The Federal Trade Commission (FTC) recently created a new interactive tool for mobile health application developers to utilize in determining which federal laws and regulations might apply to them. A Mobile Health Application is any application on a mobile device which delivers health care services. This could include applications which keep track of health information, monitor chronic illnesses, or allow a patient to directly communicate or share information with his/her health care provider.
The FTC, together with the Office of Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA), has designed a web-based tool that takes mobile health application developers through a series of questions about the nature of their applications, including the function, the data collected, and the services provided to users. Based on the answers to the questions, the tool helps mobile health application developers to figure out whether or not certain federal statutes and regulations might apply to them, including:
- Health Insurance Portability and Accountability Act (HIPAA) Rules
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Federal Trade Commission Act (FTC Act)
- Federal Trade Commission’s Health Breach Notification Rule.
The tool, which is maintained on the FTC’s website, links to each agency’s (OCR, ONC, FDA) website for more information about the laws and regulations for which they have compliance and enforcement responsibility.
The Director of the FTC’s Bureau of Consumer Protection stated, “Mobile app developers need clear information about the laws that apply to their health-related products”, and “by working with our partner agencies, we’re helping these businesses build apps that comply with the law and provide more protection for consumers.” More and more, individuals are becoming increasingly reliant on managing their health care through mobile health applications. Studies project that by 2020, the worldwide mobile health market is expected to grow to $49 billion.1 The worldwide mobile health market was valued at just $4.75 billion in 2014.
Although the tool provides an overview of the applicable federal laws, it is not meant to serve as legal guidance.
The FTC’s Mobile Health Apps Interactive Tool can be found here.