Lexology

European Parliament Endorses Digital Health Resolution

European Union - January 13 2020 On December 12, 2019, the European Parliament endorsed a non-binding resolution on enabling the digital transformation of health and care. The…

Digital Healthcare Act Takes Effect in Germany

Germany - January 7 2020 Digital health applications that meet certain requirements will be covered by the German state health insurance schemes from 2020. This is one of the…

Ideation Question #10: What Are the Priorities for the Solution?

USA - November 26 2019 Today's video explores the question: What are the priorities for the solution?…

Ideation Question #9: Who Will Own Intellectual Property Rights?

USA - November 19 2019 Ideation Question #9: Who Will Own Intellectual Property Rights?…

EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

European Union - October 21 2019 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…

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

USA - October 8 2019 On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health…

Commission relaunch of eHealth Stakeholder Group

USA - August 21 2019 On 13 August 2019, the European Commission opened a call for expression of interest to relaunch the eHealth Stakeholder Group with a view to…

ICO publishes blog post on AI and trade-offs between data protection principles

United Kingdom - August 6 2019 On July 25, 2019, the UK’s Information Commissioner’s Office (“ICO”) published a blog on the trade-offs between different data protection principles…

German Government Enacts Digital Care Act

Germany - July 15 2019 The new Digital Care Act (Digitale-Versorgung-Gesetz) is part of Germany’s efforts to expand the digitization of the healthcare system in Germany…

ICO’s Call for Input on Bias and Discrimination in AI systems

United Kingdom - June 27 2019 On June 25, 2019, as part of their continuing work on the AI Auditing Framework, the UK Information Commissioner’s Office (ICO) published a blog…