In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool has been released that is designed to help developers of mobile health apps understand the multitude of federal laws and regulations that may apply to them.
Through a series of 10 simple “yes or no” questions, mobile health app developers can learn about the laws they may be subject to, such as the Health Insurance Portability and Accountability Act (HIPAA), FDA’s medical device manufacturing regulations, and the FTC’s rules prohibiting deceptive or unfair acts or practices. Sample questions include: “Are you a health care provider or health plan?” and “Do consumers need a prescription to access your app?”
Developers that discover they are subject to HIPAA can learn more about their obligations by visiting OCR’s health app developer portal.