• Login
    • Advanced search
    • Title
    • Channel
    • Module
  • Home
  • Industry
    •  

      • Aerospace, Defense, and Government Services
      • Automotive and Mobility
      • Consumer
      • Manufacturing and Industrials
      • Education
      • Energy and Natural Resources
      • Financial Institutions
    •  

      • Insurance
      • Life Sciences and Health Care
      • Private Capital
      • Real Estate
      • Sports, Media and Entertainment
      • Technology and Telecoms
      • Transportation and Logistics
  • Practice
    • Corporate & Finance

      • Banking and Loan Finance
      • Business Restructuring and Insolvency
      • Capital Markets
      • Corporate Governance and Public Company Representation
      • Digital Assets and Blockchain
      • Infrastructure, Energy, Resources, and Projects
      • Leveraged and Acquisition Finance
      • Mergers and Acquisitions
      • Pensions
      • Private Equity, Venture Capital and Investment Funds
      • Real Estate
      • Real Estate Investment Trusts (REITs)
      • Tax
      • Transfer Pricing
    • Global Regulatory

      • Administrative and Public Law
      • Antitrust and Competition
      • Communications, Internet, and Media
      • Education
      • Energy Regulatory
      • Environment and Natural Resources
      • Financial Services
      • Food Law
      • Gaming Law
      • Government Contracts and Public Procurement
      • Government Relations and Public Affairs
      • Health
      • Immigration
      • International Trade and Investment
      • Medical Device and Technology Regulatory
      • New Nuclear
      • Pharmaceuticals and Biotechnology Regulatory
      • Privacy and Cybersecurity
      • Space and Satellite
      • Strategic Operations, Agreements and Regulation
      • Transportation Regulatory
    • Intellectual Property

      • Copyright
      • Designs
      • Domain Names
      • IP and Technology Transactions
      • IP Enforcement
      • Patents
      • Trade Secrets and Confidential Know-how
      • Trademarks and Brands
      • Unfair Competition
    • Litigation, Arbitration, and Employment

      • Business and Human Rights
      • Construction and Engineering
      • Corporate and Securities Litigation
      • Employment
      • International Arbitration
      • Investigations, White Collar, and Fraud
      • Products Law
      • Risks, Disputes, and Litigation
  • Comparative guides
  • Engage Premium
  • Login
  • Register
Hogan Lovells Engage 5.7.16
      • Title
      • Channel
      • Module
    • Hit ENTER to search in content
    • Advanced search
    • Login
  • Home
  • Industry
    •  

      • Aerospace, Defense, and Government Services
      • Automotive and Mobility
      • Consumer
      • Manufacturing and Industrials
      • Education
      • Energy and Natural Resources
      • Financial Institutions
    •  

      • Insurance
      • Life Sciences and Health Care
      • Private Capital
      • Real Estate
      • Sports, Media and Entertainment
      • Technology and Telecoms
      • Transportation and Logistics
  • Practice
    • Corporate & Finance

      • Banking and Loan Finance
      • Business Restructuring and Insolvency
      • Capital Markets
      • Corporate Governance and Public Company Representation
      • Digital Assets and Blockchain
      • Infrastructure, Energy, Resources, and Projects
      • Leveraged and Acquisition Finance
      • Mergers and Acquisitions
      • Pensions
      • Private Equity, Venture Capital and Investment Funds
      • Real Estate
      • Real Estate Investment Trusts (REITs)
      • Tax
      • Transfer Pricing
    • Global Regulatory

      • Administrative and Public Law
      • Antitrust and Competition
      • Communications, Internet, and Media
      • Education
      • Energy Regulatory
      • Environment and Natural Resources
      • Financial Services
      • Food Law
      • Gaming Law
      • Government Contracts and Public Procurement
      • Government Relations and Public Affairs
      • Health
      • Immigration
      • International Trade and Investment
      • Medical Device and Technology Regulatory
      • New Nuclear
      • Pharmaceuticals and Biotechnology Regulatory
      • Privacy and Cybersecurity
      • Space and Satellite
      • Strategic Operations, Agreements and Regulation
      • Transportation Regulatory
    • Intellectual Property

      • Copyright
      • Designs
      • Domain Names
      • IP and Technology Transactions
      • IP Enforcement
      • Patents
      • Trade Secrets and Confidential Know-how
      • Trademarks and Brands
      • Unfair Competition
    • Litigation, Arbitration, and Employment

      • Business and Human Rights
      • Construction and Engineering
      • Corporate and Securities Litigation
      • Employment
      • International Arbitration
      • Investigations, White Collar, and Fraud
      • Products Law
      • Risks, Disputes, and Litigation
  • Comparative guides
  • Engage Premium
  • Login
  • Register
  1. News
  2. A brave new world of AI liability in the EU

A brave new world of AI liability in the EU

15 May 2023
    • Share by email
    • Share on
    • Twitter
    • LinkedIn
    • Get link
    • Get QR Code
    • Download
    • Print

Manufacturers and other stakeholders contemplating the use of AI-enabled products and services should be mindful of new rules proposed by the European Commission (EC) to address product liability claims related to AI systems. With the aim of bringing product liability rules into the digital age, the proposal includes new disclosure obligations as well as a new presumption of causal link for AI systems and is intended to balance the interests of industry and consumers.

