Health AI Central
Peer-Reviewed Publication
Diagnostics (Basel)2024;14(18)September 23, 2024Journal Article

Software as a Medical Device (SaMD) in Digestive Healthcare: Regulatory Challenges and Ethical Implications.

Miguel Mascarenhas1,2,3,4, Miguel Martins1,2, Tiago Ribeiro1,2,3, João Afonso1,2,3, Pedro Cardoso1,2,3, Francisco Mendes1,2, Hélder Cardoso1,2,3, Rute Almeida4, João Ferreira5,6, João Fonseca4, Guilherme Macedo1,2,3
1Precision Medicine Unit, Department of Gastroenterology, São João University Hospital, 4200 427 Porto, Portugal.
2WGO Gastroenterology and Hepatology Training Center, 4200 427 Porto, Portugal.
3Faculty of Medicine, University of Porto, 4200 427 Porto, Portugal.
4CINTESIS@RISE, Department of Community Medicine, Information and Health Decision Sciences (MEDCIDS), Faculty of Medicine of University of Porto, 4200 427 Porto, Portugal.
5Department of Mechanic Engineering, Faculty of Engineering of University of Porto, 4200 427 Porto, Portugal.
6DigestAID-Digestive Artificial Intelligence Development, 4200 427 Porto, Portugal.
PubMed PMC DOI PDF

Abstract

The growing integration of software in healthcare, particularly the rise of standalone software as a medical device (SaMD), is transforming digestive medicine, a field heavily reliant on medical imaging for both diagnosis and therapeutic interventions. This narrative review aims to explore the impact of SaMD on digestive healthcare, focusing on the evolution of these tools and their regulatory and…

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