Digital Health Legal

Volume: 3 Issue: 10
(October 2016)


The UK Health Secretary announced on 7 September 2016 a number of digital technology measures for use by NHS patients, including the launch of a library of NHS-assessed apps, following a report published the same day by the National Advisory Group on Health IT in England, chaired by Professor Wachter (‘Report’). / read more

US medical device company St. Jude Medical filed a lawsuit on 7 September 2016 against hedge fund Muddy Waters and research company MedSec Holdings, alleging that the latter two’s claims about cyber security vulnerabilities in St. Jude’s cardiac pacemakers and defibrillators were part of a scheme designed to impact St. Jude’s stock rating. St. Jude’s lawsuit refers to the vulnerability claims as ‘false information.’ / read more

The US National Institutes of Health (‘NIH’) published its Final Rule on clinical trial information on 16 September 2016, aiming to increase the availability of information about clinical trials on the publically accessible database “The Final Rule requires the companies conducting certain types of clinical trials to provide more detailed information regarding their studies; this will give competitors a roadmap to conducting their own trials of similar products,” explains Lina R. Kontos, Counsel at Hogan Lovells. “Companies should consider requesting available extensions to delay the public release of the information where the privacy of the study design and results is important from a business perspective.” / read more


On 25 August 2016 the Medicines and Healthcare Products Regulatory Agency (‘MHRA’) updated its guidance regarding standalone software including apps (‘Guidance’), which aims to assist developers and users in resolving the question of whether their software or apps classify as regulated medical devices. Raj Gathani and Brian Kelly, of Covington & Burling LLP, examine the implications of the MHRA’s Guidance. / read more

eHealth services make extensive use of data analytics on sensitive patient and user data to provide valuable benefits to users, giving them more control over the management of their health. Anonymisation can be critical to enabling data to be shared and used freely on these applications without compromising users’ privacy. Pharmaceutical and device companies are at the same time granting greater access to patient-level anonymised clinical trial data to qualified researchers through platforms such as Richard Bird and Nicola Kung of Freshfields Bruckhaus Deringer analyse the recent decision of the UK Information Tribunal (the ‘Tribunal’) concerning a release of anonymised clinical trial data - Queen Mary University of London v. Information Commissioner in August 2016 (the ‘QMUL Decision’) - and survey the approaches to anonymisation of personal information in Korea, Japan, Hong Kong, Singapore and the US. / read more

The Commissioners of the Federal Trade Commission (the ‘Commission’) in July 2016 issued an order and opinion in the LabMD case, which was the subject of an initial decision by a Federal Trade Commission (‘FTC’) Administrative Law Judge (‘ALJ’) in November 2015. Patricia M. Wagner of Epstein Becker Green P.C. details the background to the case and the Commission’s findings. / read more

As part of its ‘Digital Belgium’ action plan, the Belgian Government has put forward the ‘Digital Health Valley,’ the aim of which is to create mobile applications to be used by patients to monitor aspects of their health, and which has already seen a large amount of money put towards supporting test bed projects to develop such an application. Jean-Marc Van Gyseghem, Partner at Rawlings Giles, discusses the objectives of the Digital Health Valley and the criteria projects need to meet to receive funding. / read more

In August 2016 the Washington think-tank the Future of Privacy Forum (‘FPF’) released Best Practices for consumer wearables and wellness apps and devices, a baseline of responsible privacy practices, while in June 2016 the European Commission (‘EC’) Code of Conduct on privacy for mobile health apps (‘Code’) was submitted to the Article 29 Working Party after being developed by a working group. Eloïse Gratton, Partner at Borden Ladner Gervais LLP, describes these initiatives and compares and contrasts their approaches. / read more

China’s Food and Drug Administration (‘CFDA’) recently ordered that third parties cease selling drugs through their own online platforms, ending pilot schemes being carried out in three Chinese provinces. This action by the CFDA might appear to indicate that the regulation of third party online drug sales platforms is now not to go ahead; however, in this article Nicolas Zhu, Partner at CMS, China, argues that this is not necessarily the case and that such regulation may still be on the agenda. / 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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