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 of the European Union (CJEU) on legal classification of software medical device is therefore instructive. The European Court’s first decision…
On December 7, 2017, the US Food and Drug Administration (FDA) announced several digital health policy documents designed to “encourage innovation” and “bring efficiency and modernization” to the agency’s regulation of digital health products. The three documents include two draft and one final guidance which address, in part, the important changes made by Section 3060 of the 21st Century Cures Act (Cures Act) to the medical device provisions of the Federal, Food, Drug, and Cosmetic…
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 particular, the classification rules for software have changed, and new requirements are likely to apply to apps and mHealth technologies.…
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 healthcare and life science sectors. Its uses include drug discovery (e.g., software that examines biological data to identify potential…
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 launched a public consultation to assess how digital innovation can be used to enhance health and care in Europe. This…
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 aims to develop tools to assess the conformity of eHealth products with those standards. In parallel with those projects, the…
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 focused on digital technologies, and recognized that the current systems in place are not sufficiently flexible to realize the full…
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 of medical device as provided by Directive 93/42/EEC (the Medical Devices Directive). Definition of a medical device As we have…
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 Data Protection Act when it provided patient details to Google DeepMind. The Trust provided personal data of about 1.6 million…
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 questionnaires. Two drafts of the guidelines have also been published for consideration, as discussed in our previous posts here and here.…