Published Paper Details:

The healthcare landscape is evolving rapidly with the integration of advanced technologies like artificial intelligence (AI) and machine learning (ML). Software as a Medical Device (SaMD) stands at the forefront of this transformation, promising groundbreaking innovations in medical diagnosis, treatment, and management. However, along with its potential benefits, SaMD brings forth significant ethical and legal considerations that necessitate comprehensive regulatory oversight. Ensuring patient safety is paramount as SaMD becomes increasingly involved in clinical decision-making. Additionally, safeguarding data privacy and addressing algorithmic transparency and accountability are critical. Effective regulatory frameworks are essential to strike a balance between fostering innovation and protecting patient welfare. By providing clear guidance and standards for SaMD development, validation, and post-market surveillance, policymakers can instill confidence in these technologies' safety and efficacy. This paper aims to explore the ethical and legal implications of SaMD regulation, focusing on key issues such as patient safety, data privacy, and algorithmic accountability. Through an examination of existing regulatory frameworks and emerging best practices, it seeks to offer insights and recommendations for stakeholders across the healthcare ecosystem. By addressing these challenges collaboratively, we can harness the transformative potential of SaMD while upholding ethical standards and patient-centered care.