Tēnā koe, 

 

Thank you for contacting Health NZ, Te Whatu Ora. This is an automatic
reply to confirm that we have received your email.  Depending on the
nature of your request you may not receive a response for up to 20 working
days.  We will try to respond to your query as quickly as possible.

 

 

Ngā mihi

 

Health NZ, Te Whatu Ora.

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Kia ora Chris

 

Thank you for your OIA request of 7 October in which you asked for the
following:

 

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.

 

As it is currently worded, your request is very broad and would require a
significant amount of research and collation. When Health NZ considers
that responding to a request may require a significant amount of our time
and resource, and necessitate diverting personnel from their core duties,
we may have to consider refusing the request under section 18(f) of the
Act – requiring substantial collation and research. 

 

We appreciate you are under no obligation to amend your request. However,
we want to work with you to ensure we can provide a response that best
meets your needs. 

 

To enable us to respond, we are seeking clarification regarding your
request as follows:

 

* 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. 

 

If you could please clarify your request by 5.00pm 29 October 2024 that
would be appreciated.

 

 

Ngā mihi

Joy

Government Services

[1][email address] 

Health New Zealand | Te Whatu Ora 

 

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Tçnâ koe Chris

 

Thank you for your request on 7 October 2024, asking Health New Zealand |
Te Whatu Ora for information under the Official Information Act 1982 (the
Act).

 

On 23 October 2024 we sought clarification to your request. On 25 October
2024, you provided clarification to your request as follows:

 

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.

 

We asked: By “leadership team” did you mean Tier 2 Directors reporting to
the Chief Executive?

You replied: Yes

We asked if you are interested in a copy of the current risk management
policy and framework.

You replied: 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.

 

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.

 

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

You replied: 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"

 

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.

 

We did not receive any clarification to question 4.

 

The Act requires that we advise you of our decision on your request no
later than 20 working days after the day we received your request.
Unfortunately, it will not be possible to meet that time limit and we are
therefore writing to notify you of an extension of the time to make our
decision, to 3 December 2024.

 

This extension is required under section 15A(1)(b), because the
consultations necessary are such that we cannot reasonably make our
decision within the original time limit.

 

If you have any questions, you can contact us
at [1][email address]. 

 

If you are not happy with this extension, you have the right to make a
complaint to the Ombudsman. Information about how to do this is available
at [2]www.ombudsman.parliament.nzor by phoning 0800 802 602.
 

 

Nâku iti noa, nâ

 

 

Joy

Government Services

[3][email address] 

Health New Zealand | Te Whatu Ora

 

 

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attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege. If you are not the intended recipient, do not read, use,
disseminate, distribute or copy this message or attachments. If you have
received this message in error, please notify the sender immediately and
delete this message

References

Visible links
1. mailto:[email address]
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3. mailto:[email address]

Kia ora Chris, 

 

Attached is a response to your official information request set out below.
 

If you have any questions, please contact us
at [1][email address]

 

If you are not happy with this response, you have the right to make a
complaint to the Ombudsman. Information about how to do this is available
at [2]www.ombudsman.parliament.nz or by phoning 0800 802 602.

 

Ngā mihi

Government Services

 

 

------------------- Original Message -------------------
From: Chris Johnston <[FOI #28680 email]>; 
Received: Mon Oct 07 2024 15:54:59 GMT+1300 (New Zealand Daylight Time)
To: [Health New Zealand request email]; 
Subject: Official Information request - Procedure for Requesting a Review
of a Health Policy or Practice in NZ

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

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received this message in error, please notify the sender immediately and
delete this message

References

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