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    Regulatory Challenges for Artificial Intelligence Applications in Healthcare

    This article addresses regulatory challenges associated with using artificial intelligence in healthcare. The authors explore challenges in regulating “digital health” and review various pathways to gain regulatory approval for artificial intelligence applications to be employed in healthcare. They recommend potential approaches for resolving regulatory challenges that may arise with the use of new technologies and discuss the variety of FDA initiatives aimed at helping t...
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    Regulatory and Economic Challenges for Gene Therapy Utilization

    This article addresses pricing and reimbursement challenges associated with clinical utilization of approved gene therapies. The authors recommend potential approaches to resolve these challenges, the implementation of which may help solve issues related to the high cost of these therapies and encourage continued innovation and further development of advanced gene therapies. Introduction Gene therapy is an experimental technique using genes to treat or prevent diseases ...
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    Resolving Gene Editing Technology's Ethical and Regulatory Challenges

    This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges. Introduction Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology is a genetic "editing" tool aimed at altering DNA sequences and modifying gene function. It offers promising opportunities for ...