作者： admin

　　Without the consent of the guardian, no "medical beauty" service shall be provided to minors; Network products and services should have "anti-addiction" function; Schools should prevent and control school bullying … … The 45th meeting of the Standing Committee of the 15th Municipal People’s Congress held this morning conducted the first trial of the Regulations of Beijing Municipality on the Protection of Minors (Revised Draft). The reporter noted that the relevant provisions of the revised draft responded to hot issues such as school bullying, Internet addiction and minors’ "medical beauty", which are highly concerned by the society.

　　Encourage schools to open sports facilities to non-school minors free of charge or at preferential prices in winter and summer vacations.

　　In order to make children develop in a balanced way, the revised draft proposes that schools should implement the national and municipal regulations on reducing the excessive study burden of underage students, cooperate with guardians of underage students, reasonably arrange students’ study time, and ensure their time for rest, entertainment, physical exercise and social practice. Moreover, schools should also carry out education and teaching activities according to the education and teaching content and curriculum set by the education department of the State Council, and should not increase the teaching content without authorization. If it is really necessary to incorporate all kinds of thematic education and publicity activities for underage students into the teaching content, they should comply with the provisions of relevant laws and regulations and adapt to the students’ age, physical and mental development stage and cognitive characteristics.

　　In order to avoid or reduce the psychological problems of minors, the school will prescribe "psychological prescriptions" for students. The revised draft proposes that schools should be equipped with full-time or part-time mental health education teachers in accordance with regulations to carry out mental health education. Conditional schools can set up psychological counseling rooms to provide daily psychological counseling and consultation for underage students; We can also cooperate with professional mental health institutions and social work institutions to establish a screening and early intervention mechanism for students’ mental health problems to prevent and solve students’ psychological and behavioral abnormalities.

　　The revised draft also proposes that schools should improve the management system to ensure that underage students use the school’s sports venues and facilities to carry out physical exercise during recess and after class; School sports facilities shall be open to students of our school free of charge or at preferential rates on national statutory holidays, rest days and cold and summer holidays. In addition, the District People’s Government should take measures to encourage and support qualified schools to open the school sports facilities to non-school minors free of charge or with preferential treatment on national statutory holidays, rest days and summer and winter holidays.

　　Do not provide tattoo services to minors.

　　"Without the consent of the guardian of the minor, medical beauty services shall not be provided to the minor." The revised draft puts forward new requirements for minors to "medical beauty". Offenders will be ordered to correct by the health department, given a warning, and fined between 10,000 yuan and 50,000 yuan; Refuses to correct or causes serious consequences, the directly responsible person in charge and other directly responsible personnel shall be given or ordered to be given the punishment of demotion or dismissal, and the relevant medical personnel may be ordered to suspend their practice activities for more than one month and less than six months.

　　Tattoo service is not allowed for minors. The revised draft proposes that offenders will be ordered by the market supervision and management department to make corrections, given a warning, confiscated illegal income, and fined between 10,000 yuan and 50,000 yuan; Refuses to correct or cause serious consequences, shall be ordered to suspend business for rectification, and may be fined not less than 50,000 yuan but not more than 500,000 yuan.

　　Script killing and escape from the secret room shall not be open to minors on "school day"

　　In recent years, script killing and escape from the secret room, which are popular among young people, also put forward corresponding restrictions on minors. The revised draft proposes that the script used in the script entertainment business premises should be provided with age-appropriate tips, indicating the age-appropriate range; If the set scene is not suitable for minors, minors shall not be allowed to enter; Except for national statutory holidays, rest days and summer and winter holidays, no scripted entertainment activities may be provided to minors.

　　In addition, except for national statutory holidays, entertainment venues are not allowed to provide electronic game equipment to minors. Selling electronic cigarettes, lottery tickets or paying lottery prizes to minors is also not allowed.

　　Network products and services should have the function of "anti-addiction"

　　In order to make minors’ safety and health "touch the net", the revised draft proposes that network products and service providers should establish a complaint and report system, disclose the ways of complaint and report to the public, and accept and handle complaints and reports involving minors in a timely manner. At the same time, we should also establish an audit system for the production and dissemination of network information, and take necessary measures if it is found that there are illegal and criminal acts against minors that may affect or endanger their physical and mental health or use the network.

　　"Anti-addiction" has also been written into the provisions of the revised draft. Internet product and service providers shall establish an anti-addiction system, set up corresponding management functions for minors to use their products and services, and shall not provide minors with products and services that induce their addiction. In order to protect children’s privacy, we should also establish a personal information protection system for minors to protect personal information such as private information of minors according to law.

　　"Prevention and Control of school bullying" was written into the revised draft

　　In order to ensure campus safety to the greatest extent, the reporter noted that "prevention and control of school bullying" was written into the revised draft.

　　The revised draft specifically proposes that schools and kindergartens should safeguard the legitimate rights and interests of underage students and children at school and in the park. For example, schools and kindergartens should prevent and control school bullying; Prevention, intervention and correction of bad behavior and serious bad behavior; Prevent and deal with sexual assault, sexual harassment and other acts that infringe on the physical and mental health of minors.

　　In addition, the public security organs can guide and supervise schools and kindergartens to fulfill their safety management obligations by means of admission guidance and police patrols, and maintain the security order around schools and kindergartens according to law.

