Digital Health Legal

Volume: 4 Issue: 9
(September 2017)


The Government commissioned ‘Life Sciences Industrial Strategy: A report to the Government from the life sciences sector’ published on the 30 August 2017 outlines multiple recommendations pertaining to digital health development in the UK. Amongst the findings of the Strategy, led by Sir John Bell, a Professor of Medicine at the University of Oxford, developed in consultation with the Life Sciences Industrial Strategy Board, is the potential for digitisation and artificial intelligence (‘AI’) to transform pathology and imaging. According to the Strategy it should be the ambition of the UK to develop and test integrated AI systems that provide real time data, as especially within the context of the UK’s National Health Service (‘NHS’) ‘no other system has the scale to provide such important data that, when captured, could produce a globally dominant commercial offering in this diagnostic space.’ / read more

The UK Medicines and Healthcare products Regulatory Agency (‘MHRA’) published on 29 August 2017 guidance on the new EU Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746) (collectively, ‘the Regulations’), in order to assist medical device and in vitro device manufacturers in understanding their obligations under the Regulations. The MHRA’s guidance includes an interactive introduction to the Regulations. / read more

The European Commission announced - through a call for expressions of interest - its mHealth Hub project on 7 August 2017, which aims to bring together best practices in the area of European mobile health, in order that the national experiences of EU Member States are shared, and that Member States are better able to introduce and operate mHealth programs within national health systems. / read more


The UK Government published ‘Your Data: Better Security, Better Choice, Better Care’ (the ‘Response’) on 12 July 2017, in response to the recommendations put forward in the National Data Guardian for Health and Care’s ‘Review on Data Security, Consent and Opt-Outs’ (‘NDG Review’) and the Care Quality Commission’s Report ‘Safe Data, Safe Care’ (‘CQC Report’). In light of the Response, Sarah Hanson and Loretta Pugh, of CMS Cameron McKenna Nabarro Olswang LLP, assess the Government’s new approach to health data security and the new opt-out model for individuals to control how their health data is used. / read more

In February 2016, the European Commission appointed a Working Group to draft mHealth app assessment guidelines (the ‘mHealth Guidelines’) with the objective of streamlining app assessment processes across Europe and encouraging reliable, compliant uptake of mobile health apps for use in healthcare. On 9 June 2017, a Report of the Working Group on mHealth assessment guidelines1 (the ‘Report’) was published, stating that it was ‘impossible to achieve and endorse any guidelines.’ Jackie Mulryne and Bonnie Clemence, of Arnold & Porter Kaye Scholer LLP, consider what has been learnt about the development of the mHealth Guidelines in light of the Report and the impact that the lack of mHealth Guidelines coming out of the Working Group will have on app developers and healthcare providers. / read more

On 1 October 2017, Ontario’s amendments to its Personal Health Information Protection Act (‘PHIPA’) will come into effect, imposing more rigorous breach notification obligations on those responsible for the protection of an individual’s health data. Michael Whitt, Sebastien Gittens and Antonia Alisauskas of Bennett Jones LLP consider the impact of the amendments to PHIPA in the context of the differing breach notification obligations across the Canadian provinces. / read more

As the UK negotiates its new relationship with the European Union, the provision of cross-border healthcare as well as the development and regulation of medical technology pose important questions. Hein van den Bos, Counsel at Hogan Lovells, provides commentary on the objectives of the Brexit negotiations for the UK and the EU, and considers how and why both sides will look to continue collaborating to develop digital health without border restrictions. / read more

Outsourcing, cloud computing and the general use of external service providers has been subject to regulatory obstacles in Germany for quite some time. Persons subject to professional secrecy, such as medical practitioners, pharmacists, and psychologists etc, need to comply with strict requirements under the German Criminal Code. This has led to various discussions and workarounds, but also to a high degree of uncertainty. Thanos Rammos, Salary Partner at Taylor Wessing, considers the impact of proposed amendments to the German Criminal Code approved by the Bundestag on 29 June 2017 which, if approved by the Bundesrat, could enable companies from the medical and insurance sectors to make wider use of outsourcing and cloud services. / read more

In France, the Health Information Institute (‘INDS’) has begun to accept requests for authorisation to access the new National Health Data System (‘SNDS’), as part of measures brought in by Act No. 2016-41 of 26 January 2016 (the ‘Reform Law’). Jeanne Bossi Malafosse, Partner at Delsol Avocats, and Carol Umhoefer, Partner at DLA Piper, assess the new authorisation procedure for the provision of health data access in France, and consider the issues that may arise from its implementation. / read more

On 19 July 2017, the European Commission (‘EC’) published a Roadmap entitled ‘Transformation of health and care in the Digital Single Market (the ‘Roadmap’), and the following day launched a public consultation of the same name (‘Public Consultation’). The EC identified areas for improvement in the EU digital health industry, set out goals for improvement going forward, and requested relevant information to inform future policy communication. Piet Weinreich, Counsel at Osborne Clarke, dissects the Roadmap and the Public Consultation and considers the teething problems Member States may continue to face when digitising their healthcare solutions. / 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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