How to raise the rise of health care smart devices into a difficult problem

OFweek Medical Technology Network March 31 news, according to foreign media reports, with Apple and other Silicon Valley companies entering the health application market, the US Food and Drug Administration (FDA) responsible for this regulation said it will be in the field of technology industry The innovation is carried out with targeted supervision.

The rise of health care smart devices

Bakul Patel, deputy director of digital health at the Food and Drug Administration, said the agency has been paying close attention to the upcoming Apple Watch and smartphone health applications. “We are taking a very loose regulatory approach and are almost completely let go. If you have only technology that motivates people to stay healthy, we will not supervise it.”

When health care and technology merge, the US Food and Drug Administration is weakening its role. Apple, Samsung and other companies are producing smart devices that collect information on blood pressure, body temperature, blood sugar levels, hydration, oxygen levels and outside air conditions. Software algorithms being developed can use the collected health-related information to provide a diagnosis for potential diseases. Proponents of these products say that ultimately these diagnoses may be more accurate than doctors.

The real question is whether the US Food and Drug Administration and other agencies have sufficient resources and personnel to handle the fast-growing health technology industry. The FDA's annual budget of about $4.5 billion is a quarter of Apple's most recent quarterly profit.

In addition to the US Food and Drug Administration, which will oversee smart devices and applications, other federal agencies will begin to understand whether these products have a life relationship with people and whether they pose a threat to user privacy.

Regulators have already entered the market, and some products that do not comply with the rules have been expelled. In February of this year, the US Federal Trade Commission cleaned up some smartphone apps that claimed to be able to diagnose melanoma based on uploaded images. At the same time, the US Office of Civil Rights and Human Services is responsible for overseeing the privacy of electronic devices and ensuring the safety of collecting patient health data.

Patel said Apple, Google and other related companies should carefully screen applications to ensure that health app developers don't overstate the benefits of their products.

Another key part of Patel's work is to improve his relationship with Silicon Valley, because the technology industry generally believes that the US Food and Drug Administration is too rude and hinders innovation. The most frequently cited example is the US Food and Drug Administration's investigation of the genetic testing company 23andMe. The company simply analyzes the health risks they may face based on their DNA profiles.

The US Food and Drug Administration has issued a number of guidelines explaining the reasons for the regulation of wearable devices and smartphone applications. The US Food and Drug Administration's focus is on devices and software that attempt to mimic the functionality of medical devices , not simply heart rate measurement or blood glucose tracking. Patel said that such a product would endanger public health if it fails. “We only focus on high-end technology, which is both good and risky for public health, and we are always trying to balance them.”

Despite this, Bob Cork, the US National Economic Council's special assistant, president of health care and economic policy, said that the startups he saw were unanimously using FDA's regulation as one of the main risks of the business. Patel has recognized these issues. But the meeting with Silicon Valley seems to be speaking on both sides. To help alleviate this problem, he said the agency is looking for experts to help improve relationships with technology companies.

The US Food and Drug Administration issued guidelines for regulating mobile applications in February, in which health-related products such as fitness tracking are largely exempt from censorship, and technologies for diagnosing, treating, and preventing disease are strictly regulated. This depends a lot on how the app is sold. If a company is promoting products to help doctors diagnose, this requires more supervision. In January of this year, the US Food and Drug Administration approved the first blood glucose monitoring iPhone app.

The US Food and Drug Administration will continue to pay close attention to emerging technologies that diagnose disease or provide advice for treatment. Apple CEO Tim Cook said this month that the Apple Watch and HealthKit systems may help diagnose diseases and cancer in the coming decades.

Patel believes that as more and more health-related products enter the consumer's attention, the regulatory duties of the US Food and Drug Administration will become increasingly important. “The regulation of the US Food and Drug Administration will provide confidence for patients and consumers to use these products.”

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