　　Relying on 12345 to establish "minors protection hotline"

　　There will be a hotline for the protection of minors in this city. According to the revised draft, the city relies on the 12345 citizen service hotline to establish a hotline for the protection of minors, and set up special staff to be responsible for accepting and referring reports, complaints and reports that infringe on the legitimate rights and interests of minors, collecting opinions and suggestions, and providing advice and help on the protection of minors; Special staff should be familiar with the physical and mental characteristics of minors and receive special training on a regular basis. In addition, the city will also rely on the 12355 youth psychological and legal service hotline to provide psychological health, legal rights protection and other consulting services for minors.

　　Government departments will formulate "Guidelines on Family Guardianship" to provide educational guidance.

　　The revised draft proposes that the municipal civil affairs department may, in conjunction with education, health, public security, online information and other departments and relevant group organizations, formulate family guardianship guidelines and announce them to the public in accordance with relevant regulations, so as to provide guidance for guardians of minors to perform their guardianship duties.

　　In addition, the municipal and district people’s governments should also provide family education guidance services. For example, family education guidance books can be compiled or adopted in combination with the actual situation in the region; Or build a family education information sharing service platform, set up public welfare online parent schools and online courses, open a service hotline, and provide online family education guidance services; Or determine the family education guidance institution according to law, and provide services to families in need in time.

　　Guardians of minors should accept family education guidance, actively participate in family education guidance activities carried out by family education guidance institutions, schools and communities, and improve their family education ability.

Let’s go back to the Baidu AI Developers Conference in 2017.

COO Lu Qi took the lead in making his debut. At 10 o’clock in the morning, he stepped onto the stage on time, occupying the field of vision of 5000 spectators, and blasting a value judgment into the minds of on-site and off-site users:AI will bring mankind into a new era just like the previous three industrial revolutions.

Lu Qi’s voice is firm, powerful and full of confidence, and there is no doubt: "We can definitely lead!"

"AI is an opportunity for Baidu, All In AI."With a wave of his right hand, Lu Qi put his index finger up, calmly "stud" and bet on the whole Baidu.

Luqi

At the end of the meeting, Liu Ji wanting more, announced on the spot:In 2020, Baidu can realize automatic driving of high-speed and urban roads.

Ok, now we can travel back to May 2020. At this time, Lu Qi has left Baidu for two years, and the situation of the artificial intelligence industry has changed greatly.Automatic driving on the high speed is far away.

Wave Computing, a foreign star AI company, laid off its employees and filed for bankruptcy protection. Horizon, a domestic AI head company, was laid off by 50%. At the beginning of this year, the report of Cheetah Global Think Tank showed that the financing amount of AI enterprises experienced a cliff-like decline after 18 years of continuous increase. Compared with 2018, the amount of financing in 2019 decreased from 148.45 billion to 96.727 billion, a decrease of 34.8%, and the amount of financing decreased from 737 to 431, a decrease of 40%.

Since the second half of 2019, IPO plans have been successively spread from Defiance Technology, Shangtang Technology, Yuncong Technology, Excellent Choice and Cambrian. Regrettably, after six months’ application for listing, the status of Defiance was still invalid. Shang Tang was delayed to go public and turned to private equity market for financing. According to the "investment circle" report, Defiance and Shang Tang were frustrated in listing one after another because the valuation was not recognized. CAMBRIAN was asked 20 questions by Shanghai Stock Exchange after applying for listing in science and technology innovation board.

The capital market, which was greeted with smiles before, was completely faceless. Gone are the days when artificial intelligence companies could get high valuations by putting AI tags on PPT two years ago.

At this time, Baidu was caught in a full-scale war with ByteDance. Li Yanhong should have discovered it long ago.All In AI is not an opportunity for Baidu, but a big pit for Baidu.

Today’s situation is particularly clear:The era has emerged, that is, the great migration of content competition from graphic to video. The new traffic generated by this great migration will profoundly affect the entire Internet industry in China. Which big company dominates this great migration will be able to hold the gate of traffic distribution in its own hands, just as Tencent has done in the past 10 years.

Baidu has fallen behind from BAT, which has long been a recognized fact. Today, the market value of Meituan exceeds 100 billion US dollars, and the most unpleasant thing may be Li Yanhong. Although the news of "Baidu delisting" was officially denied, it may not be without reason.

If you want to restore your former glory and re-tie with Erma,The ongoing content ecological war is just one of the few opportunities for Li Yanhong, if not the only one.

Li Yanhong has obviously realized this, so he will vigorously support the live broadcast platform. Baidu executives announced that they will give live broadcast of 10 billion traffic+500 million cash support. However, because it is too late to launch, live broadcast and even the whole short video field, it is already an almost impossible task for Baidu to make a preemptive strike.

If in 2017, before Aauto Quicker and Tik Tok were exposed, Baidu All in was not AI, but content ecology, would the result be different?

The slogan "All in AI" reveals the background color of Lu Qi’s character.

At the end of last year, Lu Qi accepted a late interview and made no secret that he was too confident and was considered "self-righteous" by his wife.

This is Lu Qi’s reflection after he returned to China for three years and suffered setbacks in his two career choices.

But in 2017, ALLINAI-this almost gambling action is undoubtedly a stimulant in front of the lively capital market.

Lu Qi, who put forward this slogan, has been well-known in the Chinese and American science and technology circles for many years, and his resume can’t be picked out-postdoctoral fellow at Carnegie Mellon University, executive vice president of Yahoo and global executive vice president of Microsoft, known as "the most powerful Chinese in Silicon Valley".

