EU Regulatory and Litigation

Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice

Join us for a 90-minute webinar, hosted by AdvaMed, focusing on the new EU Medical Device Regulations (MDR/IVDR), which represent the single largest regulatory change in the EU in decades. This program will highlight what the regulatory changes are, how these changes will affect your business, and what you can do to better prepare.  In

In a recent article published in Intellectual Property & Technology Law Journal, and expanding on our previous post, we discuss the legal and regulatory implications of applying artificial intelligence (AI) to the EU and US healthcare and life sciences sectors.

AI software, particularly when it involves machine learning, is being increasingly used within

The European Commission has made clear its intention to harness the potential that digital innovation can offer, and in May 2015, announced it Digital Single Market strategy. A key part of this is the digital transformation of health and care in order to improve healthcare for its citizens. On 20 July 2017, the European Commission

We have previously reported on a number of EU projects designed to promote eHealth interoperability (the ability of EU Member States to share healthcare information between their respective IT systems), including the Commission’s eHealth standards project, which aims to build consensus on the standards to be applied to eHealth products, and EURO-CAS, which

We have previously reported on the Accelerated Access Review (AAR), which made 18 recommendations to the UK government for speeding up patient access to new medical technologies. The overarching aim of the AAR was to make the UK a world-leader in healthcare innovation. The AAR report, which was published in October 2016, was particularly

On 28 June, the Advocate General of the Court of Justice of the European Union gave his opinion on the SNITEM and Philips France case against France. In this case, the Conseil d’Etat in France asked whether a particular software program intended to be used by doctors to support  prescribing decisions falls within the definition

Royal Free NHS Foundation Trust (the Trust) is one of the largest Trusts in the UK, employing more than 9,000 staff and providing services to over a million patients in North London.

On 3 July 2017, the UK Information Commissioner (ICO), the regulator overseeing data privacy, ruled that the Trust failed to comply with the

In February 2016, the European Commission established a Working Group on mHealth tasked with developing guidelines “for assessing the validity and reliability of the data that health apps collect and process”. Since this Working Group was set up, there have been a series of face-to-face meetings, open stakeholder meetings, conference calls and online

It has been almost a year since the European Commission published a final draft of a Code of Conduct on privacy for mHealth mobile applications (the “Code”). Our previous post summarizes the draft and its application to app developers. However, we noted that the Article 29 Working Party (the “WP29”), an independent advisory body comprised