Introduction 1 Recognising that European citizens are avid consumers of health related information on the internet and recognising that they are already using the types of rating system described above, the European Council at Feira on June 19-20 2000 supported an initiative within eEurope 2002 to develop a core set of Quality Criteria for Health Related Websites. 2 to draw up a commonly agreed set of simple quality criteria on which Member States, as well as public and private bodies, may draw in the development of quality initiatives for health related websites. These criteria should be applied in addition to relevant Community law 3 As a result of the meetings, as well as a web-based public consultation, a core set of quality criteria was established. The criteria may be used as a basis in the development of user guides, voluntary codes of conduct, trustmarks, accreditation systems, or any other initiative adopted by relevant parties, at European, national, regional or organisational level. By using a common set of criteria as a starting point, such initiatives can develop in a focused manner across the European Union. The objectives for the criteria were defined as follows: The quality criteria should address issues of both supplier and user education: one document that simultaneously tells suppliers how to comply with key quality criteria and educates users as to what they ought to expect from a good health website; The quality criteria should address both passive information-giving sites as well as sites that allow for transactions between service or information providers and users (i.e. information, products and services). The quality criteria should facilitate compliance with EU Directives, other current guidelines, and technical standards relevant to this area. 4 5 Quality Criteria for Health Related Websites Developed in widespread consultation with representatives of private and public eHealth websites and information providers, other industrial representatives, public officials, and representatives of government departments, international organisations, and non-governmental organisations. These criteria should be applied in addition to relevant Community law Transparency and Honesty including Transparency of purpose and objective of the site Target audience clearly defined (further detail on purpose, multiple audience could be defined at different levels). funding Authority Clear statement of sources for all information provided and date of publication of source. credentials Privacy and data protection Privacy and data protection policy and system for the processing of personal data, including processing invisible to users, to be clearly defined in accordance with community Data Protection legislation (Directives 95/46/EC and 2002/58/EC). Updating of information Clear and regular updating of the site, with date of up-date clearly displayed for each page and/or item as relevant. Regular checking of relevance of information. Accountability Accountability Responsible partnering - all efforts should be made to ensure that partnering or linking to other websites is undertaken only with trustworthy individuals and organisations who themselves comply with relevant codes of good practice. Editorial policy - clear statement describing what procedure was used for selection of content. Accessibility Accessibility 3 in italics It should also be noted that while this Communication is addressed to the Member States of the European Union and private or public bodies operating in those States, due consideration should be given to the global nature of information disseminated through websites. Accordingly bodies adopting measures to implement the criteria should be aware of the fact that their information will be accessed by many individuals of different nations and cultures. In particular, attention should be paid to the fact that the developing world is a keen consumer of health information and that culturally specific content should be clearly identifiable as such. Textbox 1 Tailoring the Criteria For Different Types of Health Related Content 6 When tailoring the content to a chosen audience, a number of factors should be borne in mind in addition to those set out above which should govern the construction of a site. These factors may be considered under the same broad headings as the general site development criteria: Transparency of Health Related Content Transparency of the health related objectives of the provider of the information, including the purpose and objective of content provision, should be clearly defined and stated. Where advice or information on particular conditions, lifestyles or medications is given, funding from producers of products thereby implicitly or explicitly endorsed should be transparent to the site user. Existing Community legislation already contains information and transparency requirements. For example Article 5 of Directive 2000/31/EC on electronic commerce concerns the general information to be provided by an Information Society Services provider; Article 6 of Directive 2000/31 which concerns additional information to be provided in the case of commercial communications which are part of or constitute an information society service and Article 10 of Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data also applies. Authority of Health Related Content Providers Where a policy of using only accredited medical professionals to generate content is adopted, this should be clearly stated and adhered to. Where a mixed group of content providers is used, (medical professionals, journalists, personal testimony, etc) the category of content provider of each item should be clearly identifiable. Where scientific evidence is cited, the sources of such evidence should be easily identifiable to the user. Where a medicinal product is recommended, EU legislation on Medicinal Product advertising should be adhered to, and any documents authorised by a regulatory authority should be made available to the site user. Where advice is offered, the site provider should always include a reminder that internet based advice, whether personalised or not, cannot replace a face to face consultation with a healthcare practitioner. Privacy and data protection of Health Data Where any personal information is collected and further processed by the site user, including data processing invisible to the users, the requirements of Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data, in particular article 8 on sensitive and health data, should be carefully assessed and full compliance assured. Updating of Health Related Information Where specific health related data are provided, the relevance of such content should be regularly verified. Accountability for Health Related Content Where specific health related user feedback is provided by the site, particularly where personalised medical advice is offered, every effort should be made to ensure that such advice is bona fide and that advisors are suitably qualified to offer advice. Accessibility in Health Related Content Where a particular type of audience is targeted (eg children), the presentation and content of information should be