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
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
- What guidance might they offer? What understanding of SaMD regulations and patient safety principles do you need before starting this appraisal?
- What specific insights do you hope to gain about the application of regulations in safeguarding patients when using SaMD? What is your current knowledge of relevant regulations and their impact on patient safety in the context of digital health tools?
- Have you discussed with your training officer which specific regulations to focus on and the scope of your appraisal? What challenges might arise in understanding and appraising these regulations? How will you approach these? How do you feel about engaging with regulatory documents and their implications for practice?
- What are your feelings about SaMD regulation before undertaking this exercise? Do you see regulations as a positive or negative thing?
In action
- What is the point of SaMD regulations? Why are they necessary? Were there any specific incidents that prompted the creation of regulation in this area?
- As you appraise the regulations, what decisions are you making about which aspects to focus on and how to interpret them in relation to patient safety?
- How are you connecting the regulatory requirements to the practicalities of ensuring patient safety with SaMD? Is this connection clear as you progress?
- Are you encountering any ambiguities or complexities in the regulations that require you to adapt your understanding or approach?
- What aspects of this appraisal feel familiar based on prior knowledge, and where do you need to exert more cognitive effort?
On action
- What were the key regulations you appraised? What were your main reflections on how these regulations contribute to patient safety?
- What did you learn about the regulatory landscape for SaMD? How has your understanding of how regulations assure patient safety in this area developed? Were there any aspects of the regulations that were surprising or particularly challenging to understand? What did you learn from exploring these? How did your thinking during the appraisal process shape your understanding of the regulations and their impact on patient safety? How important is an understanding of SaMD regulations for ensuring safe clinical practice?
- What areas of SaMD regulations do you need to explore in more detail? How will you apply your understanding of these regulations in future work involving digital health tools? What specific steps will you take? What resources or further guidance would help you deepen your knowledge of SaMD regulations?
- Do you feel any differently about SaMD regulations after completing the exercise.
Beyond action
- Have you revisited your appraisal of SaMD regulations? How does your understanding of these regulations relate to your later experiences with digital health tools?
- Have you observed how SaMD regulations are applied in practice? What has this highlighted or changed in your understanding?
- Reviewing your reflections across multiple training activities, what broader insights have you gained regarding the importance of regulation in digital health? What actions will you now consider?
- Have you discussed your understanding of SaMD regulations with colleagues? Did this offer new perspectives or confirm your understanding?
- How has appraising these regulations influenced your approach to other activities involving digital health tools, such as design or evaluation?
- How has your awareness of patient safety in the context of digital health evolved since this appraisal? How has this influenced your wider practice?
- How might this understanding of regulations impact your future work with digital health tools? What transferable skills did you develop, and what further learning is required?
- How well do you think SaMD regulations are understood in your organisation? How could understanding and compliance be improved at an organisational level?
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. |