What is the protocol for obtaining patient consent for utilizing Artificial Intelligence (AI) scribe technology during a clinical visit?

From the Guidelines

I strongly recommend using a clear, comprehensive patient consent form for AI scribe technology that addresses key concerns while remaining accessible, as supported by the most recent guidelines for clinical trial protocols and reports involving artificial intelligence 1. The following consent form covers essential elements for patient understanding and legal protection:

• "Patient Consent for AI Scribe Technology: I understand that during my visit, an artificial intelligence (AI) scribe system may be used to document my conversation with my healthcare provider.
• This technology records and transcribes our discussion to create clinical notes in my medical record.
• I acknowledge that this AI system processes my personal health information to improve documentation accuracy and allow my provider to focus more on my care.
• The recordings will be processed according to healthcare privacy laws (HIPAA) and organizational security protocols.
• My information will be stored securely and accessed only by authorized personnel involved in my care.
• I understand I can request that the AI scribe be turned off at any time during my visit without affecting the quality of care I receive.
• I may also request to review the AI-generated notes in my medical record.
• By signing below, I consent to the use of AI scribe technology during my healthcare visits.
• This consent remains valid until I revoke it in writing." This form balances necessary disclosure with simplicity, ensuring patients understand how their information will be used while providing the practice with appropriate authorization, in line with recommendations for enhancing privacy protection capabilities of AI apps 1. Key aspects to include in the consent form are:
• The intended use of the AI intervention in the context of the clinical pathway, including its purpose and intended users 1.
• The output of the AI intervention and how it contributes to decision-making or other elements of clinical practice 1.
• The integration of the AI intervention into the trial setting, including any onsite or offsite requirements 1.
• The importance of patient involvement in the development and evaluation of AI systems, as emphasized in the DECIDE-AI checklist 1.

From the Research

Patient Consent Form for AI Scribe Technology

To create an effective patient consent form for using AI scribe technology during a clinic visit, the following elements should be considered:

• The form should be concise and easy to understand, as suggested by 2 and 3, to facilitate patient engagement and minimize burden.
• The language used should be plain and accessible, as recommended by 4, to ensure that patients with varying levels of literacy and numeracy can comprehend the information.
• The form should include essential information about the AI scribe technology, its purpose, and the potential benefits and risks associated with its use.
• Patients should be informed about their rights and responsibilities, including the right to refuse or withdraw from the use of AI scribe technology at any time.
• The form should be designed to maximize accessibility for lay participants, including readers with dyslexia, literacy, or numeracy challenges, as suggested by 4.

Key Components of the Consent Form

The consent form should include the following key components:

• Introduction to the AI scribe technology and its purpose
• Explanation of the benefits and risks associated with the use of AI scribe technology
• Description of the patient's rights and responsibilities
• Information about the confidentiality and security of patient data
• Statement indicating that the patient has read and understood the information provided
• Signature block for the patient to provide consent

Best Practices for Developing the Consent Form

To develop an effective patient consent form, the following best practices should be considered:

• Use clear and concise language, as suggested by 2 and 3
• Use a format that is easy to read and understand, as recommended by 4
• Avoid using technical jargon or complex terminology
• Use active voice and present tense to make the language more engaging and accessible
• Ensure that the form is free from bias and coercion, as emphasized by 5