Training activity information
Details
Appraise current regulations covering software as a medical device (SaMD) and reflect on how these are used to assure patient safety
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee​.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Legislation, regulations and guidance concerning SaMD
- Potential for patient harm arising directly from the design and use of software as a medical device
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 |
Outcome
Appraise the risk and benefits of using Decision Support Tools in clinical practice. |
| # 3 |
Outcome
Apply the legislation and regulations applicable to Decision Support Tools. |