Digital Health Legal

Volume: 3 Issue: 12
(December 2016)


The Norwegian Consumer Council (‘Council’) sent on 3 November 2016 a formal complaint about the privacy and data practices of four manufacturers of consumer wearables, namely Fitbit Inc., Garmin Ltd., Jawbone, and Mio Technology Corporation, to both Norway’s Consumer Ombudsman and its data protection authority, the Datatilsynet. / read more

The European Data Protection Supervisor (‘EDPS’) published on 7 November 2016 guidelines on the protection of personal data processed by mobile applications provided by European Union institutions, which aims to provide practical advice to EU institutions on the processing of personal data in mobile applications. Whilst in principle the guidelines are aimed at EU institutions, any organisation interested in data protection and mobile apps may find the guidelines useful in ensuring compliance with EU data protection obligations. / read more


The Court of Justice of the European Union (‘CJEU’) held on 19 October 2016 (C-148/15) that Germany’s fixed pharmacy prices constitute an unjustified restriction of the free movement of goods principle, which cannot be justified on grounds of the protection of health and human life. Consequently, pharmacies based in EU Member States other than Germany currently have a competitive advantage over German pharmacies when supplying prescription medicines to German patients by mail order, as they may set their prices freely. As a result, the German legislator is currently considering a complete ban on the use of mail order for prescription medicines. Evelyn Schulz, Associated Partner at Noerr LLP, assesses the rationale of the CJEU’s ruling and the impact on the German market. / read more

Tom Jones, Director of Strategy and Impact at the African Centre for eHealth Excellence (Acfee), in this article provides a detailed overview of the interoperability challenges faced in Rwanda and South Africa and the vast differences between Africa’s eHealth interoperability imperatives compared to developed economies. Interoperability risks and vulnerabilities now being identified by countries like the US need balancing against the affordable eHealth investments needed to achieve Universal Health Coverage (‘UHC’) and Sustainable Development Goals (‘SDG’) in Africa. / read more

The EU General Data Protection Regulation (‘GDPR’) will apply from 25 May 2018. Due to the sensitivity of the data processed in the healthcare sector, the GDPR will have a direct impact on this sector in Europe. Dr Stefan Alich of Taylor Wessing PartG mbB describes the potential impact from a German perspective. / read more

While both of the recent privacy developments in Australia, relating to notifiable data breaches and the criminalisation of the re-identification of de-identified Government data, will apply generally, if passed, in practice they will have a particularly significant impact on all those involved with digital health and eHealth. Alec Christie, Partner at EY Law and member of the Digital Health Legal Editorial Board, provides detailed analysis of both privacy developments in the context of eHealth. / read more

Charles McFarland, Senior Researcher at Intel Security, draws on a number of reports he has been involved with over the past few years to delve into the factors that influence dynamic changes in underground markets where stolen data is bought and sold. / read more

Lee Kim of HIMSS North America discusses the launch of the HIMSS Cybersecurity Hub, which will become the focal dissemination point for all HIMSS privacy and cyber security content. / 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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