When does an AI Scribe Become a Medical Device? Understanding the MHRA’s AVT Guidance

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on ambient voice technology-enabled products (Guidance). We previously wrote about NHS England guidance on the use of ambient voice technology-enabled (AVT) products, also known as ambient scribes, which you can read here. 

The MHRA Guidance clarifies the type of AVT products which, if placed on the market or used in Great Britain, may be classified as a medical device and fall within the scope of the medical device regulations[1] (Regulations). It is therefore of particular relevance to companies manufacturing, developing and/or supplying AVT products in Great Britain.

What is an AVT product?

AVT products typically listen to doctor-patient interactions and generate outputs such as:

• Transcripts of consultations,

• Clinical notes,

• Draft correspondence,

• Suggested clinical codes,

• Workflow support outputs. 

AVT products are often generative AI-based and built on Large Language Models which means outputs may vary and information could be incorrectly inferred. It is also worth noting that an AVT product’s functionality may be updated over time. This means that an AVT product which does not initially qualify as a medical device under the Regulations may do so at a later stage if new features are added. 

Does it qualify as a medical device?

The Regulations define medical devices as any instrument, software or other article intended to be used for human beings for purposes including:

• diagnosis, prevention, monitoring, treatment or alleviation of disease;

• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

• investigation, replacement or modification of the anatomy or of a physiological process.

An AVT product is a medical device where its intended purpose falls within one or more of the above categories. 

Generally, the intended purpose will be set out in a product’s instructions for use, its labelling and any promotional materials (e.g. advertising, sales presentations and websites). Product manufacturers are expected to clearly communicate their product’s intended purpose[2].

It is worth noting that:

1. where a medical claim is made in the product’s labelling or material, a general disclaimer that the product does not fall within the purposes set out above will not be sufficient to disqualify a product from being classed as a medical device;

2. the fact a device is being used in a medical setting will not automatically mean it qualifies as a medical device; and

3. the Guidance is technology-neutral – the specific technology does not determine qualification. 

Fundamental to the assessment of a product’s intended purpose will be understanding its actual and intended functionality in a given healthcare context. 

Products that generally do not qualify as medical devices

The Guidance sets out that AVT products will generally fall outside the Regulations where they:

1. intend only to provide a transcript of a clinical conversation between a clinician and a patient.
2. intend only to provide a summary of a clinical conversation between a clinician and a patient.
3. format information from transcripts/summaries of a given encounter into structured data for a clinician to review, edit and confirm for inclusion in problems lists, current medications lists, order sets or other similar forms of documentation,.
4. suggest possible relevant clinical codes for review based upon a generated transcript or summary of a clinical conversation between a clinician and a patient.
5. draft a discharge summary or letter for a clinician to review and edit, based on patient information from sources such as the electronic patient record or transcripts/summaries of conversations from a given encounter.

In summary, those AVT products which support administration and documentation purposes only to:

• transcribe conversations,

• summarise clinical interactions,

• draft letters or documentation,

• suggest clinical codes for review by a clinician,

and are not intended to be used for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or any other medical purpose, are unlikely to qualify as medical devices. 

Products that generally qualify as medical devices

The Guidance sets out that AVT products will generally fall within the Regulations where they:

1. provide a summary that includes an option for “generated insights” based upon a clinical conversation between a clinician and a patient and which provide suggested diagnoses or relevant follow-up and treatment options.
2. provide a summary of a conversation between a clinician and a patient, where the manufacturer claims that the product “guides diagnosis and treatment planning and improves patient outcomes.”
3. operate as an ambient scribe and subsequently finalise and save transcripts to the electronic patient record without requiring a clinician’s review. The product analyses the transcript to autonomously determine necessary follow-up tests and place the relevant orders without clinician input or confirmation.
4. draft a report from a clinician’s dictation or a clinical conversation and a patient’s relevant test results from their electronic patient record. The product analyses these data and provides suggested diagnoses as diagnostic recommendations for a clinician’s review.

In summary, AVT products which intend to:

• support diagnosis,

• support treatment decisions,

• support prevention or monitoring of disease,

• generate outputs that clinicians rely upon for clinical decision-making, and

• take automated actions (for example, placing orders or triggering clinical workflows without clinician review),

are likely to qualify as a medical device. In those circumstances, the manufacturer must comply with the Regulations, including classifying their AVT product in accordance with the classification rules[3].

Key takeaways for AVT manufacturers and developers

1. Ensure intended use documentation is clearly defined;

2. Carefully review and control any marketing claims and ensure they align with the product’s purpose;

3. Consider and regularly review the product’s roadmap, as future updates may impact on its regulatory status;

4. Ensure contractual provisions, such as warranties, permitted use obligations and governance requirements reflect and support regulatory boundaries and risk.

Key takeaways for healthcare providers that purchase AVT solutions

Providers purchasing AVT products for use in a healthcare setting should not assume that all such products are regulated medical devices. Providers should:

1. seek to understand from the product supplier its specific functionality and scope of use;

2. undertake robust governance and procurement due diligence on the product;

3. ensure relevant risks are addressed in the contract; and

4. continually monitor the product’s output (including with appropriate human oversight where relevant). Such continued oversight will support in assessing whether a product’s functionality has crossed into activities which would mean the device is caught by the Regulations.

If you would like to discuss any of the above, please contact a member of our Health, Care and Life Sciences team. 

This article was written by Susannah Jury.