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Articles by Subhalakshmi Kumar
The Double-Edged Sword of AI in FemTech in the EU
AI presents many opportunities in the women’s health space, but it can also pose considerable risks. Anyone seeking to commercialise AI-enabled femtech products in the EU needs to be aware of the impact of the EU’s Regulation (EU) 2024/1689 (the AI Act) as it can impose onerous regulatory obligations. This article considers the demands imposed by the EU’s medical device regulations and the EU AI Act, and how this could impact femtech products.
ICO Publishes Its Strategic Approach to Regulating AI
On 30 April 2024, the UK’s Information Commissioner’s Office (“ICO”) published its strategic approach to regulating artificial intelligence (“AI”) (the “Strategy”), following the UK government’s request that key regulators set out their approach to AI regulation and compliance with the UK government’s previous AI White Paper (see our previous blog post here).
ICO Publishes Its Strategic Approach to Regulating AI
On 30 April 2024, the UK’s Information Commissioner’s Office (“ICO”) published its strategic approach to regulating artificial intelligence (“AI”) (the “Strategy”), following the UK government’s request that key regulators set out their approach to AI regulation and compliance with the UK government’s previous AI White Paper (see our previous blog post here).
EU Formally Adopts Cyber Law for Connected Products
On 12 March 2024, the European Parliament approved the EU Cyber Resilience Act (“CRA”) with a large majority of 517-12 votes in favor of the legislation (with 78 abstentions). The CRA aims to ensure that “products with digital elements” (“PDE”) i.e., connected products such as smart devices, and remote data processing solutions, are resilient against cyber threats and provide key information in relation to their security properties.
EU Formally Adopts Cyber Law for Connected Products
On 12 March 2024, the European Parliament approved the EU Cyber Resilience Act (“CRA”) with a large majority of 517-12 votes in favor of the legislation (with 78 abstentions). The CRA aims to ensure that “products with digital elements” (“PDE”) i.e., connected products such as smart devices, and remote data processing solutions, are resilient against cyber threats and provide key information in relation to their security properties.
Unofficial Final Text of EU AI Act Released
On 22 January 2024, an unofficial version of the (presumed) final EU Artificial Intelligence Act (“AI Act”) was released. The AI Act reached political agreement early December 2023 (see our blog post here) and had undergone technical discussions to finalize the text since.
Unofficial Final Text of EU AI Act Released
On 22 January 2024, an unofficial version of the (presumed) final EU Artificial Intelligence Act (“AI Act”) was released. The AI Act reached political agreement early December 2023 (see our blog post here) and had undergone technical discussions to finalize the text since.
EU Commission Adopts New Rules for GDPR Enforcement: the Beginning of a Centralized Enforcement Model?
On 4 July 2023, the EU Commission proposed a new Regulation for procedural rules to standardize and streamline cooperation between in EU Member State Data Protection Authorities (DPAs) when enforcing the EU General Data Protection Regulation (GDPR) in cross-border cases (GDPR Procedural Regulation). The GDPR adopts a decentralized enforcement model. National EU Member State DPAs are competent to enforce the GDPR on their respective territories.
EU Commission adopts new rules for GDPR enforcement: the beginning of a centralized enforcement model?
On 4 July 2023, the EU Commission proposed a new Regulation for procedural rules to standardize and streamline cooperation between in EU Member State Data Protection Authorities (DPAs) when enforcing the EU General Data Protection Regulation (GDPR) in cross-border cases (GDPR Procedural Regulation). The GDPR adopts a decentralized enforcement model. National EU Member State DPAs are competent to enforce the GDPR on their respective territories.
UK ICO Scrutinizes Use of Generative AI
Following the EU’s increased focus on generative AI with the inclusion of foundation and generative AI in the latest text of the EU AI Act (see our post here), the UK now also follows suit, with the UK’s Information Commissioner’s Office (“ICO”) communicating on 15 June 2023 its intention to “review key businesses’ use of generative AI.” The ICO warned businesses not to be “blind to AI risks” especially in a “rush to see opportunity” with generative AI.
UK ICO Scrutinizes Use of Generative AI
Following the EU’s increased focus on generative AI with the inclusion of foundation and generative AI in the latest text of the EU AI Act (see our post here), the UK now also follows suit, with the UK’s Information Commissioner’s Office (“ICO”) communicating on 15 June 2023 its intention to “review key businesses’ use of generative AI.” The ICO warned businesses not to be “blind to AI risks” especially in a “rush to see opportunity” with generative AI.
UK GDPR Reform Is Back! Department of Science, Innovation and Technology Introduces New Data Protection and Digital Information Bill
On 8 March 2023, the newly created Department of Science, Innovation and Technology (“DSIT”) introduced the Data Protection and Digital Information (No. 2) Bill. The “Bill” is in substance a re-introduction of the previous Data Protection and Digital Information Bill which was withdrawn from Parliament on the same day as the new Bill was published.
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