Using AI-enabled ambient scribing products in health and care settings

Health or care professionals might use ambient scribes for creating notes when they are talking with you, for example during an appointment about your care. They use these tools to make note-taking easier so they can spend more time focusing on you.

Being informed about ambient scribes

If your health or care professional is using an ambient scribe to help them take notes during a conversation, they should tell you at the beginning of the session. They may also provide information about this in public areas (for example, through posters and TV screens in waiting areas) and in newsletters you receive.

You can also read your health or care organisation’s privacy notice to find out more about how the organisation uses ambient scribes.

Objecting to ambient scribes

You can ask for an ambient scribe not to be used during your appointment. If you prefer this, tell your health or care professional at the start of the appointment. They can talk through any concerns with you and will respect your choice.

Using safe products

Before using ambient scribes, your health or care organisation will review and assess:

• the company who made the AI product
• how the AI product was created
• how the AI product works
• how safe the product is for use in supporting your care

They must be satisfied that the company and product have rules in place to make sure your information is kept safe and used in line with the law before using the ambient scribe.

Making sure notes and summaries are accurate

Notes, summaries and letters that have been created by ambient scribes might sometimes contain errors.

People using ambient scribes must check the notes or letters that have been made by the ambient scribe to make sure they are accurate. They do this before adding any information to your record and are responsible for making sure the information in your record remains correct.

The adoption of ambient scribes can transform care settings by improving clinical efficiency, enhancing patient care, reducing clinician workload and addressing the challenges of poor data quality. They make certain work tasks easier and allow you to spend more time with your patients and service users.

As a health or care professional, there are several things you need to be aware of to make sure you are working with ambient scribes responsibly.

Before using an ambient scribe

Before you use an ambient scribe it is important that you familiarise yourself with your organisation’s policies and processes for this type of technology.

You should check:

• whether the AI product you want to use has been approved by your organisation – for example, whether it has been through the organisation's due diligence procedures for technology procurement
• what rules you need to follow when using ambient scribes – to ensure your use of the product is safe and you follow legal requirements and regulatory guidelines

NHS England has produced guidance on adopting ambient scribing products in health and care settings which provides further advice.

If your organisation does not yet have policies or procedures for the use of ambient scribes, you should speak to the relevant people in your organisation about this. This may include your IT, clinical safety or IG team.

You are professionally responsible for any health and care information collected by ambient scribes on your behalf. This is why it is important to only use approved products and use them responsibly.

In some circumstances, you may consider that it is not appropriate to use an ambient scribe, such as during highly sensitive conversations. In these cases, you should use your professional judgement to decide whether or not to use an ambient scribe.

Consent

You do not need to ask for explicit consent from patients or service users before using an ambient scribe to perform tasks which deliver individual care. In these cases, it is appropriate to rely on implied consent under the common law duty of confidentiality.

However, as ambient scribes are new, you do need to inform people that you are using them. This is about being transparent and allowing people to dissent (which means you cannot rely on their implied consent), rather than asking for explicit consent (see the sections on being transparent and when someone objects to the use of ambient scribes below).

Being transparent

Information about how you use ambient scribes must be made available to patients and service users through your privacy notice (see guidance for IG professionals – transparency section for further information).

If you are using ambient scribes for individual care, you must inform patients and service users at the start of any session. This is because ambient scribes are a new technology, and it is not reasonable to assume that people will know they are being used without being informed. We have provided some wording below that may be helpful for explaining an ambient scribe to your patients or service users, which can be adapted according to your local needs.

When someone objects to the use of ambient scribes

Although you do not need to ask for people’s explicit consent to use ambient scribes for individual care, people can dissent, in which case you should respect their wishes.

People also have a right to object under the UK General Data Protection Regulation (UK GDPR) and may also exercise this right more formally. You should explain to the patient or service user how their objection might impact the care they receive, for example if there is a risk that this leads to less time to interact with them or that notes will be less structured. You may be able to resolve their concerns. However, if they still wish to make an objection, you should respect their wishes.

Your health and care organisation may have its own local procedures relating to recording objections and you should familiarise yourself with these.

When an individual lacks capacity

When you are caring for someone who lacks capacity, you should consider whether:

• someone else has the legal authority to accept or dissent to the use of the ambient scribe on the patient or service user's behalf or has been appointed to represent them
• there is any evidence that the patient or service user has previously expressed an objection or preference relating to the use of an ambient scribe, or similar technologies

If there is no evidence of a previous objection or someone who can accept or dissent on their behalf, decisions must be made in the best interest of the patient or service user.

Checking for accuracy

The user of the ambient scribe is responsible and accountable for the accuracy of information which is added to patient or service user records. It is therefore essential that you check the notes which have been produced by the ambient scribe every time it is used, within a timeframe that allows for a meaningful review.

