Digital Health Legal

Volume: 3 Issue: 5
(May 2016)


A data-sharing arrangement obtained by New Scientist, published on 29 April 2016, has revealed that Google AI company DeepMind has access to wide-ranging health data of 1.6 million patients from UK Royal Free NHS Trust (‘Trust’) hospitals. The arrangement, established in February 2016, aims to develop an app, Streams, to identify and treat acute kidney injury (‘AKI’). / read more

The global Privacy Sweep 2016, which took place between 11 to 15 April 2016, focused on data protection compliance in the context of the Internet of Things, which included an examination of health devices by some of the 29 data protection authorities taking part. / read more

Prominent Chinese internet search engine Baidu was ordered by Chinese authorities on 8 May 2016 to adjust its search rankings so that search results are based less on payment received from advertisers, with more weighting instead given to other factors, such as reputation, following the controversy involving student Wei Zexi. / read more

The UK Government put forward on 18 May 2016, amongst the legislative measures contained in the Queen’s Speech, a proposed Digital Economy Bill, which inter alia features measures relating to broadband access and data sharing across the UK, which will likely have implications for eHealth services. / read more

The Netherlands presidency of the European Council and representatives of the European Parliament reached political agreement on the proposed Medical Devices Regulation (‘MDR’) and the In Vitro Diagnostics Regulation (‘IVDR’) on 25 May 2016. The two draft regulations aim to guarantee the safety of medical devices and in vitro diagnostic medical devices, whilst allowing patients to benefit from innovative healthcare solutions in a timely manner. Both draft Regulations are still to be formally approved by the European Council’s Permanent Representatives Committee and the Parliament’s Committee on Environment, Public Health and Food Safety. / read more


Brian Kelly, Attorney at Covington & Burling and member of the eHealth Law & Policy editorial board, takes a look at the European landscape for cloud computing in health, and examines policymakers’ ongoing efforts to promote its adoption. Brian identifies several key themes and best practices in the way in which different countries are supporting the technology’s use. / read more

While there remains plenty of investment in digital health start-ups, the actual business reality of the sector still needs to mature. Dr Yossi Bahagon, CEO of Luminox-Health, a company with specialist expertise in the realisation of digital health solutions, and member of the eHealth Law & Policy editorial board, discusses the challenges facing start-ups, and looks at the use of digital health ecosystems, which connect start-ups with strategic healthcare players and investors, as a means of tackling traditionalism in healthcare. / read more

As in many jurisdictions, the rise of health and fitness-related apps on smart devices has led to opportunities for developers and pharmaceutical companies in Switzerland. Here, Dr. Lorenza Ferrari Hofer and Phillip Schmidt of Pestalozzi Attorneys-at-Law consider the application of Swiss law to such medical apps, and discuss a number of hurdles for involved parties to navigate, including around in-app advertising and data protection requirements. / read more

Despite steps taken at EU level the use of Electronic Health Records (‘EHRs’) is still fragmented within Europe and real interoperability of EHRs still faces barriers that limit patient care and possible control of public health expenditure, which is growing due to an ageing population, the dramatic increase in chronic disease and other socio-economic and cultural factors. Dr Nadia Arnaboldi and Dr Fabio Ferrara of Arnaboldi Consulting Firm, provide an overview of the main actions taken by the European Commission and documents adopted at EU level that could be helpful to identify the state of the art on the use of EHRs and future steps to achieve interoperability. / read more

The US Federal Food and Drug Administration (‘FDA’ or the ‘Agency’) has recently released two proposed guidance documents dealing with data integrity, with one relating to medical devices and the other to drugs (the ‘Guidance’). The Guidance indicates that the data supporting manufacturing processes is set to be more closely scrutinised in future, a warning that pharmaceutical companies should pay heed to. Diane Romza-Kutz, Partner at Thompson Coburn LLP, outlines the FDA’s proposed Guidance and the specific data requirements therein. / read more

Since the announcement of the My Health Record electronic health record system in September 2015, there have been developments in eHealth in Australia both at a Federal level - concerning the My Health Record pilots and funding for digital health in general - and at State government level, as well as in regard to eHealth products such as wearables. Amber Cerny, Director at EY Law, and Alec Christie, a Partner at EY Law and a member of the eHealth Law & Policy editorial board, discuss recent developments and the implications for the growth of digital health in Australia. / 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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