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Compliance In Focus
Posted by Tracey Tytko on Tue, May 24, 2016

The World of Digital Health

The_World_of_Digital_Health_II.jpgWe are in an era where mobile platforms, such as smartphones, tablets and wearable devices have become a necessity. Mobile applications that run on these platforms provide a variety of entertainment options (games, videos, etc.), allows you to check your electronic mail, and interact with family and friends. Other applications that are being developed are now allowing us to track our health and wellness, and even communicate with healthcare providers, remotely. These types of applications are known as either mobile health applications (mHealth) or mobile medical applications (MMAs).

As more MMAs are being created and utilized today, most developers are unaware if it meets the definition of a “medical device”. The Food and Drug Administration (FDA) issued guidance on MMAs to help clarify which applications are regulated.  While technology continues to evolve, the Federal Trade Commission (FTC) also released a new web-based toolfor the developers of mHealth applications. The tool was developed by the FTC in conjunction with the FDA, the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), and the Office of Civil Rights (OCR).

The interactive tool will ask series of questions about the application, such as the nature, the function, type of data to be collected and the service it will provide to users.  Based on the developer’s answers, the tool will provide which federal laws apply. The laws that may apply, includes the FTC Act, the FTC Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA), and the Federal, Food, Drug and Cosmetics Act (FD&C Act).

While we are all excited for the next big thing, that improves health and healthcare, it is important for developers to know if their MMA is regulated and which laws apply in order to assure safety and effectiveness. If you are in the process of developing a new application and you’re unsure which laws apply, the mobile health apps interactive tool can be found here. If you are unsure whether your MMA meets the definition of a “medical device” check out our previous post hereto see which categories the FDA may exercise oversight and enforcement.



photo credit: World Map via photopin (license)

Topics: Mobile Medical Applications, FDA, Digital Health,


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