FDA medical app regulation and the art of intended use

By: admin | Apr 13, 2015        

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By Bradley Merrill Thompson

Brad2With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor in deciding whether FDA regulates an app, but for those apps FDA regulates the intended use determines the degree of regulation.

Paraphrasing a bit, FDA regulates any smart phone apps intended for use in the diagnosis or treatment of disease or other conditions. And that intended use is determined mostly by examining the developer’s promotional claims as well as the features of the app.

Let’s focus here on promotional claims. This is where the art comes in. There’s a reason English is taught in liberal arts colleges, and not engineering. Words can be strung together to communicate an endless array of ideas, some of them different only in quite subtle nuances. There is nothing linear about the English language. We can state a concept clearly, or we can state it generally, or we can state it cleverly in ambiguous terms. We can be explicit or we can imply things. Language is an art form.

So if FDA’s jurisdiction is determined by the language we use, and language is an art form with many ways to express closely related but not identical thoughts, how do we know exactly where FDA draws the regulatory line? The most honest answer is we don’t, at least not exactly. There is judgment required.

But that’s not to say that chaos reigns. The system has been working reasonably well for decades because there are ways to discern which intended uses FDA regulates.  Keep reading>>


Tablet app reduces CHF patient readmissions by 53 percent

By: Aditi Pai | Apr 9, 2015        

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Health Recovery SolutionsNew York City-based Health Recovery Solutions announced that its tablet-based program reduced the 30-day readmission rate for 130 congestive heart failure (CHF) patients at Penn Medicine’s Penn Care at Home program by 53 percent.

Health Recovery Solutions looked at Penn Care at Home’s data between July 2014 and February 2015. During this time, the readmission rate fell from 8 percent to 3.8 percent.

“Since launching with HRS, we’ve had our best CHF readmission performance to date,” Anne Norris, Chief Medical Officer of Penn Care at Home, said in a statement. “In six of the last 12 months we have had zero thirty-day readmissions, and our overall rate stands at 3.8 percent. There’s a secret sauce here, using this tool to engage patients in their own self-care.”

The hospital provides patients with a cellular-enabled tablet, with the program, called PatientConnect, preloaded. Providers pay Health Recovery Solutions a licensing fee for the package.

Patients can use the system to communicate with their physician via video chat. The tablet software also encourages patients to record medication, weight, activity, and symptoms. Clinicians and caregivers can monitor this data through their own apps, ClinicianConnect and CaregiverConnect.  Keep reading>>

Survey: 42 percent of wellness program users interested in an Apple Watch

By: Jonah Comstock | Apr 9, 2015        

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Apple WatchIt’s no surprise that 94 percent of consumers currently enrolled in wellness programs have heard of the Apple Watch, given how much buzz is surrounding the forthcoming wearable. Perhaps more surprising is that less than half are interested in buying one.

HealthMine surveyed 750 consumers enrolled in wellness programs and found that only 42 percent were willing to buy an Apple Watch. Six percent hadn’t heard of the watch, and 52 percent weren’t interested regardless of cost.

Of the 42 percent willing to buy the device, only 12 percent were willing to pay $399 or more for the device (the watch will start at $349 when it launches on April 24th). Five percent were willing to pay $499 or more, and 3 percent were willing to pay $599. But most wanted a lower price point than Apple is offering, with 20 percent willing to buy the device at $199 and an additional 10 percent willing to pay $299. Keep reading>>

Roche gets FDA clearance, brief recall for diabetes management app

By: Jonah Comstock | Apr 9, 2015        

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Roche Accu-Chek ConnectIn March, Roche received FDA clearance for its Accu-Chek Connect companion app, and, less than a month later, issued a recall of that app. App recalls, which are becoming more common as more and more apps receive FDA clearance, are less severe than device recalls because they can often be ameliorated with a quick software patch.

The app, available only on Android at present, helps patients track their blood glucose readings and diabetes symptoms. It received clearance in mid-March. Notably, it includes what Roche says is the first FDA-cleared built-in prescription insulin bolus calculator, called the Bolus Advisor. The app gives people with diabetes a choice of reports to help identify trends and patterns in blood sugar levels and lets them share their data with their caregiver or healthcare team via connected online accounts, email or text message. It receives data from the Accu-Chek Aviva Connect Bluetooth-enabled meter.

“The development of the ACCU-CHEK Connect system underscores Roche Diabetes Care’s commitment to advancing technology that empowers people with diabetes to focus on the daily wins of managing diabetes and living life as normally and actively as possible,” a Roche spokesperson told MobiHealthNews in an email. “Long-term diabetes management success isn’t achieved with one sweeping action, but is realized through a series of small victories that help improve overall patient adherence, clinical outcomes and quality of living.”

During internal testing, Roche discovered that in Germany, South Africa, and Italy, the app was causing inaccurate bolus advice in situations where the phone orientation changed from portrait to landscape during the calculation, prompting Roche to issue a recall. According to the FDA, the application was only downloaded about 600 times in the affected countries before it was patched. Keep reading>>

FDA clears Mayo Clinic spin-off’s decision support software

By: Aditi Pai | Apr 9, 2015        

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Ambient Clinical Analytics AWARERochester, Minnesota-based Mayo Clinic spin-off Ambient Clinical Analytics has received FDA 510(k) clearance for a software-based decision support tool, called AWARE.

AWARE stands for Ambient Warning and Response Evaluation. It’s an interface for EMR data that prioritizes and organizes a patient’s medical information in three ways: by organ, chronologically as a timeline, or as a customized checklist that displays only the next steps relevant to that case.

According to Ambient, the goal of the product is to “clearly and concisely present actionable information to all care team members to improve patient outcomes, reduce the cost of care, and support best-care practices for ICUs and other critical care areas”.

“Being able to combine the massive amounts of EMR data with lab data and monitor data and integrate it all into a concise viewer that sorts and provides the information that’s needed at that time for that patient is novel,” CEO Al Berning told MobiHealthNews told MobiHealthNews when the company raised $1.1 million last year. “Throughout the industry, clinicians have adopted it and published research and done conferences throughout the world and gotten feedback from their peers that there’s nothing out there that does that combination.”

Ambient has developed two other offerings. One, called YES Board, is a patient tracking tool for emergency departments. The system, which has been used at Mayo for about five years, allows all staff members in the emergency department to monitor the location and status of all patients from monitor screens throughout the department. The other, called Synthesis, is a mobile viewer for both AWARE and YES Board, allowing doctors to access the same information from their iPads or iPhones.

Fitbit changes the way it tracks active minutes

By: Aditi Pai | Apr 9, 2015        

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Fitbit Surge smartwatch

Fitbit Surge

Fitbit announced today that it has changed the way it calculates and displays active minutes for users.

The company explained that its activity trackers will only count active minutes if a user participates in an activity for over 10 minutes, which is what the American Heart Association recommends. This will not affect the user’s step count numbers.

“This 10-minute rule means that walking to refill your coffee might get you ahead in a step challenge, but it will no longer count toward your active minutes,” the company explained. “It also means that from now on, your active minutes may sometimes appear lower than what you’re used to.”

But, Fitbit said it would also add moderate minutes to its active minutes count. Previously, Fitbit just counted very active minutes when calculating a user’s overall minutes. The company explained that the addition of moderate activity to the active minute count will impact users’ historical data and will give users more credit for exercises like brisk walks.

While this change doesn’t affect how activity is sensed by the device, it does change the way Fitbit users will view their activity, especially compared to how other activity tracking devices display and make sense of activity data. At the very least, a user that tracks their activity with more than one device or app will likely see a discrepancy between their Fitbit stats and other app and device data. Keep reading>>