Regulatory and Privacy Concerns Related to Mental Health and Wellness Apps During COVID-19 and Beyond
It’s no surprise that in the last few years startups have been keen to cash in on the burgeoning consumer demand for mental health and wellness apps, but what are the regulatory and privacy concerns that users should be aware of? Marketplace Tech recently came out with a podcast highlighting how COVID-19 has opened the flood gates to consumer demand for remote online therapy. Mobile app analytics companies report that downloads of mental health and wellness apps are up almost 30% since COVID-19. However, what are the privacy and regulatory concerns related to the use of these apps? There are thousands of mental health apps for consumers to download. For example, there are apps where you can engage in therapy with a robot or download an app that can help monitor your side effects to particular medications. How should these apps be regulated? Should we care that these apps are effective before they’re allowed to be put out on the market? And what privacy rights have users relinquished by using these wellness apps?
Many apps related to health and wellness do not require pre-market review because they are not categorized as “medical devices,” as determined by the Food and Drug Administration (FDA). Rather, they are categorized as “general wellness products” that are seen as low-risk products that promote a healthy lifestyle are not deemed to be a “medical device.” However, the Federal Trade Commission (FTC) has recently issued warning letters to apps that made false advertising claims related to their products’ effects on preventing or treating COVID-19. Section 5 of the FTC vests in the FTC the authority to ensure that business practices are free from unfairness, deception, unsubstantiated claims, false advertising, and anti-competitive activities. Under the FTC, any and all health-related claims an app makes must be substantiated by “competence and reliable scientific evidence.” Testimonies from consumers who have used the app will not qualify as a substantiated claim. Recently, the FTC issued forty-five letters to companies making COVID-19 prevention, treatment, or cure claims. For example, Musical Medicine received a letter requiring that it immediately cease making claims that its use of music at a specific frequency range would help consumers resist the Coronavirus, while boosting consumers’ immune systems. All general wellness apps, as well as wellness products, must substantiate their claims. Testimonies and user ratings will not meet the “competent and reliable scientific evidence” standard.
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