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ARTICLE · 08 JULY 2026

Life Sciences Outlook 2026 - Data And Digital

Arthur Cox
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The European Union's evolving regulatory landscape for artificial intelligence, cybersecurity, and health data is creating new compliance challenges and opportunities for life sciences organizations. From the AI Act's refinements to the delayed NIS2 Directive transposition in Ireland, stakeholders must navigate multiple intersecting frameworks while preparing for the European Health Data Space Regulation's implementation.

European UnionGovernment, Public Sector
Colin Rooney
Colin Rooney
Olivia Mullooly
Olivia Mullooly
Rachel Benson
Rachel Benson
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Key points

  • The Digital Omnibus on AI created an opportunity to further refine the application of Regulation (EU) 2024/1689 (“AI Act”), as well as its application to medical and in vitro devices, and to provide much needed space to make key guidance available.
  • The European Parliament and the Council of the EU are examining legislative proposals in the European Commission’s new Cybersecurity Package, to include targeted amendments to the NIS2 Directive. However, the NIS2 Directive has not yet been transposed into Irish law.
  • Ireland has taken its first legislative step towards fully implementing the European Health Data Space Regulation in Ireland, with the enactment of the Health Information Act. Further legislation is planned.

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