Abstract
When developing new digital homecare applications, including services that enable the exchange of health data between the homecare professionals and the hospital (like an electronic health record), the legal requirements are often considered as a serious bottleneck. However, only a few principles have to be taken into account for the development of a privacy-friendly eHomecare application and they come with a bonus: an easier acceptance and uptake of the application by the public. This chapter therefore wants to set forth a minimum set of legal requirements for the use of eHealth tools in Europe. The project development of an EHR in the homecare sector will function as an example.
When developing an eHomecare application, such as an EHR, mainly Medical Law and Privacy regulations need to be taken into account. The European healthcare sector is regulated by different national regulations, including Medical Law and Patients’ Rights. Although on international level the same basic principles apply in most countries, there is no European harmonization or coordination. With regard to Privacy regulations, the opposite is true. Within Europe the Data Protection Directive harmonizes the protection of personal data being processed. In sequence, the applicability, the basic legal concepts, the health data protection regime and the roles taken up by the different actors in an eHomecare project are being discussed. Next to Medical Law and Privacy it is also important to check - on a case-by-case basis - whether other legislation (such as the eCommerce and ePrivacy Directive, or sector specific laws) is relevant.
Secondly the chapter sets up a manual for the development of an eHomecare project. Points of particular interest are the question whether the project is dealing with primary or secondary use of personal data, the filing of a notification, the drafting of an informed consent for the patient and the healthcare professional and the need for an appropriate level of security.
Finally the chapter formulates ten practical recommendations, crucial to a successful privacy-friendly eHomecare project and / or application, in coherence with the timeline of a project. Going from the creation of awareness, over compliance with the law, to the protection of the patient and the healthcare professional and keeping evidence.
Related ICMCC chapter: Ann Ackaert et al., “A multi-disciplinary approach towards the design and development of value+ eHomeCare services”.
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References
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Van Gossum, K., Verhenneman, G. (2009). Privacy and Digital Homecare. In: Yogesan, K., Bos, L., Brett, P., Gibbons, M.C. (eds) Handbook of Digital Homecare. Series in Biomedical Engineering. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-01387-4_7
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DOI: https://doi.org/10.1007/978-3-642-01387-4_7
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