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Virtually all modern medical devices now include embedded software, ranging from basic user interfaces and network connectivity to sophisticated artificial intelligence (AI) and machine learning (ML). Although integrated devices (devices that tightly integrate software components to drive the function of traditional medical devices and create improved, augmented, or new capabilities) have existed for years, the size of this market has grown rapidly, with connected health care devices (devices that send and receive orders from other devices or networks, such as the internet) alone creating a market valued at USD $28.24 billion in 2020 and is expected to reach USD $94.32 billion by 2026 at a compound annual growth rate of 18.92%.1, 2 The prevalence of these integrated devices is blurring the lines between previously distinct categories, such as hardware and software, medical devices and clinical informatics, and regulated medical devices and off-the-shelf third-party software. Multiple product areas are now converging and are often even connected with one another, linked across mobile, home internet, or local area networks in medical facilities small and large. Integrated devices are poised to revolutionize everything from patient care to physician workload management to clinical trial design, but they lack a purpose-built regulatory framework to both nurture and oversee their development. The US Food and Drug Administration (FDA) currently holds them to the same risk-stratified premarket review standards as surgical instruments, x-ray machines, and other analog tools, utilizing a regulatory framework first developed almost 50 years ago.3 As these integrated devices become increasingly more sophisticated and widespread, novel regulatory systems will be necessary to keep pace with their evolution.
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The Milbank Quarterly is an editorially independent multidisciplinary journal that offers in-depth assessments of the social, economic, political, historical, legal, and ethical dimensions of health and health care policy.