Busting the myth: Is there really "too much compliance risk" in patient engagement?

A common misconception, echoed by many attendees at the HBA European Leadership Summit, is that engaging patients and collecting or using their data is seen as carrying overwhelming compliance risks. This perception, while understandable in a highly regulated industry, can become a significant barrier to progress. But is it really true?

The Compliance dilemma: Perception vs. Reality

At the heart of this myth lies a fundamental tension: the desire to put patients at the centre of healthcare innovation versus the fear of breaching regulatory boundaries. Many organisations worry that involving patients directly, or gathering patient experience data, will expose them to unacceptable legal or compliance risks. This concern often leads to hesitation, missed opportunities, and a reluctance to innovate.

However, as we have seen with the evolution of global guidelines like ICH E6(R3), the regulatory landscape is not designed to restrict patient engagement, it is evolving to support it. The latest Good Clinical Practice standards explicitly call for greater patient-centricity, encouraging organisations to design research and care models that respect patients’ needs, experiences, and voices. This evolution is thoroughly explored in our article, Embracing Change: ICH E6(R3) as a Catalyst for Innovation in Clinical Development, which details how these updated guidelines promote patient-centric approaches and foster innovation across clinical trials.

Why this myth persists

Several factors contribute to the endurance of the compliance risk myth:

• Complex Regulations: the patchwork of data protection laws (like GDPR), ethical requirements, and industry codes can feel overwhelming, especially for organisations without robust compliance infrastructure - leaving them more vulnerable to uncertainty, misinterpretation, and inadvertent non-compliance
• Lack of Clarity: the absence of definitive regulatory frameworks for new forms of patient engagement and novel approaches like digital patient communities or decentralised data collection, leaves organisations navigating a grey area. This uncertainty can foster a culture of risk aversion, where promising initiatives are delayed or abandoned due to concerns about crossing unclear legal boundaries
• Cultural Inertia: longstanding habits and risk-averse “better safe than sorry” mindset remain a significant barrier to advancing compliant, patient-centred approaches in healthcare. This resistance is not simply a reluctance to change; it is deeply embedded in organisational routines, beliefs, and the collective memory of what has “worked” in the past

The reality: compliance and patient engagement can coexist

The truth is that compliance and meaningful patient engagement are not mutually exclusive. In fact, organisations that invest in understanding the regulatory frameworks, and build strong partnerships with compliance experts, can safely and confidently involve patients at every stage of drug development.

Key points to consider:

• Regulations encourage engagement: modern guidelines, including ICH E6(R3), emphasize the importance of patient input and data to improve outcomes and trial quality. Regulators recognise that Patient Engagement, when handled responsibly, enhances - not endangers -patient safety and data integrity
• Risk can be managed: with clear processes, transparent communication, and proper documentation, organisations can mitigate compliance risks while still capturing valuable patient insights. By embedding these practices into daily operations, teams can confidently engage patients and ensure regulatory requirements are met
• Myth-busting in practice: many leading organisations are already implementing standardised roles, processes, and data governance strategies that make Patient Engagement routine and compliant. These include harmonising patient experience data, integrating compliance checks into engagement workflows, and providing targeted training to staff

Turning compliance into an enabler

Instead of viewing compliance as a barrier, forward-thinking organisations are reframing it as an enabler of innovation. By demystifying regulations and investing in robust governance, they unlock the full potential of patient partnerships - leading to better care, improved outcomes, and stronger trust.

Myth-busting compliance is not just about correcting misconceptions; it’s about empowering teams to engage patients meaningfully and safely, driving both innovation and trust across the healthcare ecosystem.

Practical steps to move forward

• Educate and train: regularly updating teams on regulatory requirements and best practices for compliant patient engagement is essential. Tailored training, including immersive scenario-based exercises (e.g. habit labs), ensures that everyone understands their specific responsibilities and the importance of compliance in fostering meaningful patient relationships
• Standardise processes: developing clear, accessible policies and templates for patient involvement and data collection streamlines engagement and reduces uncertainty. Consistent workflows and thorough documentation across departments help organisations demonstrate compliance and build trust with both patients and regulators
• Leverage technology: introducing digital tools such as patient portals, secure messaging, automated reminders, and consent management platforms, supports patient engagement while embedding compliance into day-to-day operations. Using these technologies helps reinforce consistent workflows and real-time documentation, minimising compliance risks and ensuring that regulatory best practices are routinely followed
• Collaborate early: involving compliance and legal experts from the outset of patient engagement initiatives allows organisations to anticipate and address potential risks proactively. Early cross-functional collaboration ensures that activities are both innovative and compliant, minimising barriers and clarifying ambiguous regulatory areas before they become obstacles
• Promote a culture of openness: encouraging open dialogue about compliance concerns creates a safe environment for staff to raise questions and share feedback. Transparent communication about regulatory changes and lessons learned helps demystify compliance, while fostering continuous improvement and confidence in patient engagement practices

By challenging the myth of excessive compliance risk, organisations can move beyond fear and unlock new opportunities to understand - and serve - patients better than ever before.