Digital Health Legal

Volume: 3 Issue: 1
(January 2016)


The first draft of a privacy Code of Conduct for mHealth apps was presented at a meeting organised by DG Connect and the European Commission in Brussels on 7 December. The Code is intended for use by app developers and focuses on safeguarding the privacy of data that is collected by mHealth apps, in order to guide developers’ understanding of relevant data protection law. / read more

Three plaintiffs representing a class of customers who have purchased Fitbit Charge HR or Fitbit Surge heart rate trackers filed a lawsuit in a California court on 5 January, alleging the trackers ‘consistently mis-record heart rates by a very significant margin’ and that Fitbit has defrauded consumers. / read more

The proposed Network and Information Security (‘NIS’) Directive, which was informally agreed by the European Parliament and Council on 7 December, “is broadly speaking, a positive development for eHealth in the EU,” says Brian Kelly, Associate at Covington & Burling LLP. / read more


The EU General Data Protection Regulation (‘GDPR’) has been called the most lobbied piece of legislation in the history of the EU. Before Christmas last year what is likely to be the final text of the GDPR emerged from the EU trilogue negotiations. Victoria Hordern, Senior Associate at Hogan Lovells, in this article explores what the new GDPR will mean for those collecting and handling health data, and examines a number of the provisions and themes that impact on the use of health data. / read more

Erik Vollebregt, Lawyer at Axon Lawyers and member of the eHealth Law & Policy editorial board, provides an update on the Medical Devices Regulation (‘MDR’) and In Vitro Diagnostics Regulation (‘IVDR’) proposals, which are currently being discussed by the European Commission, European Parliament and the EU Council during the trilogue process. Erik highlights a number of issues that may be of concern to the eHealth sector, for example the definition of medical device being expanded to include products, such as software, that have an ‘indirect medical purpose.’ / read more

Dr Lisa Klautzer is an independent research consultant with over 10 years of experience in policy research. In this article Lisa discusses the rise of workplace wellness programmes (‘WWPs’) in the US and sheds light on the legal landscape surrounding the increased use of eHealth technologies in the workplace. / read more

The primary objective of the Italy-US Congress, organised by the University of Bologna alongside the University of Illinois, was to cross-learn from new technology while laying the foundations for future digital health collaborations. The conference covered areas ranging from data management to legal issues pertaining to the use of technology in healthcare. / read more

In October last year the UK Court of Appeal delivered its verdict in W, X, Y and Z v. The Secretary of State for Health, a case in which the court looked at whether the sharing of NHS data to recover fees from overseas visitors was lawful. The outcome of the case contains a number of points of interest, such as what can be construed about the use of data in innovative ways to improve the efficiency and quality of NHS services. Richard Parker of Hill Dickinson LLP discusses the case. / 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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