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数字化医疗

AI and the FDA

Artificial intelligence (AI) and machine learning (ML) have opened the door to revolutionary changes in the life sciences industry. AI is having a transformative impact on the ways in which the Food and Drug Administration (FDA) and FDA-regulated entities approach the development, manufacturing, use, and oversight of medical products.

How We Add Value

Our lawyers draw on their vast experience working with FDA and unparalleled industry know-how to help guide clients through the shifting AI regulatory landscape. Sidley’s Food, Drug and Medical Device (FDMD) Regulatory Team has experience advising clients on the uses of AI throughout a product’s life cycle, including how products are developed, manufactured, and monitored. With its global platform and cross-disciplinary approach, Sidley is well positioned to help clients embrace opportunities, navigate uncertainties, prepare for, and share their thought leadership on emerging regulatory frameworks.

Representative Matters

We provide a range of services related to FDA’s approach to AI, including:

  • Counseling biopharmaceutical companies on potential FDA regulation of software functions and AI technologies used in clinical trials
  • Advising consumer health companies and systems on specific carve-outs in FDA law for certain software functions using AI technologies to support physicians
  • Counseling clients on informed consent considerations when AI is used in a clinical setting
  • Advising life sciences companies on AI governance policies, including the use of generative AI/large language models (LLMs)
  • Conducting multi-jurisdictional reviews of AI regulatory developments for global multinationals
  • Advising consumer health entities on the use of images generated with AI in marketing materials
  • Guiding pharmaceutical and medical device clients through FDA regulatory approval, clearance, or authorization and reimbursement considerations for products using AI
  • Advising on the uses of AI in pharmacovigilance
  • Counseling clients on the deployment and implementation of AI to strengthen manufacturing compliance and supply chain efficiency
  • Supporting clients on AI-related regulatory issues for mergers and acquisitions, asset purchase agreements, licensing, lending, securities offerings, and other transactional matters
  • Advising on the use and role of third parties (e.g., voluntary standards, certifications, and use of foundation models)

Sidley Thought Leadership