From: ALISON TURNER <ATURNER@ansi.org>
To: healthcare <healthcare@mailserv.ansi.org>
Subject: FW: Task Group 2 Draft Business Plan
Date: Wed, 19 Mar 97 10:03:00

Intl Healthcare Informatics/Task Group 2/N8 1997-03-09

The Case for Creating an International Committee for Standardization of Healthcare Informatics

PRELIMINARY VERSION

Source: This is the results of the work of the international task group 2 formed in New York 1996-12-17 This report was compiled by Gunnar Klein after the first meeting of the task group in Stockholm 1997-02-26/27. This is a revised version after comments from the task group.

Action: This report is distributed to all representatives of the National Standards Boards attending the New York meeting and some other interested parties. Comments and suggestions are invited before 1997-05-01 in order for the task group to prepare a final report to the NSBs by June 1.

1. Foreword

The purpose of this draft report "The Case for Creating an International Committee for Standardization of Healthcare Informatics" is to provide material for the National Standards Bodies (NSBs) for consideration of the justification and possible work plan of such a committee.

This is the first report from the international Task Group 2 created at a meeting 1996-12-17 in New York convened by ANSI with representatives of ISO member bodies (NSBs) with the purpose of discussing the possible formation of an international committee for standardization of Healthcare Informatics. The task group has been led jointly by Peter Waegemann (Chairman of ANSI-HISB) and Gunnar Klein (Chairman of CEN/TC251), the co-ordinators of standardization in the field of Medical Informatics in USA and Europe, respectively.

The task group and its objectives are presented in more detail in annex A. This report is based on the discussions of the Task group at its first meeting in Stockholm 1997-02-26/27. This draft report will be circulated for comments to the NSBs responding to the initial call for interest and participating in the meeting in New York, December 1996. A revised proposed final report will be circulated to all NSBs as a background to an international meeting in London, June 19 1997 to be hosted by BSI (Britis Standards Institution).

During the New York meeting in December it became evident that a number of standards bodies were looking forward to the establishment of international work in the area of healthcare informatics. A draft proposal describing a possible ISO Technical Committee was tabled by the US delegation outlining a possible scope and justification of such work. It was felt at that point, however, by representatives from several countries that the issue was quite complicated and that a more extensive study should be undertaken by an international ad hoc group to ensure a better background for the decision when a formal proposal might be submitted. Important issues to clarify for the Task group 2 were:

An important issue for the establishment of international work is the availability of standards in the field from various organizations around the world that could be an important input to the work or possibly submitted as is for international vote. A special task group 1 was formed under the leadership of Georges De Moor who as chairman of the working group 16 of IMIA (International Medical Informatics Association) would undertake to establish a listing of existing work. This has been started and there should be results available for the next phase of the study produced by Task group 2.

The task group was also asked in its original brief to present costs and possible financing of standardization in the field but at its meeting the Task group decided that it would not be feasible to attempt such analysis in this case. However, a NSB that is considering hosting a secretariat must of course make such a budget.

2. Healthcare and Healthcare Informatics

2.1 Introduction to the sector and some concepts

The healthcare sector is one of the largest sectors of society accounting for some 8-14 % of Gross National product. Since all citizens are potential patients, every citizen has a concern for the effectiveness of the healt care service system for themselves as well as for those that are close. As payers of services through insurance fees, taxation, or directly, also the efficiency of resource utilization is an issue, not only for the payment bodies.

Healthcare professionals and other caregivers have other interests in the development of the sector. In spite of the very intensive use of information in healthcare, so far information technology has been used much less than what is optimal. The relative weakness of standards in the area has been one limiting factor. Before going into the details it is necessary to introduce the concept healthcare informatics. In some countries the term Medical Informatics has been used instead and while the terms are roughly similar, today healthcare informatics is preferable. Informatics is a newer word for information science and technology, especially when computers are involved.

Telematics is the use of telecommunication in conjunction with informatics, e.g. the passing of information from one computer to another via a telephone line or other electronic link.

