Last month NHS England published the second version of its guidance on the use of AI-enabled ambient scribing products in health and care settings. The updated guidance is written as a high-level overview to inform Chief Information Officers and Chief Clinical Information Officers in health and care settings on the adoption of AI scribing products.
This article provides an overview of the new guidance, and sets out some of the benefits and risks to be considered before the products are adopted in clinical settings.
Overview of AI-enabled ambient scribing products
Ambient scribing products convert speech to text. The underlying speech technology in these products continues to develop with the use of generative AI and large language models. These AI scribing products are being increasingly used in health and care settings as notetakers to produce medical documentation including patient notes, record systems and personalised referral letters.
Clearly, when used effectively, these products will reduce the administrative burden on clinicians, allowing them to dedicate more time and attention to patient care. Results from a recent successful trial of AI-scribe technology across nine NHS sites in London showed a 23.5% increase in direct patient interaction time within appointments.
By automating information capture in real-time, these products help to ensure documentation remains up-to-date which in turn facilitates decision-making. A more consistent approach to data capture is also achieved, which reduces variability within patient records.
A smaller administrative workload along with higher data quality and better patient care is expected to bring cost savings and greater operational efficiency, often major goals for health and care settings. Economic modelling from York Health Economic Consortium suggests that use of these products in A&E could create an extra £658 million in capacity across England each year.
Key considerations
As AI scribing products are adopted more widely and the technology advances, care providers need to remain vigilant in terms of governance, regulation and safety considerations. Even where AI is not being implemented to make clinical decisions, outputs should be checked by clinicians.
- Legal liability
There is currently little case law establishing liability for claims associated with the use of AI scribing products. If a specific liable party can even be determined, possibly a product supplier, they may not carry full responsibility. In these situations a non-delegatable duty to ensure patient safety and quality of care may be found on the part of the NHS Trust or primary care provider. The trust or primary care provider may however, still be able to pursue legal action against a third party.
To define responsibility and liability, it may be beneficial to implement comprehensive contracting arrangements with suppliers as transparency and traceability will be important. Where AI scribing products are to be customised or developed, provision for this and its implications should be included within such contracting arrangements.
- Data compliance and security
Data compliance and security represent a major risk area for AI scribing products. Key concerns include the potential for data leakage, breaches of data confidentiality, and challenges in enforcing privacy and data protection policies. There may also be limited capability to conduct privacy impact assessments or fully comply with regulatory requirements. Many of these risks stem from patient data being stored or processed within externally hosted AI supplier environments. Additional security concerns can arise during the creation and training of AI datasets.
In light of these risks, careful consideration must be given to how confidential patient data is used, transferred, processed, and stored.
A data protection impact assessment under the UK General Data Protection Regulation (GDPR) is recommended for any major project involving the use of personal data. This should be undertaken at an early stage to identify and minimise any data protection risks.
Transparent information should be provided to patients explaining what will happen with their data. It's worth considering how and where this information is shared. Information can be explained in conversations with patients, displayed in public areas and shared online. Privacy notices may also need to be updated.
To help mitigate concerns around data processing and to protect patient data, measures such as data encryption, access controls and security audits could be adopted.
- Medical devices
Scribing products may be classified as medical devices depending on their intended purpose and level of functionality. It may be difficult to determine medical device classification where an AI scribing product provides the user with functionalities such as consultation suggestions or the ability to produce clinical codes. In addition, scribing products incorporating generative AI may unintentionally include functions that justify classification as a medical device.
Where a product is classified as a medical device, the product manufacturer has legal responsibility to conduct post-market surveillance. The Yellow Card Reporting System will also be a consideration if a medical device produces an output that negatively impacts a patient’s care.
Regardless of whether or not an ambient scribing product is determined to be a medical device, the DCB0129 clinical safety standard will apply.
Regulatory readiness and emerging guidance
There is a whole range of governance, regulatory and safety considerations for AI scribing products to comply with before these technologies are adopted for clinical use.
It will be important to remain aware and compliant particularly as the regulatory landscape is still adapting to keep pace with the new developments in this field. To assist with this, more detailed national guidance and information around AI scribing products is expected in the coming months.
The following guidance is also currently available:
- Guidance for NHS executives and Boards was published in April 2025.
- Guidance on information governance considerations for health and care settings was also published in March 2026.
- NHS England has established an ambient voice technology supplier registry which sets out an approved list of product suppliers.
For further information, please contact our commercial team.
