How to conduct compliant digital user research in pharma and healthcare

Digital user research is sometimes viewed with caution in highly regulated industries.

Teams may worry that speaking directly with patients or healthcare professionals about digital tools could create compliance risks. Questions arise around what can be discussed, how data should be handled and whether research sessions could unintentionally cross into clinical or promotional territory.

In practice, much of this concern stems from misunderstanding.

User research focused on digital experience, usability and behaviour is entirely feasible within pharmaceutical and healthcare environments when the appropriate safeguards are in place. With careful planning and clear research protocols, organisations can gather valuable insight while remaining fully compliant with regulatory and ethical standards.

The most important principle in compliant research is defining the scope clearly. User research in the context of digital products focuses on how people interact with tools, information and interfaces. It does not involve collecting clinical data, evaluating drug efficacy or conducting medical research.

Typical research questions might include:

• How easily can healthcare professionals navigate an education platform?
• Do patients understand the information presented in a support tool?
• Where do users struggle to complete key tasks in a digital product?

By focusing on usability, behaviour and experience, research sessions remain clearly separate from clinical studies or promotional activities.

Defining this scope at the outset helps reassure both internal stakeholders and research participants that the study is focused on improving digital experiences rather than collecting medical evidence.

Before any research begins, the study should be documented in a clear research plan.

This plan typically outlines:

• the objectives of the research
• the participant profile
• the research methodology
• the topics that will and will not be discussed
• how data will be captured and stored

Having a documented plan allows internal teams, including compliance and legal stakeholders, to review and approve the research approach before it begins. This step helps prevent misunderstandings later in the process and ensures everyone involved understands the boundaries of the research.

Informed consent is a fundamental part of ethical research practice. Participants should be provided with clear information about the purpose of the research, what participation involves and how their data will be used. They should also understand that participation is voluntary and that they can withdraw at any time.

Consent documentation typically explains:

• The objectives of the study
• What will happen during the research session
• How data will be stored and used
• How anonymity will be protected

Researchers should also take time to explain these points verbally before sessions begin, giving participants the opportunity to ask questions.

Transparent communication helps ensure participants feel comfortable and confident taking part in the research.

User research often involves collecting qualitative data such as interview recordings, notes and usability testing sessions. Ensuring this information is handled securely is essential.

Research data should be stored using tools and platforms that comply with relevant data protection regulations such as GDPR and HIPAA. Personal identifiers should be removed wherever possible to ensure that participants remain anonymous in reports and analysis.

Access to raw research data should also be limited to the research team and stored only for as long as necessary. These practices protect participant privacy while allowing organisations to generate meaningful insight.

Conducting research in healthcare environments often requires specialist knowledge. Researchers working with patients or healthcare professionals should understand the ethical considerations involved and be trained to recognise potential safeguarding issues during interviews.

Many research teams also complete background checks and safeguarding training when working with vulnerable participants or healthcare settings. Experienced researchers are able to moderate sessions carefully, ensuring that conversations remain within the agreed scope while still exploring user behaviour in meaningful ways.

In some situations, it may be appropriate to remove branding from digital products during research sessions. Using “white-labelled” versions of tools can help ensure participants focus on the usability and experience of the platform rather than their perceptions of a particular brand. This approach helps reduce bias and encourages participants to provide more honest feedback about the design and functionality of the product.

Recruitment practices also need to reflect ethical and regulatory standards.

Many organisations work with specialist recruitment partners who have experience sourcing participants in healthcare environments. These partners ensure that participants meet the required criteria and that recruitment processes respect privacy and consent requirements.

Recruitment partners may also help ensure that participants do not have conflicts of interest and that incentives are managed appropriately. Responsible recruitment ensures the research remains fair, transparent and unbiased.

One of the most effective ways to ensure research runs smoothly is to involve compliance teams early in the process.

When compliance teams understand the purpose and scope of user research, they are often more comfortable supporting it. Explaining how research focuses on digital experience rather than clinical information can help address concerns before they arise.

Early collaboration also allows compliance teams to review research plans and suggest any necessary adjustments before the study begins.

This collaborative approach helps avoid delays and builds internal confidence in the research process.

The risks of conducting user research are often overstated.

In many cases, the greater risk lies in launching digital products without testing them with real users. Poorly designed digital tools can frustrate healthcare professionals, confuse patients and ultimately fail to deliver their intended value.

User research provides a structured and ethical way to understand how people interact with digital products. When conducted responsibly, it allows organisations to improve usability, reduce friction and create experiences that genuinely support healthcare delivery.

In regulated industries, designing digital tools without this insight can be far riskier than conducting research itself.