Digital consent research overview

Executive summary

Across a comprehensive collection of research, there is robust evidence that digital consent offers substantive improvements over traditional paper-based consent methods across multiple domains. The research demonstrates consistent benefits across specialties using various methodologies, including prospective cohort studies, comparative analyses, micro-costing, and evaluations of patient-reported outcomes.

Key themes and findings of research

Documentation quality and error reduction

Traditional paper-based consent processes have been consistently shown to lead to significant errors and inappropriate variation in practice, with improvements across both following implementation of digital consent:

• Form completion errors: St John et al. (2017) found that 51.1% of paper consent forms contained at least one error (missing information, illegible writing, or incorrect data) compared to just 7.5% with digital consent. Dyke et al. (2023) similarly found 72% of paper forms contained errors versus 0% of digital forms.
• Omission of core risks: St John et al. (2021) found that 90.2% of handwritten forms were missing at least one core risk, compared to only 13.6% with an early digital consent offering. Loughran (2015) found that only 20% of operative complications for each operation were being documented consistently (classed as being documented in >75% of consent forms for the procedure).
• Failure to warn of serious risks: Loughran (2015) found death was documented as a risk in only 28% of emergency laparotomy cases despite carrying a 14% mortality risk, and the possibility of requiring an orchidectomy was omitted in 30% of scrotal exploration consent forms.
• Variability reduction: Wong et al. (2024) conducted a systematic review showing that digital consent significantly reduced errors compared to paper-based consent (OR 0.05, 95% CI 0.03 to 0.08).
• Standardisation with personalisation: Digital consent provides more consistent documentation of risks while still allowing for personalisation to individual patients. The number of risks documented per procedure was more consistent with digital consent, with St John et al. (2021) finding significantly more risks documented (median 15 vs 11, p < 0.001) and a narrower range (11-19 vs 2-18).

These findings collectively demonstrate that digital consent addresses multiple interrelated documentation problems in the traditional paper-based process, providing more comprehensive, legible, and consistent information to patients while reducing the risk of important omissions that could lead to inadequate informed consent.

Patient experience and shared decision-making

Digital consent has been shown to significantly improve patient-centered care metrics:

• Improved shared decision-making: St John et al. (2022) demonstrated that digital consent increased the proportion of patients reporting gold-standard shared decision-making from 28% to 72%.

• Higher patient satisfaction: Ellis et al. (2024) found that patients who consented digitally reported higher levels of satisfaction, with statistically significant improvements in ease of reading, understanding complications, and overall satisfaction.

• Better patient understanding: Dyke et al. (2023) reported that digital consent led to improved patient understanding of potential complications.

• Meaningful dialogue: St John et al. (2022) emphasised in a BMJ letter that a “meaningful dialogue is paramount” in the consent process, with digital tools supporting rather than replacing this dialogue.

Economic analysis and litigation impact

Economic analyses suggest significant potential cost savings from digital consent implementation:

• Direct process costs: Houten et al. (2025) conducted a micro-costing analysis finding that digital consent is approximately £0.90 less expensive per consent episode than paper-based consent in direct process costs.

• Litigation reduction potential: Ainsworth et al. (2023) revealed that “Fail to warn - Informed consent” litigation claims within NHS England increased from 128 to 248 claims annually between 2011-2012 and 2021-2022, with costs rising to €91,729,270, averaging €369,886 per claim. Given that digital consent has been shown to reduce missing core risks by over 75% and improve documentation quality, it addresses one of the root causes of “failure to warn” claims.

• Savings estimate: The combination of process cost reductions and potential litigation avoidance presents a compelling economic case for digital consent implementation. Houten et al. (2025) calculated that per litigation claim prevented, an average of £201,590 (€229,039) could be saved.

Information governance and digital implementation

Research also addresses the technical feasibility and governance aspects of digital consent:

• Digital accessibility: St John et al. (2021) found that 93.9% of patients had access to the internet, addressing concerns about digital accessibility.

• Cost-effectiveness: Houten et al. (2025) found that while initial setup costs exist, they become negligible when spread across numerous consent episodes.

• Clinician support: Loughran’s survey (2015) showed that 77% of surgical trainees across four UK deaneries would strongly support an online consent resource.

• Information governance: Coombs et al. (2022) published an educational piece explaining key information governance concepts relevant to digital health implementations, such as DPIAs, cloud hosting, and encryption, helping to address common questions that arise during digital consent adoption.

Multi-specialty applications

Digital consent has demonstrated consistent benefits across a wide range of specialties. The following papers were published with specialty-specific considerations:

• Trauma and orthopaedic department (Dyke et al., 2023)
• Gynaecology (Ellis et al., 2024)
• Breast surgery (St John et al., 2022)
• General surgical procedures (Green et al., 2022)
• Hysterectomy in gynaecology (Pallett et al., 2022)

This cross-specialty consistency in findings suggests the underlying issues with paper consent are universal and that digital solutions are broadly applicable regardless of specialty context.

Global applications and cultural considerations

Research has also explored how digital consent solutions can be adapted across diverse healthcare systems with different legal frameworks: St John, Moore et al. (2024) conducted a comprehensive review of informed consent practices globally), exploring how digital consent can be adapted to meet varying legal standards across jurisdictions while maintaining core benefits.

The study examined significant differences in consent standards—from the UK’s “material risk” Montgomery standard to more paternalistic approaches in some regions—and explored how digital solutions could be adapted accordingly. This analysis showed that while consent laws and cultural expectations vary globally, digital consent offers potential benefits that transcend these differences, including improved documentation, accessibility features, and support for multilingual needs. The research identified that time for consideration, a requirement in many jurisdictions, is better facilitated by digital solutions that allow information sharing in advance of procedures.

Expert Commentary and Context

In addition to the research evidence, several opinion pieces provide important context for understanding the role of digital consent in healthcare:

• St John & Faggioli (2022) highlighted the importance of SDM as a principle to adopt in vascular surgery and other specialties, emphasising that digital tools should enhance rather than replace the patient-clinician dialogue.

• St John (2022) emphasised in a BMJ letter that a “meaningful dialogue is paramount” in the consent process, noting that while digital tools can improve documentation and standardisation, they must support rather than substitute for the essential human interaction in consent.

• Green et al. (2022) explored emerging considerations in the consent process beyond traditional risks and benefits, such as incorporating carbon impact discussions, demonstrating the evolving nature of what constitutes informed consent.

Conclusions and implications

The collective research provides robust evidence that digital consent offers substantial improvements over traditional paper methods. Digital consent represents a significant advance in patient-centered care that can simultaneously improve documentation quality, reduce errors, enhance patient experience, mitigate litigation risk, and generate cost savings for healthcare systems:

Documentation quality - Digital consent significantly reduces errors, improves legibility, and ensures more comprehensive documentation of risks.

Patient understanding and engagement - Multiple studies show improved patient satisfaction, better understanding of procedure risks, and enhanced shared decision-making with digital consent.

Litigation risk reduction - With informed consent failures costing the NHS €92 million annually, digital consent offers the potential to reduce this burden by ensuring more comprehensive and consistent risk discussions.

Cost-effectiveness - Both in direct process costs and potential litigation savings, digital consent represents a cost-effective alternative to paper-based methods.

Multi-specialty applicability - The evidence spans multiple surgical specialties, demonstrating broad applicability.

Clinician support - Strong support from clinicians suggests good potential for implementation and adoption.