Digital Health Legal

Volume: 4 Issue: 8
(August 2017)


On 19 July 2017, the European Commission (‘EC’) published its Roadmap relating to its policy communication on the ‘Transformation of health and care in the Digital Single Market’ (the ‘Communication’), which the EC is planning to adopt in Q4 2017, as was originally suggested in the EC’s Digital Single Market Mid-Term Review of May this year. / read more

The UK Government published its response to the recommendations made by the National Data Guardian, Dame Fiona Caldicott (‘NDG’), and the Care Quality Commission (‘CQC’) on 12 July 2017, in relation to the data security, opt-out and consent policies for health data within the UK’s health and social care system. The response document, ‘Your Data: Better Security, Better Choice, Better Care,’ sets out the UK Government’s intention to uphold all the recommendations made by the NDG in the ‘Review of data security, consent and opt-outs’ and by the CQC in its ‘Safe data, safe care: data security’ review. / read more


On 4 July 2017 Professor Dame Sally Davies - England’s Chief Medical Officer - published her eighth annual Report, entitled ‘Generation Genome.’ The Report focused on genomic medicine and called on clinical staff, managers, those in the biotech sector and the UK Government to work together to make wider use of revolutionary genetics techniques in the battle to improve cancer survival rates and identify rare diseases faster so patients can get the right care at the earliest opportunity. In this article Sarah Ellson, Hazel Grant and Beatriz San Martin, of Fieldfisher LLP, assess the regulatory, privacy and intellectual property issues that are yet to be solved as the rise of genomics in the UK continues. / read more

The Brexit Health Alliance (‘BHA’) - an organisation aiming to support the UK in developing the appropriate ecosystem for digital health technologies - views Brexit as presenting opportunities for the UK healthcare system, as the Brexit process, while challenging, could create the conditions necessary for the UK to become the world leader in the use of data in the healthcare system. Sami Agush of the Association of British Healthcare Industries (‘ABHI’), a member organisation of the BHA, explains here why ABHI believes that digital health is data, and what this means in the context of Brexit. / read more

Whether and when software falls into the category of being classified as a medical device is a somewhat tricky question, and a particularly pertinent one given the proliferation of healthcare apps on the market. A recent dispute in France has led to a referral to the Court of Justice of the European Union (‘CJEU’) in a case that may help to clarify the software as medical device question. AG Sanchez-Bordona, providing an opinion in this case, concluded that a prescription support tool such as the one in this case falls within the category of a medical device. Lorna Brazell, Partner at Osborne Clarke, reviews the case, the AG’s Opinion and the relevant law. / read more

On 27 May 2017, Texas Governor Greg Abbott signed into law Senate Bill 1107, which significantly increases opportunities for telemedicine services in the State. The new Bill removes the requirement previously in place in Texas for a face-to-face visit or an established physician-patient relationship to be in place before most providers could offer direct-to-consumer telehealth services. Alexis Gilroy, Todd Kelly and Courtney Carrell, of Jones Day, discuss the key features of Senate Bill 1107, and assess the future of telemedicine services in Texas and beyond. / read more

EudraVigilance is a huge database containing over 10 million separate data entries. It was first launched in 2001 to manage and analyse information in the form of individual case safety reports (‘ICSRs’) on suspected adverse reactions to medicines. The system is hosted by the European Medicines Agency (‘EMA’) which operates the system on behalf of the medicines regulatory network of the Member States of the EU and EEA. EudraVigilance has evolved over the years in order to respond to the ever changing environment in which medicines are being developed, prescribed, used, monitored and regulated, including most recently in the shape of a new version of the system that is due to go live on 22 November 2017. Dr Lincoln Tsang, Partner at Arnold & Porter Kaye Scholer LLP, here explores the purpose and development of the EudraVigilance system, looks at the new, updated system, and considers the impact of Brexit on the UK’s involvement in drug safety regulation and access to the EudraVigilance system going forward. / 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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