Publications by authors named "S Gerke"

Article Synopsis
  • The growth of AI and machine learning in healthcare offers promising advancements in patient care through tools for diagnostics, monitoring, and personalized treatments, yet this progress faces regulatory hurdles due to recent Supreme Court rulings affecting agencies like the FDA.
  • The paper investigates the implications of regulatory uncertainty on the healthcare sector, focusing on how it impacts innovation in biotechnology against the need for patient safety and regulatory consistency.
  • Key Supreme Court cases are analyzed to understand changes in agency deference and regulatory authority, providing insights and recommendations for the medical community to address these emerging challenges in the industry.
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Artificial intelligence (AI) and machine learning (ML) tools are now proliferating in biomedical contexts, and there is no sign this will slow down any time soon. AI/ML and related technologies promise to improve scientific understanding of health and disease and have the potential to spur the development of innovative and effective diagnostics, treatments, cures, and medical technologies. Concerns about AI/ML are prominent, but attention to two specific aspects of AI/ML have so far received little research attention: synthetic data and computational checklists that might promote not only the reproducibility of AI/ML tools but also increased attention to ethical, legal, and social implications (ELSI) of AI/ML tools.

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Researchers and practitioners are increasingly using machine-generated synthetic data as a tool for advancing health science and practice, by expanding access to health data while-potentially-mitigating privacy and related ethical concerns around data sharing. While using synthetic data in this way holds promise, we argue that it also raises significant ethical, legal, and policy concerns, including persistent privacy and security problems, accuracy and reliability issues, worries about fairness and bias, and new regulatory challenges. The virtue of synthetic data is often understood to be its detachment from the data subjects whose measurement data is used to generate it.

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