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Clifford Chance
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The Impact of the new EU AI Act on the Healthcare Sector Part One: Scope and a Risk-Based Approach
Healthtech

The Impact of the new EU AI Act on the Healthcare Sector Part One: Scope and a Risk-Based Approach

AI can and will be used across all industries, including the healthcare sector. Therefore, the AI Act must be applied having regard to and in accordance with all industry-specific sectoral regulations in Europe. In the healthcare sector, AI will be used in medical devices in particular, and AI-based medical devices will be subject to and governed by both the EU Medical Device Regulation 2017/745/EU (MDR) and the AI Act at the same time - which will require a coordinated interaction between the AI Act and the MDR and a thoughtful application by the competent authorities in order to avoid overregulation and legal uncertainties in the very innovation-friendly health tech sector in Europe.

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The Impact of the new EU AI Act on the Healthcare Sector – Part Two: Practical Guidance – What Businesses need to do
Healthcare & life sciences

The Impact of the new EU AI Act on the Healthcare Sector – Part Two: Practical Guidance – What Businesses need to do

The use of AI in the healthcare sector also enables simplified and accelerated diagnoses of diseases by accurately analysing medical images and processing laboratory test results and patient records. In addition, robotics and telemedicine will improve existing treatments and create new ones. To capitalise on the potential of AI, stakeholders need to act now to ensure compliance and legal certainty in their strategic and operational planning. These five steps provide some initial guidance on preparing for the new regulation:

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The Impact of the new EU AI Act on the Healthcare Sector – Part Three: Liability for AI – the next legislative challenge for the EU
Artificial intelligence

The Impact of the new EU AI Act on the Healthcare Sector – Part Three: Liability for AI – the next legislative challenge for the EU

Following the adoption of the AI Act by the Council of the European Union last week (which is expected to be published in the Official Journal at the end of June 2024 and will then enter into force 20 days later), the EU is now turning to proposals to address the complex issues of AI liability. This is no less important than the regulation of AI itself, as potential liability risks for innovations have a significant impact on businesses – particularly those in the medical device sector and may be a barrier to entry into the market.

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Recent Webinars

Artificial intelligence

Webinar: Regulating AI examining global developments

In this webinar our expert panel looked at the global development of regulatory frameworks for AI, including emerging trends and diverging approaches being taken in different jurisdictions. This included the EU’s AI Act, US developments at federal and state level, the UK perspective and the measures being taken in China to tackle regulation of generative AI and deepfakes.

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Healthcare & life sciences

Webinar: Healthcare Innovations Shaping the Global Future

AI, next-gen robotics, novel drugs, healthcare without healthcare professionals, personalised medicine and big data are just some of the ways the healthcare sector is being transformed. What does this mean for you and your organisation? In this webinar our expert panel looked at the key legal issues and explored how to leverage these for your own transformation and growth.

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Cyber

Webinar: Navigating Cyber Security and Resilience

The global trend towards increased cybersecurity and resilience regulation will tighten existing requirements and affect a broader range of businesses than ever before. From updates in SEC and NYDFS cyber requirements, to Singapore’s proposed Cybersecurity Amendment Bill, our global panel examined developments in the US, APAC, Europe and the Middle East

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US Publishes Draft Rules for Cyber Incident Reporting for Critical Infrastructure Companies
Cyber

US Publishes Draft Rules for Cyber Incident Reporting for Critical Infrastructure Companies

Article looks at the core tenets of the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency's Notice of Proposed Rule Making detailing requirements for compliance with the Cyber Incident Reporting for Critical Infrastructure Act

Healthtech Trends 2024 - Five Trends to Watch

Healthtech Trends 2024 - Five Trends to Watch

From medical microrobots to patient digital twins to generative AI for the creation of synthetic health data, we take a look at the next wave of tech innovations creating opportunities and challenges for healthcare and life sciences in 2024 and beyond.

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Cybersecurity update Singapore's Cybersecurity Act extends its reach
Cyber

Cybersecurity update Singapore's Cybersecurity Act extends its reach

The article explains the recently passed Cybersecurity (Amendment) Bill in Singapore.

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SEC Invents "AI Washing" with Focus on Investment Adviser Practices
Fintech

SEC Invents "AI Washing" with Focus on Investment Adviser Practices

On March 18, 2024, the U.S. Securities and Exchange Commission (SEC) settled enforcement actions against two SEC-registered investment advisers, Delphia (USA) Inc. (Delphia) and Global Predictions Inc. (Global Predictions) for allegedly deceptive disclosures about their use of artificial intelligence (AI)

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China Revamps its Rules on Cross-border Data Transfer

China Revamps its Rules on Cross-border Data Transfer

The Cyberspace Administration of China released the Provisions on Regulating and Promoting Cross-border Data Flows (the New Provisions) on 22 March 2024, together with the second edition of the Guidelines for Security Assessment Filings and the Guidelines for Filing Personal Information Export Standard Contract, each with immediate effect.

