{
  "version" : "https://jsonfeed.org/version/1.1",
  "title" : "javai.ch — Pharmaceuticals",
  "home_page_url" : "https://javai.ch/pharma/",
  "feed_url" : "https://javai.ch/pharma/feed.json",
  "description" : "AI regulation news for pharmaceutical and life sciences",
  "items" : [ {
    "id" : "https://artificialintelligenceact.eu/ai-act-explorer/",
    "url" : "https://artificialintelligenceact.eu/ai-act-explorer/",
    "title" : "Implementation Documents",
    "date_published" : "2026-03-23",
    "summary" : "Implementation Documents Browse the AI Act online using our AI Act Explorer This page lists all documents associated with the implementation of the AI Act. It will be updated as new documents are published.",
    "_source" : "artificialintelligenceact.eu",
    "tags" : [ "global", "eu", "ai-act", "tracker", "implementation" ],
    "_relevance" : "Resource page for AI Act implementation documents — conformity assessment procedures, technical documentation requirements, and enforcement guidance."
  }, {
    "id" : "https://www.edps.europa.eu/system/files/2025-11/2025-11-11_ai_risks_management_guidance_en.pdf",
    "url" : "https://www.edps.europa.eu/system/files/2025-11/2025-11-11_ai_risks_management_guidance_en.pdf",
    "title" : "EDPS Guidance for Risk Management of Artificial Intelligence Systems",
    "date_published" : "2025-11-11",
    "summary" : "Structured AI risk management guidance covering accountability, procurement, deployment, and risk controls. One of the best official European documents on AI risk management.",
    "_source" : "EDPS",
    "tags" : [ "global", "eu", "data-protection", "risk-management", "ai-governance" ],
    "_relevance" : "Comprehensive AI risk management framework — accountability, procurement, and deployment controls"
  }, {
    "id" : "https://www.edps.europa.eu/system/files/2025-09/25-09-15_techdispatch-human-oversight_en.pdf",
    "url" : "https://www.edps.europa.eu/system/files/2025-09/25-09-15_techdispatch-human-oversight_en.pdf",
    "title" : "EDPS TechDispatch: Human Oversight of Automated Decision-Making",
    "date_published" : "2025-09-15",
    "summary" : "Highlights the need for standardised frameworks and metrics to assess whether human oversight of automated systems is actually effective.",
    "_source" : "EDPS",
    "tags" : [ "global", "eu", "human-oversight", "automated-decision-making", "metrics" ],
    "_relevance" : "Defines measurable criteria for human oversight effectiveness — affects how developers design oversight interfaces"
  }, {
    "id" : "https://digital-strategy.ec.europa.eu/en/library/guidelines-scope-obligations-providers-general-purpose-ai-models-under-ai-act",
    "url" : "https://digital-strategy.ec.europa.eu/en/library/guidelines-scope-obligations-providers-general-purpose-ai-models-under-ai-act",
    "title" : "Guidelines on scope of obligations for providers of general-purpose AI models",
    "date_published" : "2025-07-18",
    "summary" : "Commission guidelines on GPAI provider obligations: technical documentation, copyright compliance, training data summaries. For systemic risk models: risk assessment, incident reporting, cybersecurity.",
    "_source" : "European Commission",
    "tags" : [ "global", "eu", "ai-act", "gpai", "provider-obligations" ],
    "_relevance" : "Defines obligations for anyone building or substantially modifying general-purpose AI models"
  }, {
    "id" : "https://www.edpb.europa.eu/system/files/2025-04/ai-privacy-risks-and-mitigations-in-llms.pdf",
    "url" : "https://www.edpb.europa.eu/system/files/2025-04/ai-privacy-risks-and-mitigations-in-llms.pdf",
    "title" : "EDPB: AI Privacy Risks & Mitigations — Large Language Models",
    "date_published" : "2025-04-01",
    "summary" : "Practical risk treatment for LLM deployments. Discusses deployer responsibilities in relation to provider risk treatment, fine-tuning, and retraining.",
    "_source" : "EDPB",
    "tags" : [ "global", "eu", "data-protection", "privacy", "llm", "risk-management" ],
    "_relevance" : "Specific LLM privacy risks and mitigations — directly actionable for developers deploying language models"
  }, {
    "id" : "https://digital-strategy.ec.europa.eu/en/faqs/ai-literacy-questions-answers",
    "url" : "https://digital-strategy.ec.europa.eu/en/faqs/ai-literacy-questions-answers",
    "title" : "AI Literacy obligations under Article 4 of the AI Act",
    "date_published" : "2025-02-02",
    "summary" : "Article 4 requires providers and deployers to ensure sufficient AI literacy of staff dealing with AI systems. Already in force since February 2025, with enforcement from August 2026.",
    "_source" : "European Commission",
    "tags" : [ "global", "eu", "ai-act", "literacy", "article-4" ],
    "_relevance" : "Active compliance obligation — providers and deployers must ensure staff AI literacy"
  }, {
    "id" : "https://www.edpb.europa.eu/system/files/2024-12/edpb_opinion_202428_ai-models_en.pdf",
