How to deal with liability/warranty in case of system errors
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@AnnaFeiler is already working on this.
Since Sep 7, 2023.
- Dominant language
- Kotlin
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- 17
- Forks
- 4
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Description
In a plug&trust system, we no longer have a single manufacturer who is responsible/liable for system errors. This will be a concern to regulators. They do no longer know who to address in case of a malfunction of the overall system causing patient harm, that cannot be dierctly traced to a single component.
This is a placeholder ticket, summarizing the issue. Currently, there are two main aspects:
- A technical part, ensuring that we have enough consistent, accessible logging and network monitoring to trace and reproduce errors. This should also include audit logs of configuration by the resposible organization. Some important parts of this are already included in BPKP.
- An organizational part where we need some sort of independent authority that can be tasked with investigating such issues and making a decision whose fault it was. This is especially tricky, if the fault lies with a combination of manufacturers and the hospitals. The skillset and level of independence of this organization needs to be similar to a lab doing conformity assessment. So there might be an overlap between the two topics.
This is just a placeholder for now and will be split into smaller parts, once we agree how to move forwards.
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