Ethical scenarios and legislation
It must be pointed out that concrete legal requirements on the data collection depend also on national legislation.
In January 2012, the European Commission published proposals for a new framework for data protection legislation. The proposals, in the form of the draft Data Protection Regulation is to replace the existing Data Protection Directive, are now being considered and amended by the European Parliament and Council before adoption. This process may take until 2015. The Regulation covers the use of personal data across a wide range of sectors and will affect how patient data are used in research. The original proposals set out a mechanism for protecting privacy, while enabling research and included a requirement for specific and explicit consent for the use and storage of personal data, while providing an exemption for research, subject to strong ethical and governance safeguards.
In October 2013, the Civil Liberties and Home Affairs (LIBE) committee of the European Parliament adopted amendments that would severely restrict the use of personal data for scientific research purposes without specific consent.
Changes in EU Directives affect the conduct of tests with human participants in all European countries but deviation for existing conditions might differ and be relevant to national legislations and code-of-practice.
Specific guidelines from the EFGCP (the European Forum for Good Clinical Practice) and the American Psychological Association (APA) Ethical Code of Conduct are considered, including reference to vulnerable users (disabled people).
The Council of Europe Convention for the protection of individuals with regard to automatic processing of personal data is the first European instrument in this field. It laid down the basic principles of a lawful data processing addressing the threats from the invasion of information systems, such as the data aggregation, at that time. In this respect, it concerns the automatic data processing, although the Member Countries could extend its applicability to non-automatic data processing. Art. 6 states that medical data may not be processed automatically unless domestic law provides appropriate safeguards. The Convention is of limited importance for EU countries after the enactment of the EC Directives on data protection.
The Charter of Fundamental Rights dedicates a separate article to the protection of personal data. Article 8 sets out the right to the protection of personal data of an individual and thus the protection of personal data has now its own legal basis apart from the right to respect for an individual’s private life and the protection of the human dignity. Art. 8 of the Charter sets out the rules for the legitimate processing of personal data, notably that the processing shall be fair and for pre-specified purposes based on the consent of the data subject or other legitimate basis laid down by law. Reference is furthermore made to two rights of the data subject: the right of access to the data and the right to have it rectified. Finally, Art. 8 sets out the need for an which shall control the compliance with the data protection rules.
In 1999 the Council of Europe adopted the Recommendation on the Guidelines for the protection of privacy in the information highways. These Guidelines may be incorporated in or annexed to codes of conduct of Internet service provider to obtain legal validity. The Recommendation is in line with the EC Data Protection Directives regarding the principles of the lawful data processing, the duties of the Internet service providers and the rights of the data subject. The Recommendation encompasses a series of detailed information what the users and service providers shall do to reduce the risks arising from the Internet. It is worth mentioning that the users are required to use digital signature and encryption techniques. On the other hand, the service providers are required to use certified privacy enhancing technologies, to ensure data confidentiality and integrity as well as logical and physical security of the network and the services provided over the network. The service providers shall also incorporate detailed privacy statements on the web-sites. Finally, the communication of sensitive data, for instance medical data, for marketing purposes requires the previous, informed and explicit consent of the data subject.
The OECD (Organisation for Economic Co-operation and Development) is actively participating in the issues regarding the data protection, the data protection on the Internet as well as the protection of consumer rights with regard to e-commerce. First, OECD issued Guidelines governing the protection of privacy stipulating the fundamental principles (OECD, 1980).
In 1998, OECD issued a Recommendation with regard to the implementation of the aforementioned Guidelines on global networks. The Recommendation addresses mainly commercial sites offering various goods and services, such as tourism, air travel ticket sales, finance, etc. It is not legally binding, unless the Internet service providers stipulate this explicitly. Although the Recommendation does not address healthcare applications, its provisions might apply as following:
The Recommendation imposes the obligation to the web-site provider to refer with a hyperlink to the national legislation on data protection and the national Data Protection Authority. Moreover, every Data Protection Authority should be present on the Internet through relevant, well-documented and interactive sites. The web-sites shall also maintain on-line privacy statements giving details on the kind of data collected, the purpose of, the use of the clickstream data and processing to which they are subject, as well as the opportunity to opt out. In case of on-line payments by cards they should configure their systems in such a way that they ask for the card details once, provided that they store this information in highly secure files on non-networked computers. Warning messages on the risks of the Internet shall be provided in case of processing of confidential data. For confidential data the highest degree of security shall be implemented. The implementation of privacy enhancing technologies is also required. Moreover, web-sites should formally state the acceptance of full responsibility for the security and confidentiality of the personal data collected and processed. With regard to data subjects rights the Recommendation highlights the right to access on-line the information collected and stored directly or indirectly, i.e. clickstreams or purchased profiles.
