Training activity information
Details
Analyse a tool making use of AI which has been implemented in a healthcare setting through the lens of medical device and information governance regulations, present conclusions as a compliance report
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
- Definition of AI
- Ethics involved in the use of AI
- Current medical device and information governance regulations
- Software as a medical device
- Risk analysis and categorisation
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
- Consider the purpose of a compliance report in a healthcare setting. What information is typically included? What makes a report effective?
- What specific medical device and information governance regulations are relevant to AI tools in healthcare that you need to understand before starting?
- What specific frameworks and tools are there available to help with this task?
- What specific insights do you hope to gain about the practical application of regulations to AI in healthcare?
- How will analysing an implemented AI tool enhance your understanding of compliance requirements?
- What will you learn about the process of writing a compliance report for AI in healthcare?
- What is your current understanding of medical device and information governance in relation to AI?
- Discuss the specific AI tool you will be analysing and relevant regulations with your training officer.
- Research relevant medical device regulations (e.g., MDR, MHRA guidance) and information governance frameworks (e.g., GDPR, Caldicott Principles).
- Consider potential challenges in accessing information about the tool or understanding the regulations, and how you might address these.
- How do you feel about analysing technical and regulatory information and presenting it in a formal report?
In action
- How are you approaching the analysis of the AI tool and the relevant regulations? Why are you focusing on specific aspects first?
- What decisions are you making about how to structure your report, are you making use of an existing framework or reporting structure or making your own?
- Which parts of the analysis feel straightforward based on your current understanding, and which are more challenging?
- How effectively are you identifying the relevant regulatory requirements for this specific AI tool in its healthcare setting?
- What challenges are you encountering in understanding the technical aspects of the tool or the nuances of the regulations?
- What insights are you gaining about the practical application of these regulations as the analysis proceeds?
- How does this analysis align with your existing knowledge of medical device and information governance?
- If you are struggling with a particular regulation or aspect of the AI tool, what alternative resources or approaches could you consider (e.g., revisiting guidance, seeking clarification)?
- Do you need to seek any immediate support or clarification to ensure you are conducting the analysis correctly?
- Are you confident that your analysis and report are within your current level of competence and understanding of the regulations?
On action
- Summarise the key aspects of the AI tool you analysed and the main points of your compliance report. What specific medical device and information governance regulations were most relevant to the tool? What were the key challenges or areas of concern you identified during your analysis?
- What new knowledge or skills did you gain regarding AI in healthcare, medical device regulations, or information governance? Were there any unexpected findings or challenges during your analysis? What did you learn from these? How did the process of developing the compliance report enhance your understanding of regulatory requirements for AI tools? How does this activity relate to ensuring the safe and ethical implementation of AI in post-programme practice?
- What areas of regulation concerning AI in healthcare do you need to develop further? How will you apply your understanding of compliance reporting to future work with AI tools? What specific actions or ‘next steps’ will you take to improve your knowledge in this area? What resources or support might you need to further develop your understanding of AI regulations in healthcare?
Beyond action
- Have you reread your compliance report and your initial reflections on this task? How does your understanding of medical device and information governance regulations related to AI differ now compared to when you completed this training activity?
- Have you encountered other AI tools or technologies in healthcare since completing this training activity? How did your experience with this analysis inform your understanding of their regulatory compliance? How has this training activity contributed to your ability to critically analyse and report on technical implementations from a regulatory perspective in other areas of your work? What aspects of report writing and presenting conclusions did you develop through this activity that you have applied elsewhere?
- What transferable skills (e.g., critical analysis, regulatory understanding, report writing) did you develop through this training activity that will be valuable in future projects or roles involving AI in healthcare? What further learning or development in the area of AI regulation and governance might you pursue based on this experience?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Analyse, interpret and report on the regulation around AI and machine learning methods, and its application. |