8. (1) Subject to subsection (2), the Minister may prescribe as a notifiable incident:

(a) an incident which has occurred in the course of the provision of a health service;

(b) an incident which, having regard to developments in clinical practice, healthcare and patient safety, may occur;

(c) an incident which, having regard to such developments internationally, has occurred or may occur.

(2) Regulations under this section shall only be made where the Minister is satisfied that—

(a) the incident was or would be an unanticipated and unintended outcome of the health service provided, and would arise from the health service provided and not be attributable (in whole or in part) to the illness or underlying condition of the patient receiving the health service,

(b) the consequence, for a patient, of an incident referred to in subsection (1) is one which has caused—

(i) the death of the patient where the death was not wholly attributable to the illness of the patient or an underlying condition of that patient,

(ii) a permanent lessening of bodily, sensory, motor, physical or intellectual functions,

(iii) harm to that patient—

(I) resulting in one or more permanent changes to the structure of the body of that patient, the effect of which is to shorten the life expectancy of that patient, or

(II) the effect of which has impaired the sensory, motor or intellectual functions of that patient and the duration of the impairment has been, or is likely to be, for a continuous period of not less than 28 days,

(c) the obtaining, provision and dissemination of information in respect of an incident referred to in subsection (1), or a consequence referred to in paragraph (b), is required to provide knowledge and an understanding of the causes of such incident or such consequence,

(d) the application of such knowledge and understanding to the manner in which a health service is provided is required for the purposes of patient safety and avoiding, lessening or eradicating the repetition of such an incident, and

(e) it is appropriate, in respect of any such incident and such information, knowledge, application and understanding that—

(i) an open disclosure of an incident referred to in subsection (1) is made under this Act, and

(ii) notification of that incident is made under section 27, 28 or 29.

(3) Regulations under this section may make different provision for different incidents or classes of incidents referred to in subsection (1) and may make different provision for different patients and different classes of patients having regard to the different incidents and different classes of incidents and may, in respect of a consequence referred to in subsection (2) of an incident that is specified in those regulations, provide for different classes of consequences (including different classes of harm) referred to in subsection (2).