Inspiration
Gaps identified between medical devices and AI and from our own experience. We found the opportunity to bring those gaps to the surface and suggest solutions.
What it does
This essay exposes important gaps in the current regulatory landscape for radiological AI. We argue for a human-centred governance framework in which AI remains a supplementary tool to expert clinical judgement, with human oversight, data protection and compliance between the MDR and AI Act serving as central components rather than relying primarily on algorithmic and software-oriented solutions.
How we built it
Literature review of European regulations and governance
Challenges we ran into
Fragmented and sometimes conflicting guidelines, regulations and liability frameworks that create vulnerabilities throughout the AI lifecycle.
Accomplishments that we're proud of
We managed to analyse multiple resources and in-depth legal documents, while simultaneously using our technical background for analysis.
What we learned
We argue for a human-centred governance framework in which AI remains a supplementary tool to expert clinical judgement, with human oversight, data protection and compliance between the MDR and AI Act serving as central components rather than relying primarily on algorithmic and software-oriented solutions.
What's next for team doublechristos
Future regulatory frameworks should further address emerging AI applications, including LLMs and foundation models in precision medicine, personalised therapies and patient-oriented care, where increasingly sensitive personal and clinical data create additional governance challenges
Built With
- latex
- literature
- regulations.gov
Log in or sign up for Devpost to join the conversation.