Findings
A Use-Related Risk Analysis (URRA) is essential for identifying potential use-errors (actions or lack of action that may result in harm) and their associated use-related hazards (source of potential harm) when using an sDHT. The analysis must focus on user interactions with the sDHT, including all user groups (end-users, clinicians, carepartners, researchers, and administrators). Critical tasks are defined as those use-errors that may result in serious harm.

Recommendations
Developers should follow these five steps for the Use-Related Risk Analysis:
Describe all user tasks: Identify the sequence of actions a user performs to achieve a goal, which can be derived from sources like a task analysis or formative evaluations.
Describe potential use-errors: Identify and document potential actions or lack of actions that may result in harm for each task, noting that “use-error” is preferable to “user-error”.
Describe potential use-related hazards: Determine the source of potential harm resulting from each identified use-error.
Develop a plan to minimize or eliminate known risks: The preferred approach is inherent safety by design (eliminating the error). If not feasible, use protective measures (e.g., warnings) or, as a last resort, provide instructions to users. Identify methods to evaluate the effectiveness of the chosen mitigation strategy.
Keep it up to date: The URRA is a living document requiring ongoing updates throughout the sDHT development and usability validation process.

Regulatory Considerations
The URRA is presented as a fundamental step within the V3+ framework for ensuring device usability and minimizing risk, implicitly setting the groundwork for regulatory compliance related to device safety. The minimization of use-errors, particularly for critical tasks, is a central tenet of device development best practices.