Hospitals will face penalties if staff do not notify patients of serious adverse incidents under proposed new legislation.
Due to be brought to Cabinet by the Minister for Health Simon Harris in early December, it will provide for mandatory open disclosure of patient safety issues.
It is understood that the new Bill would mean that where a hospital or health service provider was satisfied that a notifiable patient safety incident had occurred, information in its possession on the issue should be disclosed.
A doctor or practitioner would be obliged to inform the patient and hospital of the incident.
Under the proposals, failure to comply with this requirement on disclosure would mean the health service provider would be penalised. The nature or extent of the proposed penalties is unknown.
The department is preparing a list of notifiable patient safety incidents for the mandatory open disclosure proposals.
Informed sources said the incidents on the list to form part of the legislation would be likely to be similar to those applying in other jurisdictions.
The new Bill would allow for open disclosure meetings to take place between the patient and/or their family and the health service provider following an incident.
The patient concerned would have to be given a statement in writing of the information provided at the meeting, or within five days of the meeting taking place.
The proposals would allow for patients to refuse to attend the open disclosure meeting, although they could change their mind within a five-year period.
Last year the author of the report of the investigation into the cervical cancer controversy Dr Gabriel Scally called for urgent changes in the "deeply flawed" open disclosure process in place in the Irish health service.
The Scally report described the current policy as deeply contradictory and unsatisfactory because it does not compel clinicians to disclose failings in the care of patients.
In the CervicalCheck controversy, hundreds of women with cervical cancer were not told for years of an audit that showed they had received incorrect smear test results. This was despite the HSE having open disclosure policies in place since 2013.
Last March the Minister promised that a mandatory open disclosure policy for the health service would be enshrined in law by the end of the year.
