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Overcoming the barriers: National to European to G7
International Journal of Medical Informatics 48 (1998) 33 – 38
Overcoming the barriers: National to European to G7 Ray Rogers European Institute of Health and Medical Sciences, Uni6ersity of Surrey, Guildford, Surrey GU2 5RF, UK
Abstract An information revolution is underway which will have an impact on all sectors of society. It will fundamentally change national and international health systems. The global Internet is a key influence and will change the balance of power within and between healthcare professions, and between them and the general public. This revolution offers enormous potential benefits to global health but there is also potential for harm. There are a wide range of barriers to realising the potential benefits. They lie in areas such as the protection of personal information; ownership and legal accountability; data meanings; structures and database navigation; deficiencies in the global Internet and lack of access by many communities. This paper considers the nature of those barriers. In 1994, the Group of Seven Nations launched an initiative to stimulate a global information society. Theme 8 deals with healthcare and therein Sub-project 5 ‘Enabling Mechanisms’, which the author leads, is seeking to identify barriers and the authoritative international sources of advise and good practice. It is conducting an international survey, the results of which should be published by the end of 1997. This paper describes the aims of this Sub-project. © 1998 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Medical information; Global information society; Health telematics; Group of Seven Nations (G7); Data protection; Intellectual property
1. The revolution Every telecommunications specialist knows than an information revolution is underway creating unparalleled opportunities for global communications and access to knowledge and news. The global Internet is playing a major role and individual nations around the world are seeking to realise that potential. It will affect how and where we live. It will
impact social structures and the essence of democracy and government. All sectors of life will be changed, not least health. Telemedicine will completely revolutionise the way healthcare is delivered. It will impact on commerce. At present, hospitals in the USA are marketing multimedia teleconsulting to the Middle East and elsewhere. London hospitals may soon be competing. It will fundamentally change the
1386-5056/98/$19.00 © 1998 Elsevier Science Ireland Ltd. All rights reserved. PII S 1 3 8 6 - 5 0 5 6 ( 9 7 ) 0 0 1 0 6 - 8
34
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
way clinical professions think and where and how they work. The impact on the skills required across the spectrum of the caring professions will cause massive transfers of power between professions within their hierarchies. The ready availability of teleconsulting and of healthcare knowledge on an international scale is beginning to pass power into the hands of the general public. That will, the author predicts, cause a major sea change over the next 10 years.
2. The need for global collaboration In this environment, no person can be an island. Nations which endeavour to run their own rules, laws and standards without careful regard to the global scene, are in for a shock. As it is, the legal control of nations over access to pornography and politically unacceptable material has suddenly weakened. In the medical environment most nations have laws and/or codes of practice on the advertising of medicinal products and their availability. The global Internet is shooting holes in that fabric. Very few nations have a real grip and grasp on this totality and what it will mean for healthcare. Meanwhile, the information revolution approaches like an express train. This revolution has enormous potential to improve health on a national and global scale. On the other hand the loss of control, such as over drug advertising, could have serious adverse effects unless new mechanisms can be found to deal with them. This paper examines some of the international barriers which are preventing, or will prevent, the realisation of the potential of telematics for the global information society in health. It outlines the work which the Group of Seven Nations Health Theme Sub-
project 5 ‘Enabling Mechanisms’ is undertaking in that context. If we are to appreciate where we need international standards in the technical sense, and in the wider context of international agreements and treaties, then it is necessary firstly to understand the barriers at which they are to be targeted. To appreciate what those barriers are, and their relative importance, it is necessary to be clear as to the areas which are driving the global health society. At this present time the author suggests these are: exchange of healthcare information across international boundaries including electronic patient data cards carried by citizens access to healthcare information on an international scale both by professionals and the public healthcare provision such as international teleconsulting. 3. The barriers What then are the barriers to achieving these ‘business ends’? The author sees them falling within four categories: protecting personal information ownership and legal accountability data meanings, structures and database navigation use of networks.
