Tag: EU

EU Artificial Intelligence Act – Legislation Adopted by the European Council

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The long-awaited European Union Artificial Intelligence Act (the AI Act) is nearing implementation following its adoption by the European Council yesterday (21 May 2024). This signals the completion of the final major stage of the European Union (EU) legislative process and the AI Act is expected to enter into force imminently. We considered the impact of this legislation in detail in our previous article: EU Artificial Intelligence Act — Final Form Legislation Endorsed by European Parliament.

The only remaining formalities are the signature of the President and Secretary-General of the European Parliament and Council and publication in the Official Journal, which is expected to happen in the coming days. The AI Act will enter into force 20 days after this takes place. The AI Act will become fully applicable 24 months after its entry into force (June 2026). However, some provisions will apply before that date.

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The UK’s New AI Proposals

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On 29 March 2023, the UK Government published its latest proposals on regulating Artificial Intelligence (“AI”). The White Paper follows on from an initial policy paper published in July 2022 (the “2022 Policy Paper”), which we discussed in detail in our previous blog post. The proposals set out in the White Paper have been informed by the feedback received as part of the UK Government’s consultation on the 2022 Policy Paper.

A central theme is that the regulatory framework in the UK must not stifle innovation, but rather harness AI’s ability to drive growth and prosperity, and increase public trust in its use and application.

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UK’s Updated Data Protection Reform Proposals

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The UK government recently introduced a new Data Protection and Digital Information (No. 2) Bill (the “New Bill”). The reforms are intended to update and simplify the UK’s data protection framework and reduce burdens on organisations, while maintaining high data protection standards.

The New Bill replaces the original Data Protection and Digital Information Bill introduced in July 2022 (the “Previous Bill”), which we discussed in detail in our previous blog post. Much of the original drafting remains the same in the New Bill. However, there are some key changes to the proposals, outlined below.

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Update: AI Regulation in the U.K. — New Government Approach

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In October 2022, the U.K. Medicines and Health products Regulatory Agency (MHRA) published its Guidance, Software and AI as a Medical Device Change Programme – Roadmap, setting out how it will regulate software and AI medical devices in the U.K. by balancing patient protection and providing certainty to industry.

Background to the Reforms

The MHRA initially announced the Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) Change Programme in September 2021, designed to ensure that regulatory requirements for software and AI are clear and patients are kept safe. This builds on the broader reform of the medical device regulatory framework detailed in the Government response to consultation on the future regulation of medical devices in the United Kingdom, which recently saw its timetable for implementation extended by 12 months to July 2024.

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UK’s Data Protection Reform Proposals Show Distinct Divergence from EU Rules

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The UK government has recently published proposals to amend UK data protection legislation with moves towards divergence from EU rules and regulation following the UK’s decision to leave the EU (“Brexit”). The Data Protection and Digital Information Bill (“DPDI Bill”) proposes to make significant changes to existing UK data protection legislation, including the UK General Data protection Regulation (“UK GDPR”) and the Data Protection Act 2018 (“DPA”). The proposals include some measures that will result in a significant divergence, particularly for companies operating on a pan-European basis. While some compliance obligations will be relaxed, most of the changes can best be described as “similar but different” in approach. It remains to be seen what the final text will look like when the bill is passed into law, with some of the more radical proposals already having been dropped from consideration. A crucial point of consideration for UK legislators when the DPDI Bill is making its way through the various stages of the legislative process in the Houses of Parliament will be whether this legislation remains sufficiently similar to the EU’s General Data Protection Regulation (“EU GDPR”) that the UK is able to retain its adequacy status for the purposes of exports of personal data from the EU to the UK by companies operating internationally.

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International Data Transfers: Clarity on Timing of U.K. Transfer Mechanisms

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The U.K. Information Commissioner’s Office recently confirmed the options and clarified the timing of new data transfer agreements for transfers of personal data out of the U.K. The situation has been somewhat confusing, even to those relatively familiar with international data transfers. Organizations can now review their data transfer arrangements with greater certainty, and this will be a key priority for 2022.

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