Table 1:

United States Privacy Laws and Terms Defined (adapted from the Federal Trade Commission Web site ⁷)

Name	Definition
Health Insurance Portability and Accountability Act (HIPAA)	Enforced by the Office for Civil Rights (OCR) within the U.S. Department of Health & Human Services (HHS), HIPAA protects the privacy and security of certain health information and requires certain entities to make aware health information breaches. HIPAA covered entities include: Health care providers who conduct certain electronic transactions, Health plans, and Health care clearinghouses
Federal Food, Drug, and Cosmetic Act (FD&C Act)	Enforced by the FDA, the FD&C Act regulates the safety and effectiveness of medical devices, including some mobile medical apps. Mobile medical apps are defined as follows: 1. An accessory to a regulated medical device; 2. An app which transforms a mobile platform into a regulated medical device e.g. a mobile platform to measure blood glucose levels; 3. An app that conducts analyses or interprets data from another medical device e.g. an app that takes the user’s information and develops a dosage plan for radiation therapy.
Federal Trade Commission Act (FTC Act)	Enforced by the FTC, the FTC Act prohibits deceptive or unfair acts/practices related to commerce, including those relating to privacy and data security, and those involving claims about apps’ safety or performance that are untrue or misleading.
FTC’s Health Breach Notification Rule	The FTC’s Health Breach Notification Rule requires certain businesses to provide notifications following breaches of personal health record information.