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Apple Watch leads health, technology boom that has FDA attention

March 30, 2015 8:48 PM
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HEALTHY LIVING: Apple CEO Tim Cook says devices and services such as Apple Watch may be able to help pinpoint some diseases and cancers in the next several decades.

With Apple and fellow Silicon Valley companies edging further into health care, the United States 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.

"We are taking a very light touch, an almost hands-off approach," Patel, the FDA's associate director for digital health, said.

"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, 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.

A pressing question is whether the FDA and other agencies have the resources and staff to handle oversight of the fast-moving industry, Gandhi said.

The FDA's annual budget of about $4.5 billion is a quarter of the $18 billion Apple generated in profit in its most recent quarter.

"We are taking a very light touch, an almost hands-off approach," Patel, the FDA's associate director for digital health, said.

"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, 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.

A pressing question is whether the FDA and other agencies have the resources and staff to handle oversight of the fast-moving industry, Gandhi said.

While the FDA oversees devices and applications, other federal agencies also have taken an interest in how these products interact with people's lives, including whether they do what they're purported to do or pose a risk to privacy.

Some products raised flags with regulators after they've reached the market. In February, the Federal Trade Commission cracked down on some smartphone apps for dubiously claiming to diagnose melanoma based on an uploaded picture.

Meanwhile, the US. Health and Human Services Office of Civil Rights is responsible for oversight of the security of patient-health data collected by electronic devices, a separate issue that is being closely watched by privacy advocates.

"I worry that there are going to be companies that are skirting the rules," Gandhi said. "We have to see the enforcement, otherwise it creates a very uneven playing field between companies that are acting ethically and those that aren't."

Patel said Apple and Google Inc. and other corporations should play a role in screening applications to be sure health-software developers aren't over-promising the benefits of their products. Both companies have visited FDA headquarters in Maryland to discuss their health initiatives, he said.

Representatives for Cupertino, California-based Apple and Mountain View, California-based Google declined to comment.

Derek Newell, chief executive officer of health-care startup Jiff Inc., who previously ran a medical-devices company said "the FDA isn't built to handle new categories" such as wearable devices, smartphone applications and other emerging technologies.

The agency plays a vital role, but it can take time to catch up, he said.

Several guidelines explaining when it intends to take a closer look at wearable devices and smartphone applications have been issued by the agency.

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.

"What are benefits to public health against the risks to public health? We always try to balance that," Patel said.

The FDA's guidelines on regulating mobile applications, released in February, leave fitness-tracking and other wellness- related products largely free from scrutiny, while technology used for diagnosis, treatment and prevention will get a closer look.

A lot depends on how the device is marketed, Patel said. If a company is promoting a product to assist doctors in making medical decisions, it will require more oversight, he said.

In January, the FDA approved a glucose-monitoring iPhone app for the first time.

The FDA will keep a close eye on emerging technologies that aim to diagnose illnesses or offer recommendations for treatment, Patel said.

Apple CEO Tim Cook said on CNBC this month that devices and services such as Apple Watch and the company's HealthKit system may be able to help pinpoint some diseases and cancers in the next several decades.

Patel said that as more health-related products get into to the hands of consumers, the FDA's oversight responsibilities will become increasingly critical.

"The FDA has a role to play for providing patients and consumers a level of confidence that they can use it," he said.

Source: stuff.co.nz

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