Digital Health Legal

Volume: 4 Issue: 2
(February 2017)


The US Food and Drug Administration (‘FDA’) published comments from the Advanced Medical Technology Association (‘AdvaMed’) in response to its Proposed Rule on the Electronic Submission of Labeling for Certain Home-Use Medical Devices on 18 January 2017, in which AdvaMed outlines its concerns that proceeding with such a rule would pose a risk to patient safety and “will do little, if anything, to enhance public health and may result in unintentional negative consequences.” / read more

The UK’s Prime Minister Theresa May announced on 17 January 2017 that the UK is to leave the EU Single Market as part of Brexit, ending months of speculation on the issue. The theme of the UK’s continued relationship with the EU was discussed in a healthcare context by the Health Secretary Jeremy Hunt in a House of Commons Health Committee hearing on 24 January, in which Mr Hunt made an analogy between exiting the Single Market and the UK’s relationship with the European Medicines Agency (‘EMA’), outlining that the UK seeks a “working relationship with the EU, when it comes to medicines and medical devices regulation, that is as close as the one we currently have” post-Brexit. / read more


Cori Goldberg, Chaula Mehta, and Krishna Kavi of Norton Rose Fulbright reflect on the US Food and Drug Administration’s (‘FDA’) enforcement action relating to the promotion of prescription drugs and medical devices online in 2016, reflecting on the draft guidance issued and what 2017 - and a Trump presidency - might hold. / read more

On 19 October 2016, the Court of Justice of the European Union (‘CJEU’) held that Germany’s fixed pharmacy prices constitute an unjustified restriction of the free movement of goods principle, which cannot be justified on grounds of the protection of health and human life. The ruling overturned Germany’s retail price maintenance regulation for prescription drugs. Here, Jan Schlimgen and Max Müller of Dutch online pharmacy DocMorris N.V. provide their perspective on this important ruling, which was instigated by a bonus system that a German Parkinson’s disease self-help organisation agreed with DocMorris. It was the legal action taken by the German Association for Protection Against Unfair Practices against this bonus system that led to the ruling from the CJEU. / read more

The European Commission, aware that SMEs in the eHealth space face considerable legal challenges in getting their eHealth ventures off the ground, has invested in assisting SMEs in this area. One such initiative is the new eHealth Hub, designed to provide legal guidance exclusively to eHealth SMEs. Here, Patrick Cahill, Solicitor and Manager at qLegal - Queen Mary University of London’s legal service for startups and entrepreneurs - outlines the work of the eHealth Hub. / read more

Sonali P. Gunawardhana, Of Counsel at Wiley Rein LLP, provides detailed analysis of the US Food and Drug Administration’s (‘FDA’) final guidance on ‘Postmarket Management of Cybersecurity in Medical Devices’ and the changes adopted by the FDA in response to stakeholder responses. / read more

José Fernández-Rańada and Jara A. Atienza of J&A Garrigues, S.L.P consider in this article the regulation of the mHealth sector in Spain. Finding that no national legislation exists to cover this area, the authors present a detailed look at how the EU as a whole handles the thorny issue of whether certain software is a medical device. / read more

Joăo Bocas - a wearables expert and digital health influencer - shares his thoughts on the rise of wearable devices in the context of digital heath and the challenges facing the industry, including the security threats. / 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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