David Rowlands,
Executive Chair, Health Informatics Technical Committee (IT-014),
Standards Australia
Purpose
Standards Australia has partnered with the Department of Health and Ageing and other key stakeholders for several years to accelerate the development of health informatics standards, in particular to support the national e-health agenda. This has been a successful and productive relationship.
This paper provides comments concerning the Productivity Commissions draft recommendations, based on experience within the health informatics domain.
Review findings
The key findings from the Productivity Commission are that:
• In general, Australia’s standard setting arrangements are working effectively, but there is scope for improvement. In particular there are needs for :
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More systematic consideration of the costs and benefits prior to any decision to develop/revise a standard, and publication of the reasons for such decisions;
More balanced stakeholder representation;
Addressing barriers to volunteer and public participation; and
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Improved accessibility, transparency and timeliness, including an improved appeals and complaints mechanism.
There is a case for increased accreditation of other standards development organisations and partnering arrangements between Standards Australia and others. Other standard
• writing bodies, including government agencies, should be actively encouraged to adopt well accepted standard-making processes.
Governments should undertake rigorous impact analysis before referencing a standard in regulation, to ensure it is the minimum necessary to achieve their objectives.
• The Australian Government should continue to support Australia’s participation in international standardisation and the role of the Standards Accreditation Board, if necessary with some reallocation of funding and possibly at an increased level overall.
Funding should also be extended to cover the development of and enable lower cost • access to, regulatory standards.
Current partnerships in health informatics standardisation
Standards Australia currently has partnership arrangements with the Department of Health and Ageing (DoHA) to accelerate the development of health informatics standards and target national interests in e-health. DoHA supplies acceleration funding for standards development, international standardisation and wide dissemination of standards, while

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NEHTA supplies a senior health executive (initially full-time and now part-time) to provide content knowledge, strategic direction, relationship building and change management services to Standards Australia’s health informatics activities. Some state health departments have also entered into less formal partnering arrangements at times.
Draft recommendations and experience in the health informatics domain
The draft report contains the following recommendations.
• The Australian Government should maintain Standards Australia’s status as Australia’s peak non- government standards development body and the role of the Standards
Accreditation Board in accrediting other standards development organisations to make
Australian Standards.
The Australian Government should, in conjunction with Standards Australia, improve the effectiveness of Australia’s participation in international standard setting fora by more clearly articulating the national interest objectives to be pursued. Australia’s future participation must be focused on those international standardisation activities with the potential for the greatest net benefits for the Australian community.
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National interest objectives for health informatics are included into the MOU between DoHA and Standards Australia and reviewed at least yearly. Australian delegations are selected on the basis of capacity to progress these objectives, and reports to DoHA include commentary on their achievement.
The Australian Government should, in consultation with Standards Australia, ensure the most appropriate expert representation in international standardisation activities and increase funding in order to address any financial barriers to such representation.
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DoHA, Standards Australia and some States and health IT providers have recognised the importance of international standardisation for many years and have contributed additional funding and/or resources in kind to ensure Australia’s
interests are effectively represented.
DoHA funded delegations are typically of 3-6 people, noting that one critical US
based standards meeting can have up to 50 concurrent meetings. Other publicly and privately funded delegates can increase the size of these delegations to 5-10 people – sufficient to cover the breadth of topic areas and concurrent activities.
As far as possible, Australian delegations include a mix of technical, clinical, managerial and consumer perspectives, and even if not possible for every meeting, this is ensured over the course of each year’s participation.
Standards Australia should facilitate more direct participation by Australian consumer bodies on the ISO Committee on Consumer Policy and its working groups.
Standards Australia has included a consumer representative in each of its ISO delegations for several years, and Australia is one of the most active participants in the Consumer Policy Committee (COPOLCO) operating within ISO’s health informatics domain.
The Australian Government should, through the Memorandum of Understanding, continue to require that in the development of Australian Standards there is a

