Digital health apps are growing in popularity. According to a recent study, there are more than 325,000 mobile health apps available for upload to smart phones or tablets.
The marketing of digital health apps to consumers brings with it numerous legal compliance obligations. Depending on the app and its functions, several federal laws and regulations may apply. These include:
Health Insurance Portability and Accountability Act (HIPAA)
The U.S. Department of Health & Human Services (HHS) enforces the HIPAA rules, which protect the privacy and security of certain health information. The HIPAA laws also require certain entities to provide notifications of health information breaches.
Federal Food, Drug, and Cosmetic ACT (FD&C Act)
The FDA enforces the FD&C Act, which regulates the safety and effectiveness of medical devices, including certain mobile medical apps. Depending on the nature of the health app, FDA oversight may apply. This may include health apps that pose a higher health risk if they do not perform as intended.
Federal Trade Commission Act (FTC Act)
The FTC Act prohibits deceptive and unfair trade practices affecting interstate commerce. These acts may include those relating to false and misleading health claims, representations regarding the performance of the app, as well as claims that impact consumer data security and privacy.
Health Breach Notification Rule (FTC)
This law applies to certain businesses that are required to provide notifications to consumers after a breach of personal health record information.
The Lanham Act is the primary federal law that governs the registration and use of trademarks in the United States. Health app providers must be sure that any trademarks that they adopt are properly cleared. If third-party trademarks are used, then such uses should be permissive or in the context of fair use exceptions.
U.S. Copyright Act
U.S. copyright laws protect original works on authorship fixed in a tangible medium. The written code of mobile health apps are considered literary works subject to registration, protection, and enforcement under the Copyright Act.
U.S. Patent Act
Certain digital health apps and its associated technology may be patentable. This will depend, in large part, on the nature of the technology and whether the invention is new and non-obvious.
Editor’s Note: Developing and marketing any health app requires careful legal compliance review. To discuss your digital health app requirements, feel free to contact the author.