
Requirement | Accurx Scribe, powered by Tandem |
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Digital Technology Assessment Criteria (DTAC): this is a framework established by the NHS to ensure that digital health technologies meet essential standards for safety, security, and usability |
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DSPT |
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Cyber Essentials Plus |
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CREST-approved Pen Testing |
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Named Clinical Safety Officer |
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Encryption |
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GDPR Compliance |
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No Unsafe Functionality (e.g. prompt injection) |
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NHS System Integration |
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Translation Accuracy Responsibility |
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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 |
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Included in Accurx’s IM1 integration |
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Has been used over 900k times across the country
Is live in over 50% of GP practices
Consultations are not used to train AI models
Audio recordings are deleted as soon as the transcript is completed
Evidence that your organisation is ensuring safe use of Accurx Scribe in patient care.
The DCB0160 clinical risk management assessment may have been completed on your behalf by your ICB or PCN.
If you are in a practice where the DCB0160 has been created at a regional level, you will still need to review it and sign it off.
It is far more common for this to be done at a practice level, in which case someone from your practice has to complete the steps. To do that you need to:
This is part of a mandatory NHS safety process (called DCB0160). It applies every time you use software that can influence patient care.
A formal process to identify, assess, and mitigate the risks that a processing activity involving personal data may pose to individuals. It is a legal requirement whenever the type of processing is likely to result in a high risk to the rights and freedoms of individuals, such as when new technologies are used to process sensitive data.
When using Accurx, it is up to the data controller (your organisation) to complete a DPIA. As a data processor, we cannot complete it for you. However, to be as helpful as we can, we have filled in the key parts of a DPIA Template for Accurx Scribe.
Download Accurx Scribe DPIA
The DTAC is a consistent question set designed by NHS England to be used by healthcare organisations to assess suppliers of digital technologies at the point of procurement or as part of a due diligence process.
You can download our DTAC here.
It is used to make sure digital technologies meet NHS England’s standards for clinical safety, data protection, cyber security, interoperability and accessibility
A legally binding contract that governs the relationship between your organisation (Data Controller) and Accurx (Data Processor), ensuring that we only process personal data on your behalf and strictly under your instructions.
Accepting the DPA is done through the in-product page that is visible to users when they click the microphone button on their Accurx toolbar.
An approved user (that holds the power to enter into a contract on behalf of your organisation) must accept the DPA to enable the functionality for your organisation.
Your organisation won’t be able to access the functionality until this has been accepted.
It is a mandatory legal requirement under data protection laws. Without a DPA, both the data controller and the data processor can be held accountable for non-compliance with the UK GDPR.
Yes.
At Accurx, we take information governance and data protection extremely seriously. Accurx Scribe is a Class I medical device under 36216 - Digital dictation system; meeting all of NHSE's guidance around the use of Ambient Scribes. Our approach is built around a comprehensive, risk-based framework that is specifically designed to meet and exceed the requirements set out by the NHS and the UK GDPR.
We’ve embedded risk management into every stage of our product lifecycle, ensuring that potential threats to privacy and security are proactively identified, assessed, and mitigated. In line with the UK GDPR’s principle of data protection by design and by default, we incorporate privacy and security safeguards into our systems and processes from the outset rather than treating them as afterthoughts.
To ensure that the same level of privacy and security is ensured when we partner with other service providers to offer a feature, which is the case for Accurx Scribe, Accurx has a structured, comprehensive and robust due diligence framework to assess these partners at corporate and product levels. This way we ensure that we only work with partners who can demonstrate a shared commitment to protecting privacy, ensuring clinical safety, and delivering safe, secure and compliant technology within the NHS.
Our Scribe solution processes the following patient information on behalf of the NHS organisations that use this service:
The sources of the data are:
The patient’s NHS number and demographic details, which are required to ensure clinical notes are saved to the correct patient’s record, are fetched directly from the electronic medical record (EMR) and/or the Personal Demographic Service (PDS). This data is obtained as part of the secure integrations that Accurx maintains with these systems.
The remaining data is generated directly from patients and healthcare professionals during their consultation where Accurx Scribe is used.
No.
While some AI systems are built to continuously learn from new data, Accurx Scribe is not. The AI model that powers Accurx Scribe does not absorb, reflect or “learn” from any aspect of the conversation between patients and healthcare professionals during a consultation.
This means that information about healthcare professionals and patients that processed through Accurx Scribe is:
never used to update, retrain or fine-tune the AI model, remaining completely separate from the development of the underlying AI technology, and
always kept private and confidential, with no influence on how the model behaves for others, now or in the future.
That said, we are firmly committed to continuously improving the safety, accuracy and reliability of our Scribe solution. That is why, as part of the post-market surveillance process, there is a manual clinical review of a small fraction of outputs generated by Accurx Scribe to monitor for AI accuracy and to improve clinical safety. The process includes a clinical investigation into why those edits were made and the application of expert clinical judgment to determine whether the issue could have had any clinical safety implications.
By default, only the healthcare professional who conducted the consultation (that is, the user whose account was used to generate the transcription) can access the associated data within the product.
A technical engineer or Tandem clinician may need to access stored data to investigate a technical issue to ensure the safe operation of the service. However, this access will always be:
The audio stream is processed in real-time during conversations and automatically deleted as soon as the audio is transcribed by Scribe. This ensures that the audio, which is highly sensitive, is not retained any longer than necessary to fulfil the necessary purpose.
Outputs generated by Scribe, such as transcriptions, clinical notes, and summaries, are retained as identifiable personal data for a period of 30 days for healthcare professional users to access.
During this 30-day period, a small number of outputs are extracted for clinical review, in line with statutory obligations relating to medical devices. The number of outputs selected for this process is derived from a statistically-robust methodology to ensure a meaningful analysis of error rates. In addition to these sampled outputs, any outputs identified by clinicians as erroneous or otherwise concerning are also included for review. Please see here for more information about how these outputs are processed for clinical safety purposes.
After this 30-day period, the majority of outputs are permanently and securely deleted. A small number, again derived from a statistically-robust methodology, are retained to support testing of any changes to the underlying AI model’s system prompt resulting from clinical review or other identified improvements. These outputs are:
Regardless of the steps taken to minimise personal data in the outputs, they continue to be treated with the same technical and organisational measures as if they were fully identifiable, further reducing the likelihood of unintended re-identification of individuals.
Accurx have also taken into account peer-reviewed research and other published guidance relating to data minimisation and re-identification risk, such as this.
All personal data processed through Accurx Scribe is stored and handled exclusively within the European Union (EU). This includes all servers, databases, systems, and processes that Accurx relies on to provide the Accurx Scribe service. No patient data is transferred outside of the EU.
This intentional approach is designed to ensure full compliance with the UK-GDPR. With the UK-EU adequacy decision, personal data may lawfully flow from the UK to the EU without additional safeguards such as International Data Transfer Agreements. The UK-EU adequacy decision confirms that the EU offers a level of protection to personal data that is “essentially equivalent” to that of the UK.