Apps for phones, such as the iPhone have already forrayed into the medical arena. With the 3.0 software, even more medical applications will be available. In fact, some predict that the iPhone will be a medical device. As part of its
software presentation, Apple showed how manufacturers might use the iPhone's external-accessories application to do things such as hook up a blood-pressure cuff to the iPhone and take someone's pressure.
LifeScan recently introduced a
prototype for an application that would allow diabetics to interface their glucometers with the iPhone.
In his news
story, Rich Thomasell, discusses the regulatory hurdles that could be met with smart phone acting as a medical device. He says, "a consumer could hook up a blood-pressure cuff and take a reading for his own knowledge, and Apple would be OK. But if the consumer then took the next logical step and passed the results on to a health-care professional, the iPhone could be considered a medical device."
Intended use and labeling is uncharted for these consumer devices. Whether smart phones are going to be considered medical devices or not, they do have the potential to provide opportunites for medical branding. A medical sponsored app that helps patients could be key. For example, I would love to be able to download an app that tracks migraines and helps identify possible triggers.
Heather Thompson
Hi Heather, Thanks for the
Hi Heather,
Thanks for the great post! We are actually working on a migraine-tracking iPhone app. People are already tracking their migraines and triggers on our website, CureTogether (migraine is our second biggest condition community), so an iPhone app is a natural extension of this.
What kind of things would you want to see in the migraine-tracking iPhone app? Incidents of migraine, pain level, time of day, suspected triggers/foods recently eaten, treatment taken....?
Thanks Heather, have a wonderful day,
Alexandra Carmichael
Co-Founder, http://www.curetogether.com/migraine/
I earlier commented that
I earlier commented that digitized x-ray results "could be" put into a folder for storage on a mobile phone. Well - they "can be" stored AND I did since my comment last week.
Radiology departments typically will put x-rays on a CD for patients who request it. So I took images from my last CT on a CD and exported this to a folder on my Blackberry phone. I could have exported the entire CT series as it was only about 500k. Instead, I exported the key comparitive images should I ever need to visit an ER out of my area. The next step would be lab results which I think I can get in a PDF file. Next after this, I could request copies of medical records from my physicians, scan these into PDF files, and export to my phone.
Regretably, the Blackberry does not come with a good PDF reader. You have buy one from its App World. I have found some of their apps to create issues with my phone. As an expert on cognitive and assistive apps and user instructions, I like much of what mobile phones are able to do today. But their main area needing improvement is in user instructions. Too much of how smart phones operate has not been widely shared, and mostly for tech and corporate users. It needs to be mainstreamed.
Today, we are very very close to seeing medical records and disease apps available on mobile phones. The only thing stopping us now is "will."
Stephen Dolle
"Stuff for your Brain"
ProfessorMac.net
Heather: Funny you ask about
Heather:
Funny you ask about a mobile phone app to follow markers and triggers in migraine. I pioneered a similar test as a stand alone device in 1997, termed the DiaCeph Test. But it was specifically for the disorder hydrocephalus. A few years ago, I spoke to Glaxo Smith Kline about what they had then as a diary for migraine and proposed it in software. In their latest migraine clinical trial, they give study participants a stand alone PDA to follow markers and triggers. Still, no stand alone apps for a phone.
As to FDA regulating phones as devices, I got into an argument with them in Jan 2009 at the Anaheim MD&M show. I mean I've got a brain shunt myself, and all I've seen is politics as far as progress. So I was really mad. It would seem that diaries and such would be exempt from regulations. But when a program is able to make a different diagnosis of subjective information that YOU input, then FDA says it is rendering a diagnosis. As to sending it to a physician electronically, I would argue that it is the "portal method" of a mobile carrier that may need a 510k. There has been remote monitoring for 5 plus years, but I'm unfamiliar with which specific frequencies and such. It would seem once a network and mobile device was approved, successive phones could come under same filing.
Since Obama has been in office, he has spoken repeatedly as to utilizing personal health software. The irony is that 3 yr old kids have maes with advanced software for all kinds of apps. Adults have golf, fitness, and financial apps. Yet the most important thing in our life, our HEALTH, has no apps. It's almost as though there's a conspiracy to control medicine, like OPEC does with oil. I believe in the free manrkets. I say open up health care to the consumer. Let US decide. Each time I get a CT or MRI, I ask for a copy on CD. But such exams could easily be put into a folder on my mobile phone.
Stephen Dolle
"stuff for your Brain"
ProfessorMac.net