Digital consent – clinical negligence claims in a changing landscape

25^th February 2024

As most practicing surgeons will no doubt be aware, the case of Montgomery v Lanarkshire Health Board (2015) placed a duty on clinicians to ensure that patients are aware of the material risks involved in any recommended treatment.

This development has been accompanied by changing guidance from the General Medical Council (GMC) and National Institute for Health and Care Excellence (NICE), which now have a focus on meaningful conversations with patients and “shared decision-making”.

A bespoke, patient-specific consent process where risks and benefits are discussed in the context of each individual patient’s personal circumstances has become the standard. Any clinician who has faced a claim for clinical negligence will be aware how difficult it has become to defend against allegations that informed consent was not obtained.

The rise in the number of successful consent claims can, in part, be explained by the standard of record keeping generally failing to keep pace with the burdens placed on clinicians brought about by the changes in clinical negligence law. Consent claims are often settled on a “litigation risk” basis – in other words, it cannot be deduced from the records whether informed consent was obtained, making defending the claim to trial extremely difficult.

However, despite these developments, in many cases we have seen little change to longstanding paper-based consent processes. When a consent claim is investigated, defendant surgeons are often asked to provide transcripts of consent forms or their handwritten notes, where the recorded risks are barely legible. It is not uncommon for there to be no record at all of discussions between a clinician and patient concerning alternative treatment options.

Digital consent has emerged as a way to streamline the consent process while improving efficiency and ideally reducing ambiguity. A digital consent process arguably results in clearer record-keeping, which should in theory lead to stronger defences against consent claims. Digital consent forms could be standardised for thousands of different procedures, acting both as a checklist for clinicians as well as firm evidence that risks and benefits were adequately discussed.

The introduction of a digital consent process has the potential to reduce clinician administrative time, allowing deeper discussions with patients during consultations. The improved efficiency could save general administrative costs associated with paper-led processes, as well as see a reduction in the carbon footprint of a healthcare provider.

However, the pivot to digital consenting may not be entirely smooth sailing. An efficient digital consent process would be dependent on the IT systems supporting the software. Investment into suitable cybersecurity features would need to be made to protect against information leaks, hacking or ransomware attacks, and breaches of data protection regulations. The IT system would need safeguards to deal with a power outage, internet connectivity failure, damage to hardware or servers, or the liquidation of the company that provided the digital consenting software.

The evolving landscape of legal precedent, such as the implications of the Montgomery case, may prompt courts to address and adapt to the complexities of digital consent processes. As organisations navigate this shift, careful consideration and investment in technology infrastructure, insurance cover and legal frameworks will be essential to mitigate risks and ensure the integrity of digital consent practices in the future.

CFC

PRASIS appointed underwriters