Published in BMJ Evidence-Based Medicine, ‘Considerations for informed consent with shared decision-making in the digital age’ explores the global landscape of informed consent, written by authors from the UK (Concentric Health), USA (Yale School of Medicine), and India (KIMS Hospital, Secunderabad).
The authors focus on considering the potential impacts of digital solutions on the process. For example, highlighting how digital tools can address current challenges while emphasizing that technology should enhance rather than replace the conversation between doctor, patient and family. The following themes are explored in the paper:
The global consent landscape
The practice of informed consent varies significantly worldwide, shaped by different legal frameworks and cultural norms. In some jurisdictions, doctors must disclose information that a “reasonable patient” would want to know. The UK’s Montgomery ruling specifically emphasizes discussing “material risks” that could influence patient decisions. These variations extend to cultural expectations, with some societies prioritizing individual autonomy while others prefer family-based decision making.
Burden of proof and compensation
The approach to consent-related litigation varies notably between countries. While patients in the USA and UK must demonstrate they suffered injury due to inadequate risk disclosure, countries like Germany and France place the burden of proof on physicians to show they provided sufficient information. Sweden, Finland, and New Zealand take a unique ‘no-fault’ approach to compensating for treatment injuries, focusing on eligibility rather than provider negligence. Interestingly, these countries report lower medical malpractice costs compared to fault-based systems.
Cultural variations in decision-making
Cultural expectations significantly shape consent practices. While healthcare systems with Greco-based bioethics emphasize individual autonomy, many Asian and African healthcare systems favour a more paternalistic model. In some regions, healthcare professionals can obtain consent signatures without extensive information exchange. Family involvement also varies substantially - countries like India and China often see treatment decisions made collectively with relatives, contrasting sharply with individually-focused Western approaches.
Timing and documentation requirements
The timing of consent discussions varies globally, with some regulators mandating specific timeframes. UK guidance requires ‘time for consideration’ as essential for patient empowerment, especially for elective procedures. However, standards differ based on procedure urgency - while advance discussions are expected for elective surgeries, emergency procedures may accept oral consent. Some countries have additional requirements for specific contexts, such as stricter disclosure rules for cosmetic surgery.
Current challenges
Healthcare providers face numerous obstacles in obtaining informed consent effectively:
- Time pressures limit the depth of consent discussions
- Patients struggle with information overload and recall
- Complex medical options can be difficult to explain clearly
- Risk communication often proves challenging
- The consent process can be stressful for patients
- Inadequate consent processes lead to increasing litigation costs
Digital opportunities in a global context
The review identifies several ways digital consent can enhance the process:
- Standardized content ensures consistent, comprehensive information delivery
- Multimedia resources improve understanding of complex interventions
- Built-in translation capabilities make information more accessible
- Accessibility features accommodate different abilities
- Efficient documentation and audit trails strengthen record-keeping
- Reduced paper usage provides environmental benefits
Future considerations
While highlighting digital benefits, we emphasize several crucial implementation factors:
- Digital solutions must enhance rather than replace the essential patient-clinician dialogue.
- Systems need to be designed with inclusivity in mind, ensuring accessibility for all patient groups.
- The timing of consent discussions remains critical - ideally occurring well before treatment.
- Success requires carefully balancing legal requirements, decision-making values, and practical realities across diverse healthcare settings.