The EU legal framework on e-health

Callens, Stefaan

doi:10.1017/cbo9780511750496.014

Cited by 16 publications

(15 citation statements)

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“…The Directive 2011/24/EU establishes, in Article 14, a voluntary network for cooperation between the national authorities responsible for e-health in each Member State, but this purpose must take into consideration the remaining European legislation in this domain, namely the Data Protection Directive, the future GDPR and the E-Privacy Directive [7], [16], [48], [49], [50], [51]. The aim of these regulations is, on the one hand to allow private data circulation, and on the other hand to adequately protect the data holder.…”

Section: Protection Of Personal Data In Telemedicine: the Data Privmentioning

confidence: 99%

Telemedicine: The legal framework (or the lack of it) in Europe

Raposo

2016

GMS Health Technology Assessment; 12:Doc03

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Section: Protection Of Personal Data In Telemedicine: the Data Privmentioning

confidence: 99%

Telemedicine: The legal framework (or the lack of it) in Europe

Raposo

2016

GMS Health Technology Assessment; 12:Doc03

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“…For domestic healthcare, national liability regimes apply, which can differ significantly in relation to medical treatment; it has been recommended that rules on compensation for damages be harmonized in the EU [21]. In one respect, liability is already harmonized, namely in product liability.…”

Section: Liabilitymentioning

confidence: 99%

“…In one respect, liability is already harmonized, namely in product liability. [22] Producers are held liable for damages caused by defective products that do not provide the safety that can be expected of the product [21]. This underlines the importance for implementations of medical architectures to comply with general standards and requirements.…”

Section: Liabilitymentioning

confidence: 99%

“…This can apply, e.g., to services allowing patients to electronically ask advice of physicians or to online medicine purchases. [21] The E-Commerce Directive imposes obligations on service providers to provide various kinds of information to users, including registration and applicable professional rules for regulated (including the medical) professions. Commercial communications should be allowed for providers in regulated professions, subject to professional rules such as professional secrecy.…”

Section: E Internal Market Regulationmentioning

confidence: 99%

“…General software, including Generic Enablers, used in e-health is not a medical device, but software manufactured or specifically adapted for medical purposes is a medical device. [21] The Medical Devices Directive imposes obligations on product safety, CE-conformity marks, and clinical evaluation [28]. Another area of internal market regulation is competition (or antitrust) law.…”

Section: E Internal Market Regulationmentioning

confidence: 99%

See 2 more Smart Citations

Norms and standards in modular medical architectures

Thüemmler

Mival

Benyon

et al. 2013

2013 IEEE 15th International Conference on E-Health Networking, Applications and Services (Healthcom 2013)

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Abstract-Recent Internet of Things (IoT) research has been aiming at interoperability of devices and the integration of sensor networks. The Future Internet -Private Public Partnership (FI-PPP) has created a whole array of different purpose-oriented modules with defined specifications, better known as Generic Enablers. This article gives an overview of legal, ethical and technical norms and standards to be considered when planning, developing and implementing modular medical architectures, integrating the Internet of Things (IoT) and Generic Enablers (GEs) in cutting edge, latest generation medical data networks.

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Setting the scene for the future: implications of key legal regulations for the development of e‐health interoperability in the EU

Kautsch

Lichoń

Matuszak³

2016

Health Planning & Management

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E-health has experienced a dynamic development across the European Union in the recent years and enjoys support from the European Commission that seeks to achieve interoperability of national healthcare systems in order to facilitate free movement. Differences that can be observed between the member states in legal regulations, cultural approaches and technological solutions may hinder this process. This study compares the legal standing of e-health in Denmark, Poland, Spain and the UK, along with key legal acts and their implications. The academic literature review along with an analysis of materials found through the desk study research (reports, legal acts, press articles, governmental web pages and so on) was performed in order to identify aspects relevant to e-health interoperability. The approach to legal regulation of e-health substantially differs by country. So do the procedures that they have developed regarding the requirement for patient's consent for the processing of their data, their rights to access to the medical data, to change the data, data confidentiality and types of electronic health records. The principles governing the assignment of responsibility for data protection are also different. These legal and technological differences must be reconciled if interoperability of European national e-health systems is to be achieved. Copyright © 2016 John Wiley & Sons, Ltd.

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The EU legal framework on e-health

Cited by 16 publications

References 0 publications

Telemedicine: The legal framework (or the lack of it) in Europe

Telemedicine: The legal framework (or the lack of it) in Europe

Norms and standards in modular medical architectures

Setting the scene for the future: implications of key legal regulations for the development of e‐health interoperability in the EU

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