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White paperMichael Clark
Extend the Safety Case
Health and care organisations in England should build AI assurance by extending the clinical risk management apparatus they already run under DCB0129 and DCB0160, while accepting, as NHS England says, that the current standards do not adequately address AI. Several existing clauses already reach AI problems, and four additions should be made, from six model hazard classes to a decision record. The first step is to establish current DCB0160 coverage before extending anything.
Key findings
- DCB0129 applies to health IT systems whether or not they are medical devices, so many AI tools are within it even where the device regime does not reach them.
- A transitional saving keeps DCB0129 and DCB0160 under the have-regard duty, but they operate as mandatory in practice through DTAC and contracts.
- NHS England, which owns the standards, says the current standards do not adequately address AI, so they are a foundation to extend and should not be presented as already adequate.
In the paper
- The standards reach further than the device regime
- Have regard in law, mandatory through procurement
- Four features AI assurance is reaching for
- Clauses that already reach AI problems
- What should be added
- Count before you extend
Michael Clark
Chief Executive Officer, Standard Intelligence
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