DGD12-055
Policy
Introduction of a New Health Technology
Policy Statement
All technologies that are new to the public health services in the ACT, or existing
technologies that are to be reviewed, will have an electronic application submitted and be
assessed by the Health Technology Assessment Committee.
Purpose
This policy aims to identify and describe the common and comprehensive approach to the
adoption of new health technologies to the public health services in the ACT.
Health technologies are defined as “Therapeutic devices, medical or surgical procedures used
in medical care, and the organizational and supportive systems with which such care is
provided.”i This definition includes therapeutic, diagnostic and screening procedures and
equipment but not the evaluation of new drugs, either for addition to the formulary or as an
individual patient therapy.
Scope
This policy applies to the adoption of new health technologies and the review of existing
technologies within public health services in the ACT.
The Health Technology Assessment Committee (HTAC) advises on the role, safety, efficacy
and resource implications of proposed new health technologies that have been supported
for use within Australia by a recognised authority, such as the Australian Government
Medical Services Advisory Committee (MSAC). This includes:
 Procedures that have not been performed in an ACT public health service;
 Any variation to an existing procedure or treatment where a new device or item of
equipment is introduced; and
 Any circumstances where a manufacturer provides a new device for a trial period at
no cost to the organisation.
HTAC does not:
 Evaluate new drugs, either for addition to the formulary or as an individual patient
therapy; or
 Engage in general disease management reviews but rather the integration of
technologies related to specific diseases and conditions.
Doc Number
DGD12-055
Version
2.0
Issued
October 2012
Review Date
October 2015
Area Responsible
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Methodology
The adoption of new health technologies and the review of existing health technologies are
underpinned by a health technology assessment (HTA) methodology. The purpose of a HTA
is to provide information on patient care alternatives to patients and clinicians, and to
inform policy decision makers about policy alternatives. It is based on a clearly defined
analytic framework that is specified before the assessment begins and is comprehensive in
scope.
The following guiding principles will apply to HTA within Health Directorate:
1. HTA is an open and accountable process;
2. HTA is used to empower clinicians and patients;
3. HTA is expeditious;
4. HTA is made at the right time, and
5. HTA evidence requirements reflect the diversity of medical technology and the rapid
pace of innovation.
In Australia, the Royal Australian College of Surgeons (RACS) has developed guidelines for
health services on the acquisition of new technologies. Developed in collaboration with a
number of health services including the Hunter Area Health Service in New South Wales and
The Alfred Hospital in Victoria, they include valuable HTA assessment tools.
The Health Directorate will adopt and modify, as required, the RACS HTA tools and apply
them to all new technologies - not just surgical procedures. These are available at the RACS
website in the ASERNIP-S section of Research and Audit: www.surgeons.org/
The HTAC processes for consideration of requests are outlined in Attachments 1 – 4.
Credentialing
Where a new health technology is introduced, doctors and dentists seeking to incorporate
this within their scope of clinical practice must formally undergo an appropriate
credentialing and scope of clinical practice process. For medical practitioners, this is
overseen by the Health Directorate Medical and Dental Appointments Advisory Committee
(“MDAAC”).
National Context
There are a number of organisations and committees involved in health technology
assessment and approval at the national level. These are:

Medical Services Advisory Committee (MSAC). MSAC advises the Commonwealth
Minister for Health of Ageing on evidence relating to the safety, clinical and costeffectiveness of new medical technologies and procedures. The advice informs
Commonwealth decisions on their public funding. www.msac.gov.au.

The Health Policy Advisory Committee on Technology (HealthPACT). HealthPACT is a
sub-committee of MSAC, advices AHMAC and MSAC on the implications of the
introduction of new technology into the Australian and New Zealand health care
system through developing Horizon scanning prioritising summaries and Horizon
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scanning reports, as well as a register of new and emerging health technologies,
including devices, diagnostic tests and procedures, and other non-surgical
interventions. http://www.horizonscanning.gov.au/

The Australian Safety and Efficacy Register of New Interventional Procedures –
Surgical (ASERNIP-S). ASERNIP-S provides assessments of new and emerging surgical
technologies and techniques for the Royal Australasian College of Surgeons.
ASERNIP-S has produced General guidelines for assessing, approving and introducing
new procedures into a hospital or health service, available at:
http://www.surgeons.org/Content/NavigationMenu/CollegeResources/Publications
/Positionpapers/New_Surgical_Procedu.htm