appropriate to the chosen target audience. The use of a metadata labelling system may be used to make health data more findable. Such a system may also be used in conjunction with quality criteria to give higher ranking by search engines to those sites or pages labelled as complying with defined quality criteria. Apply International or European standards, wherever possible, in order to facilitate notably the interoperability between different services and the cross-border provision of web based health services. Implementation of the Quality Criteria For Health Related Websites Issues for the European Community The purpose of the eEurope 2002 action on Quality Criteria for health-related Websites was to encourage the adoption of a common set of basic quality criteria for such sites. The issue of whether and how these criteria might be implemented at European level was not within the terms of the action. The implicit assumption was that this was a matter to be addressed in Member States at national or regional level, making use of the wide range of private and not-for-profit organisations which are already operating systems for implementing quality criteria for health-related websites. In view of the rapid increase in health-related websites in the European Union and the increase in the number of European Union citizens consulting such sites, it could be argued that there would be merit in the Community establishing its own system for implementing agreed quality criteria. Such a Community-sponsored system would however require considerable resources to set up and operate, and it is unclear that it would offer clear value added to the Member States. The Commission therefore considers that at the moment the difficulties inherent in a Community system would outweigh any possible advantages. Nevertheless, the issue of how and how effectively quality criteria are being implemented is of considerable significance at the European level. To ensure that European citizens have access to reliable health information on the Internet implies not only that there is a consensus on the necessary quality standards, but that those standards are satisfactorily implemented right across the European Union. This does not mean that the same method of implementation should be used everywhere - indeed it must be doubtful that any particular mechanism would be appropriate in all circumstances and in all countries For example, in pharmaceuticals the Commission is considering ways of meeting the growing demand by patients to be able to access information directly about their medicines. The Commission has included proposals within the current review of EU pharmaceutical legislation, Review 2001, to take account of this growing demand. This has also been recently reinforced by the work of the High Level Group on Innovation and Provision of Medicines - G10 Medicines - which has covered this area in their reports. However, whatever system adopted, there should be clarity about the mechanisms being used in the different Member States and the extent of the involvement of the national and regional health authorities. With the forthcoming enlargement of the European Union, this requirement for transparency becomes even greater. Some Examples of Methods of implementing Quality Criteria Simple Codes of Conduct 7 The object of this and other similar codes is to offer a process of self-assessment by health site providers. However, a basic code of good conduct, or set of quality criteria will form the basis of all the approaches described below. The way in which such codes are implemented varies. Where the code is adopted by an umbrella organisation, such as the Pharmaceutical Group of the European Union, then the organisation itself seeks to ensure that all members comply with the code. In other cases a code has been adopted for the purposes of in-house application only, as in the case of the American Medical Association. Although other organisations may cite the code, and claim to use it, the organisation developing the code makes no attempt to ensure that other parties are in fact implementing it. The costs of the code of conduct approach are generally rather low, requiring only an initial outlay on meetings to draw up the code. However, the benefit of such codes can also be rather limited given the absence of effective enforcement mechanisms. A code of conduct which addresses issues concerning the protection of personal could in itself form a Code of Conduct relevant to a specific area of practice as foreseen in Article 27 of Directive 95/46/EC on Data Protection. Any such draft community code, and amendments or extensions to existing Community codes, may be submitted to the Working Party established by Article 29 of Directive 95/46/EC on data protection. Similarly, a Code of Conduct which addresses the particular issues of electronic commerce in the health domain may be drafted in accordance with the framework foreseen in Article 16.1 of the Directive 2000/31/EC on Electronic Commerce. Self Applied Code of Conduct or Quality Label A next step in the implementation of a code of conduct can be characterised as the self applied quality label. In such a case a third party organisation develops a code of conduct and allows those who undertake to abide by the terms of the code to display a label, seal or logo which certifies compliance with the code. 8 The costs of this system of applied labelling are not very high, requiring a relatively small team to process applications for use, maintain random checks of sites displaying the label and respond to any reports of misuse. The benefits may be significant in drawing to the attention of users the importance of the criteria inherent in the label. However, the benefits must be weighed against the requirement of the users of the sites to understand the nature of the label, and perhaps more importantly, to care about its aims and objectives. User Guidance Tools A further application of the code of good conduct takes the form of a user guidance tool. In this case compliance with a code is demonstrated not by a label, but by a link to a guidance tool which invites the user to check for him or herself if a site and its contents comply with pre-set criteria. 9 10 11 While such tools are frequently adopted for the guidance of users by national health portals (such as National Health Service DIRECT in England and Wales), they may also be used as site development tools by authors and publishers of information since they define the standards which users are entitled to expect. The financial costs of the user guide are low, often not extending beyond the initial development costs. However, the burden of the use of this kind of tool falls on the internet user, mostly because of the time it takes to apply, which reduces the incentive to use it. Filtering tools Where a guidance tool is provided by a third party to a user to apply for him or herself, a filtering tool is applied to provide a searchable database of filtered and accredited information. Such filtering tools are often based on the gateway approach to organising access to Internet. The fundamentals of this approach are that Internet resources are selected for their quality and relevance to a particular target audience. They are then reviewed and resource descriptions created, which are stored, generally with the associated metadata, and generally in a structured database. The consequence of this effort is to improve the recall, and especially the precision, of Internet searches for a particular group of users. 