Digital Health Products and Their Regulatory Challenges

ABSTRACT Mobile health applications, wearable devices, telehealth platforms, artificial intelligence (AI) applications, and electronic health records have changed healthcare delivery through improving access, efficiency, and participation of patients. Regulatory affairs will have an essential part in assuring the safety, effectiveness, quality, and data security of digital health innovations as they expand and grow fast. By influencing how we classify products, evaluate risk, clinically validate, secure cybersecurity, improve interoperability, and evaluate post-market regulatory pathways, we seek to find a balance between innovation and patient safety. Keywords: Artificial Intelligence (AI), Mobile Health, Quality Assurance