Can wear medical equipment large data can only be used as a reference?

Netizen "Chen Shiming":

Since last year, smart http://www.aliyun.com/zixun/aggregation/36222.html "> Medical devices have developed rapidly, and many projects are said to have been invested, but smart medical devices have monitored data that hospitals and doctors do not recognize, Intelligent medical equipment If you really want to enter the people's family, must be accepted by the traditional medical system, may I ask guests, how long do you think the implementation of this process will take? When will intelligent medical devices really explode?

Special answer Guest, Inspiration VC managing Director Xue:

First of all, this problem appears very normal, nothing abnormal. In the past, the health care sector has been tightly regulated by the government, which is the same in the world, which is the same, the more developed countries, the more stringent, in fact, China is the least stringent countries.

In a way, China's bureaucracy is much better than America's. Because medical care is strictly regulated industry, there are strict norms, any medical equipment, a detection means must pass the country's testing and approval process.

In the past some time, wearable smart devices such as products and services generated by the Internet thinking, in a sense is not medical equipment, nor health services, but the common people do not understand this matter, if the hospital to the doctor to see, the doctor categorically can not use this thing to the doctor, absolutely not.

Therefore, it can be said that the problem is not a problem, it can be said to be a problem, in order to solve this problem, these products and services to the company to find out whether you are providing medical services or the general Internet-quality services.

I'm going to cite a real case where a company in Silicon Valley, a semiconductor sensor company, can put chips in a cell phone. There are two contacts in the back of the phone, and the user can measure the electrocardiogram by putting his finger on it. Domestic manufacturers have launched a similar mobile phone, can test the electrocardiogram, but this electrocardiogram can not be taken to the doctor, no one doctor dare to take this electrocardiogram as a diagnostic basis, as entertainment or to their daily reminders is of reference value.

How about wearing smart medical devices compared to hospital equipment? Some of the propaganda said that compared with the hospital equipment is 90% accuracy rate, I consulted the school of medical science teachers, he said the measured data up to 50%, and this 50% has been a great achievement.

If the accuracy rate reaches 90%, can it be considered to be used as a medical device? Professionals have told us that it is still not possible to define wearable medical equipment as a medical device, and if it is defined as a medical instrument, the FDA must apply for approval. So, now only with consumers that this is for you to play, refer to the line, really sick, but also to find a doctor to see.

Professionals say that it is meaningless to wear a specific value for a point in the medical device, and that it is meaningful to have long-term monitoring.

Another example, after shooting, you will find that you did not hit the bull's-eye, but the shooting point is in the seven ring that place, indicating that you hit the very accurate, may be the gun itself is not calibrated.

Therefore, the market now provides wearable medical equipment can be said to be accurate, but standing in the medical perspective is "biased." The industry has potential in the future, perhaps three or five years from now to solve the problem of genuine integration into the health care system, including the FDA may change their policies.