医療機器ソフトウェア製造業者に対する規制枠組みの影響：ガイドライン文書が実務の実施をサポートしているか？「臨床決定支援と医療機器のための新しい規制枠組み：私たちは準備できているか？－意見論文」へのコメント

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The increasing use in clinical practice of software such as mobile apps and clinical decision support (CDS) software has only recently been taken up by regulators around the world. Specifically, the European Commission and the US Food and Drug Administration (FDA) have updated their regulatory framework in the last years. Van Laere et al have given an extensive overview of the European and US approaches to regulate CDS software. This commentary further discusses regulatory differences between th