On April 8, 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 This follows a stakeholder consultation on its draft guidelines published in December 2018 (the “draft guidance”) (see our previous blog post for more information on the draft guidance). The guidance retains many of the same core elements of the draft guidance, but provides a more streamlined conceptual framework and elaborates further on some of the more nuanced aspects, such as on interaction with existing legislation and reconciling the tension between competing ethical requirements.
According to the European Commission’s Communication accompanying the guidance, the Commission will launch a piloting phase starting in June 2019 to collect more detailed feedback from stakeholders on how the guidance can be implemented, with a focus in particular on the assessment list set out in Chapter III. The Commission plans to evaluate the workability and feasibility of the guidance by the end of 2019, and the AI HLEG will review and update the guidance in early 2020 based on the evaluation of feedback received during the piloting phase.
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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 allow healthcare professionals to follow-up on the condition or habits of their patients, often in real-time. How do manufacturers determine what wearables qualify as medical devices? How do they assess whether their devices need a CE-mark? Must they differentiate between the actual “wearable” and the hardware or software that accompanies them? In this short contribution, we briefly analyze some of these questions. The article first examines what “wearables” are, and when they qualify as a medical device under current and future EU rules. It then addresses the relevance of the applicability of EU medical devices rules to these products. The application of these rules is often complex and highly fact-specific.
The European Commission estimates that the global market for the Internet of Things (“IoT”) will grow to 75.4 billion devices by 2023. It also estimates that the economic value of spectrum enabled services is at present worth €500 billion per year. This is expected to increase by 200% – up to €1 trillion a year by 2023 – making the availability of spectrum (needed to send and receive data) and the development of 5G technology increasingly significant.
The “Internet of Things” (IoT)—the network of consumer devices connected to the Internet through digital connections and sensors—has dramatically grown over the past five years. A 