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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 …

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URL: https://healthcarelifesciences.bakermckenzie.com/2024/01/30/healthcare-and-ai-who-releases-ai-guidance-for-large-multi-modal-models/

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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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Healthcare & Life Sciences Blog

WEBThe Corporate Sustainability Due Diligence Directive (“CS3D”), provisionally agreed in December 2023, will create significant behavioural and reporting obligations for many …

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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. …

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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 …

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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.; …

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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 …

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Hungarian Pricing and Reimbursement Reforms Aiming to …

WEBIn brief Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is especially true for innovative products and is …

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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, …

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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 …

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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 …

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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) …

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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 …

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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 …

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