The UK Government recently published its AI Governance and Regulation: Policy Statement (the “AI Statement”) setting out its proposed approach to regulating Artificial Intelligence (“AI”) in the UK. The AI Statement was published alongside the draft Data Protection and Digital Information Bill (see our blog post here for further details
Continue Reading UK Government Sets Out Sector-Specific Vision for Regulating AIEMEA Tech Regulation
European Parliament Adopts DSA
On July 5, 2022, the European Parliament adopted the Digital Services Act (“DSA”) with 539 votes in favor, 54 votes against and 30 abstentions, following the political deal reached on April 23, 2022 (see our previous blog here).
Key aspects
The DSA is addressed to providers of intermediary services…
Continue Reading European Parliament Adopts DSAPolitical Agreement Reached on New EU Horizontal Cybersecurity Directive
In the early hours of Friday, 13 May, the European Parliament and the Council of the EU reached provisional political agreement on a new framework EU cybersecurity law, known as “NIS2”. This new law, which will replace the existing NIS Directive (which was agreed around the same time as GDPR, see here) aims to strengthen EU-wide cybersecurity protection across a broader range of sectors, including the pharmaceutical sector, medical device manufacturing, and the food sector.Continue Reading Political Agreement Reached on New EU Horizontal Cybersecurity Directive
Online Safety Bill to Proceed Through Parliament
On May 10, 2022, Prince Charles announced in the Queen’s Speech that the UK Government’s proposed Online Safety Bill (the “OSB”) will proceed through Parliament. The OSB is currently at committee stage in the House of Commons. Since it was first announced in December 2020, the OSB has been the subject of intense debate and scrutiny on the balance it seeks to strike between online safety and protecting children on the one hand, and freedom of expression and privacy on the other.Continue Reading Online Safety Bill to Proceed Through Parliament
European Parliament and Council Strike Deal on DSA and DMA
On April 23, 2022, the European Parliament and Council of the EU announced that they reached a provisional political agreement on the Digital Services Act (“DSA”) during their final trilogue meeting. The news comes roughly one month after the provisional political agreement on the Digital Markets Act (“DMA”).
Both acts…
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Draft Version of the European Health Data Space Regulation
Update: On May 3, 2022, the European Commission published the official version of the proposal for a European Health Data Space Regulation. It’s open for feedback until July 14, 2022.
Original blog post: On March 3, 2022, a leaked version of the proposal for a regulation setting up the European Health Data Space was published. The draft regulation will set up a common framework across EU Member States for the sharing and exchange of quality health data (such as electronic health records, patient registries and genomic data). The European Commission has not yet released an official version of the proposal. It is expected to do so on May 3.
The leaked proposal is a lengthy document (126 pages, excluding annexes) that contains within it a number of different sets of rules. Key requirements that are likely to be of interest to organizations in the life sciences sector are that the draft regulation proposes to:
- create new patient rights over their electronic health data, and sets out rules regarding use of electronic health data for primary care;
- establishes a pre-market conformity assessment requirement for electronic health record systems (“EHR systems”);
- sets out rules that apply to digital health services and wellness apps; and
- introduces a harmonized scheme for providing access to electronic health data for secondary use.
Continue Reading Draft Version of the European Health Data Space Regulation
European Commission Publishes Draft Data Act
On February 23, 2022, the European Commission published the draft EU Regulation on harmonized rules on fair access to and use of data, also referred to as the “Data Act” (available here). The Data Act is just the latest EU legislative initiative, sitting alongside the draft Data Governance Act, Digital Services Act, and Digital Markets Act, motivated by the EU’s vision to create a single market for data and to facilitate greater access to data.
Among other things, the proposed Regulation:
- grants “users” of connected “products” and “related services” – meaning a digital service incorporated in or inter-connected with a product in such a way that its absence would prevent the product from performing one of its functions – offered in the EU rights to access and port to third parties the data generated through their use of these products and services (including both personal and non-personal data);
- requires manufacturers of these products and services to facilitate the exercise of these rights, including by designing them in such a way that any users – which may be natural and legal persons – can access the data they generate;
- requires parties with the right, obligation or ability to make available certain data (including through the Data Act itself) – so-called ”data holders” – to make available to users the data that the users themselves generate, upon request and “without undue delay, free of charge, and where applicable, continuously and in real-time”;
- requires data holders to enter into a contract with other third-party “data recipients” on data sharing terms that are fair, reasonable and non-discriminatory; relatedly, any compensation agreed between the parties must be “reasonable” and the basis for calculating the compensation transparent, with special rules set out for micro, small or medium-sized data recipients to facilitate their access to the data at reduced cost;
- authorizes public sector bodies and Union institutions, agencies or bodies to request access to the data in “exceptional need” situations;
- requires certain digital service providers, such as cloud and edge service providers, to implement safeguards that protect non-personal data from being accessed outside the EU where this would create a conflict with EU or Member State law;
- requires such data processing service providers to make it easy for the customers of such services to switch or port their data to third-party services; and
- imposes interoperability requirements on operators of “data spaces”.
As a next step, the Council of the EU and the European Parliament will analyze the draft Regulation, propose amendments and strive to reach a compromise text that both institutions can agree upon. Below, we discuss the key provisions of the Data Act in more detail.
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European Parliament Agrees Draft Digital Services Act
On January 20, 2022, the European Parliament agreed amendments to the draft version of the Digital Services Act (“DSA”) that the Council agreed on November 25, 2021(see the European Parliament’s announcement here and agreed text here; see our blog post about the Council’s draft here). As a next step,…
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Council Agrees Draft Digital Services Act and Digital Markets Act
On November 25, 2021, the Council of the European Union reached an agreement on the draft Digital Services Act (“DSA”) (see here and here) and the Digital Markets Act (“DMA”) (see here) bringing them one step closer to adoption. The European Parliament will discuss the drafts on December…
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European Commission Proposes New Artificial Intelligence Regulation
In April 2021, the European Commission released its proposed Regulation Laying Down Harmonized Rules on Artificial Intelligence (the “Regulation”), which would establish rules on the development, placing on the market, and use of artificial intelligence systems (“AI systems”) across the EU. The proposal, comprising 85 articles and nine annexes, is part of a wider package of Commission initiatives aimed at positioning the EU as a world leader in trustworthy and ethical AI and technological innovation.
The Commission’s objectives with the Regulation are twofold: to promote the development of AI technologies and harness their potential benefits, while also protecting individuals against potential threats to their health, safety, and fundamental rights posed by AI systems. To that end, the Commission proposal focuses primarily on AI systems identified as “high-risk,” but also prohibits three AI practices and imposes transparency obligations on providers of certain non-high-risk AI systems as well. Notably, it would impose significant administrative costs on high-risk AI systems of around 10 percent of the underlying value, based on compliance, oversight, and verification costs. This blog highlights several key aspects of the proposal.Continue Reading European Commission Proposes New Artificial Intelligence Regulation