Specific rules would apply to “high-risk” AI systems – i.e., AI systems that pose significant risks to the health and safety or fundamental rights of persons, including certain medical devices and in vitro diagnostic medical devices.

Index
  1. New disclosure obligations relating to high-risk AI systems
  2. New presumption of causal link relating to all AI systems
  3. Next steps

On Thursday, 18 May, Hogan Lovells is hosting its annual Health Care AI Law and Policy Summit, an informative and interactive program where our thought leaders and industry guests will address a variety of topics including new and emerging health care AI policies and regulatory considerations, implications for ethics and consumer safety, developments in the U.S., UK, and EU, and more. You can register for the Summit online here.

_______________________________________________________________

To adapt the European product liability landscape to the digital age, in September 2022, the European Commission proposed new rules to address liability claims relating to AI systems, including a first of its kind AI Liability Directive (AILD Proposal), targeting harmonization of the member states’ national fault-based civil liability rules for AI-enabled products and services.

New disclosure obligations relating to high-risk AI systems

 

The AILD Proposal addresses liability claims related to AI systems. According to the EC, the major difficulty with damage claims related to AI is the burden of proof. As such, with the aim of providing consumers and other persons seeking compensation for damage allegedly caused by high-risk AI systems with effective means to identify potentially liable persons and relevant evidence for a claim, under the proposal, claimants would be granted the right to request evidence disclosure both before and in the course of court disputes. Failure to comply with an order to disclose evidence will lead to a presumption of non-compliance with “a relevant duty of care” that the evidence requested was intended to prove and leaves it to the defendant to rebut this presumption. We have described the mechanics of these proposals in more detail here.

New presumption of causal link relating to all AI systems

The EC has also expressed the view that the technical features of AI (amongst others, their opacity, autonomous behavior, and complexity) make it difficult for injured persons to meet their burden of proof and obtain compensation of damages allegedly caused by AI systems. For this reason, the AILD Proposal also introduces specific tools which aim to make it easier for claimants to substantiate claims for damages caused by interaction with AI systems, through the use of a disclosure of evidence mechanism and of rebuttable presumptions. For high-risk AI systems, the proposed rules also distinguish between claims raised against the provider of a high-risk AI system and claims raised against users of the AI system, as we have detailed here.

Next steps

The AILD Proposal is at an early stage of legislative work before being enacted, possibly in 2024. Then, the new rules will need to be transposed into the member states’ national product liability systems. Business operating in the EU life sciences and health care sector should continue to monitor this changing landscape carefully.

Please contact the author or the Hogan Lovells attorneys with whom you regularly work for guidance on your specific product needs.

 

Authored by Nicole Saurin.

Contacts
Nicole Saurin
Counsel
Munich
Index
  1. New disclosure obligations relating to high-risk AI systems
  2. New presumption of causal link relating to all AI systems
  3. Next steps
Related Materials
PLEASE DO NOT USE: DUP_Intellectual property March 2019 European Court of Justice

New disclosure obligations relating to high-risk AI systems

PLEASE DO NOT USE: DUP_Intellectual property March 2019 European Court of Justice

New presumption of causal link relating to AI systems

Additional Resources
  • Digital Health and AI
Keywords Product liability, digital health, AI-enabled products, high-risk AI, medical devices, in vitro diagnostic medical devices, EU, EC
Languages English
Topics Digitalisation, Digital Health, In Vitro Diagnostics, MDR/IVDR, Medical Device Software and Cybersecurity, Chemicals and Industrial Products and Services, Conglomerates
Countries Belgium, France, Germany, Hungary, Italy, Ireland, Luxembourg, Netherlands, Poland, Spain, United Kingdom
Delete Comment ?

Are you sure want to delete comment ?

Get link
Embed
Share by email
Get QR Code

Scan this QR Code to share this content

  • Contact us
  • Disclaimer
  • Privacy
  • Cookies
  • Legal Notices
  • Terms of Use

 

This website is operated by Hogan Lovells International LLP, whose registered office is at Atlantic House, Holborn Viaduct, London, EC1A 2FG. For further details of Hogan Lovells International LLP and the international legal practice that comprises Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses ("Hogan Lovells"), please see our Legal Notices page. © 2022 Hogan Lovells.

Attorney advertising. Prior results do not guarantee a similar outcome.

Thomson Reuters HighQ Logo
© 2023 Hogan Lovells | Privacy Policy | Terms of Service