You should consider whether you need to take extra steps to validate the accuracy of an output. For example, if the ambient scribe has translated a consultation from another language, additional checks may be needed by someone who can understand the language and confirm the accuracy of the translation.

Any inaccuracies must be corrected before the information is included in records.

When you use the content produced by an ambient scribe, it is good practice to indicate within the output that it has been produced with the help of an ambient scribe. You can do this by putting this line at the end of the letter or summary, for example:

Where the ambient scribe is not integrated with a clinical system, a suffix can be added to the consultation entry to state that this was produced using AI scribing software, for example:

Reviewing third party information

Where an individual shares information about another person during a consultation, you should consider whether this should be captured in the final output as you usually would when taking manual notes. If it is your professional opinion that this information does not need to be captured in information uploaded to the health and care record, you should remove this when you conduct your review of the output.

The following section provides guidance on how to ensure that organisations are able to meet their IG obligations when using an ambient scribe and its outputs.

It is important to be aware that the use of AI tools within health and care settings, particularly those classified as a medical device, has implications and regulations beyond IG. Organisations looking to develop or implement an ambient scribe should ensure they are familiar with the wider regulatory framework. For more guidance, see AI and Digital Regulations Service (AIDRS) guidance on regulations and NHS England guidance on adopting ambient scribing products.

It is important that organisations independently assess their chosen tools for compliance with data protection legislation and the common law duty of confidentiality (CLDC), taking account of the following, which includes recommendations based on both legal requirements and best practice in IG.

You should involve the right decision makers in your organisation in your selection of an ambient scribe. This may include Chief Information Officers (CIOs) and Chief Clinical Information Officers (CCIOs), your Senior Information Risk Officer (SIRO), your board members, your Caldicott Guardian and your Data Protection Officer (DPO).

Lawful basis for processing

You will need to establish a lawful basis under both the UK GDPR and CLDC for the processing of data by an ambient scribe.

The Information Commissioner’s Office (ICO) has also produced guidance on ensuring lawfulness in AI.

Where you are using the tool and the data to assist you with providing care to individuals, for example, producing a letter for a patient following a consultation, the most likely lawful bases under UK GDPR are:

• article 6 (1) (e) Public task
• article 9 (2) (h) Health and care

The most likely lawful basis under CLDC is:

• implied consent

You do not need to ask for explicit consent under either UK GDPR or CLDC to process data for individual care, but you still need to be transparent with patients and service users regarding the use of AI and provide them with an opportunity to object and dissent (see the transparency section below for further information). If an individual dissents, you cannot then use the tool.

Transparency

The appropriate transparency arrangements when using an ambient scribe need to be carefully considered, taking into account the setting as well as the expectations and needs of the individuals who are being recorded.

As the use of ambient scribes in health and care is a new technology, individuals must be told at the beginning of a session when these technologies are being used as part of their individual care. This will help to ensure that there are no surprises to patients and service users about the recording and other elements of the data processing. As familiarity and understanding of this technology increases, it may not be necessary for individuals already familiar with the technology to be verbally notified every time the tool is being used for their individual care. It is important to keep your approach to transparency under review.

As well as verbal notification, you should:

Update your privacy notice with sufficient detail about how the data is processed and used and how individuals can request that ambient scribes are not used.

Consider other ways to promote understanding of the use of ambient scribes in the context of providing individual care, such as by providing information in public areas (for example, through posters and TV screens in waiting areas) or consultation with patients and service users. This is to create expectations of the use of ambient scribes in your setting.

Consider publishing further information about the tool so that patients and service users can learn more about these. For example, publishing information on your website or in newsletters or in leaflets for those lacking digital access.

Ensure that your transparency materials are appropriate for different audiences.

The ICO has produced further guidance on transparency in health and social care, as well as guidance on ensuring transparency in AI.

Record retention

Retaining audio recordings and transcripts

Where a recording and its transcript is summarised by an ambient scribe, and this summary is signed off as accurate and adequate for its purposes by a health or care professional, the original recording and transcript could be deleted. Retain only the summary as part of the health and care record, unless there is a need to retain further to monitor the safety and accuracy of the tool.

You should ensure that your chosen tool has functionality to comply with retention periods, using automatic deletion where appropriate.

Retaining outputs

Outputs are likely to be subject to separate and distinct retention periods depending on their use and final storage location. For example, where a summary is added to a health and care record, it should be retained in line with the retention of the health and care record.

See the section on storage below for further information and the NHS Records Management Code of Practice for guidance on retention periods.

Storage of inputs and outputs

You should check where inputs and outputs from your chosen tool are stored (whether by the provider or in an internal location) at each stage.

Once records have been transferred to the relevant (final) storage location (for example, the health and care record), they should be deleted from any other storage locations that they may have been held in while the information was processed. This will ensure that the information is not duplicated across multiple systems and is not at risk of being retained for longer than necessary.

