@Regulatory: May 2012
Regulatory implications of mobile applications in the life science industry
Everywhere you turn, it seems that there is a mobile device being used during the course of business. Advancements in the underlying enabling technologies and the explosion of the mobile device industry over the past five years due to the technology rapidly becoming smaller, faster, and cheaper has greatly expanded the mobile application (“app”) market. In 2009, healthcare apps composed about one-and-a-half percent of the total mobile app market. The actual sales figures doubled from 2009 to 2010, and they are expected to grow exponentially over the next three years. By 2015, it’s estimated that there will be 500 million smartphone users with healthcare-related apps. Innovative technologies are clearly a burgeoning area, and have become one of the challenges currently facing the U.S. Food and Drug Administration (FDA). The FDA needs to strike a balance between promoting public health and patient safety, while fostering innovation by encouraging the development of new and important products that will revolutionize the delivery of healthcare.
The FDA has had growing concern regarding the use of mobile apps, seeing that they have become more prevalent. As the list of apps that can run on mobile devices over a wide spectrum of healthcare areas continues to grow daily, it has become increasingly important for government and industry to understand their implications. This article addresses key questions and concerns with mobile medical apps, where regulations will be focused, and a look toward the mobile app future.
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