The basic promises of telematics are obvious: by giving access to any form of knowledge anywhere, it speeds up the diffusion of information, saves time, increases collaboration between individuals and groups, and improves the quality of decisions. Healthcare Telematics is the application of telematics to medicine, e.g. using telematics to send patient test results from clinical laboratories to general practitioners but it also includes the application of telematics to the whole healthcare environment and involves e.g. management and nursing, as well as medical information transfer.

Electronic Data Interchange (EDI) is the concept of 'the transfer of structured and coded data, by agreed message standards, from computer to computer, by electronic means'. The data is essentially structured. Unstructured information such as facsimile or free-text electronic mail does not strictly fall into the category of EDI, although such information can be included as part of a message.

The data is primarily intended for processing by computer applications, rather than direct interpretation by human users. The data is transferred by electronic means, by data transmission using data communications network facilities.

The current EDI standards are really only concerned with the nature of the interchanged data, and cover three main areas:

It is important to distinguish both the links and the borderline between healthcare informatics and general problems of using information and communications technology (ICT). To achieve a maximally efficient use of ICT in healthcare allowing interoperability between system components and different healthcare organizations, a major prerequisite is a suitable infrastructure of generic inter-sector standards. To a large extent suc standards exist today much more so than only 10 years ago. However, there are still important gaps where the sector problems, i.e. for security solutions could possibly be solved by inter-industry actions.

The major reason for international healthcare standardization is of course different. It is linked to a vast amount of different application specific requirements. It is hardly realistic to address more than a few of these with international standards and these areas must be carefully selected to give maximum return on investment.

A special problem in this international study is the widely different healthcare systems and differing concepts and terms in informatics used in different parts of the world, even when English is a common language.

2.2 Definitions

The following list is used for the purpose of understanding of this document only.

Clinical Information Information about a patient, relevant to the health or treatment of that patient, that is recorded by on on behalf of a healthcare professional. Note: Clinical information about a patient may include information about the patient's environment or about related people or animals where this is relevant.

Electronic Data Interchange The transfer of structured and coded data, by agreed message standards, from computer to computer, by electronic means. (International Data Exchange Association)

Healthcare Informatics Scientific discipline that is concerned with the cognitive, information processing and communication tasks of healthcare practice, education and research, including the information science and technology to support these tasks.

Healthcare Service Service provided with the intention of directly or indirectly improving the health of the people, populations or animals to whom it is provided

Healthcare Professional Person who is entrusted with the direct or indirect provision of defined healthcare services to a patient or population of patients. Example: primary care physician, dentist, nurse, social worker, veterinary surgeon, technologist, radiographer, medical secretary or clerk

Healthcare Organization Organization responsible for the direct or indirect provision of healthcare services to a patient, or involved in the provision of healthcare related services. Note: A healthcare organization may be used as a discrete entity or as a superstructure containing departments and sub-departments.

Payment bodies (healthcare purcahsers) Organizations responsible for financing and economic supervision of healthcare services. Examples: Public authorities at national, state/regional or local level, Insurance companies.

Healthcare ICT-suppliers Organizations developing and selling Information and Communications Technologies solutions (products and services) to healthcare organizations or to other ICT-suppliers for integration into end-user solutions.

Patient A person who is receiving, or is registered to receive, healthcare service

3. Requirements for standards in healthcare informatics

The purpose of all standards is to improve the degree of order in their given context. Healthcare informatics standards will benefit a number of different groups in addition to the major stakeholders, the healthcare provider organizations (users) and their informatics suppliers.

It is necessary in this context to examine both the benefits of standards as such and of international standards, in particular.

3.1 The healthcare provider perspective

Healthcare services and systems are highly complex. There is much room for informatics to improve the effectiveness and efficiency of services by providing information when and where required for automation of routine tasks, elimination of delays and avoiding duplication of labor. The purpose of standards is to enable improvements in services, not to standardize healthcare delivery. Improvements in efficiency and effectiveness will lead to lower costs for the provider.