If any data is stored with the provider of the tool at any time, you must give them clear instructions on storage and retention and ensure that they are able to comply with these.

Fairness and accuracy

The term ‘accuracy’ in the context of data protection has a different meaning from the term in the context of AI performance, though they are closely linked and must both be given sufficient consideration.

In a data protection context, accuracy refers to:

• the accuracy principle, requiring you to ensure that personal data is correct, not misleading and kept up to date

In an AI performance context, accuracy refers to:

• statistical accuracy, a measure of how often an AI produces an output that is correct

The output from the ambient scribe will not always be accurate for a number of different reasons. For example, the technology may misinterpret a word or misunderstand the context of a discussion. The output therefore must always be checked and verified by the ambient scribe user to ensure that any inaccurate output is corrected before it may impact the patient or service user. The checking of the output ensures that the information being used is both accurate and fair in compliance with the principles under the UK GDPR.

You should:

• ensure that you review your chosen tool’s performance, including statistical accuracy, to ensure that there is no significant risk of inaccurate outputs
• ensure that users of the tool are aware of and adhere to the requirement to thoroughly check outputs, for example through policies, training and audits where needed

The ICO has produced further guidance on ensuring fairness in AI.

Data controllers and processors

You must carefully assess and document who is controller and processor for each processing activity relating to the use of the ambient scribe.

When an ambient scribe is used for individual care, the health or care organisation should be the controller of the information processed for this purpose and data processing arrangements should be built with this in mind. To ensure this, the health or care organisation should:

• determine the means and purpose of the processing
• provide clear instruction to the provider of the AI tool about any data processing, including storage and retention
• ensure that instructions and responsibilities are clearly documented in agreements (see the Data Sharing and Processing Agreements (DSPAs) section below)

If an AI supplier determines some or a significant portion of the means and the purposes of processing, it may be considered a joint controller and will have joint responsibility for compliance with data protection legislation. Organisations must carefully assess processing arrangements to ensure they are happy with the controller arrangement and appropriately document these in agreements. In particular, organisations should ensure that patient data is not used by the technology provider for purposes beyond the care of the individual.

Security considerations

Ambient scribes may introduce security vulnerabilities through their own processing as well as through their integration with your systems. It is critical to engage with technical and security specialists to fully assess and mitigate the security risks prior to using an ambient scribe.

NHS England has produced further general guidance on the use of ambient scribes, and the ICO also has guidance on assessing security in AI.

Individual rights under UK GDPR

You should ensure that your chosen tool will allow you to comply with individuals’ rights under UK GDPR, where they apply. Further information on the rights and key considerations relating to ambient scribes are provided below.

The right to object

If using public task as the lawful basis for processing under the UK GDPR, you must also give individuals the opportunity to object.

Under the UK GDPR, individuals can object to the processing of their data including processing by an ambient scribe. It is important therefore to be able to comply with the extent of their specific objection when this is appropriate.

To uphold this right, you should:

• provide sufficient information to individuals before the data capture or use takes place (for example, before the ambient scribe begins ‘listening’), so that individuals have sufficient time to understand the processing and raise an objection if they wish
• ensure that individuals are made aware of their right to object, either through appropriate written materials or verbal notification
• ensure during procurement that your chosen tool has functionality that will allow for an objection to be upheld, such as by preventing it from processing data once someone has objected
• ensure that your processes factor in the potential for individuals to object, for example by making sure that health and care professionals are prepared to create their own summaries when the tool cannot be used

Objections can be overridden where there are ‘compelling legitimate grounds’ to continue to process data in this way which outweigh the rights of the individual. However, this should be assessed on a case-by-case basis.

Separately, individuals can dissent to the use of their data under common law. In practice, this means that if an individual does not want the tool to be used, you cannot then use it.

Where you have already used the tool on the basis of implied consent, dissent can only be applied to its use in future (not the use that has already happened). Individuals can still object to the processing - for example, the ongoing storage and use of the data in the tool.

The right of access

Individuals have a right to receive copies of information you hold about them. In the case of an ambient scribe, this would apply to data inputted (audio recordings) and any output (transcripts, notes and summaries).

To uphold this right, you should:

• ensure that your chosen tool has functionality that enables you to extract relevant information in a format that is accessible to the general public
• ensure that your Subject Access Request (SAR) processes take into account information held in your chosen tool and that relevant staff are able to access these to facilitate a SAR
• ensure that, once a SAR has been received, any deletion of the requestor’s data is paused
• keep in mind that your process will need to allow you to do this within one month

To enable you to extract relevant information you should ensure that, when audio recordings or transcripts are retained and a request is received, they can be downloaded in a shareable format from their storage location.