Data Protection Directive 95/46/EC
In 1995, the EC Directive on the protection of personal data was adopted by the Council. The Directive was the first attempt on EC level to recognise the right to privacy and harmonise the national laws. Some main characteristics of the Directive are that it applies equally to public and private bodies, to both automatic and non-automatic data processing, and that the protection is restricted to natural persons (as opposed to legal entities). Moreover, the data must form a part of a filing system, which is defined as any structured set of personal data accessible according to specific criteria.
The directive regulates the processing of personal data, regardless if the processing is automated or not.
Personal data is defined as "any information relating to an identified or identifiable natural person ("data subject"); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his/her physical, physiological, mental, economic, cultural or social identity;" (art. 2 a).
This definition is meant to be very broad. Data is "personal data" when someone is able to link the information to a person, even if the person holding the data cannot make this link. Some examples of "personal data": address, credit card number, bank statements, criminal record, ...
The notion processing means "any operation or set of operations which is performed upon personal data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction;" (art. 2 b).
The responsibility for compliance rests on the shoulders of the "controller", meaning the natural or artificial person, public authority, agency or any other body which alone or jointly with others determines the purposes and means of the processing of personal data; (art. 2 d).
The data protection rules are applicable not only when the controller is established within the EU, but whenever the controller uses equipment situated within the EU in order to process data. (art. 4) Controllers from outside the EU, processing data in the EU, will have to follow data protection regulation. In principle, any online shop trading with EU citizens will process some personal data and is using equipment in the EU to process the data (the customer’s computer). As a consequence, the website operator would have to comply with the European data protection rules. The directive was written before the breakthrough of the Internet, and to date there is little jurisprudence on this subject.
Personal data should not be processed at all, except when certain conditions are met. These conditions fall into three categories: transparency, legitimate purpose and proportionality.
The data subject has the right to be informed when his/her personal data are being processed. The controller must provide his/her name and address, the purpose of processing, the recipients of the data and all other information required to ensure the processing is fair (art. 10 and 11).
- Data may be processed only under the following circumstances (art. 7):
- when the data subject has given his/her consent;
- when the processing is necessary for the performance of or the entering into a contract;
- when processing is necessary for compliance with a legal obligation;
- when processing is necessary in order to protect the vital interests of the data subject;
- processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller or in a third party to whom the data are disclosed;
- processing is necessary for the purposes of the legitimate interests pursued by the controller or by the third party or parties to whom the data are disclosed, except where such interests are overridden by the interests for fundamental rights and freedoms of the data subject.
The data subject has the right to access all data processed about him/her. The data subject even has the right to demand the rectification, deletion or blocking of data that is incomplete, inaccurate or isn't being processed in compliance with the data protection rules (art. 12).
Personal data can only be processed for specified, explicit and legitimate purposes and may not be processed further in a way incompatible with those purposes (art. 6 b).
Personal data may be processed only insofar as it is adequate, relevant and not excessive in relation to the purposes for which they are collected and/or further processed. The data must be accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that data which are inaccurate or incomplete, having regard to the purposes for which they were collected or for which they are further processed, are erased or rectified; The data shouldn't be kept in a form which permits identification of data subjects for longer than is necessary for the purposes for which the data were collected or for which they are further processed. Member States shall lay down appropriate safeguards for personal data stored for longer periods for historical, statistical or scientific use (art. 6).
When sensitive data is being processed, extra restrictions apply (art. 8). The data subject may object at any time to the processing of personal data for the purpose of direct marketing (art. 14).
A decision which produces legal effects or significantly affects the data subject may not be based solely on automated processing of data (art. 15). A form of appeal should be provided when automatic decision making processes are used.
