Mobile Healthcare Apps And Wearables Pose A Serious Challenge

February 02, 2018
challenges of mobile health apps and wearables

Mobile Healthcare apps and wearables are posing a serious challenge to companies as well as to the FDA. While they are among the most forward thinking and the best thing to happen since pockets—as the saying goes—they also create real problems in their use.

There are plans and concepts in the works to help to stimulate the visual cortex in order to help the blind. There are plans and in fact products in play that actually stimulate nerves to allow people to use artificial limbs merely by thinking.

One of the problems that arises in their use is that all of these things present massive challenges in the regulation. The FDA is working to create a brand new digital health unit that is developed around people who have industry experience, health experience and AI experience. This unit is aimed to help them to understand issues such as cloud computing, big data, cybersecurity and many other things that are going to affect the wearable and the health industry market.

“We're trying to get people who have hands-on development experience with a product's full life cycle,” says Bakul Patel, the FDA’s associate director for digital health. “We already have some scientists who know artificial intelligence and machine learning, but we want complementary people who can look forward and see how this technology will evolve.”

According to Jeremy Hsu in May of 2017 “The FDA has already spent years working with the medical devices industry and issuing guidance to clarify what products and services require more strict regulation”

Patel also added that their digital health units “must also ensure that the regulatory process can accommodate the rapid and iterative process of software updates. “

Additionally there are some barriers to getting these items to market. It takes a lot of time and money to get devices such as these approved and it takes expertise in not only medical devices but cybersecurity. This area is one in which many places fall short. Some applications are not accepted or approved because they simply are too advanced and there are easier ways to accomplish things. For example, a brain computer interface may be okay but you can type with a voice assistant so there isn’t much reason to use the brain computer implant just for typing.

 As The Economist said, people are not exactly clamoring for a craniotomy or an implant in their brain.

Turning implants into products that consumers want regularly is difficult for us to imagine. There are non invasive techniques that can do the same thing in many cases and they are making advances on a regular basis.

In addition, ethical conundrums are already in play and people are concerned about the issues that may arise when companies place machinery into the brain.

All of these problems aside. The brain and the body and implants that can help us to live better are no longer pure fantasy. They are happening every day all around us. Inside the body is the next computer frontier.

Bill McCabe is an IoT expert who has worked with IBM, Deloitte, Accenture, Cap Gemini, Oracle, JDEdwards and others designing recruitment plans for high value IT and IoT talent in Sales, Marketing and Consulting.

Bill McCabe

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