3.1. Protecting personal information Issues concerning the protection of personal information come in many guises. Many nations have general data protection legislation which, at a high level, are similar. The European Union has adopted a Data Protection Directive to harmonise laws. However, the devil is in the detail where there can be extensive differences such as:
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
the extent to which individuals must consent to the use of personal information about them the scope of ‘personal information’, e.g. membership of trade unions, religion or ethnic origin the nature of restrictions on access to person-identifiable data, e.g. for research rights of access by individuals to data stored about them the nature of data which is illegal to transmit, e.g. HIV, abortions, infertility treatments rights of access to personal health data by non-health bodies such as law enforcement agencies. Thus, transmission of personal health data across national boundaries could have unknown consequences. For example, it may be illegal fail to serve an important anticipated purpose because access by the recipient was restricted in a way unknown to the sender reduce the protection afforded to an individual’s privacy. Data protection per se is not, however, a matter solely of law. Professional Codes of Ethics may be far more powerful influences in some nations. These codes will differ and could inhibit or prevent clinical collaboration, e.g. in international research. Additionally, national rules or laws may limit access to personal health data and may require proof of identity of membership of a ‘class’, e.g. a medical practitioner according to a national legal definition. Technical means are of course available for authentication, such as professional data cards. However, electronic proof of being a medical practitioner may be afforded to an individual practising certain types of medicine in Asia which might not be recognised in Europe and vice versa.
35
Finally, nations differ in laws and attitudes to encryption when communicating personal health data. Some may require strong encryption, others may prohibit the use of very strong algorithms and key lengths, or insist on key escrow. The views of law enforcement agencies differ substantially internationally.
3.2. Ownership and legal accountability Rules on intellectual property rights vary. In some circumstances, ‘intellectual property’ may belong to those who fund it but, in other circumstances, it may belong to those who create it. This may place ownership of internationally distributed clinical records in doubt, not to mention research results. Increasing numbers of databases are appearing on the ‘web’ through remote international contributions to web servers hosted by single institutions, e.g. an international library of clinical images. Who owns that data? Can only the owner pursue those who might copy or abuse it? What if the owner of the server copies the data and sells it? If the owner of the server is the owner of the data, is that institution totally legally liable for its content even if the data entry is open to anyone internationally? Differences in legal accountability for information content and accuracy can raise barriers. The need for a hand-written signature as a sign of acceptance of responsibility is buried deep in our psyche. Paper communications are assumed to be less vulnerable to easy tampering than electronic equivalents. The legal validity of electronic records and electronic signatures is unclear in many countries and, as a result, may inhibit information exchanges where ‘proof’ of accountability is important.
36
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
3.3. Data meaning and database na6igation Transmission of data often requires meaning to be carried by coded terms and extracted through classifications. If the structure of the coding or classification system is unclear, meaning can be disturbed, perhaps dangerously. Very few international classifications and coding systems exist. Even where they do, they might not be accepted universally. This makes the creation and interrogation of international databases and accurate communication of health data extremely difficult. This is worsened by differences in natural languages. Computerised natural language translation of free text, of sufficient accuracy for health applications, is some years distant. However, restricting communication to defined coded data sets or classifications may allow progress (akin to the restricted ‘police speak’ used by France and England to control the Channel Tunnel). There is another aspect of meaning. The status of scientific literature is often recognised through established peer review processes. However, electronic databases often lack external signs of national or international ‘accreditation’ even if they exist. Without ‘registration processes’ for data entry or contributions to clinical trials, the scientific standing and validity of knowledge bases may be diluted and generate distrust. Individuals are already using the Internet to search for care protocols, disease management schemes and drug information. Patients are appearing in GP practices with such downloads. Individuals can now seek second opinions by teleconsultations theoretically anywhere in the world and pay by credit card. This empowerment of the public can be good but only if the information is ‘good’. How will the public distinguish between bad and good information unless the clinical pro-
fessions involve themselves in accreditation schemes with indexing to assist the public in searches? The need for indexing as an aid to searching is wider than accreditation and the public. World Wide Web search engines commonly add sites to their directories through web crawlers which catalogue sites by analysing the titles and descriptions of the documents they encounter. Even though this technology is growing in ‘smartness’, it is far from perfect. As a result, searches become cluttered with irrelevant data and good sites are missed. An international indexing system designed for health related web sites to guarantee correct cataloguing is required.