It seems that the time has indeed come: in 2016, the "man-machine war"-Alpha Dog defeated Li Shishi in the ninth stage of Go, turned AI, which was originally confined to the fields of science and science fiction, into a popular hot topic on everyone’s lips.

The geographical location has also been created: outside the Fifth Ring Road in Beijing, Lu Qi sat in the Baidu AI conference venue, and the real owner of Baidu, Li Yanhong, performed a stunning scene of unmanned driving outside the Fifth Ring Road. Despite being issued a ticket, compared with the seemingly upcoming driverless era, such a price is completely insignificant.

That night, Baidu’s market value rose by nearly $18 billion.

Half a month later, the State Council released the "New Generation Artificial Intelligence Development Plan", which added another fire to the development of AI at the policy level, and the market quickly detonated. Ma Yun founded the Dharma Institute, Ma Huateng proposed AI in all, and Huawei released the full-stack full-scenario AI strategy. Investors throw money into the wind.

In July of the same year, Shangtang Technology raised $410 million, which was the highest financing record in the world at that time. Three months later, Defiance Technology completed $460 million in financing. At this point, AI Company entered the financing race mode and its records were constantly updated. In May 2018, Shangtang Technology raised $620 million, and Ubisoft completed $820 million. In June, Yunzi raised $1 billion from technology, in July, Shang Tang received $1 billion from Softbank, and in November, Horizon raised $1 billion …

Under the fierce fire, the market soon proved that everyone overestimated the commercial liquidity of AI. At the beginning of 2018, Kai-Fu Lee bluntly said in an interview with China International Television: The bubble of AI will burst. "Every entrepreneur wants to package his startup into an AI company, and every VC wants to flaunt himself as an AI investor. But AI investment is actually not suitable for novices to participate. If you don’t understand the AI ? ? technology itself, you are eager to participate in the early stage of AI, and such people will lose even their pants. "

Baidu’s complex organizational structure casts a shadow over the All in AI strategy.

Lin Ning, a former Baidu cloud worker, said frankly: "Baidu feed stream, driverless and cloud technology all belong to AI, but all departments are running in parallel and are not harmonious with each other."

On the one hand, Li Yanhong led a team to do the familiar and profitable search +feed streaming business, on the other hand, Lu Qi focused on betting on driverless driving.

Both of them are commercialized. Even by 2020, looking at the world, the goal of unmanned commercial mass production is still at the conceptual stage.

Taking Waymo, a driverless company owned by Google, as a reference, Waymo started research and development in 2009, and completed the first phase-10 billion mileage test in 10 years. The mass production stage of the second stage is still stuck.

According to Waymo’s good news at the beginning of this year, it raised 2.25 billion US dollars to produce 80,000 cars. However, according to a survey from the media "high-tech smart car", Waymo’s mass production is unrealistic. Waymo invested more than 5 billion US dollars in research and development in the first ten years. Considering the hardware and software costs of 80,000 vehicles, 2.25 billion US dollars can only be regarded as a drop in the bucket.

Back in the domestic market, the situation of driverless driving is even less optimistic. A Baidu employee told the alphabet list that at present, Baidu’s driverless driving is only used in a limited range. "The domestic landing conditions are immature and the social infrastructure development is not matched, so it is difficult to land on a large scale."

According to Li Deyi, an academician of China Academy of Engineering,Driverless driving will be in the product incubation period before 2025, and mass production is expected to be in 2060.

Driverless driving is difficult to realize, and the profit model of search +feed has already run through, and Li Yanhong’s choice does not need to be guessed at all.

Q1 financial report released in April 2018 shows that revenue increased by 31% year-on-year and net profit was RMB 6.7 billion, up by 277% year-on-year. The unmanned business has no revenue, and search and feed streams have become profit anchors. Asked about the commercialization of AI in the earnings conference call, Lu Qi’s response was vague, and he hoped for the future between the lines.

If you pull the camera back to April 2017 and Lu Qigang joined Baidu’s three-month earnings conference call, his response will be much simpler-face the commercialization of driverless technology raised by analysts and give a clear answer:Realize the commercialization of driverless cars in 2020.

When he joined Baidu in early 2017, Lu Qi shared an experience: jumping on the right boat at the right time. By the late interview at the end of 2019, his quotation added one more sentence: take a step back and broaden the horizon.

In Lin Ning’s view,It is inevitable for Lu Qi to leave Baidu. "Lu Qi chose a track that Baidu is not good at."

Lin Ning said frankly that driverless driving is a very good AI landing scene, and Baidu’s technology is also very good, but the Apollo program is just a famous sound, and the products can’t land at all. "BMW, Mercedes-Benz, Baidu and Apple are all driverless, and what do Internet companies take? Compared with car manufacturers?"

More importantly, this led Baidu to take a fork in the road in strategy and completely fall behind in content layout.

The core of Baidu is search, and the essence of search is content.Baidu tried to rely on AI to make a turnaround, so that it was underinvested and lacked foresight in the main channel of the times-content ecological competition.Throughout 2016, Ali announced the creation of "super consumer media". Tencent has Daily Express and Tencent News to seize the consulting market. The headline is 1 billion, and it is necessary to focus on supporting short videos …

Although Baidu has already made preparations. In 2016, he also laid out 1 billion layouts of 100 numbers. At the media meeting to welcome Lu Qi in January 2017, Li Yanhong emphasized the importance of information flow. "I am confident that users can rely on Baidu to obtain information." In the end, the center of gravity fell on AI. Li Yanhong received a ticket at the Fifth Ring Road, Lu Qi used the Apollo plan to ripen the AI bubble, and the All in AI strategy can be said to be of no help in revenue.