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Brands and Digital Platforms Beware: ACCC's War on Deceptive Influencer Marketing in the Digital Age
Media & entertainment

Brands and Digital Platforms Beware: ACCC's War on Deceptive Influencer Marketing in the Digital Age

The Australian Competition and Consumer Commission (ACCC) is targeting misleading and deceptive influencer marketing in 2024-25.

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EU Cyber Resilience Act Approved by European Parliament

EU Cyber Resilience Act Approved by European Parliament

On Tuesday 12 March, the European Parliament approved the Cyber Resilience Act, a milestone EU regulation which will set cyber security rules for 'products with digital elements' made available on the EU market. The CRA is now awaiting formal approval by the Council and is expected to enter into force in the coming months, with its rules becoming fully applicable over various transition periods. We overview key aspects of the CRA and flag some of the changes that have been introduced since the original Commission proposal.

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Digital Services Act (DSA) Checklist

Digital Services Act (DSA) Checklist

The EU Digital Services Act applies in full since 17 February 2024. We have prepared a PDF which contains an overview of some of the key items to confirm as part of a business's Digital Services Act status checks given this major milestone. The document is interactive – if you want to find out a bit more detail on some aspects, just click where marked

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Legal 500: Life Sciences Comparative Guide

Legal 500: Life Sciences Comparative Guide

We are very proud to have launched the new Legal 500 Life Sciences Comparative Guide as a joint project of The Legal 500 and Clifford Chance. The aim of this guide is to provide its readers with a pragmatic overview of life sciences law across a broad variety of jurisdictions. We have provided the Q&A template for each chapter and also contributed country-specific chapters for the EU and UK. Each chapter provides information about the current issues affecting life sciences practice in a particular country and addresses topics such as legislative framework, regulatory processes, advertising, restrictions, risks of liability and compliance standards as well as insight and opinion and any upcoming legal changes planned for their respective country

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US-states_600x400px

US State Privacy Laws

U.S. data privacy has entered a new era. Historically, the data privacy legal landscape has been dominated by sector-specific legislation, such as the Graham-Leach-Bliley Act and Health Insurance Portability and Accountability Act, often with a focus on cybersecurity or preventing misuse of certain types of personal information. The California Consumer Privacy Act was the first comprehensive (i.e., broad sweeping) state data privacy law added to this U.S. regulatory framework that focused on consumer protection. Since its adoption, various state-level regulatory and legislative activity has been building momentum. Today, several states have enacted or are continuing to develop comprehensive data privacy laws with requirements that apply across nearly all business sectors. Understanding the scope, applicability, and requirements of these state data privacy laws are more crucial than ever for companies operating in the U.S.  Read our individual overviews of currently enacted comprehensive state data privacy laws to learn more.

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A Focus on Transparency in AI By the ONC
Healthtech

A Focus on Transparency in AI By the ONC

The US Office of the National Coordinator for Health Information Technology (ONC) recently released a final rule titled "Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing" that updates the Health IT Certification Program and implements provisions of the 21st Century Cures Act. This rule significantly impacts the transparency and interoperability of health information technology and electronic health records, with a strong focus on AI and predictive algorithms.

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How to attack (and defend) an AI system: a primer on security
Cyber

How to attack (and defend) an AI system: a primer on security

In January 2024, the US National Institute of Standards and Technology (NIST) published a report aimed at establishing a framework for analysing adversarial machine learning, with the ultimate goal of helping defend against threats. The 107-page report was not just a technical manual, but also a reminder that AI technologies are subject to unique security and privacy risks. The European Union's AI Act also addresses security risks. With this background in mind, we discuss the key issues and considerations for security governance in this article.

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EU and US AI Regulatory Push Overlaps Across Global Business
Artificial intelligence

EU and US AI Regulatory Push Overlaps Across Global Business

As jurisdictions race to understand and build appropriate regulatory and governance structures around artificial intelligence, the EU is frequently regarded as the frontrunner. However, the US is forging its own federated approach and isn’t necessarily behind. For organizations, is alignment with one or the other the best path to success? Ultimately, the choice won’t be either-or.

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Data Centre World and The Tech Show - Key takeaways
Infrastructure

Data Centre World and The Tech Show - Key takeaways

There is huge global demand for data centres driven by cloud computing, high performance computing, AI and 5G, but the industry faces an increasing number of hurdles. Teams from Clifford Chance recently attended two major events – Data Centre World and The Tech Show – which highlighted some of the challenges ahead. Read our key takeaways.

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President Biden Issues Executive Order to Protect American's Sensitive Personal Data
Data

President Biden Issues Executive Order to Protect American's Sensitive Personal Data

On February 28, 2024, President Biden issued Executive Order 14117: Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern (EO 14117), directing the Department of Justice (DOJ) and other US agencies to put measures in place to prevent and restrict access to US sensitive personal data by countries of concern.

