Shaping the Future of Digital Health: Technology, Regulation, and Ethics
The Feature Article is brought to you by the Life Sciences Practice Group
- November 01, 2025
- James Wabby , AbbVie Inc.
- Adam Cargill , MediView XR, Inc.
- Jennifer Chillas , Bristol Myers Squibb
- Crew Weunski , MediView XR, Inc.
The high rate at which digital health technologies are growing has greatly changed how health care is offered, measured, and administered. At the core of such change is the introduction of digital health care tools, which include high-tech software programs, into the sphere of clinical practice, monitoring, diagnostics, and treatment.1 Nonetheless, this transition comes with regulatory oversight issues, ethical considerations, data management requirements, and the need to build stakeholder trust. As new technologies, like Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and artificial intelligence (AI)-based health technology, offer the potential to improve outcomes and efficiency, they also create ambiguity concerning patient safety, algorithm responsibility, privacy, and legal conformity.2 The main concern is that the system of regulations and ethical principles that these technologies fall under is complicated and frequently disjointed. This article explores how existing frameworks address ethical challenges in digital health, identifies remaining gaps, and highlights key studies that inform ethical progress in the field. The aim is to synthesize the existing body of knowledge to offer a basis for understanding the situation between innovation, oversight, and ethical practice in digital health.
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