Health Apps Increase In Popularity Despite FDA Difficulties
iPhones. Android phones. These phones are becoming increasingly popular to use. According to the Chicago Tribune, half of cell phone users in the U.S. utilize smart phones like Android-based software devices or iPhones. With this rise in popularity, there has been a growing market of phone apps that can address many issues and daily tasks that users have. In particular, Samsung recently announced the launch of the S Health application for¬†Galaxy S III that can help users track and understand their personal wellness; it corresponds with the influx of health apps that have inundated the market in recent months.
The S Health app was first shown at the Galaxy S III Unpacked launch event last may. The presentation emphasized how the S Health pools health data to help users have a healthier lifestyle. In particular, it works with healthcare sensors like blood glucose meters, blood pressure monitors, and body composition scales. The sensors then transfer the pooled information to the Galaxy S III.]
“S Health can provide real benefits in terms of tracking and monitoring health and wellness for our customers. We’re delighted to bring this innovative application to the Galaxy S III’s portfolio of diverse content and applications to suit different needs,” remarked Simon Stanford, Vice President of Telecommunications and Networks for Samsung UK and Ireland, in a prepared statement.
Based on the information collected, the S Health will create graphs or tables from the results to provide a complete health update. The app can also track and chart health readings over time to assist users who need to monitor their health on a more regular basis. Other details like diet, exercise, and medication intake can be manually inputted.
Furthermore, the app is connected to social networks to promote the accomplishments of individuals in achieving specific health goals. It is thought that these social networks will provide motivation and a rallying point for people to continue in their healthy endeavors. In particular, message and health updates can be posted online through Twitter.
Other smartphone apps have similar features to the S Health app. According to USA Today, there are currently 40,000 medical apps that can be downloaded on smartphones or tablets. However, the increase in apps has made it difficult for the U.S. Food and Drug Administration (FDA) to regulate. Doctors and patients are also unsure which app to use and which can provide correct information.
“We’re seeing mobile apps updated and created on a daily basis,” Joel White, executive director of the Health IT Now Coalition, told USA Today. “The life cycle is dramatically different.”
Last year, the FDA released a preliminary draft of guidelines that states that medical-related mobile apps must apply for FDA approval. This is similar to the current process for medical devices who wanted to be proved as safe and effective for the marketplace. However, the process can be expensive and drawn out.
“These apps already exist,” Orrin Franko, an orthopedic surgery resident at the University of California, San Diego who reviews orthopedic apps for doctors and patients on \TopOrthoApps.com, noted in the USA Today article. “And people are using them in hospitals to make medical decisions, but no one knows if they’re actually doing what they claim to be doing.”
The¬†Government Accountability Office states that it takes as approximately six months to approve a medical device that has similar attributes to a product that is already on the market. For brand new devices, it takes 20 months for it to be approved. According to USA Today, the FDA is slated to release final guidelines on mobile health apps this year. However, many companies do not want to wait for the guidelines and have already started applied through the formal application process; the FDA has approved a few of the apps.
“There are two completely different mindsets,” commented Merrill Matthews, a resident scholar at the¬†Institute for Policy Innovation, in a Chicago Tribune article. “The app people think: Where is there a need and how do I fill it? And the FDA thinks: Where is there a problem and how can I control it?”
Apart from time consuming, the approval process can be is expensive. A Stanford University study found that it takes between $24 million to $75 million for the FDA to approve a standard medical device. If a product can be approved, it can be a lucrative venture; Research2Guidance, a mobile research group, discovered that the health app market is currently worth approximately $718 million.
“The FDA approval process adds months, if not years, and potentially millions of dollars to what it takes to bring a solution to the market,” stated Liz Boehm, a director at consulting firm ExperiaHealth, in the Chicago Tribune article.
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