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Tech Trends 2024 - Five Trends to Watch

Tech Trends 2024 - Five Trends to Watch

This year will see a surge of digital regulation and enforcement. AI is transforming both business strategies and legal landscapes, privacy and cyber laws are proliferating, and child online safety is coming to the forefront. Delayering, decarbonisation and demand for connectivity are impacting deal-making and investment in digital infrastructure. Rapid legal changes, continuing strides in tech, and geopolitical instability, will create complex challenges as well as opportunities. We look at five trends across AI, data, cyber, digital infrastructure and emerging tech, that are shaping 2024.

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Fintech: Five Trends to Watch

Fintech: Five Trends to Watch

While 2023 saw ongoing uncertainty and high-profile financial sector failures, it also brought regulatory progress around the world, including for landmark regulations on digital assets and AI. In 2024, we will see the next stage of pioneering regulation as blueprints and best practices begin to emerge, alongside compliance challenges.

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Global M&A in 2024: Five trends to watch

Global M&A in 2024: Five trends to watch

Following a challenging year for mergers and acquisitions (M&A), the macroeconomic climate is now stabilising, and confidence returning to boardrooms. As a result, we expect the recent growth in M&A to gain momentum into 2024, with deal-making influenced by geopolitics, new technology, and the regulatory response to it.

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2024 Data Centre Industry Outlook

2024 Data Centre Industry Outlook

The data centre industry continues to develop at an increasing pace due to technological advancements and market trends. Significant global market growth, rising rack density and pricing dynamics present a number of challenges and opportunities. In this briefing we examine the drivers of change in the evolution of digital infrastructure such as sustainability and AI, and how they will impact data centres and the companies that use them.

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AI-600x400px-1

Responsible AI in Practice

Public awareness of AI is increasing and, with it, questions on how AI will be used and the impact it will have on our lives. To help identify the pressures faced by policymakers and demands from stakeholders, our report, in partnership with Milltown Partners – Responsible AI in Practice – analyses the results of focus groups of policy-informed individuals conducted in the US, the UK and Germany. Groups were asked about issues such as bias, consent, copyright, transparency,  content moderation and AI governance.  We found that people's attitudes towards AI are developed and nuanced. They are optimistic about the potential of AI, but there is work to do to demonstrate that it will be used responsibly and safely.

Read the Report
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Who we are

We are one of the world's pre-eminent law firms, with significant depth and range of resources across five continents. Our Tech Group is a single global team delivering strategic tech law advice to help clients stay ahead of the curve and outstrip the pace of change.

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Talking Tech Newsletters

Global Fintech Update
Fintech

Global Fintech Update

Our weekly global fintech round-up, summarises fintech regulatory developments that have happened around the world along with our Clifford Chance fintech publications and upcoming events

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Tech Policy Unit Horizon Scanner
Tech

Tech Policy Unit Horizon Scanner

The Tech Policy Unit Horizon Scanner is our monthly dive into the key tech policy and legislative developments around the world.

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Sustainability: ESG Developments
ESG

Sustainability: ESG Developments

This monthly newsletter is intended to assist banks, financial investors and corporates in keeping up to date with ESG developments.

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The Advertising Brief
Media & entertainment

The Advertising Brief

Our quarterly newsletter delivering concise summaries of the most interesting cases from the UK's Advertising Standards Authority (ASA) with our key takeaways for all brand owners to be aware of

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Global Crypto Round-Up
Fintech

Global Crypto Round-Up

This monthly newsletter provides you with a monthly brief into the world of digital assets, keeping you up to date with regulatory developments, publications and events from across jurisdictions.

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Stories from the Wild
Cyber

Stories from the Wild

This monthly newsletter will bring you the latest stories in information security and cybersecurity.

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Latest Podcast

australia-tech-connectivity

LabChat: Blockchain in Asia Pacific (with Joanne Chuang, Jack Hardman and Marc Liew)

Create+65 Innovation Lead Joanne Chuang and Dubai Partner Jack Hardman talk to Marc Liew, Head of Ecosystem Development for APAC at R3, about some of the key developments in the blockchain space including whether the current state of the market still presents an opportunity for reflection and innovation, as well as Clifford Chance's collaboration with R3 through the Venture Development Programme.  

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Latest Events

digital-eye-600x400-3

9 July 2024: Central Bank Digital Currencies with Clifford Chance and the International Monetary Fund (IMF)

We are delighted to invite you to join us on Tuesday 9 July for a virtual event focused on the evolving legal questions around the development of central bank digital currencies (CBDCs) with the International Monetary Fund (IMF) and Clifford Chance. This insightful session will bring together leading global industry experts advising on CBDC design and implementation to discuss the crucial legal considerations and latest developments as more jurisdictions around the globe meaningfully explore the introduction of CBDCs. View full details of the Programme and Speakers.

Time: from 9:00 EST/ 14:00 BST / 15:00 CEST / 17:00 GST / 21:00 SGT

To Register, please complete the online registration form.