As the Apple Inc. and related companies Silicon Valley advance to the territory of medical care, the body responsible for supervising this field in the US said that will give freedom for the technology industry develop new products without excessively strict regulations.
Bakul Patel, who runs the new wave of health products for the consumer in the Food and Drug Administration (FDA), said most of the equipment to wear, such as Apple Watch, which will be launched soon, and smartphones for applications with focus on health, have some wiggle room before undergoing a thorough examination of the government agency.
“We are taking a very light approach, almost without interfering,” said Patel, digital health deputy director of the FDA, in an interview. “If there is a technology that can motivate people to be healthy, do not want to get involved.”
The FDA is defining its role in a time when health care and technology targeted to the consumer are blending.
Apple, Samsung Electronics Co. and other companies are creating products equipped with sensors that have the potential to collect any information on blood pressure, body temperature, glucose levels, hydration, oxygen levels and conditions outside air.
Software algorithms are being developed to collect separate information on the health of a person in order to offer a diagnosis of possible diseases that, according to its supporters, could end up being more accurate than that of a doctor.
Resources and guidelines
An urgent question is whether the FDA and other agencies have the resources and personnel needed to supervise this sector advancing by leaps and bounds, said Malay Gandhi, managing director of Rock Health, a venture capital firm focused on health and headquartered in San Francisco.
The annual FDA budget is about $ 4.5 billion, a quarter of the $ 18 billion in profits generated by Apple in its most recent quarter.
Patel said that Apple, Google Inc. and other corporations should have a role in reviewing applications to ensure that software developers are not exaggerating the benefits of their products. Both companies visited the headquarters of the FDA in Maryland to discuss their initiatives in health, he said.
The agency issued several guidelines to explain when you want to examine more closely the device wear and smartphone apps.
The FDA concerns focus on accessories and software that attempt to reproduce the functions of a medical device – not the features that simply monitor the steps or heart rate, Patel said. A key issue is how a person could be injured if the product fails.
FDA guidelines on the regulation of mobile applications, published in February, leaving the physical activity monitoring applications and other products for the well-being virtually out of control, while the technology used for diagnosis, treatment and prevention will be examined more closely.
A lot depends on how the device is marketed, Patel said. If a company promotes a product that helps doctors to make medical decisions, this will require greater supervision, he said. In January, the FDA first approved an iPhone application that monitors the glucose level.
trust
The FDA closely observe the new technologies that claim to diagnose diseases or recommend treatments, Patel said. The Apple CEO Tim Cook said on CNBC this month that devices and services such as Apple Watch and the HealthKit system your company may be able to help identify some diseases and cancers in the next decades.
“We need to have confidence in what we get,” said Patel. “The path was traced and all signs point in that direction, but, likewise, research and science need to give us that confidence. It comes down to if it will work or not. “
Patel said that as more products related to health into the hands of consumers, FDA oversight responsibilities will become increasingly critical.
“The FDA has a role to play to provide patients and consumers a level of trust where they can use (these products),” he said.
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