3.4. Use of networks There are many barriers to a global information society relating to the use of networks such as the following: service levels are generally not guaranteed applications directly connected can be exposed to unauthorised access security of transmitted data in terms of integrity, availability and preservation of confidentiality is uncertain at times, there can be severe network congestion with serious consequences for time critical applications whilst the Internet has grown on the back of cheap or even free access to information, this may change markedly through commercialisation and the advent of premium or stratified services enabled by new filtering and processing technologies. The major issue, however, is that the gradual replacement of paper or other material communications, knowledge stores and publications with electronic versions, may deprive whole communities without electronic access, or with access only to limited bandwidth. This may seriously damage the underpinning
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
theology of many national health systems, i.e. equity of access. It may add information as a further deficiency of society’s underclass which already suffers a health deficit.
4. Global ‘solutions’ Many of these barriers require global solutions in the form of international standards, agreements, treaties and laws. In the area of technical standards for health informatics, the European formal standards activity within the CEN technical committee TC/251 is impressive. There are also substantial national standard programmes in medical informatics in countries such as the USA, Australia and Canada. The proposal to create an international ISO Standards Committee for health informatics is very welcome to further internationalise these endeavours. However, these bodies only cover a subset of the solutions required. Some clearly ‘belong’ to international bodies such as WIPO (World Intellectual Property Organisation) or WHO for some clinical classifications or IETF (Internet Engineering Task Force) overseeing Internet ‘standards’ where something new seems to emerge almost monthly. Some solutions will require harmonisation of laws such as for data protection in the European Union. Some will emerge from Research and Development programmes such as the various phases of the European Union Telematics ‘Frameworks’. An example would be the digital ‘water marking’ of electronic documents to trace ownership and spot abuse and tampering. In areas like indexing of health related databases on the Internet, expertise from the library environment will be necessary. For detailed clinical classifications, international clinical professional associations should play a leading role.
37
One thing which is clear is that a holistic approach to enabling a global information society in health will require those involved in health telematics to make an input to, and seek contributions from, sectors with which there has been little involvement to date. Flexible ‘federations’ of a wide range of contributing organisations, covering very diverse skills and knowledge, will be required to achieve success. 5. G7 Sub-project 5 In 1994, the G7 nations in Naples, agreed to promote development of a global information infrastructure to be pursued within 11 themes. Theme 8 is healthcare. Within the healthcare theme, Sub-project 5, which the author leads, deals with ‘Enabling Mechanisms’. Its aims are: to identify the most important issues to be faced and solved if a global information society for health is to be enabled and international health projects are to succeed, at least in the context of the G7 nations to distinguish between the features of these issues which are either specific to health or which have a special significance for health applications to discuss and recommend appropriate procedures to solve open questions in this context to provide, for any existing or new G7 health project, a platform of information of the current status of key enabling mechanisms, if not globally then at least in the G7 nations, including sources of authoritative standards or advice to liaise with non-health G7 groups, so that they may be aware of the general and specific issues found in enabling a global information society in health, in order to take them into account in their work
38
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
through the G7 coordinators, and by other agreed means, to alert G7 policy makers of the key issues that need to be resolved in legal, commercial and other contexts, if a global information society in health is to be realised. At the time of writing, Sub-project 5 is seeking the views of over 300 international experts in medical informatics relating to the barriers to a global information society in health, their relative importance and authoritative sources of advice on their solutions. The results should be published by end 1997.
.
6. Conclusions A global information society in health offers enormous potential for improving health on a national and global scale. However, there are barriers to be solved and there could be risks to health if they are not. A holistic approach to finding these solutions will require collaboration between many diverse bodies, extending far beyond formal health informatic standards bodies such as CEN and ISO.
