A statutory duty of candour in the NHS will cover a wider set of incidents than previously expected, and will force NHS trusts to apologise to affected patients, it has emerged.

The government has laid regulations in Parliament introducing measures including a legal duty of candour, a “fit and proper person test” for NHS directors and “fundamental standards”  to be enforced by the Care Quality Commission. The changes are part of the government’s response to last year’s Francis inquiry final report.

Under regulations for the duty of candour, patients will have to be informed when an incident occurs that “could” have led to severe or moderate harm, or death. Previously, the duty was expected to apply only where incidents had led to harm or death.

The rules also state for the first time that when such an incident takes place NHS organisations will have to write to patients and include an apology. This will not amount to an admission of liability. The duty will come into effect from October.

Peter Walsh, chief executive of Action Against Medical Accidents, which has campaigned for the duty, told HSJ: “The addition of the word ‘could’ and the wider duty means more patients and families will know the truth. It is one of the most important things to come out of the Francis inquiry.”

The regulations also include a “fit and proper person test” for NHS trust directors, to apply from October. They set out that trusts will not have committed an offence if they do not apply the test, as had been expected. Instead, it will be an offence if trusts do not comply with a direction from the Care Quality Commission in relation to directors who do not pass the test.

The Department of Health has estimated seven NHS directors could be deemed unfit each year. Care minister Norman Lamb said: “It is only an estimate but nonetheless do you want seven people who are not fit and proper to be directors of a health trust?”

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