2nd September 2024
2nd September 2024
Amendments to the Medical Director of Health and Public Health Act - Notification of serious incidents
On 1 September 2024, amendments to the Medical Director of Health and Public Health Act came into force regarding, among other things, the reporting of serious incidents in healthcare.
-Automatic translation
A serious incident means an unexpected event in healthcare that has caused or could have caused serious damage to a patient, such as death or permanent disability.
Healthcare institutions and operators providing healthcare services shall notify the Directorate of Health without delay of serious incidents. Furthermore, the patient and his/her immediate family members, such as spouse, parent or heir, shall be informed of the serious incident without undue delay, as appropriate, see Article 28(5) of the Law on the Rights of the Patient, No. 74/1997.
As of 1 September 2024, the patient or their closest relative can also report a serious incident to the Directorate of Health.
The change also means that the Directorate of Health can investigate a serious incident on its initiative, even if it has not been formally reported. The Directorate of Health also decides whether there are sufficient grounds for investigating serious incidents, taking into account, among other things, “the severity and extent of the incident and other factors that may be relevant, the lessons learned from such investigations and the likelihood that the outcome of the investigation will lead to a similar incident not occurring again and increase safety and quality in healthcare.”
Furthermore, the change was that:
Patients who suffer from a serious incident have the right to information on the progress of the investigation, to access evidence other than interview data according to Article 10c(3), and to express their views. The same rights apply to the patient's next of kin in the event of death or inability to express their views.
On 1 September 2024, the Act was also amended to include access to data, investigative time, and procedures.
The changes have yet to be included in the full text of the Act on the Medical Director of Health and Public Health, but they can be accessed on the Althingi parliament's website. See also changes to the Law on Healthcare, No. 40/2007, and the Law on Patients’ Rights, No. 74/1997.
More information
Kjartan Hreinn Njálsson, Assistant to the Medical Director of Health
kjartan.h.njalsson@landlaeknir.is