Serious incidents in hospitals will have to be notified by law within 24 hours and a preliminary assessment will have to be completed within five working days.
The National Standards for the Conduct of Reviews of Patient Safety Incidents, drawn up by the Health Information Quality Authority (HIQA) and the Mental Health Commission, have been designed to end the long drawn out process of investigating serious incidents in hospitals.
Concise internal reviews will have to be completed no later than 60 calendar days after a serious incident is reported.
Medical institutions will be given 120 calendar days (four months) to carry out a full external independent review.
The standards were drawn up following the State's chief medical officer's 2014 report into Portlaoise Hospital Maternity Services which identified problems in the reporting of risk across the health service.
Relatives of babies who died also complained about the length of time it took for the investigation to be carried out into services at the maternity hospital.
The new guidelines, which have been approved by the Minister for Health Simon Harris, make it mandatory for serious incidents to be reported to the senior accountable officer. By law every medical facility has a senior accountable officer such as a chief executive of a hospital or a clinical director.
The standards will be part of a Health Information and Patient Safety Bill which will create a mandate for reporting of serious events.
Mr Harris said the purpose of the guidelines will be to “review and investigate incidents in order to determine as quickly as possible what may have transpired”.
The results will also be forwarded to other health institutions to prevent a re-occurrence.
The standards will be implemented as part of the HSE’s safety incident management policy.
Mr Harris said it was important there was a “proportionate approach to reviewing incidents” and that patients were confident any investigation would be carried out in an open manner.
The Mental Health Commission's director of standards Rosemary Smyth said the guidelines amount to a "clear and transparent framework for reviewing patient safety incidents".
She added: “They encourage an open approach to incidents, which ensure the patient is at the heart of every review. The standards acknowledge that sometimes things go wrong, but that lessons can be learned and shared across services, both locally and nationally, to improve patient safety.”
HIQA's director of standards and health information Rachel Flynn said the standards will "promote a person-centred approach" to the review of patient safety incidents.