Digital Health Legal

Volume: 1 Issue: 9
(October 2014)


The European Medicines Agency (EMA) adopted its new policy on the publication of clinical reports on 2 October, which will require drug companies whose products are available for sale in the EU to make all clinical data relating to the approval of their medicines available to third parties for non-commercial use. The policy is accompanied by a Q&A document. / read more

The US Food and Drug Administration (FDA) published on 2 October its final ‘Content of Pre-market Submissions for Management of Cybersecurity in Medical Devices’ guidance, urging device manufacturers to document and address cybersecurity risks during the manufacturing process. / read more

The General Pharmaceutical Council launched a consultation on 17 September on its draft guidance for the regulation of online pharmacies, which aims to find the balance between protecting patients and supporting innovation. / read more


Charlotte Davies, Lead Healthcare Analyst at Ovum, explains the need to effectively share digitised health information between the various providers involved in healthcare delivery, and why there is now a case for dynamic consent. / read more

On 10 September 2014 the Italian Data Protection Authority (‘Garante’) published the result of its survey on mHealth apps, which was conducted between 12 and 18 May 2014. The survey was part of the international initiative ‘Privacy Sweep 2014,’ promoted by the Global Privacy Enforcement Network (‘GPEN’), and was aimed at encouraging organisations to comply with privacy legislation and enhancing cooperation between data protection enforcement authorities. Dr. Nadia Arnaboldi, Chartered Accountant and Auditor Certified Information Privacy Professional, Europe and US (CIPP/E/US). / read more

Euan Ashley, Sharat Israni and Lloyd Minor of Stanford University’s School of Medicine, discuss big data in the context of modern medicine and the grand challenges that must be overcome for the benefits that data presents for global health to be fully realised. / read more

Fostering innovation has become a touchstone for governments and private industry as they seek to create growth and remain competitive. In the health sector, access to the healthcare system to allow the testing and validation of new products can be a key stumbling block in the route to market for innovative ideas. Following on from a successful trial of a demonstrator project based at University College Cork (the ‘Cork Hub’), the Irish Government has announced that a National Health Innovation Hub (the ‘HIH’) will be established in Ireland in 2014. By Douglas McMahon, Solicitor at McCann FitzGerald, Ireland. / read more

On 7 March, the State Council of the People’s Republic of China announced a new revision of China’s Regulations on Supervision and Administration of Medical Devices (the ‘2014 Regulations’), which took effect on 1 June and aims to reduce the industry threshold for governmental approval, whilst strengthening administration for the entire lifecycle of medical devices on the market. Vincent Wang and Sherry Zhang of Davis Wright Tremaine LLP discuss the amendments to the law. / read more

Innovators in any field require a strong grasp of the intellectual property (‘IP’) rights that could apply to their innovations – not just in terms of protecting an innovation but also in terms of how IP rights can be maximised. This is especially applicable in the field of eHealth, where innovations are of utmost importance as the healthcare sector is transformed by technology. Nigel Jones, Co-Head of the Healthcare Sector and IP Partner at Linklaters LLP, provides a breakdown of the types of IP rights available to an eHealth innovator. / read more

The world of biomedical technology and the new technology driven world of health and fitness apps are colliding and have the potential to produce new exciting healthcare networks. Jon Neiditz, Big Data, Privacy and Information Security Practice Lead at Kilpatrick Townsend & Stockton LLP, and a member of the eHealth Law & Policy Editorial Board, explains how this collision may give the US healthcare system its best chance at improving health. / read more

Cyberspace is a dangerous place for a doctor’s reputation. That most valuable and nebulous asset is more exposed than ever before in the fickle and fragmented online world. The internet provides people with the means and outlets to attack medical reputations anonymously and without accountability. Doctors must learn to manage and protect their reputation online and that begins with an awareness of the risks. By Magnus Boyd, Partner at Hill Dickinson. / 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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