Healthcarelifesciences.bakermckenzie.com
Healthcare and AI: WHO Releases AI Guidance for Large Multi …
WEBThe World Health Organisation (WHO) has issued new guidance on the ethics and governance of large multi-modal models (LMMs). The guidance details over 40 recommendations for governments and companies involved in healthcare and …
Actived: 2 days ago
AI in the Medicinal Life Cycle: 6 Takeaways on the EMA's …
WEBThe European Medicines Agency (EMA) has published a draft reflection paper which considers the application of artificial intelligence (AI) and machine learning (ML) to the development, regulation and use of medicines.This paper, which is now …
AI for Health: Regulatory Considerations Published by the WHO
WEBIntroduction. Following our post here on the EMA’s consultation on the use of Artificial Intelligence (AI) in the medicinal product lifecycle, which is open for public consultation until 31 December 2023, it is the turn of the World Health Organization …
EU Standard Clauses for AI Procurement: 5 Takeaways for Pharma …
WEBThe EU has published its draft Standard Contractual Clauses for the procurement of AI (AI SCCs).These are drafted for public organisations (such as public hospitals) wishing to procure AI systems developed by an external supplier, and are …
Ethical AI Meets the EU AI Act: What Does This Mean for …
WEBThe European Union’s draft AI Act is an ‘early-mover’ in the arms race towards a global blueprint for AI regulation. In December 2022, the European Council approved a compromise version of the AI Act, and next month, the European Parliament …
EU AI Act: Top 10 Changes for Pharma and MedTech in the Latest …
WEBAt the end of last week, two European Parliament Committees published the latest version of the EU AI Act. The new draft reflects months of political wrangling, but it also demonstrates that EU legislators have listened to the (many) criticisms levied at the …
AI as a Medical Device: MHRA’s Five Principles for Predetermined …
WEBManufacturers of Machine Learning-Enabled Medical Devices (MLMDs) face a key challenge: existing requirements and processes on the notification and management of ‘substantial’ and ‘significant’ changes to medical devices need adapting for MLMDs. …
UK vs EU Approach to Regulating AI: From One Extreme to Another
WEBIn its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in stark contrast to the more static and prescriptive approach of the EU AI Act. Instead of …
Healthcare & Life Sciences Blog
WEBKey Legal Trends in The United States For Healthcare And Life Sciences In 2024. In brief As we look back at 2023, we reflect on a year marked by significant developments in the legal framework governing the life…. Today the European Commission has finally …
The UK's MHRA Publishes Roadmap for AI and Software as a …
WEBKey takeaways. The key takeaways from each work package are: SaMD. Qualification: Providing clarity to manufacturers regarding what qualifies as a SaMD.; Classification: Classifying software proportionate to the risk that it might pose to the …
Six Takeaways From the ICO Consultation on Transparency in …
WEBThe UK’s Information Commissioner’s Office (ICO) has launched a public consultation on its draft guidance on transparency in the health and social care sector. The proposed guidance emphasises the importance of going beyond the legal requirements …
The European Commission launches an investigation into Chinese …
WEBOn 24 April 2024, the European Commission announced the launch of a formal investigation into the measures put in place and practices followed by China in its public procurement of medical devices. The announcement responds to the Commission’s …
A New Dawn for the EU Pharma Regulatory Regime
WEBToday the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years.This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot …
EU Reaches Agreement on AI Regulation: Impact on Pharma and …
WEBOn Friday 8 December, after intense negotiations, EU lawmakers reached a major political agreement on the EU Artificial Intelligence (AI) Regulation. This is the bloc’s landmark legislation regulating the development and use of AI in Europe and one of the …
New German Pharmaceutical Strategy Promises to Bolster …
WEBOn 13 December 2023, the German government published a long-awaited strategy outline of intended upcoming legislative measures to counter both the dwindling significance of Germany as a strong hub for pharmaceutical innovation, and threats to supply chain …
Spain Adapts National Regulations on Medical Devices to the EU …
WEBIn more detail. The new Royal Decree 192/2023, which regulates medical devices (RDPS) complements the application of the provisions of Regulation (EU) 2017/745, on medical devices (MDR) in Spain.It replaces the provisions of Royal Decree …
New Emirates Drug Corporation Soon to be Operational Replacing …
WEBTo future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 20231. As a new independent regulator, the EDC will replace the Ministry of Health and Prevention (MOHAP) for the regulation …
Spain Speeds up the Application Process for EU Centrally …
WEBIn brief The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been …
Reverse-Payment Patent Settlements in the Pharmaceutical Sector: …
WEBIn Brief In a judgment of 18 October 2023 (T-74/21), the EU’s General Court roundly dismissed the appeal by Teva and Cephalon against the European Commission’s 2020 decision imposing fines of approximately €30 million on each of them for …
Top Categories
Popular Searched
› Midwest health solutions omaha
› Lake regional health system website
› Ot assessments for mental health
› Cheap health insurance omaha
Recently Searched
› Centene health net rancho cordova
› Saskatchewan online health records
› Police attending mental health incidents
› Individual health insurance increase rate
› Home health care saratoga springs ny
› Health care programs for mental health
› Coalition for action health workers
› Tn government mental health department
› Country health care and rehab
› Sanford health delivery pregnancy