What does Accurx Scribe do?
Accurx Scribe uses AI to transcribe audio from a patient consultation or dictation and to summarise it into a structured form for medical notes. Clinicians can review and edit these notes, generate other documents, save these notes to the patient record and share documents with patients and other services.
Is Accurx Scribe a medical device?
Accurx Scribe is powered by ambient scribe technology developed by Tandem Health. Tandem is registered with the MHRA as a Class I medical device under 36216 - Digital dictation system, as TANDEM HEALTH GLOBAL LIMITED.
How Accurx Scribe powered by Tandem meets NHSE’s AVT guidance:
Accurx welcomes the recent communication shared by NHS England (NHSE) clarifying the requirements for suppliers and NHS organisations considering the use of Ambient Voice Technology (AVT), such as Accurx Scribe powered by Tandem.
As a responsible partner to the NHS supporting over 10,000 healthcare organisations, with a proven track record of clinical safety and governance best practice, we have ensured that Accurx Scribe powered by Tandem already meets or exceeds the requirements outlined in NHSE’s guidance.
Core Platform Assurance Requirements
Requirement | Accurx Scribe powered by Tandem |
DTAC-compliant | ✅DTAC ready. If required for your organisation, review Accurx’s DTAC. Contact our User Support team at support@accurx.com or use the in-product support chat to request a copy. Accurx is also ISO 27001 certified |
DSPT | ✅Maintained annually, with “exceeding standards” |
Cyber Essentials Plus | ✅Certified Yearly [Current certificate is valid till 02/12/2025] |
CREST-approved Pen Testing | ✅Regularly tested, latest report available on request |
Named Clinical Safety Officer | ✅CSO for Accurx: Dr Chris Sartori Tandem: Dr Paul Jewell Healthcare organisations are required to have a named CSO with oversight of clinical systems in use |
Encryption | ✅Enforced across all sessions, as well as at point of storage on hardened Microsoft Azure infrastructure |
GDPR Compliance | ✅Accurx DPIA template and Data Flow Diagram has been provided to all organisations for completion and approval |
No Unsafe Functionality (e.g. prompt injection) | ✅Risks arising from usage of AI have been assessed and mitigated to acceptable levels as part of ongoing clinical validation and post-market surveillance |
NHS System Integration | ✅API integration with EMIS, SystmOne, RiO, CITO, PDS, and Vision. Compatible with HL7/FHIR standards, supporting write-back to EHR |
Translation Accuracy Responsibility | ✅Translation functionality not currently available, will be in place once clinical safety has been evaluated |
For more information on Governance and compliance considerations for using Accurx Scribe, see our article here.
Enhanced Requirements
Requirement | Accurx Scribe powered by Tandem |
Medical Device Classification: Class I for summarisation Class IIa for enhanced functionality |
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Data Protection: UK GDPR and Data Protection Act 2018 compliance |
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System Integration | ✅API integration with EMIS, SystmOne, RiO, CITO, PDS, and Vision. Compatible with HL7/FHIR standards, supporting write-back to EPR. |
Clinical & Operational Threshold Benefits
Evidence of real-world clinical validation in NHS care settings | ✅Evidence of clinical validation and benefits available on request |
Clear economic justification and workforce impact | In an evaluation independently designed and conducted in primary care:
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