The availability of international standards compared with national or regional healthcare informatics standards implies for the provider that: The services can be developed on an international market. This has limited value other than in a few specific border areas and highly special niches but this aspect may increase in the future.

Two special providers of services may be mentioned in particular in this context. One is the information service provider that often operates internationally already. The other is the pharmaceutical industry that is dependent on multinational clinical trials to meet the high requirements for documentation by regulatory authorities. It is obvious that international standards greatly facilitate such activities. Similarly the supply of information on production characteristics and various other analyses to be provided by pharmaceutical industry to authorities in various parts of the globe to obtain market approval will become digital and greatly benefit from international standards.

International standards will facilitate the availability of competitive products from a world market of suppliers probably leading to lower costs and better products.

3.2 The healthcare ICT supplier perspective

In conventional sectors of industry, standards are well known for increasing companies' market opportunities and for lowering the cost of equipment and services to users.

The same arguments hold for the field of healthcare informatics, where European industry currently supplies to a fragmented market, products, which have a short life cycle and are over-customized and therefore expensive to develop, to buy or to maintain. Agreement on common requirements will reduce the cost of healthcare information systems and open up the market.

The healthcare informatics suppliers need standards to enable them to work and do business with each other (other than on a one to one basis). The complexity of healthcare information flow requires "horizontal" links between software designed to do different tasks (for example between GPs and hospitals). In addition, standards will also enable "vertical" links between suppliers, creating chains of added value (e.g. between the suppliers of software components and system integrators), based on specialization and division of labor and economies of scale. Such supplier chains are found in all "mature" industries.

While standards may be considered beneficial in the longer term for industry, there may also be some short-term reluctance since new standards demanded by the customers lead to substantial development costs. Also some companies may regard the more open market and increased competition as a problem. Generally, industry welcomes international open markets without barriers but it should be recognized that it is mainly large enterprises that can utilize the global market while many smaller suppliers, common for instance as developers of GP information systems, only operate on a domestic market that may be as small as the Icelandic with only 250,000 in total population.

In contrast the big multinationals developing imaging and radiology information systems, all operate on an international market and will strongly support standardization. It may not be obvious however that they prefer the formal standards bodies with its somewhat slow process. If an industry consortium could develop the required standards much quicker that may be a preferred solution. On the other hand, industry groups usually have difficulty in long term stability and some companies may feel excluded by other market actors. The formal standards bodies with their assurance that all involved actors get a fair treatment and long term stability may be regarded as very important as a protection for the large investments necessary in some fields of healthcare informatics.

3.3 The healthcare payment body perspective

Standards for healthcare reimbursement messages have had a very large impact already. The trend is strong towards at least national solutions since most payment bodies deal with essentially all healthcare provider organizations in a country although there may be some strong preference for a smaller group. In many countries, including the US, the state as a payment body for healthcare at least for certain groups exerts a strong influence and pushes the move towards standards.

It is only to a limited extent that there exist any payments of healthcare cross borders. The requirement for international standards may therefore be questioned. While international standards could always be considered a good thing had they existed before current developments were made, they can be regarded as a problem if change of heavy payment management systems will be necessary.

It is clear that various national legislations and market situations means that there exists large differences in the way payment bodies interact wit the healthcare providers. It is therefore probably difficult to achieve quick win-win situations for internationally standardized payment related transactions. However, the payment bodies also have a strong interest in an increased efficiency of the healthcare provider organizations and possibly their lower costs. There should be little doubt that in some areas of healthcare informatics there are clear benefits of international standards that indirectly will be much appreciated by any payment body.

3.4 The healthcare authority perspective

Standards in healthcare facilitate the task of healthcare authorities to collect information for planning of healthcare services and follow up of public health and, not least, for advancement of the medical sciences through various research clinical and pre-clinical. In some geographical areas e.g. in Europe, where information (e.g. administrative patient information) crosses management boundaries and in many cases regional and national boundaries, agreement on message structures and information content is necessary on a supranational basis.