12 The costs of such a filtering tool are relatively high in that a team of trained experts must be employed to search for, abstract and classify information on the internet in order that it may be entered into the database. The benefits of such a tool, for the initiated user, are also high since it provides a valuable shortcut to individual searches of the internet using non-specific search engines. Third Party Quality and Accreditation Labels The most advanced, and also most costly, of the mechanisms available for implementing quality criteria for health related websites, is the third party accreditation system. A third party issues a label to certify the compliance of the site with the criteria of evaluation. A range of implementations fall into this category, from lower cost intra-organisation bodies for quality certification, acting in a similar to the notified bodies used in CE marking, to high cost external independent assessors who perform audits and grant accreditation. At present no third party accreditation bodies are fully operational in Europe, although two noteworthy pilots are running in MEDCERTAIN (a demonstration project of the European Union "Safer Internet Action Plan") and TNO QMIC, a pilot study of the Netherlands Organisation for Applied Scientific Research. 13 14 Purposes of Implementation of Quality Criteria For Health Related Websites The general purpose of any quality initiative, whatever method of implementation is chosen, must be the protection of the consumer. However, in some cases that general purpose may be best achieved through educating the user of the service while in other cases the provider of the service will be the target of the quality initiative. In order to assist in the selection of an appropriate implementation method, the targeted purposes of the various methods are examined in more detail below Educating Users In their daily lives as consumers of information delivered via the traditional media, most people learn to use a wide range of assessment tools: judging the nature of the outlet providing the information (a general or specialist bookshop or a work exclusively available from the author), the look and feel of the publication as a whole (a magazine with several contributions or a one page pamphlet). In addition, most people know whom to contact for further information (librarian, bookshop assistant, publisher). In the world of internet content, however, it is less evident what are the relevant indicators of quality. It is for this reason that quality marks and user guides have proliferated, namely to educate the consumer and to provide a recognisable "quality" label which site creators may use to promote their sites. Accordingly, for such codes to be effective it is highly important that the public are informed about the existence of the Codes through public education campaigns. Assisting searchers 15 Educating Site Providers The problem is not only with the torrent of information, but also with the behaviour of its purveyors. Whilst it may take considerable effort to find an outlet for unusual or extreme ideas in the traditional media, virtually anyone with a modicum of computer skills and very little money can create their own website. The objective of many of the code of conduct initiatives is therefore to educate both the providers and consumers of information about the processes and good practices that a website should be able to demonstrate. In order to educate not only the provider, but also the consumer of information a further set of actors have developed a wide range of user assessment tools. Such tools are usually in the form of on-line check lists which ask the consumer to check off types of information as they find them: statement of aim, explicit statement of source of information, explicit date of information, etc. Some may be rather short (HON), some quite detailed (NETSCORING); some are aimed at specific markets (DISCERN - for treatment choices) and some aimed at children (QUICK) to mention but a few. Assuring Quality Most of the organisations publishing and administering such codes operate on a simple selflabelling processes in which the site provider undertakes to follow the code and in return displays its "trustmark" relying on spot check and vigilant users to identify those who are not complying with the given code of conduct. While this may not be as effective as a fully policed trustmark system of the type we are used to seeing as regards, for example, electronic products, it nonetheless addresses a need in a reasonably effective manner. Conclusions The eEurope initiative was launched by the European Commission on 8th December 1999, with the adoption of the Communication `eEurope - An Information Society for all (COM (1999), 687 final, of 8.12.1999)'. The "eEurope 2002 Action Plan - An Information Society For All", was adopted by the Commission on 14th June 2000, and politically endorsed by the European Council in Feira (Portugal) on 19-20 June 2000. It detailed the policy actions which are required to meet these objectives by 2002. Modern online public services actions taken by Member States to make health information as accessible as possible to citizens as well as initiatives to implement quality criteria for web sites e it is critical that e-health content and services are developed efficiently, are available for all and health related web sites comply with established quality criteria With respect to the enlargement of the European Union it should also be noted that the eEurope+ Action Plan, which was adopted by the accession States to mirror the eEurope 2002 Action Plan, includes similar action on quality criteria for health related websites. Accordingly it will also be important to monitor the activities undertaken pursuant to that Action Plan. 3 implement the Quality Criteria for Health Related Websites in a manner appropriate to their website and consumers. develop information campaigns to educate site developers and citizens about minimum quality standards for health related websites. draw on the wide range of health information offered across the European Union and localise such information for the benefit of citizens (translation and cultural adaptation). exchange information and experience at European level about how quality standards are being implemented. Finally, within the context of the Information Society activities and as part of the implementation of the European Union public health programme, consideration will be given to the possibilities of developing and operating a joint action, with the plans drawn up under eEurope, to improve availability to the general public on the Internet of information on health matters, and considering the possibilities for establishing a system of recognizable Community seals of approval for Internet sites.