Overcoming the barriers: National to European to G7 Ray Rogers European Institute of Health and Medical Sciences, Uni6ersity of Surrey, Guildford, Surrey GU2 5RF, UK
Abstract An information revolution is underway which will have an impact on all sectors of society. It will fundamentally change national and international health systems. The global Internet is a key influence and will change the balance of power within and between healthcare professions, and between them and the general public. This revolution offers enormous potential benefits to global health but there is also potential for harm. There are a wide range of barriers to realising the potential benefits. They lie in areas such as the protection of personal information; ownership and legal accountability; data meanings; structures and database navigation; deficiencies in the global Internet and lack of access by many communities. This paper considers the nature of those barriers. In 1994, the Group of Seven Nations launched an initiative to stimulate a global information society. Theme 8 deals with healthcare and therein Sub-project 5 ‘Enabling Mechanisms’, which the author leads, is seeking to identify barriers and the authoritative international sources of advise and good practice. It is conducting an international survey, the results of which should be published by the end of 1997. This paper describes the aims of this Sub-project. © 1998 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Medical information; Global information society; Health telematics; Group of Seven Nations (G7); Data protection; Intellectual property
1. The revolution Every telecommunications specialist knows than an information revolution is underway creating unparalleled opportunities for global communications and access to knowledge and news. The global Internet is playing a major role and individual nations around the world are seeking to realise that potential. It will affect how and where we live. It will
impact social structures and the essence of democracy and government. All sectors of life will be changed, not least health. Telemedicine will completely revolutionise the way healthcare is delivered. It will impact on commerce. At present, hospitals in the USA are marketing multimedia teleconsulting to the Middle East and elsewhere. London hospitals may soon be competing. It will fundamentally change the
1386-5056/98/$19.00 © 1998 Elsevier Science Ireland Ltd. All rights reserved. PII S 1 3 8 6 - 5 0 5 6 ( 9 7 ) 0 0 1 0 6 - 8
34
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
way clinical professions think and where and how they work. The impact on the skills required across the spectrum of the caring professions will cause massive transfers of power between professions within their hierarchies. The ready availability of teleconsulting and of healthcare knowledge on an international scale is beginning to pass power into the hands of the general public. That will, the author predicts, cause a major sea change over the next 10 years.
2. The need for global collaboration In this environment, no person can be an island. Nations which endeavour to run their own rules, laws and standards without careful regard to the global scene, are in for a shock. As it is, the legal control of nations over access to pornography and politically unacceptable material has suddenly weakened. In the medical environment most nations have laws and/or codes of practice on the advertising of medicinal products and their availability. The global Internet is shooting holes in that fabric. Very few nations have a real grip and grasp on this totality and what it will mean for healthcare. Meanwhile, the information revolution approaches like an express train. This revolution has enormous potential to improve health on a national and global scale. On the other hand the loss of control, such as over drug advertising, could have serious adverse effects unless new mechanisms can be found to deal with them. This paper examines some of the international barriers which are preventing, or will prevent, the realisation of the potential of telematics for the global information society in health. It outlines the work which the Group of Seven Nations Health Theme Sub-
project 5 ‘Enabling Mechanisms’ is undertaking in that context. If we are to appreciate where we need international standards in the technical sense, and in the wider context of international agreements and treaties, then it is necessary firstly to understand the barriers at which they are to be targeted. To appreciate what those barriers are, and their relative importance, it is necessary to be clear as to the areas which are driving the global health society. At this present time the author suggests these are: exchange of healthcare information across international boundaries including electronic patient data cards carried by citizens access to healthcare information on an international scale both by professionals and the public healthcare provision such as international teleconsulting. 3. The barriers What then are the barriers to achieving these ‘business ends’? The author sees them falling within four categories: protecting personal information ownership and legal accountability data meanings, structures and database navigation use of networks.
