Understanding the medicolegal risks when using AI scribes

The way we work in healthcare has changed considerably due to evolving technology, and the introduction of Artificial Intelligence (AI) has accelerated this shift. We know doctors are curious about incorporating AI scribes into their practice due to their desire to bring about efficiencies and spend more time with their patients. At Medical Protection, we have seen growing interest in this area, with doctors calling our advice line to ask about the medicolegal risks associated with using this software.

AI transcribing programmes—often referred to as AI scribes—include advanced ambient voice technologies (AVTs) which record a consultation and transcribe this into written note form. This has the potential advantage of saving time taking written notes.

The Malaysian Medical Council (MMC) has published its MMC Guideline on the Ethical Use of Artificial Intelligence (AI) in Medical Practice, to provide medical practitioners with a practical approach to integrating AI into medical practice and ensure AI is used responsibly.

When considering using AI scribes, doctors should ensure they have an understanding of the MMC’s guidelines, the potential medicolegal risks associated with the use of scribes, and how these may be mitigated.

It is important to remember that doctors remain responsible for maintaining clear, contemporaneous and complete medical records, regardless of whether AI tools are used to assist them.  

Doctors should also ensure the notes produced by the transcription software are an accurate reflection of the consultation and do not omit potentially relevant information. Notes should also be proportionate and not contain unnecessary information which may impact future patient care.

Issues such as data protection and consent should also be considered when using AI scribe software.

Consent

Health information is classified as sensitive personal data and its processing requires the express consent of the data subject. The Personal Data Protection Act 2010 (PDPA) requires that there is a lawful basis for processing this type of data, and doctors should ensure that when implementing AI software, they continue to comply with these obligations, including the Notice and Choice Principle as per Section 7.

There should be a clear policy regarding the use of AI systems, including guidance on when informed patient consent should be obtained. It is important that when clinics or clinicians are using AI scribes, patients understand that the technology is being utilised, are given opportunity to ask questions about this—for example, patients may have questions about the processing and flow of their personal data—and are asked explicitly whether they consent to its use. Consent for the use of scribe software should also be documented in the medical records.

The MMC guidance on decision making and consent provides further guidance and emphasises that patients should be provided with sufficient information to make informed decisions.

As part of the consent process, doctors should therefore be prepared to explain how AI scribe software works, how their information is processed, whether the data will be stored or transferred externally and what safeguards are in place to protect confidentiality. Of course, this should be a true choice for patients, and clinicians should be prepared to proceed with the clinical interaction if the patient does not provide their consent for scribe use, without negatively impacting patient care.

Data Protection

Doctors and healthcare facilities will need to carefully consider their legal and regulatory obligations when implementing specific AI software, including AI scribes.

The MMC’s AI guidelines emphasise this, stating that “privacy and data protection must be ensured when developing and deploying AI systems. A good understanding of data protection laws and a robust system against breaches are necessary to prevent harm.” Compliance with the PDPA, as well as cybersecurity considerations, is crucial to preserving data privacy, patient confidentiality and, therefore, public trust in the healthcare system.

Any transfer of data externally, particularly cross-border transfer would require further data protection considerations (CBPDT).

Indemnity

Understandably, doctors may have questions about whether they can request assistance should medicolegal issues arise from their use of AI scribes.

At Medical Protection, we appreciate the benefits that AI as an aide to clinical practice can bring, so members can request assistance with matters arising from the use of AI systems, provided that these are not fully autonomous systems and a human retains oversight or final decision-making authority.

Medical Protection would not normally provide indemnity for issues relating to the failure of AI software itself—for example, if the software has been incorrectly programmed or developed.

Doctors should take care when entering into contracts or agreements with AI suppliers and be cautious about agreeing to indemnify against a claim.

Summary

AI tools are evolving at pace, and their use in healthcare is likely to continue growing. Doctors should continue to work in a manner consistent with MMC guidance and PDPA legislation.

At Medical Protection, our aim is to support doctors in embracing AI, while helping them to understand and navigate the associated medicolegal risks. Last year we launched the AI Safer Practice Framework, aimed to help doctors integrate AI safely and responsibly into practice. The framework is made up of two parts: INFORMED and RECORDS.

INFORMED guides ethical decision-making using AI, while RECORDS documents AI-assisted decisions for accountability and clinical rationale. The framework has been structured around these acronyms for ease of use.

The AI Safer Practice Framework can be accessed at: https://www.medicalprotection.org/ai-framework