On the other hand, in 2017, advertising revenue reached 15 billion yuan, accumulating hundreds of millions of creators around the world, and hitting the target of 50 billion in 2018. At that time, there were 1 million creators in the same starting point, and the advertising revenue of information flow was less than 10 billion.

In January 2018, before Lu Qi left Baidu, Li Yanhong attended the geek conference, in addition to emphasizing himself.Never said "All in AI"In addition, information flow is specifically mentioned. "Information flow is the focus of Baidu. Most of Baidu’s resources are on Baidu search and Baidu feed stream."

Li yanhong

Looking back now, reassessing Lu Qi’s choice to leave Baidu can be said to be the best of both worlds.

Lu Qi became an investor and joined YC. Later, he founded Miracle, laid out AI consistently and did what he liked.

When Lu Qi left, public opinion fell to the ground and felt sorry for Lu Qi. With data, Baidu couldn’t keep people. In 10 years, he left at least 10 vice presidents and more than 20 executives. Rumors such as internal palace fights and couples seizing power are rampant. Coupled with the bad impression of hemophilia bar and Wei Zexi incident to the public, Baidu was simply sprayed into a sieve.

But I have to say,It is wise for Baidu to loosen the throttle and win Lu Qi in AI strategy, at least it is better late than never.

After Lu Qi left, the voice of Baidu All in AI disappeared. In the Q3 financial report of 2018, the revenue of search and feed stream business accounted for 80% of the total revenue. At the Baidu World Congress held in the same year, the whole package revolved around the content ecology, such as empowering creators, supporting short videos and landing applets, and upgrading Baidu APP into a "comprehensive content consumption and service platform". It also played a tit-for-tat with the headlines, and the frequency of infringement lawsuits by both sides was much higher.

A few days ago, Baidu launched the "Gathering Energy Plan" to supplement the live broadcast business, which can be said to be the foundation of a comprehensive return to the content ecology.

At the same time, the implementation of Baidu’s driverless strategy is obviously more rational. "Driverless gambling is the future, and the return is too far. At present, we can only reduce the research and development costs slowly." A former Baidu employee said.

At the Baidu AI Developers Conference in 2018, Baidu announced the official mass production of the Apollo 3.0 version "Apollon"-"the world’s first L4-class self-driving car". However, compared with Waymo’s mass production of 80,000 vehicles, Baidu’s mass production of "Apollon" is a little shy, with only 100 vehicles. The activity space can only be limited to relatively closed and fixed-line environments such as parks, airports, scenic spots and factories.

Social supervision also needs Baidu to take it slowly. In 2019, Baidu L4 driverless taxis were put into trial production in Changsha. According to national business daily, drivers are on standby at the driver’s position of driverless taxis. These drivers, also known as "security officers", are prepared in accordance with official requirements to ensure the safety of passengers.

According to the unmanned management measures introduced in Shanghai last September, such as vehicles must be equipped with drivers, enterprises must not charge passengers, and must not engage in transportation or business-related activities. This also means that it will take N years for the enterprise’s driverless products to be truly commercialized.

It is not difficult to understand that although Baidu will definitely mention AI in every financial report, people in the industry know that Baidu’s revenue can only rely on content business.

At the end of February this year, the annual financial report with a total revenue of 107.4 billion yuan in 2019 was released, and the search +feed stream sang the leading role. The unmanned appearance only emphasizes business progress, such as cooperating with 23 cities and getting 40 autonomous driving licenses in Beijing. Revenue data has not been disclosed so far.

By May 19th, the latest Q1 financial report with revenue of 22.5 billion yuan and net profit of 3.1 billion yuan, the main force of Baidu’s revenue has not changed, and the financial data of AI business is still missing. The driverless business is completely playing soy sauce in the financial report, and the cloud business has been taken over. The only AI product that is emphasized is only a small one, a smart speaker.

Baidu’s development path in AI strategy is almost the commonality of domestic AI companies.

"Technical improvement is difficult to completely solve the fundamental defects of current AI, which determine that its application space is limited to specific fields-most of them are concentrated in image recognition and speech recognition." This is the conclusion that Zhang Yue, president of Tsinghua University Institute of Artificial Intelligence, accepted in Economic Observer last May.

At the same time, another conclusion of Zhang Yue is that artificial intelligence based on deep learning has technically touched the ceiling.

This seems hard to understand. As far as we can see, AI products appearing on the market, except intelligent robots, face recognition, intelligent customer service and intelligent speakers, have hardly seen products with more advanced technology research and development. Why is the ceiling of AI so low?

However, the reality is in front of us. From the "man-machine war" in 2016, there has been a lot of talk about AI replacing labor. Kai-fu Lee once asserted that 50% of human work will be replaced by AI within 15 years, but four years later, the development process of domestic AI is not optimistic.

At the AI International Conference in June last year, Ma Ziya, Intel’s technical director, said frankly: Emerging technologies such as big data and AI are difficult to land. At present, only 2% of the data is really used to help human production and life.

Back to the AI commercial market. Even in Ali and JD.COM, which have scene advantages, only basic products such as robots and intelligent customer service have been widely used, and more intelligent technologies are still in the conceptual stage.

