Digital Health Legal

Volume: 3 Issue: 3
(March 2016)


The German Federal Supreme Court (‘FSC’) released on 1 March its judgment in case no. VI ZR 34/15, in which it specified the monitoring duties of medical professional review portal operators, finding it necessary in some cases for such operators to verify the validity of user reviews. / read more

The Dutch Data Protection Authority (‘DPA’) has found that the processing of employee wearable data by employers is in breach of the Dutch Data Protection Act, explains an 8 March press release. The DPA’s examination of two companies’ processing of wearable data found that the data collected by wearables is personal health data and thus subject to strict legal requirements, and that in an employment relationship, in which the employee is dependent on the employer, consent to such processing of health data cannot be freely given. / read more

The CDS Coalition, a US-based group of stakeholders lobbying for appropriate clinical decision support (‘CDS’) software regulation, released on 26 February survey results, which found, inter alia, that a third of 48 respondent companies had abandoned CDS product development due to uncertainty about US Food and Drug Administration (‘FDA’) regulation of CDS. / read more


On 7 December 2015, after nearly three years of negotiation, the EU institutions reached an informal agreement on the EU Network and Information Security (‘NIS’) Directive, which inter alia imposes security and incident reporting obligations on ‘operators of essential services’ in critical sectors and on some digital service providers. Mark Young and Brian Kelly of Covington & Burling LLP explain how the NIS Directive will impact on the security of eHealth in the EU. / read more

5G - the fifth generation of mobile networks - has the potential to enhance the use of eHealth technologies far beyond what is currently being achieved with 3G, for example in terms of its use in medical diagnosis. However, Collette Johnson, Director at Plextek Consulting, argues that there is a need for a suitable legislative framework for the network, with concerns relating to security being taken into account. Here, Collette explains the benefits of 5G and advocates for solutions to the issues 5G poses to be found quickly in order for eHealth to take full advantage of 5G’s potential. / read more

The European Union Agency for Network and Information Security (‘ENISA’) recently conducted a study into cyber security and eHealth systems. In this article, Dimitra Liveri, a Network and Information Security Expert at ENISA, discusses the organisation’s findings and outlines ENISA’s key policy recommendations for achieving better security for health information systems and services. / read more

In the recent study ‘Every Step You Fake: A Comparative Analysis of Fitness Tracker Privacy and Security,’ Open Effect, a Canadian not-for-profit applied research organisation, analysed data and information gathered from eight fitness tracking applications and devices currently available in Canada. The study seeks to determine what kind of information such systems gather and how that information is treated. The better portion of the study is yet to be published, but the version available (published on 2 February) contains a number of interesting findings. Michael Whitt QC and Graeme Harrison of Bennett Jones LLP discuss the study, which they believe raises numerous legal questions in Canada. / read more

Telemedicine presents countless opportunities for the provision of effective healthcare. Dr Marian Arning, a Lawyer at Osborne Clarke, describes the current prohibition in Germany in regards to remote treatment and the recent guidelines published by the German Medical Association that provide valuable clarity on navigating this prohibition for the adoption of telemedicine in practice. / read more

The Notice of Health and Family Planning Working Essentials for 2016 (the ‘Notice’) was issued in late January by the National Health and Family Planning Commission of the People’s Republic of China. Simon Fuller, Associate Editor of eHealth Law & Policy, spoke to Vincent Wang, Partner at Davis Wright Tremaine, and Nicolas Zhu, Partner at CMS, China, about the Notice and what it means for health technology in China. / read more

Part of a series of initiatives that aim to modernise the collection, use and management of information in the Irish health system, Ireland’s proposed Health Information and Patient Safety Bill would have a significant impact on the privacy and data protection laws of Ireland as they apply to the health sector. Adam Finlay, Partner at McCann FitzGerald, reviews the proposed Bill and notes that it is of interest to anyone who handles health information that relates to individuals. / read more

About Digital Health Legal:

Digital Health Legal is the monthly publication covering legal and regulatory issues and providing industry perspectives in the health IT sector. The publication covers eHealth, mHealth apps, data protection and privacy, electronic patient records, health data security and data breaches, telehealth and telemedicine, medical devices, online pharmacies, social media, standardisation, pharmacovigilance, patient safety, Big Data, health care informatics, cloud services in healthcare, liability, IP rights and HIPAA... /read more

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