Bill to include mandatory open disclosure of serious incidents

New legislation which would make mandatory the open disclosure to patients of serious incidents in the health service is being prepared, the Department of Health has said.

The department said on Friday that the measure would form part of a new Patient Safety Bill on which it was currently working.

The Department of Health also said on Friday that new regulations that would provide for legal, voluntary open disclosure of patient safety issues would be signed into effect by the Minister for Health Simon Harris in the weeks ahead, probably by the end of June.

The department’s comments come following the case of Vicky Phelan and subsequent news that more than 200 women diagnosed with cervical cancer should have received notification that earlier tests they were given should have been followed up.

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The regulations follow from the Civil Liability (Amendment) Act which was passed by the Oireachtas and signed into law by the President last November.

The Department of Health said on Friday it was now finalising regulations on foot of this legislation to provide for these open disclosure measures. They should be signed by the Minister in the coming weeks.

Commitment

Correspondence seen by The Irish Times shows that Mr Harris, in a letter to the head of the HSE, Tony O’Brien, sent on January 22nd this year, said that they both shared the view that a commitment to patient safety and open disclosure were key to the delivery of safe, quality healthcare.

“Open disclosure is an important element of the range of initiatives being progressed to improve the management of patient safety incidents and to promote a comprehensive patient-centred approach to preventing, managing and learning from incidents,” he wrote.

The Minster told Mr O’Brien that the Government intended to commence in the spring Part IV of the Civil Liability (Amendment) Act 2017which provided for open disclosure of patient safety issues.

“The provisions in Part IV of the Civil Liability (Amendment) Act 2017 are designed to give legal protection for the information and apology made to a patient when made in line with the legislation.

"The apology cannot be interpreted as an admission of liability and cannot be used in litigation against the provider. This approach is intended to create a positive voluntary climate for open disclosure and will support the national policy on open disclosure which was developed jointly with the HSE and the State Claims Agency in November 2013," the Minister said, in his letter to Mr O'Brien.