On 11 May 2023, members of the European Parliament’s internal market (IMCO) and civil liberties (LIBE) committees agreed their final text on the EU’s proposed AI Act. After MEPs formalize their position through a plenary vote (expected this summer), the AI Act will enter the last stage of the legislative process: “trilogue” negotiations with the European Commission, Parliament and the Council, which adopted its own amendments in late 2022 (see our blog post here for further details). European lawmakers hope to adopt the final AI Act before the end of 2023, ahead of the European Parliament elections in 2024.
In perhaps the most significant change from the Commission and Council draft, under MEPs’ proposals, providers of foundation models – a term defined as an AI model that is “trained on broad data at scale, is designed for generality of output, and can be adapted to a wide range of distinctive tasks” (Article 3(1c)) – would be subject to a series of obligations. For example, providers would be under a duty to “demonstrate through appropriate design, testing and analysis that the identification, the reduction and mitigation of reasonably foreseeable risks to health, safety, fundamental rights, the environment and democracy and the rule of law prior and throughout development” (Article 28b(2)(a)), as well as to draw up “extensive technical documentation and intelligible instructions for use” to help those that build AI systems using the foundation model (Article 28b(2)(e)).
Continue Reading EU Parliament’s AI Act Proposals Introduce New Obligations for Foundation Models and Generative AI
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 