Anathem AI; Complete Compliance with NHS England
AVT Requirements

Anathem AI Complete Compliance with NHS England AVT Requirements

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.

Core Platform Assurance Requirements

Requirement

Anathem

Anathem

DTAC-compliant

DTAC-compliant


✅ Fully Compliant. Anathem is also ISO 27001 certified.

✅ Fully Compliant. Anathem is also ISO 27001 certified.



DSPT

DSPT



✅ Fully Compliant

✅ Fully Compliant



Cyber Essentials Plus



Cyber Essentials Plus



✅ Fully Compliant


✅ Fully Compliant


CREST-approved Pen Testing


CREST-Approved Pen Testing


✅ Regularly tested


✅ Regularly tested


Named Clinical Safety Officer


Named Clinical Safety Officer


✅ CSO for Anathem: 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.


✅ CSO for Anathem: 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.


Encryption


Encryption


✅ Enforced across all sessions, as well as at point of storage on Microsoft Azure infrastructure


✅ Enforced across all sessions, as well as at point of storage on Microsoft Azure infrastructure


GDPR Compliance


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


✅ 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 (e.g. prompt injection)


No Unsafe Functionality (e.g. prompt injection)


✅ 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.


✅ 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


NHS System Integration


✅ Anathem is fully compatible with HL7/FHIR standards and in discussion with integration into EPR’s


✅ Anathem is fully compatible with HL7/FHIR standards and in discussion with integration into EPR’s


Translation Accuracy Responsibility


Translation Accuracy 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. 


✅ 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. 

Enhanced Requirements

Requirement

Anathem


Medical devices accreditation


Medical devices accreditation


✅ Anathem is registered with the MHRA as a Class I medical device under 36216 - Digital dictation system, as ANATHEM LTD.

→ MHRA Database.

We are working towards class IIa for our advanced functionality.


✅ Anathem is registered with the MHRA as a Class I medical device under 36216 - Digital dictation system, as ANATHEM LTD.

→ MHRA Database.

We are working towards class IIa for our advanced functionality.


Data Protection


Data Protection


✅ 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


✅ 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

Clinical & Operational Threshold Benefits

Requirement

Anathem


Evidence of real-world clinical validation in NHS care settings


Evidence of real-world clinical validation in NHS care settings


✅ Anathem has evidence of effectiveness and quality through 6 NHS pilots.


✅ Anathem has evidence of effectiveness and quality through 6 NHS pilots.

faq
How long is data stored on Anathem for?

Depending on your requirements, Anathem can customise data storage options— from 1 day to multiple years. You can set this during onboarding with the Anathem team. Data is stored within the UK.

Do my interactions get used for AI model training?

No sensitive information is used for training our model. You can check out our privacy policy for more information.

How does Anathem account for written information that is not explicitly given to the model?

We believe outputs from AI should be explainable and fact based. All statements generated can be traced back to source, so that users can see the direct evidence from the source.

How does Anathem prevent the AI hallucinating?

Responsible AI necessitates enhanced accuracy measures. Our inferability engine verifies statement accuracy and derivability, highlighting uncertain claims for user verification. For more information, get in touch and we can talk you through it.

What happens if I have a weak wifi connection?

Anathem has an offline mode, so it will continue working in the background until your device reconnects.

How can I access Anathem?

Once set up, you can access Anathem via your web browser. We also have a mobile app coming early 2025.