The Federal Trade Commission has created a new web-based tool for developers of health-related mobile apps, which is designed to help the developers understand what federal laws and regulations might apply to their apps. The FTC developed the tool in conjunction with the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (Office of the National Coordinator for Health Information Technology (ONC) – Located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS), the Office of the National Coordinator (ONC) coordinates nationwide ... More), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA).
The guidance tool asks developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers to those questions, the guidance will point the app developer toward detailed information about certain federal laws that might apply to the app. These include the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (The Health Insurance Portability and Accountability Act (HIPAA) was enacted by the U.S. Congress in 1996. Title II of HIPAA, known as the Administrative Simplification (AS) provisions, requires the establishment of national standards for electronic h... More) and the Federal Food, Drug and Cosmetics Act (FD&C Act).
This new tool contains a wealth of needed information for mobile apps that typically are only asked after the product is on the market. Hopefully the FTC and some external groups will find novel ways to market this helpful tool so it reaches product managers before they go to market.
And, another thing mobile devs need to consider is integrating their product data with healthcare providers. Our CTO gave a presentation on this very topic to the Health 2.0 organization a few years back. Read, "Dave's advice to health tech entrepreneaurs: Start with the long tent pole"