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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 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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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.
ReadAI, 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.
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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Read the May 2024 edition of the Clifford Chance Global Antitrust Healthcare & Life Sciences Newsletter, providing an overview of recent antitrust developments and trends of particular relevance to companies active in the healthcare & life sciences sector.
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The Potential impact on the use of AI in healthcare - EU White Paper on Artificial Intelligence
ReadPanacea or hype?
ReadThe renaissance of one of the world's oldest cultivated plants
ReadAnalysis
Where is AI already being used in healthcare today? What risks and opportunities does it offer and how can medical device manufacturers prepare for the future in terms of compliance? [In German]
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The renaissance of one of the world's oldest cultivated plants
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READUpcoming Tech Events
What makes procuring AI different from procurement of other software or services? How does this affect your contract terms and supplier onboarding and management processes? When there is limited scope for negotiation, where should you focus your efforts? In this session we will discuss strategy and practical tips for contracting for AI.
Time: 08:00 EDT / 13:00 BST / 14:00 CEST / 20:00 HKT
To Register, please complete the online registration form.
Clifford Chance
