Dear Health New Zealand,

OIA 1) Are there documented policies or procedures for assessing new information about a health policy or practice in Health NZ, that would lead to a formal review of the evidence, and a potential change in approach? Please provide the documents that describe this policy or procedure.

There may be many such documents - eg a procedure as a result of a decision by another regulatory body (eg MedSafe), or a request/warning from a professional body, a warning on a product (tool or certified technique/guideline), a Ministerial or Ministry of Health initiative (screening programme), or a set of findings in the medical literature that flag that a safety issue or unintended consequence of a practice needs attention, or surveillance/epidemiological/ACC reporting identifies an issue, or a concerned group from the public documents an issue.

OIA 2) Please identify all areas (including but not limited to the above) where Health NZ has an explicit risk management strategy in place to monitor and respond to feedback and requests from key stakeholders. For example, Health NZ may be able to provide a document from each of its senior leadership team that describes how they manage the risks and safety feedback from their stakeholders. There may also be a central dedicated Evaluation Unit that clinically assesses Health NZ initiatives for effectiveness, and focuses warnings and alarms generated internally and externally. The expected outcome of this is a list/table.

OIA 3) Please provide all Job Titles that deal with emerging warnings and risks and group them within the Health NZ organisational structure so that their role can be assessed in context and their leadership team executive identified. Eg Public Health/Hospital/Primary Health/Stakeholder Management/Executive. The expected outcome of this is a list/table.

OIA 4) Please list the Criteria a suitably qualified Group from the Public would have to meet, in order for Health NZ to commence a formal review into a scientifically documented and quantified Issue of Concern. To be clear:
- This Group from the Public would not have any commercial or regulatory relationship with Health NZ - but might be entitled to use the services purchased or supplied by Health NZ or be self/privately funded.
- The Issue of Concern would be regarding a substantial initiative by Health NZ - such as a Public Health initiatives (eg a screening programme, vaccination - eg Thalidomide, forced medication of the population through consumer products), medical practice (Cervical Screening at Greenlane Hosptial), pharmaceuticals (eg ultimately leading to product recalls or severe limitation in the indication). Therefore substantial impact, liability and potential embarrassment.

Such Criteria would have therefore been used and documented in policy papers considered by the Executive team, Ministry of Health and at Ministerial level where a significant reversal of policy was involved. There will have been many examples over the years - as illustrated above - so the criteria will be well developed and documented.

If not already provided in the earlier documents, please provide this list of Criteria.

If there is no central list of Criteria, then please provide the last 10 documents considered by the Health NZ Executive team members (individually or collectively), illustrating any Criteria being applied to such Issues of Concern raised by a Group from the Public. The outcome/decision on each of the 10 documents should be provided.

Yours faithfully,

Chris Johnston

Dear hnzOIA,

Thanks for your reply asking for clarification in the following areas:
"* By “leadership team” did you mean Tier 2 Directors reporting to the
Chief Executive?
* We have a risk management policy and framework that covers all risks,
not just risks specific to stakeholders. Are you interested in a copy
of the current risk management policy and framework?
* Please clarify what you mean by “emerging warnings and risks” as this
request is very broad. Please specify particular areas, projects or
initiatives you are wanting information about. "

1) By “leadership team” did you mean Tier 2 Directors reporting to the Chief Executive? YES

2) Are you interested in a copy of the current risk management policy and framework? YES. For this request I am also happy for only the Risk Management Policy/Framework/Registers in the Public Health part of Health NZ to be supplied - Eg screening programmes, immunisation, medication via consumer products/services etc. - and only entries related to community/clinical safety, and safety signals detected or raised with Health NZ and what rating/mitigating actions are being taken.

3) Please clarify what you mean by “emerging warnings and risks” as this request is very broad. Please specify particular areas, projects or initiatives you are wanting information about.

I am interested in topics related to Health and Disability services purchased/funded by Health NZ. For example I am not interested in property management or supply chain logistics issues/risks etc. I have provided a suggested rewording below. Please let me know if this needs further refinement based on how Health NZ operates or is structured.

"OIA 3) Please provide all Job Titles that receive/detect/manage emerging warnings and risks that may indicate a safety issue with a health and disability product or service supplied, funded or mandated by Health NZ. Please group the Job Titles within the Health NZ organisational structure so that their role can be assessed in context and their leadership team executive identified. Eg Public Health/Hospital/Primary Health/Stakeholder Management/Executive. The expected outcome of this is a list/table - which may include job titles such as - Data Scientist, Epidemiologist, Contract Manager, Clinical Safety Officer, (Re)Evaluation Unit Manager, General Manager of Breast Screening, Clinical Audit, Rest Home Auditor, MedSafe Liaison Officer"

Please let me know if this helps decrease the response workload to a reasonable level.

Yours sincerely,

Chris Johnston