Another consideration that healthcare authorities may undertake is that standardized healthcare informatics is a requirement for a possible control of quality that may be deemed necessary from the point of view of public safety. Mandatory control and certification may become a reality for some classes of healthcare information systems just as we have it for pharmaceuticals and medical devices in many countries today.

Just as for certain other groups, one important benefit of international standards that public authorities may appreciate is the presumably higher technical quality when drawing upon the expertise of the world's leading knowledge in the field. In total, probably fewer resources have to be devoted and better results can be expected when moving from national standardization, often sponsored by the national governments, to international standards.

3.5 The healthcare professional perspective

The scientific medical knowledge base has always been international. This is one reason why healthcare professionals will welcome international standards in healthcare informatics. This may facilitate the use of information data bases not related to individual patients but to general knowledge. Examples are information on pharmaceutical drugs or advanced cancer therapy. It is expected that with the advent of Internet there will be an explosion in the use of such global information sources.

Standards will facilitate the interaction of healthcare professionals, between various professions, geographical areas and even cross-border. There is little doubt that this group will appreciate international standards.

More and more will be seen an emerging market of specialized assistance in interpreting the condition of an individual patient using experts from other countries. One example is for the evaluation of very rare diseases where telemedicine is employed to transfer histopathological images to a remote "superexpert" for judgement, often as a second opinion only.

Needless to say, international standards for healthcare informatics will improve the possibilities for international clinical research, which is an important activity for many healthcare professionals.

3.6 The patient perspective

By improving the ability of public administrations, of research centers studying medical effectiveness and of healthcare professionals to share critical information, standards in healthcare telematics and informatics may improve the health of individual patients. This will mainly be achieved by making the largely local healthcare provider organizations more effective.

However, in some special situations relatively large numbers of citizens travel cross borders and will be in need of healthcare in a country other than that normally resided in. The most common is for an acute condition to occur that may be better treated if contact can be established (and in the future through the global networks) with the previous healthcare provider and professional. There are also situations when a planned transfer of a patient will occur to another country for a very specialized type of care that cannot be provided in the country of origin. Also in these situations international standards could have a direct influence on the quality of care. One example where telematics is already used in a multinational collaboration is in the European collaboration for transplantation of bone marrow and other organs.

4. Major areas of interest

It would be desirable to have a common conceptual model of healthcare informatics for the formulation of a strategy including both selection of items and a possible sub-structure of subcommittees and working groups. However, it is not meaningful to build this on an academic model of the subject area, but it should be restricted to possible feasible standardization projects.

There have been some attempts to build such a model in various parts of the world, e.g. when creating the European standardization committee for Medical Informatics or in the US draft proposal for an ISO committee. In reality the various bodies that contribute to standardization usually follow a muc more pragmatic path. The task group briefly discussed such an overall model and two alternatives are presented below for consideration. It was concluded however, that it is more important to agree on a number of urgent work items than to ensure a comprehensive model for the whole area.

The broad subject areas as proposed in the US draft proposal amended by suggestions from Peter Treseder and Pat Village:

  1. Development of models, including:
  2. Electronic health records and informatics concerning health care functions, including:
  3. Confidentiality/security for healthcare, including:
  4. Health information, including:
  5. Healthcare concept representation, including:
  6. Communication, including:

5. Proposed work items for selection

In order for a better understanding of what the proposed scope may mean, the task group compiled a list of possible specific work items for the new work plan. Please note that these items are just candidates for consideration. Each of these has to be elaborated as to the specific content, strategy of work and deliverables. The task group welcomes suggestions for details of work item descriptions as well as comments stating priorities for or against the proposed items and of course any other items considered as top priority. Please note that in ISO and JTC1 all individual work item descriptions are subjected to international vote of approval once a formal committee has been established. In order to speed up the actual start of the work, it is desirable that the most urgently needed work items are formulated and discussed internationally. It is certainly preferable when starting up a new area for standardization if at least a few initial work items are formulated in advance. This allows the NSBs to obtain a better idea of the scope and strategy of the new committee and will ensure that the relevant work can start as soon as possible avoiding perhaps years of discussions once the formal committee has been established.

