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ArXiv Preprint

The dawn of the digital medicine era, ushered in by increasingly powerful embedded systems and Internet of Things (IoT) computing devices, is creating new therapies and biomedical solutions that promise to positively transform our quality of life. However, the digital medicine revolution also creates unforeseen and complex ethical, regulatory, and societal issues. In this article, we reflect on the ethical challenges facing digital medicine. We discuss the perils of ethical oversights in medical devices, and the role of professional codes and regulatory oversight towards the ethical design, deployment, and operation of digital medicine devices that safely and effectively meet the needs of patients. We advocate for an ensemble approach of intensive education, programmable ethical behaviors, and ethical analysis frameworks, to prevent mishaps and sustain ethical innovation, design, and lifecycle management of emerging digital medicine devices.

Sudeep Pasricha