A typical example is Iflytek, the leading brother in the field of intelligent voice. In September, 2018, I was questioned about "AI simultaneous interpretation fraud". Finally, Liu Qingfeng, the chairman of the board, delivered the hammer himself, claiming that the intelligence level of the current machine could not replace simultaneous interpretation for the time being. By October, CCTV revealed that Iflytek had illegally occupied the Chinese alligator National Nature Reserve in Xuancheng City, Hui Province, and was suspected of using land to build villas under the guise of "AI".

The financing boom that was rolled up like a storm in the past is now flying everywhere.

AI Unicorn Shangtang Technology has raised nearly $3 billion in 9 rounds in 6 years, and its valuation once exceeded $7 billion. Its business covers smart cities, smart phones, pan-cultural entertainment, smart cars, smart health, smart business, education and advertising. Since 2018, it has frequently exposed packaged and sold assets, which has been questioned by observers and has not formed core technical barriers so far.

The company, which competed with Shang Tang for the dominant position in financing, set a new loss record year by year, from a loss of 343 million in 2016 to a direct loss of 5.2 billion in the first half of 2019, and was forced to fall on the road of IPO of Hong Kong stocks.

The Cambrian lost nearly 1.6 billion yuan in three years. In March this year, it submitted an application for IPO in science and technology innovation board, and planned to issue 40.1 million shares, raise at least 2.8 billion yuan, and value itself at 28 billion yuan. Even it was not afraid to show its cards in the prospectus: it could not guarantee profitability in the next few years, and it might face the risk of delisting after listing.

……

Looking back at AI now, the attitude of investors is the most intuitive. Wu Shu, the founder of Qushi Capital, has been paying attention to AI since 2011. He told the alphabet list (ID:wujicaijing): "Many AI directions are promising and valuable, and business models have gradually emerged, butPart of AI was speculated by a group of irrational investment institutions in the early stage, which led to the high valuation deviating from the value, and continued investment became a take-over man. In the end, no one could take it."

Lu Qi, who is also an investor, not only admitted that he was overconfident, but also listed the investment projects he participated in, such as robotics, biotechnology, telecommuting and cloud computing technology.Only there is no unmanned driving.

The last time I responded to the question about driverless driving was in a late interview at the end of last year. When I was asked about the three most optimistic AI landing scenarios, Lu Qi only gave two answers-smart place and new mobile (robot driving).

Facing the reporter’s innuendo on the issue of unmanned driving, Lu Qi said:It is a long process for unmanned driving to completely land in commercialization.

(Lin Ning is a pseudonym)

[Some References]

Dialogue with Lu Qi: It is inevitable to do something long-term and valuable and not be understood, later, December 13, 2019.

"Baidu executives interpret the first quarter financial report, Lu Qi said that it is necessary to strengthen AI innovation", Sina Technology, April 28, 2017;

"Lu Qi: An" outsider "who broke through the fog of Baidu", people, June 28, 2018;

"Shenwang | Baidu’s" new "era after Lu Qi’s curtain call", Shenwang, June 7, 2018.

"Lu qi’s reform is not completed. Baidu returns to the old road? ",Beijing News, May 23, 2018

"Unmanned driving enters the" mass production era "? Dawn at dawn, or a crazy daydream, high-tech smart car, March 8, 2020.

Li Deyi: mass production of driverless cars is expected to be in 2060, China Auto News, May 22, 2019.

"AI Company, Began to Bankruptcy", investment community on May 6, 2020.

"exclusive interview with academician Zhang Wei: deep learning touches the ceiling, and the AI miracle is hard to continue", Economic Observer, May 28, 2019.

Shangtang Technology was exposed to IPO: the listing is uncertain after nine rounds of financing, Blue Whale TMT, March 27, 2020.

On December 22nd, the Shanghai Municipal Market Supervision Bureau issued the Decision on Administrative Punishment on the grounds of monopolizing four pharmaceutical companies, namely Shanghai Shangyao No.1 Biochemical Pharmaceutical Co., Ltd., Wuhan Huihai Pharmaceutical Co., Ltd., Wuhan Kede Pharmaceutical Co., Ltd. and Hubei Minkang Pharmaceutical Co., Ltd., with the penalty amount exceeding 1.2 billion yuan.

The investigation by Shanghai Market Supervision Bureau also found that Wuhan Huihai Pharmaceutical Co., Ltd., Wuhan Kede Pharmaceutical Co., Ltd. and Hubei Minkang Pharmaceutical Co., Ltd. belong to the same actual controller.

The three enterprises in Wuhan Huihai were fined 762 million yuan this time. The reporter found that Wuhan Huihai received a ticket in May this year.

monopolize

On social platforms, many patients spit out that the price of polymyxin B sulfate for injection is too expensive, and a few grams of a bottle sells for 2303 yuan. A user’s father is sick and uses 5 pieces a day.

It is understood that this drug specializes in killing Acinetobacter baumannii and Pseudomonas aeruginosa, and there is no substitute in the market. It must be used after the above bacteria are infected. Although the price is expensive, I have to accept it.

However, there are also patients who can buy imported products, the price is only 300 yuan-400 yuan, and the effect is just as good.

Patients are used to the fact that the price of imported products is higher than that of domestic products, but in this product, the price of domestic products is much higher than that of overseas products.