presumption in favour of adopting international standards, and that Standards Australia must publish the compelling reasons where an Australian Standard departs from an equivalent international standard. However, the suitability of such standards must continue to be assessed on a case-by-case basis by Standards Australia and by governments through their regulatory impact analysis processes where the Standards are to be referenced in regulation.
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IT-014 works strongly from the principle that international standards should be used where possible in health informatics. Australia imports a significant proportion of its health IT, and seeks to embed Australian requirements in targeted
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international standards so that imported software built on these can meet our needs.
This also reduces the need for Australian health IT exporters to bear the cost of supporting multiple standards across markets.
Accordingly, Standards Australia leads several international standardisation committees in health informatics, contributes heavily to the development of targeted work items, as localises international standards rather than develop alternates.
Building Australia’s ability to influence international standards development requires sustained and persistent relationship building as well as technical expertise – these are essentially lobbying forums, and IT-014 takes a strategic approach to influence building as well as technical intervention.
• Standards Australia’s justification process for the development of new or amended standards and the setting of priorities should be made more transparent and robust including by the publication of reasons for decisions, the establishment of a more open appeals process, and ensuring that the primary decision criterion must be a net benefit to the community as a whole.
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The health informatics work program is developed annually via a planning process spanning about three months and involving extensive consultation with key stakeholders.
The program, with “fact sheets” describing each work item and the significance of its development, will be published on the e-health standards site implemented during 2006.
The planning process for 2007-08, including appeals mechanisms, will also be published to make it more transparent and robust.
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For standards that are to be referenced in regulation, a rigorous impact analysis must be undertaken by governments in compliance with the RIS requirements of the relevant jurisdiction (or COAG requirements for intergovernmental action).
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To date, health informatics standards have not been referenced in regulation.
However, this recommendation may have applicability to NEHTA, which will be selecting standards for inclusion in public sector procurement processes.
• In order to best facilitate consideration of other regulatory and non-regulatory alternatives, RISs must be commenced at the earliest practicable opportunity.
While the preparation and coordination of the RIS is the responsibility of the regulating government, Standards Australia should provide technical input and other information as required by the drafters of the RIS and where such input is substantial and additional to normal activities, be compensated accordingly.

• Consistent with the fundamental principle of transparency and accessibility of legal requirements, the Australian Government, or other relevant governments, should fund
Standards Australia to provide low cost access to Australian Standards referenced in regulations. The implementation of this recommendation will require further examination by the Australian Government of the current contractual arrangements between Standards Australia and SAI Global (under which SAI Global holds the exclusive rights to sell Australian Standards).
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DoHA and Standards Australia have made Australian health informatics Standards and related publications available free of charge via electronic download for several years, via an annual fee paid by DoHA to SAI Global. This has dramatically widened accessibility to and knowledge of these standards. (Note – this arrangement cannot apply to direct text adoptions of international standards, where the intellectual property resides with international organisations.)
• Given the cost of access to Australian Standards, the Australian Government, and other governments, should seek to minimise the number of referenced standards and, in particular, avoid unnecessary cross references to Standards which make it necessary to purchase multiple Standards documents.
• Standards Australia should improve the balance of interests represented on committees by:
increasing the participation of small business, consumer and other community interests;
requiring sector boards to be more rigorous in ensuring appropriate balanced representation on technical committees, including by regular reviews of the
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composition of such committees; requiring all committee membership lists to state publicly not only the name of the nominating organisation but also the name of the company or entity from which members come; and improving complaint handling processes to deal with concerns about the lack of representational balance.
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Significant efforts have been made to improve committee balance within the health informatics domain. IT-014 (Health Informatics) includes representation from over
40 organisations spanning clinical, technical, consumer, private and public, industry, professional and academic interests. Membership is reviewed yearly and relevant organisations encouraged to join.
IT-014 consistently includes consumer, small business and clinical representation, however ensuring this requires persistent effort
An industry forum was held in March 2006 to attempt to widen health IT sector participation, and communication and marketing activities are ongoing.
However, securing active participation in standards development activities is an ongoing challenge.
• Standards Australia should continue to adopt the consensus decision making model for the development of Australian Standards. Standards Australia should make the standards development process more accessible to the general public, including by:

