Digital Health Legal

Volume: 1 Issue: 10
(November 2014)


Northern Ireland’s Health and Social Care Board (HSCB) launched a consultation on the proposed eHealth and Care Strategy for Northern Ireland (NI) on 8 October. The Strategy is a key part of the transformation and modernisation plan for health and social services in Northern Ireland through the use of technology. / read more

The US Office of the National Coordinator for Health IT (ONC) revealed on 15 October the latest draft of its interoperability roadmap, which presents a ten year plan towards a ‘nationwide interoperable health IT [HIT] infrastructure.’ / read more

NHS England published on 24 October its Five Year Forward View (5YFV), setting out the direction of the NHS for the next five years and explaining how it will change. Notably, the 5YFV focuses on accelerating innovation in delivering care, new care models and exploiting ‘the information revolution.’ / read more


The European Medicines Agency 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 Europe to make all clinical data relating to the approval of their medicines available to third parties for non-commercial use. Marie Manley and Edward Bray of Bristows LLP analyse the requirements of the new policy, the issues and what it means for pharmaceutical companies operating in the EU. / read more

Guangdong No. 2 Provincial People’s Hospital launched telemedicine in October, the first hospital in China to be approved to do so by the provincial Health and Family Planning Commission. Nicolas Zhu of CMS China provides a closer look at the development of telemedicine in China and the legal uncertainties to be addressed before it can really take off. / read more

Cyber attacks against connected medical devices are a growing area of concern for regulators. Regulatory action in the US so far includes the Food and Drug Administration’s (‘FDA’) ‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices’ guidance, which inter alia addresses the key elements necessary for establishing a cyber security management system. Sonali P. Gunawardhana and Megan L. Brown of Wiley Rein LLP discuss the regulatory response so far in the US. / read more

Mobile health (‘mHealth’) apps have the potential to greatly benefit the delivery of patient care, but there are liability issues that could result when something goes wrong and patient health is damaged. Manoj Vaghela, Partner at Pinsent Masons, discusses the issues surrounding mHealth liability within the context of both product and professional liability. / read more

Following the publication of the NHS Five Year Forward View, Sophie Cameron, Editor of eHealth Law & Policy, spoke to Beverley Bryant, Director of Strategic Systems and Technology at NHS England about what innovation means for the NHS, how the risks associated with digitialisation are being minimised and what NHS care might look like in 10 years time. / read more

Laure Le Calvé, Co-founder of LCH Avocats, provides an overview of the guidance issued in March by France’s National Agency for the safety of drugs and health products (‘ANSM’) on the promotion of medical devices via online media, and the challenge that these new rules pose for both French and foreign companies operating in the medical devices industry. / read more

A decree to implement electronic health records (‘EHRs’) in Italy is currently in draft form, following the passing of a law in 2012 establishing the rules and principles necessary for implementing EHRs. The Italian Data Protection Authority, the Garante, has issued a favourable verdict on the draft but has argued for some amendments, as Laura Liguori of Portolano Cavallo Studio Legale explains. / 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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