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Dec. 5, 2023

AI: Considering the Regulatory and Legal Implications

By Michael J. Halaiko, Esq., CIPP/E, Alexandra P. Moylan, Esq., CIPP/US

Medical Device & Diagnostic Industry

In an article published on Nov. 29, 2023, in Medical Device & Diagnostic Industry, Mike Halaiko and Alexandra Moylan discuss data privacy and compliance considerations for the use of AI in clinical research.

"AI can make the data collection and analysis process involved in clinical research more efficient; it can help the research team identify patterns, and correlations and evaluate efficacy and safety," said Halaiko and Moylan. "Nonetheless, from a legal and regulatory perspective, compliance with data privacy and protection regulations is paramount as AI systems and models rely on data inputs. That can be challenging given the evolving legal and regulatory landscape, and requires input from various teams including legal, clinical, compliance and others."

To read the full article, click here.