New FDA regulations have significant impact on health apps for mobile devices

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The Food and Drug Administration (FDA) is considering a proposal that would apply stricter regulations to mobile apps that are designed to provide medical information or advice.

This type of application has been growing in popularity as smartphones are used by Americans on an increasing basis, as they make additional efforts for their own healthcare management. Current estimates are suggesting that by the year 2015, if regulations remain as they are, there will be approximately 500 million consumers using medical apps. Clearly, the demand for health related information is very large among the mobile device using world.

The FDA is currently investigating a number of different options for the regulation of medical apps for mobile devices under the Food, Drug and Cosmetic Act, especially in terms of patient safety and adverse event reporting. On the other hand, many in the mobile industry are objecting to this type of regulation by saying that as the apps are still in a formative stage, any expensive or complicated FDA regulatory structures might hamper the ability for developers to innovate.


Technology Quotes That Invite Thought - "If your plans don't include mobile, your plans are not finished." - Wendy Clark, Coca-Cola


The Obama administration, Congress, patients, and healthcare providers have been leaning heavily toward the use of technology in order to improve various forms of strategies for care coordination, and for the use of risk-based models in order to help to enhance the outcomes for patients and lowers the cost of care.

One of the strategies that was expected to be the most promising was the integration of mobile apps with patients and clinicians for electronic and personal health records. However, this and other similar programs may not be possible should the proposal be put into effect by the FDA.

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