Dara Calleary (Mayo, Fianna Fail)
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385. To ask the Minister for Health the planned timeline for the introduction of legislation in relation to the duty of candour; and if he will make a statement on the matter. [27831/18]

Simon Harris (Wicklow, Fine Gael)
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The Government recently gave approval to the drafting of legislative provisions to provide for mandatory open disclosure through the development of the General Scheme of a Patient Safety Bill. The General Scheme has been developed by officials of my Department, with a view to having this item brought to the Government for consideration in early July 2018.

These provisions to provide for mandatory open disclosure of serious patient safety incidents (referred to as duty of candour in other jurisdictions), will be in addition to the provisions for open disclosure contained in the Civil Liability (Amendment) Act 2017. The Regulations to prescribe the process for open disclosure in line with the Civil Liability (Amendment) Act 2017 are also being drafted at present and are expected to be finalised shortly.

The Patient Safety Bill, in addition to addressing mandatory open disclosure, will also provide for a number of other important patient safety concerns, including in relation to mandatory reporting of serious incidents to an appropriate regulatory body such as HIQA, enabling the Minister for Health to issue guidance in relation to clinical audit, and extending the remit of HIQA to private hospitals.