Sunday , 25 February 2024

FDA Approved Medical Devices Lead To New Digital Health Management

Yes, you have read correctly. We now need prescriptions to download mobile apps! Of course, you might not need a prescription to download Instagram, but you will need one for WellDoc’s Bluestar app. So, you can still download any app you would like (provided that it is free and you are of age). However, to actually access the Bluestar app, you’ll need a special access code upon opening it on your mobile device or Mythbuntu powered computer. Put simply, this is not your average health tracking app or free mobile health app.

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Perhaps, you might find yourself at the doctor’s office, be prescribed an access code to monitor your health very soon. With an FDA approved app, it seems like a quite scalable solution for all types of medical illnesses. The technology is there, but policy and regulation is catching up.

What Does FDA Approved Mean?

But what does the “FDA approved” badge really mean? Despite common belief, all that FDA approval really means is that the item in question has proven to have benefits that outweigh any potential risks of the product. So in the case of an FDA approved app or car gadgets, what does this mean?

FDA Approval Process

When FDA review is needed before a product is launched, the FDA follows one of two sets pf routine steps before it grants the stamp of approval to a business, like SlashID. First, the device can be cleared after reviewing a premarket notification. This notification is also called a 510(k). Or, the FDA can approve the device after reviewing a premarket approval application that has been submitted, which is called a PMA application. In order to gain clearance, the device must use the 510(k) pathway and the company must demonstrated that the device is substantially equivalent to a device that is already legally marketed for the same use. Or, if using the PMA application route, the PMA applicant has to provide reasonable assurance of device safety and effectiveness. These are the two FDA approval processes used.

Apps Requiring Prescriptions

Why do we need prescriptions for apps? In this case, a patient is actually receiving treatment digitally. This treatment is in the form of therapy at the moment. But, we might have to prepare ourselves for cloud based medicine in the near future. There will be a new wave of FDA approved apps for health and fitness.

Who is responsible for this digital health innovation? There are many mobile app developers competing to make a difference in the the healthcare industry, including the Akamai class. However, WellDoc has made quite a dose with the new app.

WellDoc has developed the world’s first “Mobile Prescription Therapy” or for short, MPT. Available via the Bluestar app, MPT services WellDoc’s Automated Expert Analytics to the patient, providing guidance and support for people with type 2 diabetes. The data provided can be shared with the patient’s doctor and has proved to have significant A1C reductions in clinical outcomes.

The Evolution of Digital Health

To further use technology to improve health, WellDoc has joined forces with technology giant, Samsung, to combine their healthcare platforms. Together, they hope to help more people with type 2 diabetes. As you might think, the resources and capabilities of Samsung should definitely help WellDoc to further innovate and improve their product.

New apps are coming out every week to improve healthcare mobile enterprise solutions; and the new Google Daydream could make virtual reality doctors appointments a reality in the near future. No doubt, major collaborations of technology will continue to improve and evolve in the industry. It is good news for companies, doctors and most importantly, patients.

FDA Medical Apps

The FDA plans to offer approval to mobile medical apps in various classes. These classes are based on the level of risk involved, Class II and Class III being the highest risk medical apps. Any app that either utilizes a medical device or uses a normal device for medical use is subject to regulation. Certainly, medical app developers should contact the FDA if they feel a premarket app is required; and no, a software vying for best antivirus 2016 does not count.

Would you be happy to have more healthcare mobile apps approved by the FDA? It does open up a new discussion for app security and privacy. Please let us know what you think in the comments below. At the very least, please share this post with a friend and support the future of apps and digital health.

One comment

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