Anathem is a Class l certified medical device that meets all of NHS England's guidelines.
What does Anathem do?
Anathem uses AI to transcribe patient consultations and clinician dictations into structured medical notes. Clinicians can review and edit the notes, generate additional documents, add them to the patient record, and share them with patients or other services.
Is Anathem a medical device?
Anathem is registered with the MHRA as a Class I medical device under 36216 - Digital dictation system, as ANATHEM LTD.
| Requirement | Tandem Health Compliance |
|---|---|
| DTAC | ✅ Fully Compliant. Anathem is also ISO 27001 certified. |
| Data Security and Protection Toolkit (DSPT) | ✅ Maintained annually, exceeding standards |
| Cyber Essentials Plus | ✅ Cyber essentials certified |
| CREST-approved Penetration Testing | ✅ Penetration tests conducted regularly |
| Clinical Safety Officer (CSO) | ✅ Named CSO: Dr Guy Northover, Consultant Child and Adolescent Psychiatrist; MSC Digital Clinical Leadership, Associate Medical Director for Digital and Clinical Safety (incorporating the role of CCIO) for Berkshire Healthcare, Chair Faculty of Child and Adolescent Psychiatrist. All trusts using Anathem have their own named CSO. |
| End-to-end Encryption | ✅ Enforced for all data sessions, as well as at point of storage on Microsoft Azure infrastructure |
| GDPR Compliance | ✅ Yes. Transcription only, no audio recording. |
All data deleted from Anathem after 10 days (fully customisable to individual trusts).
Data stored on Microsoft Azure South West Servers
All data processed on Microsoft Azure South West Servers
No patient data used to train models | | No Unsafe Functionality | ✅ Anathem develops its own prompts and tests all prompts against synthetic transcripts prior to release. Prompts are personalised to specific service requirements. Once prompts are deployed into the live environment they are improved through a process of feedback from users to our prompt engineers who will extensively test any improvements prior to the prompts going live.
Anathem is resistant to jail-breaking and LLM manipulation as clinicians are not able to add their own prompts or modify existing prompts.
Anathem prompt design and schema and implemented guardrails recognises and avoids model manipulation of outputs via inputted transcripts and documents .
Anathem routinely tests for impact of malicious transcripts. | | NHS System Integration | ✅ Anathem is fully compatible with HL7/FHIR standards.
🔜 In discussion with integration into EPR’s | | Translation Responsibility | ✅ Translation functionality not available on Anathem whilst information is gathered. Transcription quality is monitored by Anathem and clinicians alerted if transcription quality is deemed low. |
| Requirement | Tandem Health Compliance |
|---|---|
| Medical Device Classification | ✅ Anathem is registered with the MHRA as a Class I medical device under 36216 - Digital dictation system, as ANATHEM LTD. |
🔜 Class IIa certification in progress | | Data Protection (UK GDPR, DPA 2018) | ✅ Fully compliant; patient data de-identified after 30 days | | System Integration | ✅ Audio not stored; no local storage; no model training using patient data |
| Requirement | Anathem |
|---|---|
| Real-world Clinical Validation & Clear Economic and Workforce Impact | ✅ Validated across 6 NHS pilots |
Richard Apletree, CEO
Anathem
Dr Guy Northover, Chief Clinical Safety Officer