The development of artificial intelligence (AI)-based technologies in medicine is advancing rapidly, but real-world clinical implementation has not yet become a reality. Here we review some of the key practical issues surrounding the implementation of AI into existing clinical workflows, including data sharing and privacy, transparency of algorithms, data standardization, and interoperability across multiple platforms, and concern for patient safety. We summarize the current regulatory environment in the United States and highlight comparisons with other regions in the world, notably Europe and China.