05 Dec, 2023 AI in healthcare: the World Health Organisation’s regulatory considerations By Hester Borgers Dr. Nils Lölfing The World Health Organisation (WHO) has published regulatory considerations on artificial intelligence (AI) for healthcare in October...
14 Sep, 2023 EMA’s envisaged risk-based and human-centric approach to regulate AI By Hester Borgers Christian Lindenthal, LL.M. Dr. Nils Lölfing Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
10 Aug, 2023 AI and the life sciences, navigating the complex legal landscape By Hester Borgers Christian Lindenthal, LL.M. Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
22 May, 2023 AI as a Medical Device By Sophie Vo To add to all the chatter about AI, let’s talk about AI as a medical device. Last month, the Medicines & Healthcare products Regulatory...
24 Apr, 2023 An international overview of the regulatory legislation concerning telemedicine By Katrina Dang Johanna Harelimana Emma Stok Christian Lindenthal, LL.M. Hester Borgers Enrique Rivas Pieter Erasmus Patrick Brown +5 more... Show less Telemedicine has been available to healthcare providers for several years. However, it was not until quite recently that the field of...
17 Feb, 2023 The Impact of the NIS2 Directive and the CER Directive for Medical Device Manufacturers and the Healthcare Sector By Deirdre Kilroy Georgina Parkinson The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased focus on the risks for medical...
31 Oct, 2022 Update on the UK’s future medical device regulations: Extended timelines By Pieter Erasmus The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction of a 12-month extension to the...
07 Oct, 2022 The Activation of Payback on Medical Devices By Simone Cadeddu Mauro Turrini The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure ceiling for medical devices in...
25 May, 2022 Artificial Intelligence Systems for Medical Diagnosis By Mauro Turrini The Italian Ministry of Health has published a document on its website entitled “Artificial Intelligence Systems as a Diagnostic Support...
05 May, 2022 The European Health Data Space Proposal of the European Commission By Dr. Nils Lölfing Unleashing the full potential of health data through facilitating secondary use? On 3rd May 2022, the European Commission launched the...
07 Apr, 2022 The UPC Committees rule! By Wouter Pors Start of the Provisional Application Phase and first committee meetings The Provisional Application Phase of the Unified Patent Court...
17 Mar, 2022 International Comparative Legal Guide to Digital Health 2022 By Sally Shorthose Toby Bond Pieter Erasmus Emma Drake +1 more... Show less Our Life Sciences IP, Regulatory and Data Protection experts Sally Shorthose, Toby Bond, Emma Drake and Pieter Erasmus have written the...