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The tragic failure of the global supply chain in the face of the current coronavirus outbreak has caused acute shortages of essential frontline medical devices and personal protective equipment, crushing fear among frontline health workers and causing fundamental concerns about the sustainability of the health system. Much more coordination, integration, and management of global supply chains will
This article analyzes the impact and associated legal challenges of cross-border data transfers in the pharmaceutical sector after the recent Court of Justice of the European Union (CJEU) decision in Case C-311/18 Data Protection Commissioner v Facebook Ireland Limited, Maximillian Schrems (Schrems II). In Schrems II, the CJEU invalidated Decision 2016/1250 on the adequacy of the protection provid
Governments are always actively trying to improve their health care systems, and the secondary use of health data is one way of reaching this goal effectively. The secondary use of health data involves the use of health care data collected for a new purpose, such as research and policy planning. This data is usually collected from hospitals and health care systems – large databases containing admi
By Marcelo Corrales Compagnucci, Janos Meszaros & Timo Minssen Empirical studies in behavioral economics have demonstrated how people are biased and often make poor decisions against their best interests. This has led policy makers to promote choice-preserving approaches, a.k.a. nudges. However, there has also been an increasingly vocal group of legal scholars who are interest in asking whethe
Purpose: Alpha-synuclein often co-occurs with Alzheimer's disease (AD) pathology in Dementia with Lewy Bodies (DLB). From a dynamic [18F]flortaucipir PET scan we derived measures of both tau binding and relative cerebral blood flow (rCBF). We tested whether regional tau binding or rCBF differed between DLB patients and AD patients and controls and examined their association with clinical character
There is no doubt that COVID-19 will have a substantial impact on access to biologics and biosimilar uptake, as well as on the related ethical, legal, and social dimensions of prioritization decisions. This holds especially true for Denmark and European markets, where governments are expected to cover most of the pharmaceutical needs of their citizens and where the crisis has been leading to an im
As the world rushes to identify safe and effective vaccines and therapeutics to counter the COVID-19 epidemic, attention is turning to the next step: manufacturing these products at enormous scale. To speed up the process, firms are even es-tablishing manufacturing capacity “at risk,” before products receive regulatory approval (1). Yet for at least some complex COVID-19 vaccines and biological th
There has been a rapid rise in papers modelling the impacts of autonomous vehicles. Drawing on a review of this literature, we analyse and discuss the messages conveyed by these studies from a policy-making perspective. An overview of the studies is provided to highlight the different policy frames. We consider the roles that modelling knowledge should have in policy-making in the context of unsta
Whether the E.U. Trade Secrets Directive sufficiently and appropriately covers cutting-edge complex technologies is of critical interest to policy-makers, scientists, and commercial developers alike. One such technology—adaptive immune receptor repertoire sequencing, or AIRR-seq—raises difficult questions concerning what information is and should be protected under the new Directive, and how to be
The EU Trade Secrets Directive (‘the Directive’) has standardized the national laws in EU member states for the protection of trade secrets. For the first time, a harmonised definition of what constitutes a ‘trade secret’ is established as well as common measures aimed at preventing the misappropriating of trade secrets and rules for procedures and sanctions.The adoption of the Directive reflects
The growing significance of trade secrets (TS) in today's society and business has unleashed an unprecedented boom in litigation, legislation, and in media and scholarly attention. Many factors contribute to this development, such as the rise of digitalization & artificial intelligence, increasing mobility, a changing intellectual property (IPR) landscape, the greater flexibility and applicabi
This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable EU regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the softwar
This chapter will map the ethical and legal challenges posed by artificial intelligence (AI) in health care and suggest directions for resolving them. Section 1 will briefly clarify what AI is and Section 2 will give an idea of the trends and strategies in the United States (U.S.) and Europe, thereby tailoring the discussion to the ethical and legal debate of AI-driven health care. This will be fo
In February, 2020, the European Commission published a white paper on artificial intelligence (AI) as well as an accompanying communication and report. The paper sets out policy options to facilitate a secure and trustworthy development of AI and considers health to be one of its most important areas of application. We illustrate that the European Commission's approach, as applied to medical AI, p
The Swedish response to the Corona-crisis has been relatively moderate compared to most other countries. Sweden did not opt for a total lockdown, did not close elementary schools, day cares, bars, restaurants, movie theaters, and other places of business. Public gatherings of up to 50 people are still allowed until further notice. Sweden’s intra EU borders remain open – in contrast to its neighbor
Companies and healthcare providers are developing and implementing new applications of medical artificial intelligence (MAI), including the AI sub-type of medical machine learning (MML). MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, incl