3.1. Protecting personal information Issues concerning the protection of personal information come in many guises. Many nations have general data protection legislation which, at a high level, are similar. The European Union has adopted a Data Protection Directive to harmonise laws. However, the devil is in the detail where there can be extensive differences such as:
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
the extent to which individuals must consent to the use of personal information about them the scope of ‘personal information’, e.g. membership of trade unions, religion or ethnic origin the nature of restrictions on access to person-identifiable data, e.g. for research rights of access by individuals to data stored about them the nature of data which is illegal to transmit, e.g. HIV, abortions, infertility treatments rights of access to personal health data by non-health bodies such as law enforcement agencies. Thus, transmission of personal health data across national boundaries could have unknown consequences. For example, it may be illegal fail to serve an important anticipated purpose because access by the recipient was restricted in a way unknown to the sender reduce the protection afforded to an individual’s privacy. Data protection per se is not, however, a matter solely of law. Professional Codes of Ethics may be far more powerful influences in some nations. These codes will differ and could inhibit or prevent clinical collaboration, e.g. in international research. Additionally, national rules or laws may limit access to personal health data and may require proof of identity of membership of a ‘class’, e.g. a medical practitioner according to a national legal definition. Technical means are of course available for authentication, such as professional data cards. However, electronic proof of being a medical practitioner may be afforded to an individual practising certain types of medicine in Asia which might not be recognised in Europe and vice versa.
35
Finally, nations differ in laws and attitudes to encryption when communicating personal health data. Some may require strong encryption, others may prohibit the use of very strong algorithms and key lengths, or insist on key escrow. The views of law enforcement agencies differ substantially internationally.
3.2. Ownership and legal accountability Rules on intellectual property rights vary. In some circumstances, ‘intellectual property’ may belong to those who fund it but, in other circumstances, it may belong to those who create it. This may place ownership of internationally distributed clinical records in doubt, not to mention research results. Increasing numbers of databases are appearing on the ‘web’ through remote international contributions to web servers hosted by single institutions, e.g. an international library of clinical images. Who owns that data? Can only the owner pursue those who might copy or abuse it? What if the owner of the server copies the data and sells it? If the owner of the server is the owner of the data, is that institution totally legally liable for its content even if the data entry is open to anyone internationally? Differences in legal accountability for information content and accuracy can raise barriers. The need for a hand-written signature as a sign of acceptance of responsibility is buried deep in our psyche. Paper communications are assumed to be less vulnerable to easy tampering than electronic equivalents. The legal validity of electronic records and electronic signatures is unclear in many countries and, as a result, may inhibit information exchanges where ‘proof’ of accountability is important.
36
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
3.3. Data meaning and database na6igation Transmission of data often requires meaning to be carried by coded terms and extracted through classifications. If the structure of the coding or classification system is unclear, meaning can be disturbed, perhaps dangerously. Very few international classifications and coding systems exist. Even where they do, they might not be accepted universally. This makes the creation and interrogation of international databases and accurate communication of health data extremely difficult. This is worsened by differences in natural languages. Computerised natural language translation of free text, of sufficient accuracy for health applications, is some years distant. However, restricting communication to defined coded data sets or classifications may allow progress (akin to the restricted ‘police speak’ used by France and England to control the Channel Tunnel). There is another aspect of meaning. The status of scientific literature is often recognised through established peer review processes. However, electronic databases often lack external signs of national or international ‘accreditation’ even if they exist. Without ‘registration processes’ for data entry or contributions to clinical trials, the scientific standing and validity of knowledge bases may be diluted and generate distrust. Individuals are already using the Internet to search for care protocols, disease management schemes and drug information. Patients are appearing in GP practices with such downloads. Individuals can now seek second opinions by teleconsultations theoretically anywhere in the world and pay by credit card. This empowerment of the public can be good but only if the information is ‘good’. How will the public distinguish between bad and good information unless the clinical pro-
fessions involve themselves in accreditation schemes with indexing to assist the public in searches? The need for indexing as an aid to searching is wider than accreditation and the public. World Wide Web search engines commonly add sites to their directories through web crawlers which catalogue sites by analysing the titles and descriptions of the documents they encounter. Even though this technology is growing in ‘smartness’, it is far from perfect. As a result, searches become cluttered with irrelevant data and good sites are missed. An international indexing system designed for health related web sites to guarantee correct cataloguing is required.
