3.1 Changes to the Health Act 1956
Section 8 of the Health Amendment Act 2006 will insert the following section 74AA into the Health Act 1956 as from 18 December 2007.
Medical laboratories to give notice of cases of notifiable disease
1. The person in charge of a medical laboratory must take all reasonably practicable steps to ensure that there are in place in it efficient systems for reporting to him or her (or to any other person for the time being in charge of it) the results of a test or other procedure undertaken in it that indicate that a person or thing is, has been, or may be or have been, infected with a notifiable disease.
2. The person for the time being in charge of a medical laboratory to whom results are reported under subsection (1) (or who himself or herself becomes aware of results of a kind to which that subsection applies) must immediately tell the health practitioner for whom the test or other procedure concerned was undertaken, and the medical officer of health, of the infectious nature of the disease concerned.
3. A person who fails to comply with subsection (2) –
a) commits an offence against this Act; and
b) is liable to a fine not exceeding $10,000 and, if the offence is a continuing one, to a further fine not exceeding $500 for every day on which it has continued.
The Ministry of Health commissioned legal advice on a number of issues raised by the sector at regional meetings and via the advisory group. This legal advice is set out below. Laboratories may wish to seek their own legal advice rather than rely solely on the advice provided here.
Do all notifiable diseases need to be reported from December 2007?
From 18 December 2007 any notifiable disease reported to the person in charge of a medical laboratory must be reported to those persons set out in section 74AA(2). If the person in charge of a medical laboratory does not report those results, he or she commits an offence under the Act and may be liable to a penalty.
Section 74AA(1) places the onus for ensuring that an efficient reporting system is in place on the person in charge of a medical laboratory. That person ‘must take all reasonably practicable steps’ to ensure that efficient reporting systems exist so that he or she receives results of tests where a notifiable disease has been identified.
In terms of the words’ ordinary meaning, the dictionary definition of ‘practicable’ is ‘capable of being done; feasible’ (Collins English Dictionary), and in law the use of the word ‘reasonable’ implies an objective test. What is considered reasonable will be measured against what a reasonable person in those circumstances would have done.
Therefore, the person in charge of a medical laboratory must take all steps that are ‘objectively feasible’ to ensure a reporting system is in place.
In the context of this legislation, what does ‘immediately’ mean, and does this apply to all diseases on the schedule?
‘Immediately’ will bear its ordinary meaning of ‘without delay or intervention; at once’ (Collins English Dictionary).
The reporting requirements of section 74AA relate to notifiable diseases (see subsection ). ‘Notifiable disease’ is defined by the Health Act 1956 as meaning ‘any notifiable infectious disease, and any disease for the time being specified in Schedule 2’. The requirement to ‘immediately tell the health practitioner ... and the medical officer of health of the infectious nature of the disease’ relates to all notifiable infectious diseases listed in part one of Schedule 1, and Schedule 2, of the Health Act.
The reporting requirements may also apply to any other notifiable infectious disease even if not listed in a schedule to the Health Act (this would include, for example, all forms of tuberculosis [notifiable under the Tuberculosis Act 1948]).
What are the privacy responsibilities of the PHUs that receive information under section 74AA? What onus is on laboratories to ensure that non-relevant patient information is not sent in the first instance?
The Privacy Act and the sections of the Health Act that relate to personal and/or health information (sections 22B to 22I) place the responsibility for ensuring the protection of that information on the organisation that collects and holds the information.
Once a PHU receives health information, it must handle that information in accordance with the Health Information Privacy Code (the Code); that is, the PHU must have sufficient systems or processes in place to store and protect any health information it receives. Rule 10(1)(d) permits a PHU to use the health information to prevent or lessen a serious and imminent threat to public health, and, if necessary, rule 11(2)(d) enables a PHU to disclose the health information for similar reasons.
In relation to the labs, they must be satisfied that they also have suitable systems to store and protect all personal and/or health information they collect. A laboratory may disclose personal and/or health information relating to a notifiable disease to a Medical Officer of Health in accordance with section 74AA under the following provisions.
Section 22C(1)(b)(i) of the Health Act provides that a person (this includes a lab) may disclose health information if that disclosure is permitted under the Code.
Rule 11(2)(d) of the Code enables health information to be disclosed without requiring the consent of the person to whom the information relates, if the disclosure is necessary to prevent or lessen a serious and imminent threat to public health or public safety. The reason for requiring the notification of certain specified diseases is to enable an appropriate person (a Medical Officer of Health) to determine whether certain public health actions/interventions are necessary.
It is important to note that rule 11(3) provides that disclosure under 11(2) is only permitted to the extent necessary for the particular purpose. Labs should therefore consider what information is necessary to disclose (eg, name, address, notifiable disease, clinician), and what additional information the laboratories have obtained that will not be required by PHUs and so should not be disclosed.
The Ministry of Health has been advised that it may be difficult for labs to remove test information not relating to a notifiable disease from the information the labs will send to PHUs. However, given the requirement in rule 11(3) of the Code, labs may be breaching their privacy obligations if they disclose additional personal or health information that is not required under section 74AA.
Labs may need to obtain their own independent legal advice on how they should collect, store and disclose information relating to notifiable diseases.