It’s a claim substantiated every day by innovators across the globe: Digital health is revolutionising healthcare.
Whether it’s software as a medical device, clinical decision support (CDS), artificial intelligence and health IT systems — or more consumer-facing technology like mHealth apps, fitness trackers, wearable devices and telehealth systems — digital health is rapidly changing how we predict, monitor, manage and make decisions about health.
As digital health continues to evolve and revolutionise healthcare, health authorities worldwide are faced with a challenge: Rethinking regulation in ways that support rapid innovation in the highly iterative world of software development.
To shed light on the need for new regulatory paradigms as well as possible solutions, Steve Burnell, PhD, and Denelle Miller, JD, two experts representing digital health development and regulation from Roche Diagnostics, discuss the issues.
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