AI scribes and patient consent

We have been asked why it is necessary to obtain patient consent when using an AI scribe in your practice. 

There are three reasons to obtain patient consent: 

1. to comply with privacy obligations  
2. to avoid inadvertently breaching surveillance devices legislation
3. to be transparent about the use of AI and enhance trust.

We’ll explore each of the three reasons below.

The first reason you need to obtain patient consent to use an AI scribe relates to your privacy obligations. This section outlines privacy obligations that apply when working in the private sector.  Similar obligations will apply in the public sector. Always check your hospital and health service’s policies and procedures for their specific requirements.

Because an AI scribe collects and processes patients’ health information, privacy obligations apply. Under privacy legislation, information is ‘collected’ when it is gathered, acquired or generated from other data. The Office of the Australian Information Commissioner (OAIC)’s guidance on privacy and the use of commercially available AI products confirms that privacy obligations apply to any personal information input into an AI system as well as the output data it generates. Information collected by the AI scribe must be handled in accordance with the Australian Privacy Principles. 

Four elements of consent

Under privacy legislation, you must obtain consent from patients to collect their personal health information. The four elements of consent are:

• the individual is adequately informed before giving consent
• the individual gives consent voluntarily
• the consent is current and specific
• the individual has the capacity to understand and communicate their consent.

Consent can be express or implied, written or verbal. 

To meet your privacy obligations, you need to let patients know that you will be using an AI scribe to collect their information, what access the AI scribe has to their personal information and how that information will be used. 

AI scribes contain sophisticated technology which apply algorithms to process audio data received by the tool to produce a ‘summary’ of the information. 

AI scribes collect and process personal information through a system separate from your medical records technology. You need to understand what the tool does with the patient’s information – that is, whether it is retained, if so where it is retained – in servers that are Australian-based or overseas, and for how long, and is the de-identified information proposed to be shared with any other entities?  You should be able to find out this information from the AI provider.

Obtaining and documenting ongoing consent

You do not need to obtain written consent from the patient to use the AI scribe before each consultation. Once you have provided information to the patient on the first occasion you use the scribe about how the scribe works and how it will be used in your practice, it is sufficient for you to seek the patient’s verbal confirmation that they consent to the use of the tool at the start of each subsequent consultation and then document this in the patient’s records. This will allow the patient an opportunity to “opt out” of the use of the scribe.   

Documenting patient consent can be done simply. Once the scribe is turned on, ask the patient to confirm their consent, and check that this has been documented in the AI-generated clinical note. Otherwise, make a note in the patient’s record for the consultation to the effect that the patient consents to the use of the scribe, as you would when obtaining consent for any intervention.

If a patient does not consent, you will need to proceed with the consultation without using the AI scribe. 

As with any other intervention or use of health information, if a patient doesn’t have the capacity to consent, you should obtain consent from the appropriate substitute decision-maker.

 Updating your privacy policy

The OAIC’s guidance confirms that your practice’s privacy policy should be updated to include clear and transparent information about your practice’s use of AI. Your policy should state if the information is stored in cloud-based storage or on overseas servers.  If it is stored overseas, additional privacy obligations apply. (For more details see the Office of the Australian Information Commissioner’s Chapter 8: APP 8 Cross-border disclosure of personal information).

The second reason that patients must be asked to consent to the use of an AI scribing tool is to avoid inadvertently breaching surveillance devices legislation. 

In the context of private practice, an AI scribe “listens to” or “records” what is a private conversation between you and your patient. Depending on how the scribe operates and where geographically the consultation occurs (because the legislation differs between jurisdictions), the provisions of the surveillance devices legislation may be triggered. In some states and territories, recording a private conversation without consent is a criminal offence.

Obtaining patient consent each time before using the AI scribe will prevent you from inadvertently breaching surveillance devices legislation. This is reflected in the guidance released by the Australian Health Practitioner Regulation Agency (Ahpra) Meeting your professional obligations when using artificial intelligence in healthcare.  

The third reason to obtain patient consent is linked to the need for transparency to encourage patient trust in the use of AI. Ahpra’s guidance states that health practitioners should inform patients about their use of AI and consider any concerns that are raised. 

One of the challenges with AI scribes is the complexity of the evolving technology. To ensure that your patient’s consent is fully informed, patients need to understand what the technology does. For example, you need to inform patients that the technology will provide a summary of the consultation not a word-for-word transcription. Simply saying, ‘I’m using software to assist with your medical record’ may not meet the standard required for informed consent because it does not reflect the use and collection of their data by the AI scribe to generate a clinical note documenting the matters referenced during the consultation.

When it comes to getting patient consent for AI scribes, it is important to take a broad approach. Don’t rely on one conversation or sign. Socialise the concept broadly with your patients. Implement different ways to inform your patients about the use of these tools. You could put up signs in the waiting room, add details to your website or appointment app, and include information on new patient registration forms.

The first time you have a conversation with your patient it needs to be detailed, covering the information we have mentioned above. This conversation must happen before the recording begins. An example of how you might start the discussion would be:

I have started using an AI software tool that listens to our consultation and then summarises the information into a clinical record. This means that I can have a conversation with you without having to stop and take notes. When you leave, I will check that the information is correct and then add it to your file. The recording is stored securely and when I am finished the draft is deleted.

Do you have any questions or concerns?

If you are happy to go ahead, I will be using the tool for this appointment and future appointments, but you can decline its use at any time.

The patient’s consent should be documented in the clinical record each time it is provided.

As well as updating your privacy policy, review other practice policies such as your cyber security and business continuity plans, and make any changes needed to reflect your use of AI scribe tools.

As AI scribe technology becomes more common in healthcare, it is vital to prioritise informed consent and transparency to maintain patient trust. Here are some key points to keep in mind:

• Gain and document consent: Ensure informed consent is obtained and documented before each consultation begins.  
• Prioritise privacy: Inform patients about how their data will be accessed and stored.
• Foster communication: Use signs and website updates to inform patients about AI scribe use.
• Build patient trust: Address any concerns about AI scribes to strengthen relationships.
• Respect patient choice: Allow patients to opt out of AI scribe use at any time.
• Remain informed: Read the OAIC’s guidance to understand your privacy obligations.

By focusing on informed consent and patient privacy, you can enhance your quality of care while building patient trust.

Avant members can watch our ‘AI scribes: cascading consequences’ webinar on-demand. We also offer a Measuring Outcomes activity for this webinar for 0.5 CPD hours. 

Avant factsheet: An introduction to artificial intelligence  

Avant factsheet: Artificial intelligence for medical documentation 

Avant factsheet: AI scribes – a checklist of things to consider 

For medico-legal advice, please contact us here, or call 1800 128 268, 24/7 in emergencies.