Private as well as public health services will have to disclose serious patient safety incidents under planned legislation expected to come before the Dáil within weeks.
The Patient Safety Bill, published by Health Minister, Simon Harris, lists several patient safety incidents that will be subject to mandatory open disclosure.
It also includes a new process to allow the minister to designate other notifiable patient safety incidents.
Mr Harris said this "flexible approach" will ensure that the list of specified patient safety incidents that must be reported can be kept up to date.
A spokesperson for the minister said the bill is expected to be introduced in the Dáil within the next two weeks.
Serious Safety incidents must be reported to the State's health services watchdog, the Health Information and Quality Authority and other regulators.
The minister said poor communication between patients and health practitioners has been at the heart of many patient safety issues.
“I want us to have a culture of open disclosure where health practitioners are supported and were patients' voices are heard,” he said.
It is important that when things go wrong a sincere and genuine apology is offered; that there is an understanding of what happened and an assurance that it would not happen again.
“This new legislation seeks to support a just culture in our health services, which is focused on openness, learning and improvement rather than blame,” said Mr Harris.
However, in many situations where patients are harmed, the error or mistake occurred because systems are not in place to support the healthcare professional or team in identifying that error.
Mr Harris said the Patient Safety Bill places “clear” responsibility and obligations on the health service provider to ensure that the regulator is notified about a serious patient safety incident.
This is to ensure health service employers take responsibility for ensuring the appropriate governance, systems, processes and resources are in place to support health practitioners in making disclosures.
It is almost a year and a half since the Government approved the drafting of provisions of the bill that will oblige a health service provider to disclose all information about a serious safety incident to a patient and/or their family.
The recommendations made in the report of the scoping inquiry into the CervicalCheck Screening Programme, conducted by Dr Gabriel Scally, also informed the legislation.
Patient advocate, Stephen McMahon, said it was brave cancer campaigner, Vicky Phelan, who eventually convinced the Taoiseach, Leo Varadkar and Mr Harris to legislate for mandatory reporting.
Progress on patient safety has been “glacial” over the past 30 years, said Mr McMahon, who is chairman and co-founder of the Irish Patients' Association.
“Resistance to statutory open disclosure as advocated by the IPA and other patient advocates was significant,” he said.
“When the bill becomes law – it still has to get over the line, its success will be built on a respectful but not tokenistic relationship with patients and, or their advocates.”