Digital Health Legal

Volume: 4 Issue: 6
(June 2017)


The European Medicines Agency (‘EMA’) announced on 22 May 2017 that an improved EudraVigilance database system for the collection and monitoring of suspected adverse reactions will launch on 22 November 2017, with the EMA Management Board having signalled that the new system has reached full functionality. The updated system, which reports on medicines either authorised or being studied in the EEA, aims, inter alia, to simplify the reporting of individual case safety reports, to offer enhanced search and data analysis capabilities and to support larger volumes of use via increased system capacity and performance. / read more

The European Commission (‘EC’) published on 10 May 2017 a mid-term review of its Digital Single Market Strategy, which assesses the progress made so far and comments on a number of areas relating to digital health. The review notes the progress made in achieving cost-effective, efficient and digitised healthcare services but also outlines areas where more needs to be done to achieve its goals. / read more

The UK’s National Institute for Health and Care Excellence (‘NICE’) through its Scientific Advice service unveiled on 30 May 2017 the Medtech Early Technical Assessment (‘META’) online tool, which aims to assist medical device and diagnostic product developers in gathering the evidence needed to prove their products are clinically and cost effective, and prepare developers to engage with health technology assessment organisations and payers, thus increasing the speed to market of the product. / read more


The latest medical data sharing controversy to attract the interest of regulators and the press involves the Royal Free London (‘RFL’), one of London’s biggest hospitals, and its arrangements with DeepMind, involving the transfer of 1.6 million identifiable patient records, without explicit patient consent, as part of the development and testing of an application relating to acute kidney injury. ‘Streams’ integrates different types of data and tests results, and can be used by clinicians to quickly identify patients with acute kidney injury, with the aim of saving medical staff valuable time and improving patient outcomes. Attention on the arrangements, in particular the Information Sharing Agreement between the RFL and DeepMind, intensified following a letter from Dame Fiona Caldicott, the UK’s National Data Guardian, on the subject of the Agreement, which was sent to Professor Powis, Medical Director at the RFL and published in the national press. Adam Rose and Nina O’Sullivan of Mishcon de Reya LLP assess the Agreement and the concerns put forward by Dame Caldicott. / read more

The European Commission has recently published a mid-term review of its Digital Single Market (‘DSM’) Strategy. Amongst the aspects of the DSM Strategy that are relevant for the digital health sector is the ‘European Cloud Initiative,’ which aims to encourage the sharing and re-use of data and tools for research and bolster Europe’s high performance computing (‘HPC’) infrastructure. Brian Kelly, Partner at Covington & Burling LLP and member of the Digital Health Legal Editorial Board, examines the Initiative and its progress to date. / read more

The recent WannaCry ransomware attack, which made headlines after affecting a number of NHS Trusts’ computers as well as those of many other organisations, has revealed the parlous state of many IT systems and brought the cyber security of healthcare organisations in the UK and beyond to the fore. Will Richmond-Coggan, Partner and Solicitor-Advocate at Pitmans LLP, looks at the WannaCry attack in the context of health IT, and at the need to protect against such cyber attacks, especially in light of the General Data Protection Regulation (‘GDPR’), which comes into effect in May 2018. / read more

On 25 May 2018, the General Data Protection Regulation (‘GDPR’) is due to come into effect. The GDPR will apply to all organisations that process personal data established in the EU or that target or monitor individuals in the EU. Whilst the GDPR does not fundamentally change the approach to data protection in the EU, it imposes stricter requirements on organisations to strengthen the rights of individuals over their personal data, while the GDPR specifically defines genetic data and regulates its use. Lilly Taranto and Sam Choi of Hogan Lovells examine how the GDPR changes data protection considerations for organisations using genetic data, whether for clinical, insurance or research purposes. / read more

In this article, Gustaf Duhs, Partner and Head of Competition and Regulatory Law at Stevens & Bolton LLP, sets out a brief summary of the recent case before the CJEU relating to fixed pharmacy prices involving online pharmacy DocMorris and what this ruling means for the online sale of pharmaceuticals in Europe; further, Gustaf considers the latest developments in Germany and more generally in the EU following the CJEU’s decision on the matter. / read more

In this article, Benjamin Gaw, Director at Drew & Napier LLC, sets out an overview of the rise in the use of Big Data in the context of healthcare and the legal framework in Singapore  relating to personal medical data, before examining the implications for organisations that make use of anonymised Big Data specifically in the healthcare context both under the Singapore Personal Data Protection Act and the Human Biomedical Research Act. / 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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