The use of artificial intelligence (AI) in research and
development and the research and development of AI solutions
themselves create far reaching legal and policy questions in the
clinical research context.
In one of the latest installments of Reed Smith's video
series "AI explained", Reed Smith attorneys
Nancy Bonifant Halstead and Sarah Thompson Schick provide an overview of
the important legal and policy considerations raised by (1)
research and development of AI solutions that require access to
patient data and (2) AI used in the design and implementation of
clinical trials.
The video covers how existing aspects of U.S. law, particularly
HIPAA and the Common Rule, have historically balanced individual
privacy rights with public health goals. They also discuss whether
the introduction of AI requires a change to this balancing act. In
addition, both discuss FDA and industry efforts to navigate how,
and to what extent, AI can or should be used in life
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