    "url" : "https://www.edpb.europa.eu/system/files/2024-12/edpb_opinion_202428_ai-models_en.pdf",
    "title" : "EDPB Opinion 28/2024 on AI models and personal data",
    "date_published" : "2024-12-17",
    "summary" : "Addresses when AI models may be considered anonymous, whether legitimate interests can support model training, and consequences of unlawful personal data processing in model development.",
    "_source" : "EDPB",
    "tags" : [ "global", "eu", "data-protection", "privacy", "gdpr", "ai-models" ],
    "_relevance" : "Directly governs how developers may train AI models with personal data — core reading for any ML team"
  }, {
    "id" : "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689",
    "url" : "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689",
    "title" : "Regulation (EU) 2024/1689 — the EU AI Act enters into force",
    "date_published" : "2024-08-01",
    "summary" : "The EU AI Act entered into force, establishing the world's first comprehensive legal framework for AI. Sets risk-based obligations for providers and deployers including conformity assessment, risk management, documentation, logging, human oversight, and declared accuracy metrics.",
    "_source" : "European Commission",
    "tags" : [ "global", "eu", "ai-act", "legislation" ],
    "_relevance" : "The binding legal framework defining all provider and deployer obligations for AI software in the EU"
  }, {
    "id" : "https://www.edpb.europa.eu/system/files/2024-05/edpb_20240523_report_chatgpt_taskforce_en.pdf",
    "url" : "https://www.edpb.europa.eu/system/files/2024-05/edpb_20240523_report_chatgpt_taskforce_en.pdf",
    "title" : "EDPB Report of the ChatGPT Taskforce",
    "date_published" : "2024-05-23",
    "summary" : "Shows how EU data protection authorities think operationally about generative AI services. Covers governance, transparency, lawful basis, accuracy, and safeguards for LLM deployments.",
    "_source" : "EDPB",
    "tags" : [ "global", "eu", "data-protection", "gdpr", "chatgpt", "generative-ai" ],
    "_relevance" : "Practical supervisory expectations for deploying generative AI — transparency, accuracy, and safeguards"
  }, {
    "id" : "https://www.iso.org/standard/81230.html",
    "url" : "https://www.iso.org/standard/81230.html",
    "title" : "ISO/IEC 42001:2023 — AI Management System standard published",
    "date_published" : "2023-12-18",
    "summary" : "International standard for AI management systems covering risk management, documentation, and continuous improvement for organisations developing or using AI systems.",
    "_source" : "ISO",
    "tags" : [ "global", "standard", "iso-42001", "ai-management-system", "certification" ],
    "_relevance" : "Certification standard for AI management systems — directly applicable to AI software vendors"
  }, {
    "id" : "https://doi.org/10.6028/NIST.AI.100-1",
    "url" : "https://doi.org/10.6028/NIST.AI.100-1",
    "title" : "NIST AI Risk Management Framework (AI RMF 1.0)",
    "date_published" : "2023-01-26",
    "summary" : "Framework for managing AI risks emphasising Govern, Map, Measure, and Manage functions. Unusually strong on measurement and ongoing risk monitoring, including thresholding, validation, and drift detection.",
    "_source" : "NIST",
    "tags" : [ "global", "standard", "risk-management", "us", "monitoring", "measurement" ],
    "_relevance" : "Best-practice engineering framework for AI risk measurement, monitoring, drift detection, and validation"
  }, {
    "id" : "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/artificiel-intelligence.html",
    "url" : "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/artificiel-intelligence.html",
    "title" : "Swissmedic: Framework conditions for the use of AI in medicinal product development and the regulatory process",
    "date_published" : "2024-01-01",
    "summary" : "The key Swissmedic page on AI in the medicinal-product context — development, manufacture, and regulatory process.",
    "_source" : "Swissmedic",
    "tags" : [ "swiss", "pharma", "biotech", "medicine", "swissmedic", "ai-governance" ],
    "_relevance" : "Defines Swissmedic's framework for AI in medicinal products — directly applicable to pharma AI systems",
    "_featured" : true
  }, {
    "id" : "https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf",
    "url" : "https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf",
    "title" : "EMA: Reflection paper on the use of AI in the medicinal product lifecycle",
    "date_published" : "2024-07-01",
    "summary" : "Central EU guidance for pharma teams using AI in R&D, clinical development, manufacturing, pharmacovigilance, or regulatory submissions.",
    "_source" : "EMA",
    "tags" : [ "eu", "pharma", "biotech", "medicine", "ema", "ai-governance" ],
    "_relevance" : "EU regulatory expectations for AI across the pharmaceutical product lifecycle",
    "_featured" : true
  } ]
}