So you have a great idea for an app. Not so fast: it took two years and over half a million dollars to get ours cleared for marketing by the US Food and Drug Administration (FDA).
Our app, DANA uses a mobile phone to records peoples’ reaction time during game-like tests. It also provides questionnaires that help clinicians evaluate brain health. Commissioned from AnthroTronix by the Department of Defense, the app will help diagnose concussion, depression and Post-Traumatic Stress Disorder (PTSD).
For something so important, a serious investment of time and money for clearance may not sound extravagant, but few small companies can afford a two-year go-to-market delay, not to mention the significant investment and heartache that goes with it. And although the FDA has tried to facilitate regulation by providing guides like the Mobile Medical Applications Guidance Document and the Mobile Medical Applications website, the regulatory process remains confusing.
Here are five simple lessons from our own experience that will help other entrepreneurs to do the right thing and engage with the FDA:Continue reading…
As government involvement in U.S. health care deepens—through the Affordable Care Act, Meaningful Use, and the continued revisions and expansions of Medicaid and Medicare—the politically electric watchword is “socialism.”
Online, of course, social media is not a latent communist threat, but rather the most popular destination for internet users around the world.
People, whether out of fear for being left behind, or simply tickled by the ease with which they can publicize their lives, have been sharing every element of their public (and very often, their private) lives with ever-increasing zeal. Pictures, videos, by-the-minute commentary and updates, idle musings, blogs—the means by which people broadcast themselves are as numerous and diverse as sites on the web itself.
Even as the public decries government spying programs and panics at the news of the latest massive data-breach, the daily traffic to sites like Facebook and Twitter—especially through mobile devices—not only stays high, but continues to grow. These sites are designed around users volunteering personal information, from work and education information, to preferences in music, movies, politics, and even romantic partners.
So why not health data?
The hype around wearables is deafening. I say this from the perspective of someone who saw their application in chronic illness management 15 years ago. Of course, at that time, it was less about wearables and more about sensors in the home, but the concept was the same.
Over the years, we’ve seen growing signs that wearables were going to be all the rage. In 2005, we adopted the moniker ‘Connected Health’ and the slogan, “Bring health care into the day-to-day lives of our patients,” shortly thereafter. About 18 months ago, we launched Wellocracy, in an effort to educate consumers about the power of self-tracking as a tool for health improvement. All of this attention to wearables warms my heart. In fact, Fitbit (the Kleenex of the industry) is rumored to be going public in the near future.
So when the headline, “Here’s Proof that Pricey Fitness Wearables Really Aren’t Worth It,” came through on the Huffington Post this week, I had to click through and see what was going on. Low and behold this catchy headline was referring to a study by some friends (and very esteemed colleagues) from the University of Pennsylvania, Mitesh Patel and Kevin Volpp.
That’s right…it really happened.
At the conclusion of a recent doctor visit, he gave me his cell phone number saying, “Call me anytime if you need anything or have questions.”
In disbelief, I wondered if this was a generational thing – and whether physicians in their late thirties had now ‘gone digital’.
My only other data point was our family pediatrician, who is also in her late thirties. Our experience with her dates back nearly seven years when my wife and I were expecting twins. A few pediatricians we met with mentioned their willingness to correspond with patients’ families via email as a convenience to parents. The pediatrician we ultimately selected wasn’t connected with patients outside of the office at that time, but now will exchange emails.
I’ve always been a little skeptical of the push to get doctors to prescribe apps.
To begin with, it would be awfully easy for us to replicate the many problems of medication prescribing. Chief among these is the tendency for doctors to prescribe what’s been marketed to them, rather than what’s actually a good option for the patient, given his or her overall medical situation, preferences, and values.
Then there are the added complexities peculiar to the world of apps, and of using apps.
A medication, once a pharmaceutical company has labored to bring it to market, basically stays the same over time. But an app is an ever-morphing entity, usually updating and changing several times a year. (Unless it stops updating. That’s potentially worse.)
Meanwhile, the mobile devices with which we use apps are *also* constantly evolving, and we’re all basically forced to replace our devices with regularity.