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Regulations and Ethics

When developing healthcare products with the intent to bring them to market there are a number of regulatory guidelines and standards that need to be adhered to. Among the many engineering standards, there are standards that have been written specifically relating to the human factors. When conducting these studies it is important that studies are done so in an ethical manner.

The following sections will provide information on regulatory guidelines and standards for usability, ethical considerations, and some additional resources to help when implementing human factors studies.

Regulatory Guidelines and Standards

There are a number of regulatory guidelines and standards that should be followed when developing healthcare products. These aim to ensure that medical devices are designed to reduce use errors to ensure safety to users and recipients of medical devices. There are three standards to assist in ascertaining the usability of a product: ANSI HE75 (Human Factors Engineering – Design of Medical Devices), IEC 60601-1-6(General requirements for basic safety and essential performance), and IEC 62366 (Application of usability engineering to medical devices).


These standards detail the human factors methods used to help identify use errors and high-risk scenarios so that the design of the system can either remove or mitigate these risks. To achieve this, they recommend using the methods provided on this website to identify, describe, and categorise use errors and hazard-related use scenarios. Using these same methods, they advocate conducting formative evaluation alongside the design development and ending in conducting a summative usability evaluation.


In Annex D of IEC 62366-2:2016, it specifies that not all reports are required in order to comply with the standards, but rather recommended to promote good usability engineering practice without becoming a paperwork generation exercise. However, there are a number of reports that are required, including: use specification, user interface characteristics related to safety and potential use errors, known foreseeable hazards or hazardous situations, hazard related use scenarios, user interface specifications, user interface evaluation plan, formative evaluation usability test reports (if conducted), and the summative usability evaluation test protocol with accompanying test report. Using the methods outlined on this website, these reports can be generated to ensure the standards requirements are met.


For more information on understanding how to apply human factors to the development of healthcare products, please visit the UK government’s medical devices regulation and safety website. Other regulatory authorities have published local guidance that can complement this – for example, guidance from the US FDA.

Ethical Considerations

When conducting investigations with users it is important that ethical clearance is obtained to protect participants (the users). The participant should be informed in a detailed document exactly what the purpose of the study is and what is required of them, which they are required to sign in acknowledgement that they understand the study they are involved in. Alongside this, the mode of which data is being recorded should also be transparent to the participant. If at any time the participant wishes to withdrawal from the study, they are free to do so and may ask that all of their collected data is also removed.


Additional to collecting data, all participant information when recorded should be pseudonymised and any published data should be anonymised. This is in keeping with the main purpose of ethics to protect the participant.


When conducting user-centred studies, it is important that data protection and information governance is adhered to. This information relates to the safeguarding of participants information in the storage and distribution of data. Current legislation and additional information within the UK can be found on the NHS health research authority website. For other countries, please check your local government websites for advice.


All ethical applications need to be reviewed and approved by a Research Ethics Committee (REC), who are independent of research sponsors, thus allowing them to ensure that the participants are properly protected. The health research authority have additional information on ensuring that research is carried out correctly and describing the REC review process.

Additional Resources

For examples on how to create human factors documents to assist with exploring and understanding user needs, UX for the masses has a number of helpful contents. These include: personas, process diagrams, scenario maps, scenarios, usability reports, and more. Further information on human factors methods that can be applied to healthcare products, such as risk and incident analysis methods, is available via the clinical engineering division website.