Juana Vasella /
Andrea Voëlin
The article evaluates possible liability constellations from the patients’ point of view that could be relevant for them when using the Electronic Patient Record (EPR). The authors first offer a summary of the EPR and its implementation, as well as the involved individuals and institutions, before analysing potential events of damage and specific legal relations in detail. They conclude that the existing liability standards provide at least conceptually sufficient balancing rules for events of damage and that no additional legislative provisions are required. (ah)
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Category: Articles
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Region: Switzerland
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Field of law: E-Health
Isabel Baur
Das elektronische Patientendossier unter strafrechtlichen Aspekten
The Federal Act on the Electronic Patient Record came into force on 15 April 2017. This law not only contains several specifications on processing and on the objectives, but also includes a penal provision on unauthorised access to the Electronic Patient Record (EPR). Additionally, the miscellaneous criminal offences of the Penal Code are applicable; they are outlined and associated with the EPR in this article. It becomes clear that cybercrime does not spare the EPR. The protection of health data must be of utmost priority, if the EPR is expected to obtain approval in the general public and if the willingness to use it shall be encouraged. (ah)
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Category: Articles
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Region: Switzerland
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Field of law: E-Health, Criminal Law, Cybercrime
Thomas Steiner
Data protection and data security are decisive factors for the acceptance of eHealth solutions. This also applies to the introduction of the Electronic Patient Record (EPR) in Switzerland. The author examines the legal framework for data breach notification obligations of actors involved in the EPR system. He advocates harmonization of the data protection laws of the Confederation and the Cantons with regard to notification and investigation obligations. Further, he stresses the importance of cooperation between the competent supervisory authorities with regards to notices of data security incidents concerning the EPR.
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Category: Articles
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Region: Switzerland
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Field of law: E-Health, Data Security, Data Protection
Kerstin Noëlle Vokinger
Im Spannungsfeld zwischen Wirkung und «unerwünschter Nebenwirkung» unter Berücksichtigung von medizinischen Aspekten und den (Grund-)Rechten des Patienten
The first so-called «digital pill» has been approved in the USA in November 2017. Both the medical chances of the digital pill and the accompanying legal risks for the patients' (fundamental) rights in Switzerland are subsequently discussed in an initial overview. (ah)
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Category: Articles
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Region: Switzerland
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Field of law: E-Health
Yvonne Prieur
Instead of leaving the evaluation of health technologies to the EU Member States, the EU commission wants to gradually carry them out itself. Those compulsory assessments cover all pharmaceuticals as well as specific classes of medicinal products, including in-vitro diagnostics. (ah)
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Category: Articles
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Region: EU
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Field of law: E-Health
Jurius
The parliamentary fractions oppose to the EU proposal for a Regulation on Health Technology Assessment and amending Directive 2011/24/EU. (ah)
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Category: News
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Region: Germany
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Field of law: E-Health
Jurius
The main association of the Austrian social insurance agencies and the Austrian medical association will jointly implement a number of e-services within the next years. The objective is to disburden patients, doctors and social insurances from administrative processes. (ah)
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Category: News
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Region: Austria
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Field of law: E-Health
Jurius
In its meeting of 31 January 2018, the Federal Council amended the Regulation on the Electronic Patient Record. The changes pertain to the accreditation of certification authorities as well as to a technical condition on how data on health professionals has to be registered in the query service. (ah)
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Category: News
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Region: Switzerland
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Field of law: E-Health
Jurius
On 31 January 2018, the Commission has put forward a proposal to boost cooperation amongst EU Member States for assessing health technology. Greater transparency will empower patients, by ensuring their access to information on the added clinical value of new technology that could potentially benefit them.
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Category: News
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Region: EU
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Field of law: E-Health