Top Trends in the European Digital Health/AI Market
Digital health AI technologies are transforming the advancement of drug development and healthcare delivery at an unprecedented speed, backed by governments facilitating the momentum to improve healthcare for their growing populations. Sidley’s European life sciences lawyers Josefine Sommer, Eva von Mühlenen, and Francesca Blythe share a timely take on the top 5 life sciences industry trends being shaped by pioneering digital technologies. We are delighted to present a series of insightful interviews with leaders from a diverse digital health ecosystem giving their perspectives from Roche, Origen Genetics, FemTech Insights, Verge, Steto, and Clario.
Advisor to the CJEU Confirms GDPR Fines For Subsidiary Infringements Should Reflect Group Turnover
On 12 September 2024, Advocate General Medina issued their Opinion in Case C-383/23 in which they confirmed that supervisory data protection authorities must, when calculating the fine for a GDPR infringement committed by a subsidiary, take into account the total annual turnover of the entire group—a concept known as parental liability.
Asia-Pacific Regulations Keep Pace With Rapid Evolution of Artificial Intelligence Technology
Regulation of artificial intelligence (AI) technology in the Asia-Pacific region (APAC) is developing rapidly, with at least 16 jurisdictions having some form of AI guidance or regulation. Some countries are implementing AI-specific laws and regulation, while others take a more “soft” law approach in reliance on nonbinding principles and standards. While regulatory approaches in the region differ, policy drivers feature common principles including responsible use, data security, end-user protection, and human autonomy.
DORA – ESAs Publish Draft Technical Standards on ICT Subcontracting
On 26 July 2024, the European Supervisory Authorities (EBA, EIOPA and ESMA, collectively, the “ESAs”) published their joint final report on the draft Regulatory Technical Standards (“RTS”) specifying the elements that a financial entity should determine and assess when subcontracting ICT services supporting critical or important functions under Article 30(5) of the Digital Operational Resilience Act (“DORA”). The RTS are intended to assist with the enhancement of the digital operational resilience of the financial services sector by improving in-scope entities’ ICT risk management, specifically with respect to the issue of ICT subcontracting.
EU Governments Sign-off Proposed Reforms to GDPR Procedural Rules and Council Reaches Common Member States’ Position
On 24 May 2024, the Council of the European Union (the “Council”) released new details of a proposed reform of the General Data Protection Regulation’s (“GDPR”) procedural rules, which representatives of EU national governments approved on 29 May 2024. On 13 June 2024, the Council issued a press release detailing its agreed common Member States’ position that maintains the general thrust of the original proposed reforms, but which seeks to: (i) introduce clearer timelines; (ii) improve efficiency of cooperation; and (iii) provide an early resolution mechanism.
UK proposes New Cyber Security and Resilience Bill to Boost the UK’s Cyber Defences
During the King’s Speech on 17 July 2024, the newly appointed UK Prime Minister announced the UK Government’s intention to introduce a new Cyber Security and Resilience Bill to strengthen the UK’s defences against the global rise in cyberattacks and to protect the UK’s critical infrastructure. In background briefing notes published together with the King’s Speech, the UK Government stated that the new Cyber Security and Resilience Bill will “strengthen our defences and ensure that more essential digital services than ever before are protected.” According to the briefing notes, the Cyber Security and Resilience Bill intends to address the concern that the UK has not kept up-to-date with recent legislative advancements made by the EU in the cybersecurity space, resulting in the UK being “comparably more vulnerable.” Although the form of the proposed Cyber Security and Resilience Bill has yet to be released, the UK Government has indicated that it plans to introduce the bill in the coming months.
Heightened Focus in the EU for the Protection of Minors Online
The protection of minors online continues to be a focus for EU regulators. Following the publication last year by the European Parliament of its guidelines on online age verification methods for children, the European Commission has recently announced it will be holding a dedicated stakeholder workshop in September 2024 to discuss guidelines for age verification and protecting minors. Whilst the issue has been flagged as a priority by the European Data Protection Board (“EDPB”) and we are seeing an increase in guidelines and (in some cases) laws addressing the issue at a national Member State level, this is also a focus of the new EU Digital Services Act (“DSA”).
An Artificial Intelligence, Privacy, and Cybersecurity Update for Indian Companies Doing Business in the United States and Europe
Pivotal shifts have occurred in global data privacy, artificial intelligence (AI), and cybersecurity from executives facing more pressure to monitor their organizations’ cybersecurity operations, to an unprecedented wave of consumer data privacy laws and rapid advancements in AI technology use and deployment. Indian organizations should establish best practices to address these new (and emerging) laws, regulations, and frameworks.
One Step Closer: AI Act Approved by Council of the EU
On 21 May 2024, the Council of the European Union approved the EU Artificial Intelligence Act (the “AI Act”). This is the final stage in the legislative process and comes after the EU Parliament voted to adopt the legislation on 13 March 2024. This final vote clears the path for the formal signing of the legislation and its publication in the Official Journal of the EU in the coming weeks. The AI Act will then enter into force 20 days after such publication with staggered transition periods of 6 to 36 months.
The Digital Markets, Competition and Consumers Act is Approved: Key Things to Know About the UK’s New Competition and Consumer Powers
On May 23, 2024, the UK finally passed its Digital Markets, Competition and Consumers Act (DMCCA), introducing a new “pro-competition” regime for digital markets and marking the biggest reform to UK competition and consumer laws in a decade. The DMCCA is the latest piece of legislation aiming to tackle the power of Big Tech, as regulators around the world debate new ways to oversee competition in the digital sector.