According to the statistics of the third party, in 2022, the weighted average price of polymyxin B sulfate for injection in other countries and regions is 65 yuan/branch, and the net price in China market is 35 -44 times of this price.

The truth behind this is that Wuhan Huihai Department manipulated and monopolized imported raw materials, and the raw materials purchased from overseas 73 yuan/gram -94 yuan/gram were gradually pushed up to 18,000 yuan/gram-35,000 yuan/gram through price increases. Finding the biochemical production of medicine, the biochemical production of medicine only earns processing fees, and Wuhan Huihai sells it to all parts of the country. Although all places are bidding, the retail price is more than 2,000.

Wuhan Huihai not only monopolizes the sale of polymyxin B sulfate for injection, but also uses the secret song.

On the evening of May 28th, the State Administration of Market Supervision published on its official website the administrative penalty decision on the case of Yuanda Pharmaceutical and Wuhan Huihai reaching and implementing a monopoly agreement and abusing market dominance.

According to the investigation by the General Administration of Market Supervision, since 2010, only Yuanda Pharmaceutical and Shanxi Zhendong Taisheng Pharmaceutical Co., Ltd. have the qualification to produce norepinephrine and epinephrine in China. Wuhan Huihai actually controls the sales of norepinephrine and epinephrine in Shanxi Zhendong Taisheng through underwriting.

These two companies are competitors, and should have provided quality services or competitive prices in the market to promote the benign development of the market.

But the two companies have joined forces.

According to the penalty decision, from June 2016 to July 2019, Yuanda Pharmaceutical and Wuhan Huihai reached and implemented a monopoly agreement on the sale of norepinephrine bitartrate (hereinafter referred to as norepinephrine) and epinephrine.

Yuanda Pharmaceutical sells norepinephrine injection and epinephrine hydrochloride injection to Wuhan Huihai at a low price, and then repurchases them at a high price; Yuanda Pharmaceutical requires related pharmaceutical companies to sell norepinephrine injection and epinephrine hydrochloride injection to Wuhan Huihai at low prices, and then resell them at high prices by Wuhan Huihai.

As a result, the relevant pharmaceutical companies can’t buy this kind of raw materials from channels other than Yuanda Tianqing, and the supply of raw materials and the sales of preparations are also controlled by Yuanda Pharmaceutical, which pushes up the prices of emergency rescue drugs norepinephrine injection and epinephrine hydrochloride injection, increases the cost of patients’ medication and the national medical insurance expenditure, and harms the interests of patients and social public interests.

According to the previous report of Health Times, since 2015, the prices of most first-aid drugs have been rising rapidly, with a small increase of three times and a large increase of nearly 60 times. For example, norepinephrine increased nearly 4 times, cedilanid increased 25 times, phosphoryl iodide increased 49 times, and phosphoryl chloride increased 51 times.

Wuhan Huihai

In the former case, Wuhan Huihai was in a dominant position, while the latter was in a subordinate position. In the former case, Wuhan Huihai was confiscated and fined 762 million yuan, while in the latter case, the illegal income of Wuhan Huihai was confiscated and fined 4126800 yuan.

Wuhan Huihai was rarely reported before. According to the disclosure of the regulatory authorities, Wuhan Huihai, Wuhan Kede and Minkang Pharmaceutical are the companies actually controlled by Li Meilin and Annababy Zeng.

Wuhan Huihai not only monopolizes the sale of polymyxin B sulfate for injection, but also uses the secret song.

Wuhan Huihai Pharmaceutical Co., Ltd. belongs to Hubei Minkang Pharmaceutical Group. official website introduced that the company originated from the famous "Xingshengxiang" medicinal material number in eastern Sichuan and western Hubei at the end of Qing Dynasty. At the beginning of 1954, "Xingshengxiang" and two other medicinal materials "Yi Anshun" and "Yi ‘an" jointly established Yichang Minkang Pharmaceutical Factory, the largest pharmaceutical enterprise in eastern Sichuan and western Hubei at that time.

In August 1954, Yichang Minkang Pharmaceutical Factory merged with Shanghai Fei’s (private) pharmaceutical factory, in 1986 Minkang Pharmaceutical Factory merged with Yichang Limin Chemical Factory, and in 1994 it merged with Yichang No.4 Pharmaceutical Factory. In October of the same year, Yichang Minkang Pharmaceutical Co., Ltd., a Sino-foreign joint venture, was established with Singapore Meizuo Private Co., Ltd. and Singapore Universe Private Co., Ltd., and in September 2003, it was restructured into a Singapore-owned enterprise, Hubei Minkang Pharmaceutical Co., Ltd.

According to the latest industrial and commercial data, in December 2021, Hubei Minkang Pharmaceutical Group Co., Ltd., as a new shareholder, held 66% equity of Hubei Minkang Pharmaceutical Co., Ltd. Zeng Yi is the major shareholder of Minkang Group, holding 85% of the shares.

Annababy Zeng is the son of Li Meilin, and both of them have little public information. In 2019, Xiaogan. com published an article "Merrill Lynch: Dormancy and Xu Li". Li Meilin was a Yunmeng person and started a successful business abroad. At the beginning of 2010, Li Meilin really felt the change and development potential of Yunmeng County when he returned to his hometown to visit relatives, and he had the intention to invest in Yunmeng. The Yunmeng county government attached great importance to it, and relevant departments organized special class personnel to rush to Wuhan to get in touch with her. Inspired by nostalgia and affection, in April 2010, Hubei Merrill Lynch Pharmaceutical Co., Ltd. settled in the county economic development zone, covering an area of 300 mu. Committed to the research and development of pharmaceutical excipients, new chemical raw materials and preparations. Li Meilin also moved Wuhan Huihai, which was originally located in Wuhan, back to Yunmeng.

disastrous effect

There is a world of difference between the profits generated by sub-operation and monopoly.

