Digital Health Legal

Volume: 2 Issue: 3
(March 2015)


The French Council of State (‘Conseil d’Etat’) annulled, on 24 February, some of the provisions of the French Sunshine Act, which imposes disclosure obligations on healthcare companies, following legal action by the French Medical Board and a non-profit organisation against the law’s implementing decree and its explanatory circular. / read more

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published on 24 February its ‘Delivering High Standards in Medicines Advertising’ report, which states that the amount of complaints received by the MHRA regarding drug adverts fell from 283 to 193 between 2013-2014, but reports a rise in the proportion of complaints about adverts for prescription only medicines (POMs) to the public online. / read more

The Indian government set up a committee in late February to prepare pharmacovigilance guidelines that will set out adverse drug reaction reporting requirements for pharmaceutical companies, in a move that could see pharmacovigilance made mandatory in India. / read more


Before entering the world of politics, I worked as a medical doctor and surgeon during the 1970’s and 1980’s in my home country, Lithuania. Looking back at how things were then compared with now, among the things that strike me the most is the impact of technology on our health. Today health systems and health practitioners are faced with increasing demands and challenges, and also the choices that being a member of the EU offers. However, technological advancement has given us more efficient and innovative tools to counterbalance the challenges and make life easier for both doctors and patients. One of these tools is eHealth and as the EU Commissioner for Health, I am committed to ensuring that we create an environment in which such practical, innovative, and cost effective solutions thrive. By Vytenis Andriukaitis, European Commissioner for Health & Food Safety European Commission. / read more

Denmark’s government is working towards a national strategy on digitising its Healthcare Service, but despite its well established eHealth market in comparison to some other jurisdictions, legal and regulatory issues still remain. Arly Carlquist and Henrik Syskind Pedersen of Bech-Bruun provide an overview of the regulation of the eHealth sector in Denmark in the context of IT systems and data privacy. / read more

Data and transparency are crucial to the future of the NHS and better healthcare. Karen Thomson, Head of Data Sharing & Privacy at NHS England, provides her views on the use of data within the NHS, and how data collection and generation can be optimised to deliver better care. Karen explores the legal and ethical context specific to the UK, the complexities of the UK’s legal framework and how this impacts public bodies, and what the NHS needs to do to find the right balance between the rights and freedoms of the individual and those of the wider society. / read more

The United States Food and Drug Administration (‘FDA’) has made a significant regulatory shift with the publication of its final guidance ‘Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, Guidance for Industry and Food and Drug Administration Staff’ on 9 February. This guidance, which finalises draft guidance issued by the Agency in June 2014, reflects the FDA’s continued efforts to apply a risk-based framework that avoids over-regulation of certain low-risk medical software products, as Sonali P. Gunawardhana, Of Counsel at Wiley Rein LLP, explains. / read more

On 21 August 2008 Belgium adopted the law on the creation and organisation of the eHealth Platform. The Platform was conceived as a public institution with the objective of exchanging electronic services and information between all stakeholders in the healthcare field. The eHealth Platform was designed to provide safeguards in terms of data security and patient privacy and the quality and continuity of healthcare services, as well as patient safety. At the same time, the eHealth Platform was also expected to promote the simplification of administrative formalities and support the government’s healthcare policy. By Wim Nauwelaerts, Partner at Hunton & Williams LLP. / read more

The Article 29 Working Party (‘WP29’) published a letter addressed to the European Commission (‘EC’) on 5 February, in response to the Commission’s request for clarity on the scope of health data collected through lifestyle and wellbeing mobile health (‘mHealth’) apps. The WP29’s position will be of interest to the mHealth industry, as the WP29 inter alia highlights that whether an app is considered a medical device or not has no bearing on whether the data it collects is health data. Mónica Oliveira Costa of Coelho Ribeiro & Associados discusses the details of the WP29’s letter and what it means for the mHealth industry. / read more

The pharmaceutical industry is looking to strengthen its reputation, and pharmaceutical companies’ efforts across social media can play a big part in this transformation. Alexandra Fulford, a strategy consultant specialised in digital media and social media in the pharmaceutical industry, explores how social media is playing a part in this reputational shift. / 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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