One of the fundamental precepts of the U.S. legal system is “Ignorantia juris non excusat,” which means that ignorance of the law is no excuse. This can pose a significant challenge for someone who wants to produce a new product or service, because it’s difficult to know what you don’t know. And that’s why it can be important to seek the counsel of a well-prepared lawyer. The problem is especially significant for products that relate to health or medical applications, as there can be a maze of laws and regulations that may come into play.
That’s why it’s helpful that the Federal Trade Commission (FTC) recently released a tool to guide companies that are developing health-related mobile apps. The web-based system was created with the help of other federal agencies: the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR), and the Food and Drug Administration (FDA). By coordinating their efforts, the result covers a wide range of rules and regulations, from the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA), and the Federal Food, Drug and Cosmetics Act (FD&C Act).
The website provides guidance by asking a series of questions. For example, it starts of with “Do you create, receive, maintain, or transmit identifiable health information?” If you answer Yes to that question, you are then directed to “Are you a health care provider or health plan?” As you work your way through the ten questions, you will learn which laws are likely to apply to your product or service. This guidance will help you then find out what is required to comply with those regulations and how to incorporate those requirements into your system.
This one web page is not going to solve all compliance issues for mobile Health Tech app developers, but it does provide a simple, accessible starting point.