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Wellness App Regulations

Meaning

Wellness app regulations refer to the complex and evolving set of legal and ethical guidelines governing the development, deployment, and use of software applications designed to promote general health and well-being. These regulations address critical areas such as data privacy (e.g., HIPAA, GDPR), data security, truthfulness in marketing claims, and the boundary between regulated medical devices and unregulated general wellness products. Navigating this regulatory landscape is essential for app developers to ensure compliance, protect user data, and establish clinical credibility in the digital health space. The primary goal is to protect consumers from misleading claims and ensure the secure handling of sensitive personal health information.