The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect. The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply. In advance of these … Continue Reading
On 19 September 2019, the European Parliamentary Research Service (“EPRS”)—the European Parliament’s in-house research service—released a briefing paper that summarizes the current status of the EU’s approach to developing a regulatory framework for ethical AI. Although not a policymaking body, the EPRS can provide useful insights into the direction of EU policy on an issue. … Continue Reading
On 8 April 2019, the EU High-Level Expert Group on Artificial Intelligence (the “AI HLEG”) published its “Ethics Guidelines for Trustworthy AI” (the “guidance”). This follows a stakeholder consultation on its draft guidelines published December 2018 (the “draft guidance”) (see our previous blog post for more information on the draft guidance). The guidance retains many … Continue Reading
On March 28, 2019, the Council of Europe* issued a new Recommendation on the protection of health-related data. The Recommendation calls on all Council of Europe member states to take steps to ensure that the principles for processing health-related data (in both the public and private sector) set out in the Appendix of the Recommendation … Continue Reading
On 15 February 2019, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their Joint Big Data Taskforce’s summary report (available here) setting out recommendations for understanding the acceptability of evidence derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators. The Taskforce has sought to clarify … Continue Reading
Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases … Continue Reading
On 6 December 2018, the European Economic and Social Committee (EESC) published an opinion (“Opinion”) addressing the European Commission’s recent Communication on the digital transformation of health and care in the Digital Single Market (issued 25 April 2018). The EESC is an advisory body of the European Union (“EU”) comprising representatives of workers’ and employers’ … Continue Reading
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar: Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company … Continue Reading
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered topics such as … Continue Reading
On 14 September 2017, the Committee for Human Medicinal Products (“CHMP”) of the European Medicines Agency adopted ICH Guideline E18 (the “Guideline”) on genomic sampling and the management of genomic data. The Guideline takes effect on 28 February 2018. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) … Continue Reading
On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices. … Continue Reading
Digital health solution providers, and users of digital health services, should take note of three recently launched EU public consultations in the digital health space, and may wish to make submissions to help shape the future of digital health initiatives in the EU. The earliest deadline for submissions is 16 August 2017. EU Commission Transformation … Continue Reading
The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to sign an … Continue Reading
On May 11, 2017, the European Cloud in Health Advisory Council (ECHAC) – a group of healthcare organizations, technology companies and patient representatives – launched its second whitepaper focused on use of data to improve health outcomes and delivery of care. ECHAC launched the whitepaper at an eHealth Week 2017 session attended by ECHAC participants and … Continue Reading
The UK Government has opened a consultation, running until September 7, 2016, regarding how UK National Health Service (NHS) patient data should be safeguarded, and how it could be used for purposes other than direct care (e.g. scientific research). The consultation comes after two parallel-track reviews of information governance and data security arrangements in the … Continue Reading
On 15 July 2016, the European Commission updated MEDDEV 2.1/6 (the “MEDDEV Guidance), its medical device guidance on the qualification and classification of stand alone software used in the healthcare setting. The updated version replaces an earlier version of MEDDEV 2.1/6 issued by the European Commission in January 2012. MEDDEV 2.1/6 generally stands as a … Continue Reading
Following a 2014 mHealth consultation and two open stakeholder meetings in 2015 (see here and here), the European Commission has announced the formation of a new working group aiming to draft guidelines on mHealth app data quality.… Continue Reading
May 2015 saw a number of developments in the EU mHealth sector worthy of a brief mention. The European Commission announced that it would work on new guidance for mHealth apps, despite the European Data Protection Supervisor and British Standards Institution publishing their own just weeks earlier. In parallel, the French data protection authority announced … Continue Reading
The Article 29 Working Party has published a letter (with Annex) to the European Commission, clarifying the scope of the key legal term “health data” in relation to lifestyle and wellbeing apps.… Continue Reading
Our colleague Monika Kuschewsky recently published a post on the InsidePrivacy blog describing how the Article 29 Data Protection Working Party (Working Party), an independent EU advisory body on data protection and privacy, responded to a request from the European Commission made in the framework of the Commission’s mHealth initiative to clarify the definition of data … Continue Reading
The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation. The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health The consultation covered a broad range of important issues for mHealth, including legal frameworks, privacy and data protection, patient safety, … Continue Reading
