Or is it? Bones was a licensed medical professional. He knew what to do with that information. With the advent of Google Fit and Apple Healthkit, we will have access to not just our steps taken and our heart rate, but possibly our blood sugar, our blood cholesterol, and our blood pressure.
FDA regulations are such that if a device is used for diagnosis or treatment of a medical condition, it is deemed a medical device and is subject to FDA approval. Approval process of a medical device is a lengthy and expensive one, similar to that for pharmaceutical medicines. An example of this type of device would be iBGSTAR, a small glucose meter that attaches to a smartphone and software that reads glucose. A company I worked for was involved in the production and approval of this product as a medical device. Apple approached the FDA and wanted guidance for how their software was going to be perceived by the FDA. The response they got from the FDA was that their product differed from iBGSTAR because it was expected to be used by “healthy” people, not diabetics. Therefore it would not be a medical device.
“The current mobile medical app guidance indicates that FDA does not view apps that are purely educational or informational as medical devices. Apps that actively measure something are considered diagnostic. For instance, a glucometer would be considered diagnostic because it measures blood sugar; it would not be considered merely information although it “informs” the user of the blood sugar level.
The display screen of the glucometer would not be regulated, as it only receives the data and shows it. The software that does the measuring is the part that is regulated. FDA will regulated based on the intended use of a device.
Using the glucometer example, the glucometer may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition.
If the glucometer is marketed for diabetics, however, it would more likely be regulated as a medical device. FDA looks at how devices are actually used”
http://9to5mac.com/2014/06/09/fda-details-high-level-meeting-with-apple-moral-obligation-to-do-more-with-health-innovative-sensors/
But herein lies the rub in the reasoning of the two parties:
Based on data from the CDC, a large number of people are in for quite a shock.
- Nearly 30 million people in the US have diabetes (10% of the population) and of those, 8.1 million do not know it (based on values of almost 30% from the NHANES study)
- 68 million adults have high blood pressure (1 in 3), but 45 million are untreated and almost 14 million are unaware they have high blood pressure
- 71 million people in the US have high LDL (bad) cholesterol, meaning (1 in 3) Americans, yet less than half get treatment, and because high cholesterol has no symptoms, many people do not know they have high cholesterol until that first heart attack.
Then what happens?
According to regulation and law, as non-medical devices, Apple Healthkit and Google Fit are not allowed to diagnose and treat.
The consumer is left in a gray zone. They are given potentially life-saving information without any support. A diabetic has different blood pressure targets than a person with normal glucose. Will the devices be legally able to adjust for that? They are at risk for neuropathy and amputation and diabetic ketoacidosis. Does the device monitor for those things as well?
I have not seen this scenario addressed at all in any of the briefings on these devices and I am very interested to know how these manufacturers intended to resolve these questions. There is a great potential here for early intervention, increased adherence, and education. But the lines for diagnosis and treatment by licensed medical professionals need to be maintained. I see more discussion with the FDA needed as technology and healthcare forges where no app has gone before.
http://www.opptrends.com/2014/06/google-inc-goog-might-enter-health-data-space-with-google-fit/
http://www.forbes.com/sites/parmyolson/2014/06/12/exclusive-google-to-launch-health-service-google-fit-at-developers-conference/
http://www.wired.com/2014/03/apple-healthbook-is-just-the-beginning/
http://www.cdc.gov/cdcgrandrounds/pdf/gr_mh_all_final_feb28.pdf
http://www.cdc.gov/nchs/data/databriefs/db107.pdf
http://www.diabetesmine.com/2011/12/newsflash-fda-approves-the-ibgstar-meter-for-iphoneipod-touch.html
http://9to5mac.com/2014/06/09/fda-details-high-level-meeting-with-apple-moral-obligation-to-do-more-with-health-innovative-sensors/
Photo attribution
http://commons.wikimedia.org/wiki/File:DeForest_Kelley,_Dr._McCoy,_Star_Trek.jpg#mediaviewer/File:DeForest_Kelley,_Dr._McCoy,_Star_Trek.jpg