Take polymyxin B sulfate for injection as an example. In 2022, the sales income of Shangyao Biochemical was 4.14 billion yuan, and the illegal income was 338 million yuan. The sales of Wuhan Huihai, Wuhan Kede and Minkang Pharmaceutical last year were 138 million yuan, 907 million yuan and 248 million yuan respectively, and the illegal income was 47.58 million yuan, 617 million yuan and 2.05 million yuan respectively. The sales revenue of this medicine is 5.414 billion yuan, and the illegal income is 1 billion yuan.

Partners in this chain can also reap huge profits. In 2019, SAIC Biochemical requested to increase the processing fee from 140.4 yuan/piece (including tax) to 200 yuan/piece. In January, 2023, the parties again demanded that the processing fee be increased from 200 yuan/Branch to 230 yuan/Branch. This processing fee is more expensive than the sales price in many overseas countries. In addition, all aspects of product sales are likely to be stakeholders. As medical practitioners, the price difference between China and foreign countries is clear at a glance.

Wuhan Huihai skillfully compiled the network, plundered the excess benefits, and suffered the medical insurance funds and patients.

However, illegal business operations will eventually be countered. In June this year, Zhendong Pharmaceutical responded to investors. Shanxi Zhendong Taisheng Pharmaceutical Co., Ltd., a subsidiary of the company, had previously supplied Wuhan Huihai Pharmaceutical Co., Ltd. at the price agreed in the contract. The price was reasonable, and the company did not participate in the follow-up sales process. At present, the company no longer sells the above APIs to Wuhan Huihai.

Proofreading: Peng Qihua

　　CCTV News:Autumn grain is the bulk of grain production in the whole year. At present, it is in the critical period of the formation of autumn grain output, and many places in the country have started the harvest mode one after another.

　　Recently, more than 45,000 mu of winter wheat in Guide County, Hainan Tibetan Autonomous Prefecture, Qinghai Province enjoyed a bumper harvest. Grain farmers seized the fine weather and stepped up their efforts to harvest wheat.

　　In a wheat field in Guide County, the wheat ears are full and the stalks are thick, and the agricultural hand drives a large combine harvester to gallop in the field, harvesting, threshing and loading in one go.

　　It is understood that in 2023, Guide County planted more than 45,000 mu of winter wheat, and the local organization dispatched 145 harvesters for machine harvesting, with a machine yield of 86%. Up to now, except for some winter wheat in alpine mountain areas, the rest areas have been basically harvested.

　　Large-scale mechanical harvesting is busy when wheat enters the harvest season.

　　At present, Heihe City, Heilongjiang Province has entered the wheat harvest season. In Handaqi Town, Aihui District, Heihe City, the weather is fine these days, the mature ears of wheat are shining in the sun, and large harvesters shuttle through the waves of wheat, threshing and crushing straws in one go.

　　It is understood that in 2023, Heihe City planted a total of 85,000 mu of wheat. At present, the sickle has been harvested one after another.

　　100,000 mu of ratooning rice seedlings and heading to strengthen field management

　　Recently, 100,000 mu of ratooning rice in Kaizhou District of Chongqing has entered the seedling and heading stage one after another. Local agricultural technicians went deep into the fields to guide growers to strengthen field management.

　　This is a reclaimed rice field in Zhuxi Town, Kaizhou District, Chongqing. The newly-developed rice seedlings are lush and green, and they have started jointing and heading. Agricultural technicians guide farmers to strengthen water and fertilizer management for reclaimed rice fields with poor growth.

　　Regenerated rice is an effective way to increase grain production and farmers’ income by using rice piles to re-sprout seedlings and long ears for another season after rice harvest in finger season. It is understood that in 2023, the storage area of ratooning rice in Kaizhou District is more than 100,000 mu, which is expected to mature in October.

　　Agricultural technicians go deep into the fields to help increase corn production.

　　Since the summer of 2023, Yongdeng County, Lanzhou, Gansu Province has experienced continuous sunny and hot weather and less rainfall. At present, the locally planted corn has entered the filling stage, and aphids appear on the corn plants due to the lack of rain.

　　The local agricultural technicians were sent to the fields to provide technical support for farmers, and the mixed liquid with the functions of killing insects, sterilizing, regulating growth, resisting drought and preserving water was sprayed for farmers free of charge to help farmers protect crops and increase production.

　　Hua jiao hong man shan jiao Nong xiyangyang

　　These days, the peppers in Xiaxian and Hejin in Yuncheng, Shanxi Province have matured and ushered in a bumper harvest.

　　In a pepper planting base in Yaozhang Town, Xia County, Yuncheng, from the air, the pepper trees all over the mountains are lush. Due to the sufficient light and the large temperature difference between day and night, the local pepper grains are rich in red and strong. In 2023, the output of Zanthoxylum bungeanum in Nianzhang Town is expected to reach more than 2,400 tons.

　　In Xiahua Township, Hejin City, the local pepper also ushered in maturity. In 2023, the planting area of pepper in Xiahua Township reached more than 19,000 mu. In order to broaden the market, the local people brought goods through live broadcast to help pepper walk out of the mountains and help farmers increase their income.

