Earlier this year the US Food and Drug Administration (FDA) heralded the forthcoming launch of its pre-certification pilot program for new digital health software which it hopes will help revolutionise the regulation of digital healthcare solutions in the US and allow innovations to safely reach the global market in a timely way, to the benefit of end users.”We need to modernise our regulatory framework so that it matches the kind of innovation were being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices, said FDA Commissioner Scott Gottlieb, M.D.Warming to this user-centric theme, in a July FDA blog post, Gottlieb wrote: “This new program embraces the principle that digital health technologies can have significant benefits to patients lives and to our healthcare system by facilitating prevention, treatment and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings.

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