3.4. Use of networks There are many barriers to a global information society relating to the use of networks such as the following: service levels are generally not guaranteed applications directly connected can be exposed to unauthorised access security of transmitted data in terms of integrity, availability and preservation of confidentiality is uncertain at times, there can be severe network congestion with serious consequences for time critical applications whilst the Internet has grown on the back of cheap or even free access to information, this may change markedly through commercialisation and the advent of premium or stratified services enabled by new filtering and processing technologies. The major issue, however, is that the gradual replacement of paper or other material communications, knowledge stores and publications with electronic versions, may deprive whole communities without electronic access, or with access only to limited bandwidth. This may seriously damage the underpinning
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
theology of many national health systems, i.e. equity of access. It may add information as a further deficiency of society’s underclass which already suffers a health deficit.
4. Global ‘solutions’ Many of these barriers require global solutions in the form of international standards, agreements, treaties and laws. In the area of technical standards for health informatics, the European formal standards activity within the CEN technical committee TC/251 is impressive. There are also substantial national standard programmes in medical informatics in countries such as the USA, Australia and Canada. The proposal to create an international ISO Standards Committee for health informatics is very welcome to further internationalise these endeavours. However, these bodies only cover a subset of the solutions required. Some clearly ‘belong’ to international bodies such as WIPO (World Intellectual Property Organisation) or WHO for some clinical classifications or IETF (Internet Engineering Task Force) overseeing Internet ‘standards’ where something new seems to emerge almost monthly. Some solutions will require harmonisation of laws such as for data protection in the European Union. Some will emerge from Research and Development programmes such as the various phases of the European Union Telematics ‘Frameworks’. An example would be the digital ‘water marking’ of electronic documents to trace ownership and spot abuse and tampering. In areas like indexing of health related databases on the Internet, expertise from the library environment will be necessary. For detailed clinical classifications, international clinical professional associations should play a leading role.
37
One thing which is clear is that a holistic approach to enabling a global information society in health will require those involved in health telematics to make an input to, and seek contributions from, sectors with which there has been little involvement to date. Flexible ‘federations’ of a wide range of contributing organisations, covering very diverse skills and knowledge, will be required to achieve success. 5. G7 Sub-project 5 In 1994, the G7 nations in Naples, agreed to promote development of a global information infrastructure to be pursued within 11 themes. Theme 8 is healthcare. Within the healthcare theme, Sub-project 5, which the author leads, deals with ‘Enabling Mechanisms’. Its aims are: to identify the most important issues to be faced and solved if a global information society for health is to be enabled and international health projects are to succeed, at least in the context of the G7 nations to distinguish between the features of these issues which are either specific to health or which have a special significance for health applications to discuss and recommend appropriate procedures to solve open questions in this context to provide, for any existing or new G7 health project, a platform of information of the current status of key enabling mechanisms, if not globally then at least in the G7 nations, including sources of authoritative standards or advice to liaise with non-health G7 groups, so that they may be aware of the general and specific issues found in enabling a global information society in health, in order to take them into account in their work
38
R. Rogers / International Journal of Medical Informatics 48 (1998) 33–38
through the G7 coordinators, and by other agreed means, to alert G7 policy makers of the key issues that need to be resolved in legal, commercial and other contexts, if a global information society in health is to be realised. At the time of writing, Sub-project 5 is seeking the views of over 300 international experts in medical informatics relating to the barriers to a global information society in health, their relative importance and authoritative sources of advice on their solutions. The results should be published by end 1997.
.
6. Conclusions A global information society in health offers enormous potential for improving health on a national and global scale. However, there are barriers to be solved and there could be risks to health if they are not. A holistic approach to finding these solutions will require collaboration between many diverse bodies, extending far beyond formal health informatic standards bodies such as CEN and ISO.