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FDA Takes an Almost Hands-off-Approach to Apple Watch Health Related Applications


It's being reported today that With Apple and fellow Silicon Valley companies edging further into health care, the U.S. agency in charge of oversight says it will give the technology industry leeway to develop new products without aggressive regulation.


Bakul Patel, who oversees the new wave of consumer-focused health products at the Food and Drug Administration, said most wearable gadgets such as the soon-to-be-released Apple Watch and health-focused applications for smartphones have a way to go before warranting close scrutiny from the agency, reports Bloomberg.


"We are taking a very light touch, an almost hands-off approach," Patel, the FDA's associate director for digital health, said in an interview. "If you have technology that's going to motivate a person to stay healthy, that's not something we want to be engaged in."


The FDA is mapping out its role at a time when health care and consumer technology are blending. Apple, Samsung Electronics Co. and other companies are building products loaded with sensors that have the potential to eventually gather all sorts of information about blood pressure, body temperature, glucose levels, hydration, oxygen levels and outside air conditions. Software algorithms are being developed that gather different information about a person's health to provide a diagnosis of potential illness that backers say may eventually be more accurate than a doctor.


"The FDA sits at one of the most, if not the most, critical junctures in terms of modulating the burgeoning category of digital medicine," said Malay Gandhi, managing director of Rock Health, a health-focused venture capital firm in San Francisco.


The agency has issued several guidelines explaining when it intends to take a closer look at wearable devices and smartphone applications. We covered this back in a January report titled "The FDA Publishes a Draft Covering Policy for Low Risk Devices."


The FDA's concerns are focused on gadgets and software that try to mimic the function of a medical device — not features that simply track steps or heart rate, Patel said. A guiding question is what harm might be done to a person if a product fails.


"We are focusing only on the higher end of technology," Patel said. "What are benefits to public health against the risks to public health? We always try to balance that."


In a follow-up report in February titled "Apple Drops Some Apple Watch Health Sensors ahead of Launch," we noted that the Wall Street Journal reported that Apple "likely would have needed" regulatory approval if it were to interpret data that came from blood pressure and blood oxygen sensors to give health advice." That's the balance that the FDA is trying to maintain. For more on this story, you could read Bloomberg's report by Adam Satariano here.


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