The Therapeutic Goods Administration (TGA). TGA provides a national framework
for the regulation of therapeutic goods in Australia to ensure the quality, safety and
efficacy of medicines and ensure the quality, safety and performance of medical
devices. The TGA does not assess the clinical or cost effectiveness of therapeutic
goods. Further information is at http://www.tga.gov.au.
Roles & Responsibilities
Health Technology Assessment Committee
The Health Technology Assessment Committee (HTAC) coordinates the adoption of
technologies that are new to Health Directorate. It also coordinates the adoption of
modifications to, and upgrades of, existing technologies.
The Health Technology Assessment Committee (HTAC) informs technology-related
policymaking in the public health sector in the ACT, by assessing the direct and indirect
consequences of the introduction of a new health technology. HTAC does not consider the
use of new technology in a research context.
The work of HTAC will complement work currently undertaken by national bodies, such as
the Australian Government Medical Services Advisory Committee (MSAC), that assess new
and emerging technologies or the Health Policy Advisory Committee (HealthPACT) that
supports MSAC and reviews, reports and promotes new and emerging technologies.
The HTAC provides advice to:
 The Director-General if a health technology has the potential to involve more than
one Division or
 The Deputy Director-General Canberra Hospital and Health Services (CHHS) or Chief
Executive – Calvary if the health technology involves only one Division of the relevant
organisation.
Director-General: approves the introduction of the health technology if it involves more
than one division across the public health service.
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Review Date
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In a rare and exceptional circumstance, the Director-General may provide interim approval
for a health technology to be implemented pending the decision of the HTAC.
Deputy Director-General Canberra Hospital & Health Services and Chief Executive- Calvary:
approves the introduction of the health technology, decides on the scope of introduction
and the financial commitment to this health technology.
Clinical Unit Director and Division Executive Director: indicates their support for the
application by the provision of approval prior to its submission.
Applicant: Will submit their application on the HTAC electronic submission form, available
from the HTAC secretariat (Contact: Health Services Planning Unit, 6205 0525), with
approval gained from the Clinical Unit Director, Division Executive Director and DeputyDirector General – CHHS, or Chief Executive – Calvary prior to doing so.
NB: Signatures gained from the above, reflect approval for the application to be considered
by HTAC and does not imply approval for the adoption of the technology, approval for the
commitment of funding.
Evaluation
Outcome Measures
1. Any application for new health technology follows the endorsed application process
Method
1. Number of applications following endorsed application processs compared with total
number of applications submitted (as assessed by HTAC secretariat)
Related Legislation and Policies
Policies
 Royal Australasian College of Surgeons (RACS) / ASERNIP-S: General Guidelines for
Assessing, Approving & Introducing New Surgical Procedures into a Hospital or Health
Service
 Sydney South West Area Health Service: New Interventional Procedures: The Safe
Introduction of New Interventional Procedures into Clinical Practice
 Standard Operating Procedure (SOP): Credentialing and Defining the Scope of Clinical
Practice
Standards
 Australian Standard AS3551.2004 Technical Management Programs for Medical
Devices
Legislation
 Therapeutic Goods Act 1989
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Review Date
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References
Medical Technology and Costs of the Medicare Program (Washington, D. C.:
U.S.Congress,Office of Technology Assessment, (OTA-H-227, July 1984).
Attachments
Attachment 1: Flowchart 1 - Process for Consideration of New Technology
Attachment 2: Flowchart 2 - Expedited Process for Consideration of New Technology
Attachment 3: Decision-Making Process
Attachment 4: Pathway for the Introduction of New Health Technologies.
Disclaimer: This document has been developed by Health Directorate, specifically for its own use. Use of this
document and any reliance on the information contained therein by any third party is at his or her own risk and
Health Directorate assumes no responsibility whatsoever.
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Review Date
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Attachment 1
Process for Consideration of New Health Technology - Flowchart 1
Flowchart 1: Process for Consideration of New Health Technology
Applicant obtains application electronically from Health Service Planning Unit (62050525)

Application form completed and signed by applicant

Application and supporting documentation submitted to Unit Director for signature

Application and supporting documentation submitted to Division Executive Director for signature

Application and supporting documentation submitted to Deputy Director-General CHHS or Chief
Executive – Calvary Hospital for signature

Application submitted to the Health Service Planning Unit electronically

Application logged and given to Executive Director, Service & Capital Planning
Application noted at next HTAC meeting

Chair of HTAC initiates review

Application referred to Senior Manager, Health Services Planning Unit, who then forwards the
application to an appointed evaluator
(within 3 working days)

Draft Recommendation Brief sent to Health Services Planning Unit
(within 8 weeks)

