Digital Health Legal

Volume: 1 Issue: 8
(September 2014)


Apple updated its App Store Developers Review Guidelines on 2 September with specific requirements for iOS 8 applications making use of its new HealthKit platform. Developers of mobile apps using HealthKit, a platform that will aggregate, share and track health and fitness data across third party apps and Apple’s new Health app, will be prevented from sharing user data with third parties without user consent. / read more

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), announced on 5 September that it is leading a consortium of organisations in a three year project, known as WEB-RADR, to develop new ways of gathering information on suspected adverse drug reactions (ADRs) in response to the increased use of smartphones, apps, and social media for discussing medicines and health issues. / read more

Google has committed to spending at least $250 million over a five year period to fight rogue online pharmacies targeting US consumers through the use of Google’s AdWords service, in an agreement made public on 8 August in court documents from the US District Court, Northern District of California. / read more

NHS England released on 11 August a consultation on its draft Information Standard for accessible information, which aims inter alia to ensure that NHS and adult social care bodies provide patients/service users with information in a format they understand, for example via email; the Standard has been under development since June 2013. / read more


Genomic technologies have hit the headlines recently in the UK with the announcement of the 100,000 Genomes Project, which aims to sequence 100,000 genomes by 2017. Genomic medicine projects such as this bring with them legal, ethical and policy issues, and those active in the eHealth space should take note. In this article, Simon Phillips, Partner at Bird & Bird, London, outlines the 100,000 Genomes Project and the challenges it generates, whilst providing a very useful introduction to genomic science. / read more

The Federal Communications Commission’s (‘FCC’) recent Notice of Proposed Rulemaking on the issue of net neutrality has instigated a substantial amount of heated debate. A facet of this issue is that the direction the FCC takes with regard to net neutrality will likely help - or hinder - the development of telehealth. Todd D. Daubert and Sara Kuehnle of Dentons provide an outline of the net neutrality debate and its relevance for telehealth. / read more

On 26 June 2014, the UK’s Department of Health launched a consultation, the aim of which was to reach a better understanding of the security conditions necessary to guarantee the confidentiality of patient data when they are shared for medical, administrative or research purposes. In France, this debate was reignited recently in a report published by the Opendata Santé commission set up by the French Ministry of Health (‘Ministry’), as Renaud Bouvet and Etienne Minvielle, of the French School of Public Health, and Pierre Desmarais of Desmarais Avocats, explain. / read more

Kyungsun Kyle Choi and Yong Hoon Cho of Kim & Chang’s Health Practice Group discuss the potential liberalisation of remote medical services in South Korea. / read more

eHealth and telemedicine applications are particularly well-developed and promoted in countries with sparsely populated regions, given that there is a practical need to do so. Does that necessarily mean that rather densely populated countries are, by their nature, lagging behind or even excluded from further development? Dr. Boris Handorn and Fabian Raddatz, LL.M. of Noerr LLP assess the situation in Germany. / read more

Canada’s Health Informatics Association - COACH - publishes best practice guidelines on the privacy and security of personal health information (‘PHI’). Sarah Courtney and Grant Gillis of COACH explain the aim and evolution of its most recent set of Guidelines for the Protection of Health Information. / 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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