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Preparing for the implementation of the EU Health Technology …

WebThe EU Health Technology Assessment (HTA) Regulation (Regulation (EU) 2021/2282), which entered into force in January 2022, will start to apply from January …

Actived: Just Now

URL: https://www.biosliceblog.com/2024/05/preparing-for-the-implementation-of-the-eu-health-technology-assessment-regulation/

Commission Communication on biotechnology and …

WebOn 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication …

Category: Health Go Health

EU legislators reach provisional agreement on the European …

WebThe agreement reached among the EU legislators is based on the European Commission proposal for a Regulation creating a European Health Data Space, which …

Category: Health Go Health

AI and IP: Implications for digital health from possible …

WebPotential implications for the digital health sector. On 16 June 2021, the UK government announced 38 new pioneering AI projects with a total award value of £36 …

Category: Health Go Health

Virtual and Digital Health Digest, March 2024 BioSlice Blog

WebThis digest covers key virtual and digital health regulatory and public policy developments during February 2024.. Of note, the UK continues to pursue a “pro …

Category: Health Go Health

Draft EU guidelines on the concepts of controller and …

WebOn 7 September 2020, the European Data Protection Board (EDPB) initiated a public consultation on draft Guidelines 07/2020 on the concepts of controller and processor in …

Category: Health Go Health

MHRA’s guide to the new EU Medical Devices Regulations

WebOn 26 May 2017, the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force. In order to aid preparations for the …

Category: Medical Go Health

Virtual and Digital Health Digest, December 2023 BioSlice Blog

WebThank you to all who joined us for our December 13 panel titled the “Race to Regulate.” In case you missed it, unpack this year’s pivotal legal challenges impacting …

Category: Health Go Health

Virtual and Digital Health Digest, February 2024 BioSlice Blog

WebThis digest covers key virtual and digital health regulatory and public policy developments during January 2024.. Regulatory Updates. Publication of a Roadmap for …

Category: Health Go Health

New EU Regulation Reinforcing the Role of the EMA BioSlice Blog

WebOn 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal …

Category: Medicine Go Health

Virtual and Digital Health Digest BioSlice Blog

WebThis inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health …

Category: Health Go Health

Classification of software as a medical device BioSlice Blog

WebThe European Court’s first decision on the classification of software in the context of medical devices legislation. On 7 December 2017, the CJEU issued its …

Category: Medical Go Health

MHRA response to consultation on the regulation of medical …

WebOn 26 June 2022, the MHRA published the UK Government’s response to the consultation on the regulatory framework for medical devices in the UK (the Response), …

Category: Medical Go Health

Clinical trial consents under the EU GDPR: where do we stand

WebThe General Data Protection Regulation entered into force on 25 May 2018 and, in the absence of any transition period, companies are now expected to be in full …

Category: Health Go Health

Recent GDPR developments relevant for the life sciences sector

WebAnother key GDPR development that is directly relevant for the life sciences sector and international transfers of personal health data (e.g., conduct of cross-border …

Category: Health Go Health

New MHRA guidance on non-medical devices BioSlice Blog

WebOn 12 October 2018, the MHRA issued Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) providing …

Category: Medical Go Health

New 2021 Code of Practice for the British Pharmaceutical Industry

WebClause 19 of the 2019 Code has been replaced by Clause 23 of the 2021 Code, which refers to ‘donations and grants’ and covers the provision of such benefits to …

Category: Health Go Health