Yahoo Finance:
When AAPL released the Apple Watch, it included a heart rate sensor. It has proven extremely accurate in testing, recently coming within 2% of the numbers reported by an electrocardiograph (EKG). However, AAPL has never marketed it as a medical device, because doing so would mean FDA certification.
Once under FDA regulation, the company would have to get each Apple Watch certified, in a process that could require months. Having to go through FDA certification would also reveal AAPL’s products before release — something the secretive company would hate — and could delay rolling out software updates.
But:
The FDA just announced its new Digital Health Innovation Plan, and it could change everything.
Noting that digital technologies used in consumer devices “have the power to transform health care,” the agency is trying to streamline the process needed for FDA approval. With a fall target for the pilot program, the FDA says it’s considering creation of a:
“Third party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review.”
The implications for AAPL and the Apple Watch are huge.
Risky path, privacy implications abound. But a perfect path for Apple.
Cue the anti-Trumpers! This is most likely more “Trump Effect”!
One fine day, y’all will realize this, and some will relent, some will further implode.
Proper testing by FDA is very important. We probably need more funding for FDA to speed up approval. But since something like the Apple Watch is really hardware + software when it comes to medical stuff, another approach is necessary. Perhaps the FDA should be approving hardware+software combinations rather than hardware alone if the hardware, as shipped, is not used for medical purposes.
I am concerned that streamlining might mean “we don’t test it properly.” And that usually results in bad decisions. There is a huge problem in medicine where many results of drug tests are never published and the hiding of these studies results in approval of drugs that should never have been approved.
Thanks to decades of budget cuts and industry-approved appointments, federal agencies like the FDA and the EPA are crippled shadows of their former selves. All are still vitally needed.
It wasn’t Trump who crippled the FDA, but it will probably be Pence/Ryan/McConnell who end up killing it.
you can’t claim everything is Trump. otherwise you have to give credit to Obama for all the improvements to the economy, unemployment, stock market, gas prices, etc, under his 8 years. Which you won’t.
Agreed! As someone who’s depends on accurate (and timely) medical information to make life/death treatment decisions I’d rather decision were made in favor of the patient over one company’s desire for secrecy.