Posting in Government
What type of FDA regulation should mHealth devices go through? Should it be the same faced by the makers of thermometers, or the same regime we expect pace makers to go through?
You are probably hearing a lot about mHealth these days.
It's short for mobile health.
At it's simplest it's using existing mobile phone links to get data to doctors from remote clinics.
At its most complex it's tiny devices that measure important health metrics -- blood sugar, blood pressure, even glaucoma -- deliver the data via a wireless link to some analysis software, then sound an alert where necessary. (The illustration is the logo of the UN's mHealth Alliance.)
I started writing about this in 2003. The idea has lately gained enormous traction, now that nearly everyone has a mobile phone, WiFi has become ubiquitous, and single-chip sensors have become cheap as, well chips.
The problem, he notes in a blog post, is that the solutions haven't gone through the (very expensive) regulatory hoops medical devices and products are expected to go through.
mHealth is not a stand-alone market. It is part of a mature, two trillion dollar healthcare business. To be successful, mHealth devices and services have to understand how the healthcare market operates; how it is funded and regulated; and, most important, how buying decisions are made. Developing a way to use a mobile device to measure blood glucose and send the data to another location may be interesting but is not nearly enough.
Right now the industry is relying on consumers to pick up the tab, he writes. Consumers only pay 12% of health care costs. The rest is paid for through insurance and government. Before solutions go through those channels they have to jump through a lot of hoops, says Linkous.
Which makes this a very parlous moment. Jumping through regulatory hoops costs big money, resulting in big price tags on whatever comes out the other side.
To take one example. Integrating any data with the nation's health care system means following HIPAA rules on privacy and security of that data. That may mean taking the data stream out of, say, WiFi or the general cellular market, giving clients their own dedicated frequency.
What type of FDA regulation should such devices go through? Should it be the same faced by the makers of thermometers, which is pretty simple, or (since it may connect to a doctor in a hospital) the same regime we expect pace makers to go through?
The Administration seems to be on top of these problems. Major federal regulators have said they will expedite things, together, But that promise is only good for this Administration, and it may not hold before the plaintiff's bar, especially after some bad kit comes out from (say) China.
Linkous fears that, even in this Administration, any success for mHealth will be closely followed by tighter regulation in the name of patient safety. The Obama Administration has been kind, he notes, but kindness lasts only until the first scandal.
These are good fears to have out there. But it's also important to note that mHealth devices don't really do anything that hasn't been done before. Integrated circuits, whether in monitors or phones, are more reliable than earlier technology. (When was the last time you needed your TV repaired?)
The promise of mHealth is that guys like me, whose hearts tend to break, can get help before we break down completely, and so can those with other chronic conditions. No new medical ground is being broken. The wheel is not being reinvented.
Something worth remembering as courts and regulators approach the mHealth revolution. We shouldn't let our desire for complexity overcome the savings inherent in mHealth's cheap solutions.
Jul 30, 2010