In certain circumstances individuals may also have the right to access information about deceased people. In these cases, the Access to Health Records Act will apply to the inputs and outputs of an ambient scribe.

The right to rectification

Individuals have the right to request that inaccurate or incomplete data you hold about them is corrected.

An audio recording can be seen as a factual capture of a conversation. However, an individual may still contest the accuracy of its content. For example, if a health or care professional makes a statement during the recorded conversation about the individual having a certain diagnosis, when the individual does not have that diagnosis.

A transcript that is generated by the AI may not accurately record a conversation, in the same way that the AI output generated from an audio recording may not be accurate.

If the audio recording or transcript is only used to produce an output (such as a summary or a letter) and not retained or used beyond this, if there is a mistake or an inaccuracy, when the output is corrected and the audio recording and transcript are deleted, this right will have been upheld.

Audio recordings and transcripts may be retained for a more significant amount of time or used for other purposes (such as beyond the initial production of a summary or letter). In this case, while you are not expected to amend the audio recording or transcript itself, which may remain an accurate capture of the conversation (including the mistake), you would have to ensure that records reflect the fact that information in the recording or transcript is inaccurate. This would ensure that decisions are not based on it, and any onward use of the recording or transcript, or summaries based on that recording or transcript, do not inadvertently repeat the inaccurate information onto other records.

It is also possible that, while the content of a recording is accurate, an ambient scribe may still produce inaccurate outputs. Outputs must always be checked by the responsible professional to ensure that the outputs are correct before they are added to a health and care record. If incorrect information is saved into other records, it is important that those records are corrected.

To uphold this right you should:

• ensure that it is possible within your chosen tool or processes to highlight inaccuracies in a way that sufficiently protects against the risk of this information being taken or used as fact in decision-making processes
• ensure that your chosen tool and storage of outputs allows for editing or updating of incomplete or inaccurate information

The right to erasure

There are a number of circumstances where the right to erasure may not apply in health and care settings. This includes where you process data:

• to perform a task carried out in the public interest
• for public health purposes
• for the purposes of preventative or occupational medicine
• for medical diagnosis
• for the provision of health or social care
• for the management of health or social care systems or services

Therefore, in the case of an erasure request it is important to assess your lawful basis for continued retention on a case-by-case basis depending on the reasons for processing and retaining the information.

The right to restrict processing

When an individual has challenged the accuracy of the data you hold about them (right to rectification) or they have objected to the processing (right to object), they also have the right to ask you to restrict the processing of their data until their request has been considered. This means that you must not do anything with the data, including deleting it, until the restriction is lifted.

When you are using automated systems, technical measures may be required to ensure that processing does not take place while a restriction is active.

To uphold this right, you should ensure that:

• you have a way of marking data as 'restricted', either within your chosen tool or in a separate place such as the health and care record - this should prevent staff from continuing to use the data while a restriction is active
• your chosen tool has functionality to retain records (recordings, transcripts and outputs) for longer when they are subject to a restriction
• your processes factor in the potential for individuals to request restriction - for example, you could make sure that health and care professionals are prepared to create their own summaries when the tool cannot be used

Rights related to automated decision-making

Automated decision-making means decisions made without any human involvement. The purpose of the ambient scribe is to act as a tool to aid health and care professionals with creating notes and other documents. They do not to make decisions about an individual’s care. Therefore this right does not apply.

National Data Opt-Out

The national data opt-out will not apply when you are using an ambient scribe for individual care.

Data Protection Impact Assessments (DPIAs)

A DPIA is highly likely to be a legal requirement for the use of an ambient scribe in a health or care setting because:

• they usually require large-scale processing of special category data
• they usually involve systematic evaluation of personal aspects about individuals based on automated processing
• the technology and its use in health and care is new and not widely understood by the public

NHS England has produced a tailored DPIA template for the use of an ambient scribe for individual care which can help you fulfil this requirement.

As a possible addition to your DPIA, the ICO has produced an AI and data protection risk toolkit which provides practical pointers on potential risks and how to mitigate these. The ICO also provides further guidance on the accountability and governance implications of AI.

Data Sharing and Processing Agreements (DSPAs)

It is important to have appropriate documentation in place which describes your arrangements with any parties involved in sending, receiving or using data as part of your use of an ambient scribe. Your agreements should clearly document the processing as well as the roles and responsibilities of each party.

NHS England provides a template DSPA which can be used to fulfil this requirement.

Policies, training and guidance for staff

It is important that staff are aware of their obligations and the requirements associated with the use of an ambient scribe. These obligations include its permitted use, undertaking appropriate checks and knowing how to comply with individual rights. You should consider the best way to share these requirements in your setting. This may include:

• providing training to users of the tool, including assessments of competence
• writing policies or guidance specific to your setting, including an AI policy, and monitoring compliance