EXECUTIVE SUMMARY

NHS England requires suppliers to provide a clear DPIA, with transparent explanation of data flows, sub‑processors, retention periods, and access controls. Local governance approval must be supported with documented artefacts.

AISA® and Amplify+® follow privacy‑by‑design principles. Data minimisation ensures only essential information is processed. Where possible, identifiable data is captured in structured fields rather than dictated, reducing transcription of patient identifiers. All data is encrypted in transit and at rest. Access is controlled by role‑based permissions and full audit logs. Our DPIA includes flow diagrams, processor registers, and retention schedules. Audio and transcripts are retained for 90 days unless the Trust requests a shorter period, while documents are retained for one year under client control. These configurable retention policies give organisations confidence that information governance obligations are met.

NHS England requires suppliers to meet clinical safety standards DCB0129 and DCB0160, including appointment of Clinical Safety Officers, hazard logs, risk assessments, and safety cases.

AISA® and Amplify+® are supported by an active clinical safety governance programme. We maintain a Clinical Risk Management File including hazard log, risk controls, residual risk acceptance, and safety case. Independent review is undertaken by an external clinical safety consultancy. Each deployment includes a site‑specific safety plan, co‑signed with the Trust’s Clinical Safety Officer. Risk mitigations are tailored to local workflows and updated through change control. This approach ensures that any residual risks are transparent, reviewed, and acceptable. 

By embedding clinical safety throughout the lifecycle, Trusts can be assured that deployment of AISA® is consistent with NHS standards.

NHS England requires AVT systems to demonstrate secure operation, including encryption, identity management, and incident response.

AISA® and Amplify+® enforce security at every layer. All traffic is encrypted with TLS 1.2 or higher, and data at rest uses AES‑256 encryption. Identity is managed through optional NHS single sign‑on integration (SAML/OIDC) with multi‑factor authentication. Audit logs capture every action taken, from audio capture through review, approval, and filing.

A documented incident response framework ensures rapid action if an event occurs, with root cause analysis and service improvement following. Disaster recovery and business continuity plans are tested, with defined RPO and RTO. This level of governance ensures Trusts that security risks are actively managed and mitigated.

NHS England has highlighted concerns that unconstrained AI models could generate unsafe or inappropriate outputs. AVT systems must not expose clinicians to unrestricted prompt injection or free‑form AI.

AISA® and Amplify+® are designed with strict guardrails to prevent unsafe behaviour. Generation is bound to pre‑approved templates per specialty and encounter type. Outputs cannot include sections outside the schema, ensuring that only clinically relevant, expected content is produced. The assistant is configured to summarise clinical facts captured in consultation, and it cannot invent diagnoses, medications, or care plans. All drafts require human review and sign‑off before filing to the EPR. Prompts and models are version‑controlled, and inputs are sanitised to prevent injection attacks. Outputs are scanned against policy to suppress speculative content. This layered control ensures Trusts that AISA® cannot be misused or produce uncontrolled outputs.

NHS England requires AVT systems to integrate safely with PAS/EPR systems using HL7 and FHIR, supporting structured data exchange and controlled document write‑back. 

AISA® and Amplify+® achieve this through standards‑based integration. HL7 v2 interfaces (ADT, ORU, MDM) and FHIR APIs are supported to retrieve demographics and file outputs. Controlled write‑back ensures documents are sent with metadata including author, encounter, and version identifiers. Distribution is routed deterministically to GP, referrer, or patient channels using MESH, GP Connect, NHSmail, or managed print. Exception handling, reconciliation, and retry mechanisms guarantee delivery. 

This integration model provides Trusts with confidence that information is exchanged reliably, safely, and in line with NHS interoperability frameworks.

AISA® is embedded into end‑to‑end clinical workflows. Audio is captured ambiently or via dictation, then transcribed and structured into clinical notes, GP letters, and patient letters. Outputs are routed into QA workflows where administrators or clinicians can review, edit, and approve. Once approved, documents are filed back into the EPR and distributed. This ensures that AI augments clinical processes rather than bypassing them. The benefit for Trusts is consistency of documentation, reduced administrative burden, and assurance that all records are valid and properly approved.

NHS England requires suppliers to accept responsibility for the accuracy of transcription and summarisation.

We operate a continuous validation loop, gathering feedback, categorising errors, and updating models and prompts under change control. Patient letters are checked for readability standards such as SMOG. Specialty‑specific templates ensure clinical fidelity. By adopting responsibility for the accuracy of our system, we provide Trusts with confidence that documentation will be consistent, reliable, and safe.

NHS England requires AVT systems to provide transparency, auditability, and clear attribution.

Every document generated by AISA® carries a provenance manifest including transcript references, template identifiers, model version, and user actions. All edits and approvals are logged with user and timestamp details. This enables retrospective review, clinical audit, and medico‑legal defence.

By maintaining explainability and transparency at every stage, Trusts can be assured that the system does not operate as a black box, but as a traceable and accountable tool within clinical governance.

Pilot deployments are essential to validate safety, effectiveness, and benefit realisation.

AISA® pilots begin with a baseline study of current documentation processes, turnaround times, and after‑hours burden. Controlled cohorts of clinicians then use AISA® in defined settings. Stress testing includes different accents, noise levels, and multi‑speaker encounters. Metrics include turnaround time from consultation to filed document, clinician time saved, backlog reduction, readability of patient letters, and user wellbeing feedback. Exit criteria include demonstrable improvement versus baseline and no outstanding high‑severity risks. Pilot outcomes are formally reviewed with the Trust CSO before scale‑up. This structured approach gives Trusts measurable evidence of benefit and safety.

AISA® and Amplify+® are hosted in UK sovereign Microsoft Azure regions, ensuring compliance with NHS data residency requirements.

High availability is built in, with resilient architecture, backup, and disaster recovery. SLAs define uptime, RPO, and RTO. Telemetry monitors latency, job queues, and error rates, with alerting for proactive resolution. Support playbooks ensure that both clinical and IT teams have clear escalation routes. Trusts benefit from a service that is robust, transparent, and supported by a dedicated team