Addressing the challenges of regulating the dynamic, diverse and smart world of mobile health apps

The evolution of mobile smartphones, devices and apps continues to influence how we communicate, work and live. Healthcare is no exception. The market for mobile health technologies and apps is estimated to be worth US$23‑billion and brings real and potential benefits to new areas and patient groups.

Critically, however, the pace of change – particularly in the dynamic apps market – poses a fundamental challenge for regulators. In the EU for example, current guidelines fall way short of what is required to assess mobile medical applications (MMAs) and ‘general wellness products’. Despite the potential dangers associated with such apps, the clinical content in most medical apps undergoes no formal review before entering the market. Apps of lesser quality inevitably slip through. In the US in 2013, for example, only 0.1% of the 10,000+ medical apps on sale were approved by the FDA. Even in the US where federal agencies (i.e. FDA, FTC) have attempted to address deceptive practices and bolster guidance, the struggle to keep abreast of complex and diverse software and app developments is immense. Ultimately, the evolution of regulation needs to catch up with that of smart devices if the safety of mobile apps is to be ensured.

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