Iga Małobęcka-Szwast | In Principle

In clinical trials, a standard practice is that the sponsor, i.e. the entity responsible for undertaking the clinical trial, managing it and arranging for its funding, does not have access to data directly identifying the study participants. Typically, the patients’ data reach the sponsor in pseudonymised form. Thus sometimes sponsors assume that since they are only processing pseudonymised data of clinical trial participants, they are not subject to the GDPR. Nothing could be further from the truth. Indeed, pseudonymisation poses additional challenges for sponsors as data controllers.

In this episode dr Iga Małobęcka-Szwast, LL.M., discusses what are the legal risks of using generative AI and how to mitigate them.

In this episode dr Iga Małobędzka-Szwast, LL.M., discusses how to deal with personal data breaches.

The Digital Markets Act or DMA (Regulation (EU) 2022/1925 of the European Parliament and of the Council of 14 September 2022 on contestable and fair markets in the digital sector), which entered into force on 1 November 2022, creates many new obligations for businesses operating in the digital sector, particularly so-called “gatekeepers.” The DMA will impact the functioning of the entire digital ecosystem—not only gatekeepers, but also other participants in digital markets, including business users and end users of core platform services, competing providers of core platform services, and providers of other digital services.

“Dark patterns” used by online platform providers have been controversial for some time, but recently there has been a growing buzz about them, in particular due to actions undertaken by EU and national data protection and consumer protection authorities. (For an overview of cases and decisions by EU and national authorities, see the European Commission’s “Behavioural study on unfair commercial practices in the digital environment: Dark patterns and manipulative personalisation, Final Report,” pp. 61–70.) Primarily, these measures are intended to combat deceptive practices in the digital environment, but also to educate consumers and draw their attention to the most common types of practices.

The world pins high hopes on the development of artificial intelligence systems. AI is expected to generate huge economic and social benefits across various aspects of life and sectors of the economy, including the environment, agriculture, healthcare, finances, taxes, mobility, and public administration. The progressing development of AI systems is forcing the creation of appropriate legal frameworks, which on one hand should facilitate further growth of AI technologies but on the other hand should ensure adequate protection of persons using such systems and raise societal confidence in the operation of AI systems.

On 30 November 2021, the Council of the European Union and the European Parliament reached a provisional agreement on the final wording of a draft Data Governance Act (DGA) (COM/2020/767 final). The aim of the proposal is to promote the availability of data and to build a trustworthy environment facilitating the use of data (both person and non-personal) for research and creation of innovative new products and services. It is also intended to create a legal framework for easier sharing of data and mechanisms facilitating re-use of certain data held by the public sector, including data involving health, agriculture and the environment.