September 20th, 2011 by Felasfa Wodajo, M.D. in News
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The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
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Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
*This blog post was originally published at iMedicalApps*
March 17th, 2011 by Felasfa Wodajo, M.D. in News
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The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play. Clearly, some apps do play a role in guiding physicians in making diagnoses or making treatment decisions. Others simply provide information that would otherwise be available in textbooks or online.
What the FDA will consider a medical device or not has been an important topic, with many clues that it will consider its provenance broadly, as we have reported previously. As of now, only a few medical apps have been granted FDA approval, including AirStrip and MobileMIM.
According to the medical device consulting firm Emergo, the FDA said conclusively that they will be starting regulatory review of medical apps starting in 2011 at the recent FDA townhall meeting on March 10: Read more »
*This blog post was originally published at iMedicalApps*
February 27th, 2011 by Bryan Vartabedian, M.D. in Better Health Network, Opinion
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This is something. Jay Parkinson on the Future Well blog has suggested that health apps are overrated. Then on Twitter came a remark that the post represented “fightin’ words.” While I think the tweet was in jest, I’m sure there are some who will take offense to the less-than-flattering remarks about our coveted health apps.
We love the concept of health apps for what they represent more than for what they really offer us. We want to feel that we’ve got it all in the palm of our hand. After all, technology might do for us what we won’t do for ourselves.
Like Jay I’m underwhelmed, but I don’t think that’ll always be the case. The post’s criticism should start a conversation about what’s real in mobile health and what isn’t. Even the fantasy of Health 2.0 has been questioned, and that’s a good thing. This dialog about reality versus rainbows and unicorns needs to continue.
Youngme Moon in Different: Escaping the Competitive Herd wrote, “The way to keep criticism from devolving into cynicism is to make it a starting point rather than a punctuation mark.” Jay Parkinson’s post is a starting point.
*This blog post was originally published at 33 Charts*
February 22nd, 2011 by Felasfa Wodajo, M.D. in News, Research
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The word cancer comes from the greek word for crab “karkinos,” so named by Hippocrates who visualized the tumor and its surrounding vessels looking like a crab, dug stubbornly into the sand with its legs. We know far more about cancer today than the ancient Greeks, but the vision of an entrenched opponent, almost impossible to extract whole, appears to be vividly prescient.
What we have realized over the last half century is that removal of the visible tumor is not enough. Even as we learned how to do bigger and more destructive surgeries, the cancer still managed to sneak back in, growing later at different locations. The crab’s legs are still embedded in the patient.
Thus the discovery that certain chemicals could extinguish these rogue cells opened the modern era of cancer therapy and led to the first “cures” from cancer. Many of these compounds were exquisitely toxic. Early experimenters even used nitrogen mustard, quite literally a poison, as Siddhartha Mukherjee tells in his excellent history of cancer, “The Emperor of All Maladies.”
To many, the battle looked grim. For the founder of CollabRx, who himself was living in the shadow of advanced melanoma, this was the signal to take his expertise in internet information technologies and apply it to cancer. Thus a “biomedical software company” was founded, with the mission:
…to save lives by using information technology to personalize cancer treatments and accelerate research.
The rapid proliferation of knowledge about the molecular underpinnings of different cancers, has brought hope for a new age of “targeted” therapies. These drugs are designed to find and destroy cells with aberrant biochemical pathways, while bypassing the normal body tissues. Immense hopes rest on them. Read more »
*This blog post was originally published at iMedicalApps*
December 30th, 2010 by Iltifat Husain, M.D. in Better Health Network, News, Research
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Imagine walking into the room of a patient with ascites and pulling out your iPad (which you were just using to put in orders on another patient), pulling an ultrasound probe out of your pocket, connecting the two, and finding a fluid pocket from which to drain the abdominal fluid.
We’ve already shown how iPad’s can be useful in the OR. Now they, along with other tablets and smartphones, can be applied to bedside diagnostics and therapeutics to enhance patient safety while reducing costs. It’s a pretty exciting prospect being put forth by an mHealth startup called Mobisante. And having won awards at an MIT Enterprise Forum as well as the Mobile Health Expo, others certainly seem to buying in as well.
Mobisante, an mHealth company based in Redmond, WA, has recently been showing a new smartphone peripheral at conferences across the country: An ultrasound probe. According to the MIT Technology Review, the current prototype connects to a Toshiba TG01 smartphone and was originally developed as a laptop peripheral by David Zar, a computer engineer at Washington University in St. Louis. Read more »
*This blog post was originally published at iMedicalApps*
The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
