The Federal Trade Commission (FTC) in conjunction with the Office for Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology, and the Food and Drug Administration, have developed a new web-based interactive tool to assist developers of health-related mobile apps identify applicable federal laws and regulations. The tool identifies laws and regulations from the three federal agencies that may apply to mobile apps that collect, create, or share consumer information, or which diagnose or treat a disease or health condition including the Health Insurance Portability and Accountability Act (HIPAA), the FTC Act, the FTC’s Health Breach Notification Rule and the Federal Food, Drug and Cosmetics Act. The web-based tool can be found at https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool.
OCR has also added a new resource to its health app developer portal which can be used to analyze whether HIPAA applies to a health app. To learn more about OCR’s Developer Portal, visit http://www.hhs.gov/hipaa/for-professionals/special-topics/developer-portal/index.html.