Final Recommendation Brief sent to HTAC with applicant’s comments and evaluator’s response
(within 2 weeks)

HTAC considers Recommendation Brief and makes recommendation


NO
YES
Option of re-submission in twelve months
Doc Number
DGD12-055
Version
2.0
Issued
October 2012
Recommendation sent to:
 Director-General or
Deputy Director-General - CHHS or Chief
Executive – Calvary Hospital
 Applicant
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October 2015
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Attachment 2
Expedited Process for Consideration of New Technology - Flowchart 2
Flowchart 2: Expedited Process for Consideration of New Technology
Applicant obtains application electronically from Health Service Planning Unit (6205 0525)

Application form completed and signed by applicant

Application and supporting documentation submitted to Unit Director for signature

Application and supporting documentation submitted to Division Executive Director for signature

Application and supporting documentation submitted to Deputy Director-General CHHS or Chief
Executive – Calvary Hospital for signature

Application submitted to the Health Service Planning Unit electronically

Application logged and given to Executive Director, Service & Capital Planning
(within 3 working days)

Chair of HTAC considers application for expedited review


NO
YES
Option of re-submission following the normal
process.
The following steps apply

Application referred to Executive Director, Service & Capital Planning (S&CP). Application delegated
to an appointed evaluator (within 3 working days).

Draft Recommendation Brief sent to Executive Director, S&CP (within 15 working days)

Draft Recommendation Brief sent to applicant for comments.
Response must be received within 5 working days.

Applicant’s comments provided to evaluator for final response
(3 working days)

HTAC Executive considers all information and make a final recommendation
(Recomendation Brief, applicant’s comments and evaluator’s response)


NO
YES
Option of re-submission in twelve months
Doc Number
DGD12-055
Version
2.0
Issued
October 2012
Recommendation sent to:
 Director-General or
Deputy Director-General - CHHS or Chief
Executive – Calvary Hospital
 Applicant
Review Date
October 2015
Area Responsible
S&CP
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Attachment 4
HTAC – Decision Making Process
Decision-Making Process
The Health Technology Assessment Committee (HTAC) is responsible for advising on the role, safety,
efficacy and resource implications of proposed new technologies.
Decision by Health Technology Assessment Committee
In accordance with the Health Directorate policy, entitled “Introduction of New Health Technology”,
HTAC is responsible for making one of the following recommendations in relation to proposed new
technologies:
1
Unrestricted Recommendation
The technology is recommended, as is, with no
further need for assessment.
2
Restricted Recommendation – Audit
The technology is approved but only under audit
conditions, when not enough data is known.
Conditions may relate to trial in a specific number
of patients, or may require minimum hours of
surgeon’s training. Conditions are specific to the
technology.
3
Restricted Recommendation – Clinical Trial
The technology is endorsed and approval will be
provided subject to Human Research Ethics
Committee (HREC) approval.
4
No Recommendation
The technology is not recommended.
HTAC provides its recommendations in relation to proposed new technologies to:
 The Director-General of Health Directorate if the health technology has the potential to
involve more than one Division of Health Directorate; and
 The Deputy Director-General – CHHS or Chief Executive – Calvary Hospital, if the health
technology involves only one Division of Health Directorate.
The making of a favourable recommendation by HTAC in relation to a proposed new technology
provides in-principle support for the approval of the introduction of the health technology. A decision
on the scope of introduction and the financial commitment to the health technology must then follow.
Refer to the Pathway for the Introduction of New Health Technologies, below.
In rare and exceptional circumstances, the Deputy Director-General, Strategy & Corporate may provide
interim approval for a health technology to be implemented, pending the decision of HTAC.
Doc Number
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Version
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October 2012
Review Date
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Attachment 4
Pathway for the Introduction of Proposed New Health Technologies
Pathway for the Introduction of Proposed New Health Technologies
HTAC in-principle support for introduction of proposed new health technology, that is:
 Unrestricted Recommendation;
 Restricted Recommendation – Audit; or
 Restricted Recommendation – Clinical Trial.

HTAC recommendation to:
 Director-General of Health Directorate if health technology has potential to involve more
than one Division; and
 Deputy Director-General-CHHS or Chief Executive- Calvary Hospital if health technology
involves only one Division.

Director-General or Deputy Director-General, CHHS or Chief Executive, Calvary Hospital
considers HTAC recommendation for proposed new health technology during operational
planning.
Th relevant delegate decides on whether it is required to submit a business case for
consideration

Business case considered by the Health Directorate
Doc Number
DGD12-055
Version
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Issued
October 2012
Review Date
October 2015
Area Responsible
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