Safety cases for digital health innovations: can they work?

Safety cases for digital health innovations: can they work?

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Innovations in digital health, such as the introduction of smart infusion pumps, have the potential to improve patient safety, even though the evidence base remains weak. Equally, however, new risks can be introduced, which might contribute to adverse events and patient harm. The Healthcare Safety Investigation Branch (HSIB), which carries out independent investigations into patient safety concerns in the National Health Service (NHS) in England, published in December 2020 its findings from a national investigation into the procurement, usability and adoption of smart infusion pumps. The report includes safety observations (suggested actions for wider learning and improvement) that suggest the use of (clinical) safety cases in order to demonstrate that patient safety risks have been addressed rigorously and proactively.

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