Supervisory authority and the public register of processing operations
Each member state must set up a supervisory authority, an independent body that will monitor the data protection level in that member state, give advice to the government about administrative measures and regulations, and start legal proceedings when data protection regulation has been violated. (art. 28) Individuals may lodge complaints about violations to the supervisory authority or in a court of law.
- The controller must notify the supervisory authority before he/she starts to process data. The notification contains at least the following information (art. 19):
- the name and address of the controller and of his/her representative, if any;
- the purpose or purposes of the processing;
- a description of the category or categories of data subject and of the data or categories of data relating to them;
- the recipients or categories of recipient to whom the data might be disclosed;
- proposed transfers of data to third countries;
- a general description of the measures taken to ensure security of processing.
- This information is kept in a public register.
Art. 29-Data Protection Working Party: Working Document on Privacy on the Internet
The Data Protection Working Party has been established by art. 29 of Directive 95/46/EC and is the independent advisory body on data protection and privacy. Its tasks are laid down in art. 30 of Directive 95/46/EC and in art. 14 of Directive 97/66/EC. The opinions and recommendations of the Working Party are not legally binding, reflect, however, the current trends on European level and influence the decisions taken by the European Commission and the Committee established by art. 31 of Directive 95/46/EC.
This working document seeks to raise awareness and to promote the public debate on issues of on-line data protection. It therefore provides detailed information on technical aspects of how the Internet and the communications through the Internet are organised and what are the main privacy risks arising from the use of the Internet. In this context, it aims at the same time to provide an interpretation of the data protection Directives in that field. It follows a "holistic" approach by basing the analysis of privacy risks, the obligations and rights of the involved parties on both the general data protection Directive 95/46/EC and the privacy and telecommunications Directive 97/66/EC.
The risks to privacy arise from the activities of the various intermediaries. For instance, the use of routers, e.g. the telecommunications nodes in the Internet, which have the characteristic that the information may pass through a non-EU country which may or may not have adequate data protection, if this at the time of transmission is the "shortest" way of transmission.
According to the opinion of the Working Party, Directive 97/66/EC applies to telecommunication service providers who connect Internet users and ISPs and access service providers who provide the requested Internet service, transfer the request from the Internet user to proxy server and then to the requested website. It also applies to providers of routers and connecting lines. Moreover, the Directive 97/66/EC shall apply also to Internet Service Providers (ISPs) providing hosting services, such as portal services, who may log the requests, the referring pages and post cookies on the hard disk of the user and make profiles. The latter is, however, arguable since the host service providers transmit content information and thus it should rather come under the general data protection Directive. The working document recognizes that the applicability of the Directive 97/66/EC to the activities of the host service providers is not always clear. When the provider hosts its own portal site comes under the general data protection directive whilst it comes under the specific when he plays the role of the access service provider.
The providers of Internet services, dependent on the aforementioned distinctions, are subject to the obligations to confidentiality and security laid down in both Directives (art. 4, 5 97/66/EC, art. 6 - 8, 16, 17 95/46/EC). Traffic data provided by providers of routers and connecting lines, ISPs and telecommunication providers shall be protected as content data according to art. 5 of Directive 97/66/EC as this is the case in the proposal for an amendment of 97/66/EC.
Interception of communication is unacceptable unless it fulfils three fundamental criteria in accordance with art. 8 (2) EHRC, and the European Court of Human Rights interpretation of this provision: a legal basis, the need for such a measure in a democratic society, and conformity with one of the legitimate aims listed in the Convention.
The Working party strongly recommends the use and offer of encryption tools by the providers of email services at no additional cost. The providers should also offer secure connection for the transmission of the emails. The need of integrity and authentication should be considered as well.
A means for ensuring encryption is the Secure Socket Layer (SSL) which is implemented in most popular browsers and establishes a secure channel between the client and server computers. This is achieved by means of encryption and digital certificates. SSL enables the authentication of the server to whom the information shall be sent and the integrity of the data. It does not ensure the authentication of the client. These difficulties shall be overcome by the protocol SET (Secure Electronic Transactions) that provides for confidential transmissions using encryption, authentication of the parties, integrity and non-revocation (through digital signatures). The Working Party seems to support the use of the SET protocol instead of SSL, especially when sensitive information, such as the credit cards data, will be transmitted. Moreover, if a higher level of security is needed, the digital certificates should be stored on smart cards.