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better promotion of public comment opportunities and guaranteeing minimum time periods for consultation; and making all significant documents and other information readily accessible via the internet.
Standards Australia has developed an “e-health portal” via which quick access is provided to standards and related material. Public comment opportunities can be more widely notified, and steps will be taken to do this during 20006-07.
• Standards Australia should reduce barriers to volunteer participation on technical committees by adopting measures to reduce the cost of participation. In addition to the same measures necessary to improve efficiency and timeliness (see draft recommendation 8.4), Standards Australia should fund volunteers, particularly small business and consumer representatives not supported by their employers, for travel and accommodation expenses.
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Volunteers are assisted to participate in international standarisation activities via payment of a per diem allowance. The implications of assisting volunteers for domestic activities can be explored, but will probably need to be assessed at a
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Standards Australia wide level. This issue will be explored during negotiations for funding in 2006-07.
The contribution of academic staff may also be increased if participation in the research and publication activities could count towards university based activities.
It is understood that this is not the case at the moment, partly because the resulting works are not associated with volunteers’ names. However, academia is a powerful, largely untapped resource for standards developers.
• Standards Australia must continue to improve the efficiency and timeliness of
Standards development, including by:
making greater use of independent experts to prepare early drafts of Australian
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Standards; reducing face-to-face meetings, including through better use of technology;
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increased use of partnering arrangements; and improving project management.
All of these initiatives have been/are being undertaken within the health informatics domain. In 2006-07DoHA is funding substantial use of contracted experts to prepare early drafts; teleconferences and web-meetings are regularly used;
Standards Australia is partnering with DoHA and NEHTA; and significant effort has been made to improve project management.
• Standards Australia should strengthen its formal appeals and complaints handling processes. Such processes must be robust, transparent and sufficiently independent and cover all grievances relating to any aspect of the standards development process, including appeals against decisions relating to the development of a new or amended standard.
• The Australian Government should continue to support, with some reallocation of funding and possibly at an increased level overall, Australia’s participation in international standardisation activities, including:

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partial funding for Standards Australia’s membership of, and participation in, ISO and IEC and regional standardisation activities; partial, but increased, funding for industry participation in ISO and IEC meetings; support for involvement in a broader range of specified international fora; and full funding for participation by consumers in the ISO Committee on Consumer
Policy.
DoHA has funded increased participation in international standardisation for several years, with very positive results in advancing national interests.
In addition, support should be provided, through funding or in-kind support, for domestic standardisation activities, including:
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the secretariat of the Standards Accreditation Board; on a case-by-case basis, development of regulatory standards and input into the preparation of associated regulation impact statements; and enabling low-cost access to regulatory standards.
• The Australian Government should continue to use the Memorandum of Understanding
(MOU) as the most appropriate instrument for setting out the basis for its relationship with Standards Australia. While the terms of the current MOU generally remain appropriate, some changes are necessary including to:
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give effect to many of the specific draft recommendations in this report; improve the clarity of the document and its objectives, in particular by better
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defining public interest activities; deal with the special requirements of regulatory standards; and require public reporting on an annual basis of its performance against the MOU obligations.
Outcomes
The speed of production of health informatics standards – always an issue in a rapidly changing technology environment, has increased markedly as has the volume of production. In 2006-07 IT-014 has some 40 projects underway. This represents exceptionally good value for the relatively little money invested by Government.
The diagram overleaf demonstrates productivity increases over recent years.

Australian health informatics Standards and related publications published, by year,
1995-2006
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9
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Conclusions
Many of the Productivity Commission’s draft recommendations have already been implemented over several years in the health informatics domain. Experience therein suggests the recommendations are well founded.
The partnership approaches implemented between Standards Australia and DoHA and
NEHTA over recent years has anticipated and implemented the majority of the Productivity
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Commission’s recommendations, with great success in accelerating standards development in health informatics and increasing Australia’s international influence in areas of high national interest.
Areas for further exploration include:
• accreditation of and/or requirements for other developers of standards and specifications in health to adopt recognised good practices (anticipated in NEHTA’s
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Management framework for Standards Development , but requiring follow-up to promote adoption); funding for targeted volunteer groups likely to be under-represented; publication of the planning process for the 2007-08 work program, and wider notification of public consultation processes.
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National E-Health Standards Development, A Management Framework, Version 1.0 — 15/03/2006