. 2020 May 6;27(6):976–980. doi: 10.1093/jamia/ocaa036

Table 1.

Relevant laws and regulations relating to the safety, effectiveness, data protection, and privacy of mobile health apps and their data

Country	Law/regulation	Covers
United States	Health Insurance Portability and Accountability Act (HIPAA)²⁷	Data security and privacy of health information, health information breaches
United States	Federal Food, Drug, and Cosmetic Act (FD&C Act)²⁸	Safety and effectiveness of medical devices (includes some mobile apps)
United States	Federal Trade Commission Act (FTC Act)²⁹	Privacy, data security, validity of claims about safety and effectiveness
United States	Federal Trade Commission’s Health Breach Notification Rule³⁰	Personal health information breaches
Europe	General Data Protection Regulation (GDPR)³¹	Data protection, privacy, sharing of personal data outside the European Union/European Economic Area
Europe	Medical Device Regulation³²	Safety and effectiveness of medical devices (includes some mobile apps)
United Kingdom	Data Protection Act 2018³³	Data protection and privacy