All the listed work items and thus possible standards below will as its full title be preceded by "Healthcare Informatics "

6. Organization of the work - ISO vs. JTC1

In the initial initiative by ANSI to seek the interest in an international committee for healthcare, it was assumed that such a committee would be hosted by ISO. This is still a very plausible proposal but an alternative has been proposed and also deserves consideration by the NSBs. This is to form a new subcommittee within JTC1, the large joint organization between ISO and IEC (International Electrotechnical Committee) that is responsible for standards in IT and including communication protocols. So far the 31 subcommittees of JTC1 have been concerned mostly with inter-sector application independent standards but with a few exceptions. However, partly due to the fact that a number of basic issues have been solved and the increasing need for application specific standards, the JTC1 plenary meeting in December approved a resolution aiming at a reorientation towards application specific standards development (See Annex E). Also, the possibility of a healthcare specific group was discussed and it was decided to specifically welcome such an establishment within JTC1. The JTC1 chairman also presented this to the New York meeting on December 17.

The task group does not wish to make any recommendation at this point but is aiming to do so in the May report. However, a number of issues for consideration are listed (See Annex D) and the task group welcomes any comments by the NSBs on the issue of the most suitable hosting for a new healthcare committee, ISO or JTC1.

7. Action plan to create an international committee

The following steps should be considered:

Continued work to achieve international consensus on strategy for the new committee Comments to the draft report invited until April 30, 1997. Next meeting of the Task group 2 planned for Chicago, May 15-16. Final report 1997-05-31. Formulation of at least a few specific work item descriptions where consensus is likely Consideration of individual standards boards for the possibility and suitability of offering a secretariat including a resource estimate and securing long term financing Development of a formal proposal to ISO or JTC1

Annex A. Task Group 2. Scope and membership

The following persons attended the Stockholm meeting February 26-27 meeting and have contributed to the report:

Gunnar Klein and Karin Kajbjer HSS (Sweden), Peter Waegemann, Medical Records Institute (USA) and Sharon Standford, American Dental Association (USA), Otfrid Schaefer, Central Research Institute of Ambulatory Health Care (Germany), Sue Besbrode, BSI (UK), Pat Village, NHS (UK) and Tim Benson, European Health Telematics Industry Association, (UK), Michio Kimura, Hamamatsu University Hospital (Japan) and Tetsuro Kiyotani, MEDIS-DC (Japan), Georges De Moor, University of Gent (Belgium) and Matti Ojala, Stakes (Finland), Peter Treseder, Standards Australia IT/14 (Australia).

It must be emphasized that the task group that has worked on this report is an international group of individual experts with the task to produce material for consideration by the NSBs. The resulting recommendations may not be unanimous in all aspects and should not be regarded as formally representing the opinions of their respective countries.

Annex B. Existing standards and standards bodies relevant for healthcare informatics

There exist already a large number of standards in the healthcare informatics field. Some are formal standards developed by the National standards bodies with their accredited organizations. Examples can be found in the, USA were a very large number of standards exists, Canada, and Australia. In Europe an intensive regional work program started in 1990 within CEN/TC251 has resulted in soon 30+ European standards which are also adopted as national standards in the 18 CEN countries that largely overlap with the European Union.

Some of the specifications developed outside of the formal standardization bodies as industry consortias or joint user-supplier groups have gained wide use all over the world in certain areas. Most noteworthy is perhaps the standard for Image communication (DICOM).

The work of Task group 1 investigating existing standards in the field will be summarized in the next edition of this report and a reference given to the results of the enquiry placed on the Web.

In addition to the work being performed by the formal standards bodies, the activities of groups like CorbaMED will also be outlined where relevant.

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Alpo Värri

Signaalinkäsittelyn laitos, Tampereen teknillinen korkeakoulu, PL 553, 33101 Tampere, Puh. 03-3652575, Fax. 03-3653857, E-mail: varri@cs.tut.fi.