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Synthetic data emerges as a potential solution to privacy concerns in healthcare, allowing the use of realistic but artificial datasets to ensure data security and compliance. Meanwhile, challenges persist in decentralized trials and AI applications in medicine, such as ensuring data protection, managing bias, and maintaining patient rights when AI influences clinical trial participation. Regulatory bodies like the FTC are enforcing stricter data handling practices for health apps, and new legislative initiatives, such as the UK’s “Data Protection and Digital Information Bill” and the EU’s forthcoming pharmaceutical reform, aim to address data protection and healthcare accessibility issues amid evolving technological and societal demands.