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The rapid growth of mobile health (mHealth) apps has resulted in confusion among health care providers and the public about which products rely on evidence-based medicine. Only a small subset of mHealth apps are regulated by the US Food and Drug Administration. The system similar to that used to accredit and certify laboratory testing under the Clinical Laboratory Improvement Amendment offers a potential model for ensuring basic standards of quality and safety for mHealth apps. With these products expanding into the realm of diagnosis and treatment, physicians and consumers are in a strong position to demand oversight that delivers safe and high-quality mHealth apps.
Richard S. Larson (Sat,) studied this question.
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