Data Protection Impact Assessment (DPIA) template for NHS deployments is available on request. Our Data Protection Officer can be contacted at privacy@flowen.digital.

Technical assurance

Flowen is a cloud-native web application. Key technical specifications:

• Browser-based — no app store dependency, works on any modern browser including NHS-managed devices
• 99.9% uptime SLA with scheduled maintenance windows communicated 72 hours in advance
• Automated backup with 4-hour RPO and 8-hour RTO
• Multi-region failover with active health monitoring
• Continuous dependency scanning and automated security patching
• Change management process with clinical safety review for significant updates

Usability & accessibility

• WCAG 2.2 AA conformance (accessibility statement available at flowen.digital/accessibility)
• Tested with assistive technologies including JAWS, NVDA, and VoiceOver
• Plain English content rated at Flesch-Kincaid Grade 8 or below
• Mobile and tablet compatible for use across devices
• Onboarding completion rate >88% in beta cohort

Interoperability

Flowen supports data export in structured formats for integration with clinical systems. Current integrations and roadmap:

Procurement routes

NHS commissioners can procure Flowen through several routes depending on contract value and local policy:

G-Cloud 14 (Digital Marketplace)

Flowen is listed on Crown Commercial Service G-Cloud 14 under the Cloud Software category. G-Cloud is available to all NHS bodies and local authorities without the need for a formal tender process, regardless of contract value. Search for "Flowen" on the Digital Marketplace at digitalmarketplace.service.gov.uk.

Direct award (under threshold)

For contract values below the NHS procurement threshold (currently £213,477 for services), commissioners may award directly following a proportionate market assessment. Flowen's annual contract value for most ICB deployments falls well within this threshold. We can provide a completed supplier information pack to support your assurance process.

NHS Shared Business Services (NHS SBS)

Flowen is available through NHS SBS frameworks where applicable. Contact our commercial team at hello@flowen.digital to obtain a tailored quote and framework reference.

Evidence base

Flowen's clinical approach is grounded in the following evidence domains:

• Fluency shaping: Easy onset, diaphragmatic breathing, and prolonged speech have the strongest evidence base for fluency gains in adults who stammer (Guitar, 2014; O'Brian et al, 2014)
• Biofeedback augmentation: Real-time acoustic and visual biofeedback significantly enhances acquisition of speech techniques versus instruction alone (Ingham et al, 2012; Bothe et al, 2006)
• Digital delivery: Technology-mediated stuttering treatment demonstrates non-inferiority to in-person delivery for adult participants (Carey et al, 2010; Jones et al, 2014)
• Self-managed practice: Daily practice frequency is the primary predictor of long-term fluency maintenance (O'Brian et al, 2014)

A full evidence summary document is available in our /resources/biofeedback-evidence guide. Clinical publications and grey literature references available on request.

Commissioning model

Flowen can be commissioned under two primary models:

A hybrid model — where initial assessment and goals are set by an SLT and ongoing practice is self-managed — is also supported and recommended for most ICB deployments.

Service level commitments

Implementation

Flowen's implementation process for NHS commissioners typically takes 4–8 weeks from contract signature to go-live:

• Week 1–2: Contract and DPA execution; DSMFT completion; staff onboarding for clinician portal
• Week 2–3: Configuration of referral pathway and white-label URLs if required
• Week 3–4: Clinician training (1-hour webinar + self-paced materials); patient information leaflet customisation
• Week 4–6: Soft launch with first cohort; 2-week check-in call with implementation lead
• Week 6–8: Full go-live; quarterly review cadence established

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