mHealth and data protection – the letter and the spirit of consent legal requirements

Abstract

In this article, the role of consent is discussed in the framework of fundamental rights and in the context of mobile health technologies (mHealth), such as smart phones, mobile phones or tablet/palm-held computing devices to provide healthcare. The authors surmise how, in practice, although there will be more emphasis on informed consent formally, there will be less space for genuine individual consent. This betrays a focus more on the letter of consent rules in data protection than their spirit. This risks reducing consent to a tick box operation in a manner analogous to consumer transactions, something manifestly unsuitable for consent, even if only in informational terms, during medical procedures.

Keywords:

• consent
• data protection
• mobile health technologies (mHealth)

Acknowledgements

This contribution is based on the work completed in the European FP7 project ‘REACTION’ in addition to the FP7 ‘Marie Curie Industry-Academia Partnerships and Pathways Action VALUE AGEING’, funded by the European Commission.

Notes

1. Directive 95/46/EC also envisages two other exceptions for the processing of mHealth outlined in Article 8 (2). This are in (c) processing is necessary to protect the vital interests of the data subject or of another person where the data subject is physically or legally incapable of giving his consent; or (d) processing is carried out in the course of its legitimate activities with appropriate guarantees by a foundation, association or any other non-profit-seeking body with a political, philosophical, religious or trade-union aim and on condition that the processing relates solely to the members of the body or to persons who have regular contact with it in connection with its purposes and that the data are not disclosed to a third party without the consent of the data subjects; or (e) the processing relates to data that are manifestly made public by the data subject or are necessary for the establishment, exercise or defence of legal claims. These are unlikely to apply to mHealth or are not likely to be contentious if they do.

2. Explanatory Memorandum to the Proposed Regulation, Chapter II – Principles, Paragraph 3.4.2. European Commission (2012). Proposal for a Regulation. COM(2012) 11/4, Article 12 According to Article 12(6), the European Commission is empowered to adopt acts setting forth standard forms and procedures for individuals to exercise their rights, which should eliminate the need to follow separate procedures in individual member states.

3. The Commission may adopt such procedures according Articles 5, 7 and 8 of Decision 1999/468EC.