　　Grape fragrance fruit farmers are busy with sweet harvest for another year

　　At present, 113,700 mu of grapes on the Gobi Desert in Bazhou, Xinjiang have ushered in a "sweet" harvest season. The growers are busy picking and shipping, and the scene is full of harvest.

　　In the past two days, in the thousand-acre grape planting base of Qixingzhen, Yanqi County, Bazhou, Xinjiang, crystal clear grapes are covered with branches and sweet smell. Workers are busy picking grapes, and the picked grapes will be loaded and transported to the press workshop.

　　In 2023, Bazhou planted a total of 113,700 mu of grapes, including 73,500 mu of wine grapes and 40,200 mu of table grapes. In recent years, the local area has given full play to its advantages in resources and location, continuously extended the industrial chain, increased the added value of products, and formed an industrial chain integrating grape fruit brewing and processing, which has driven villagers to increase their income and become rich.

Strengthen scientific and technological innovation of digital agriculture

　

　

　

　 Tang Huajun, Academician of China Academy of Engineering and Dean of China Academy of Agricultural Sciences

　

　　Recently, the Ministry of Agriculture and Rural Affairs and the Central Network Information Office jointly issued the "Digital Agriculture and Rural Development Plan (2019-2025)" to make top-level design and systematic planning for promoting the development of digital agriculture and rural areas. To fully implement the deployment requirements of the plan, it is necessary to strengthen scientific and technological innovation in digital agriculture and rural areas and create new engines and kinetic energy for agricultural and rural modernization.

　　The integration of digital technology and agriculture and rural areas is accelerating, but the development of digital agriculture and rural areas still faces many challenges.The new generation of information technology, represented by mobile Internet, big data, cloud computing and artificial intelligence, is developing with each passing day. The data is exploding and growing, gathering in large quantities, and digitalization, networking and intelligence are accelerating to penetrate into the agricultural industrial system, production system and management system, profoundly changing the global economic landscape. The CPC Central Committee and the State Council vigorously promoted the construction of digital China, implemented the strategy of digital countryside, continuously improved the ability of scientific and technological innovation, significantly accelerated the research and development of facilities and equipment, vigorously developed remote sensing, Internet of Things and big data applications, synchronized development of digital industrialization and industrial digitalization, and the emergence of new digital industries and formats, which promoted the digital transformation and upgrading of traditional agriculture and rural areas. Compared with industry and service industry, the application of digital research in agriculture and rural areas is obviously lagging behind. The infrastructure is still weak, the construction of data resource system is not perfect, and the lack of standards hinders the application collaboration and develops the foundation "gap"; The research and development strength of core key technologies is insufficient, the adaptability of agricultural robots and intelligent agricultural machinery equipment is poor, and the innovation ability is "out of gear"; The integration of digital technology with agriculture and rural areas is insufficient, data integration is insufficient, development and application are insufficient, and the level of industrialization is "broken", so it is urgent to fill the "short board" of insufficient digitalization.

　　Promote scientific and technological innovation in digital agriculture and rural areas and empower agricultural and rural modernization with data.We should take "data-knowledge-decision-making" as the main line, break through the core key technologies, equipment and integrated systems, and lay a solid foundation for the development of digital agriculture and rural areas. First, strengthen the innovation of accurate perception and data collection technology, build an agricultural and rural information collection technology system integrating "sky and land", carry out research on data collection, input, summary, application and management technology, improve the ability of obtaining and processing raw data, and solve the basic problem of "where does the data come from and how to manage it". The key point is to promote the research and development of professional remote sensing satellites to meet the needs of agriculture and rural areas, break through the common key technologies of UAV agricultural application, overcome the special sensors for agricultural production environment and physiological signs of animals and plants, and realize cross-regional, all-factor and multi-level data collection of agricultural resources and environment, production, management, management and service in important agricultural areas and pastoral areas; Research and develop a big data management platform for agriculture and rural areas, and break through key technologies such as "centralized+distributed" integrated cloud architecture and data security for agricultural and rural resources and assets. The second is to strengthen the innovation of data mining and intelligent diagnosis technology, build an intelligent processing and analysis technology system for agricultural big data, strengthen the advanced layout of strategic cutting-edge technologies such as artificial intelligence, virtual reality, blockchain+agriculture, and big data cognitive analysis, and solve the key problem of "how to process and analyze data". The key point is to tackle key problems in common, integrate agronomy knowledge and models, computer vision, deep learning and other methods, and develop proprietary models and algorithms for monitoring, identifying, diagnosing, simulating and regulating animal and plant production, so as to realize digital and intelligent diagnosis of all factors and the whole process of agricultural production;Focusing on rural digital services, we will strengthen the research and development of key technologies such as agricultural and rural data resource association mining, intelligent retrieval, intelligent matching and deep learning to meet farmers’ all-round information needs for public welfare services, convenience services, e-commerce and experience services. The third is to strengthen the technical innovation of precise management and information service, build a technical system of intelligent decision-making and management in agriculture and rural areas with data empowerment, speed up the digital transformation of industry management and service processes, and solve the export problem of "how data serves". The key point is to strengthen the integration research of agricultural and rural proprietary software and information system, and develop ambient intelligence control system, rapid detection of agricultural product quality and cold chain logistics technology, and reliable traceability technology of agricultural products; Strengthen the independent research and development capabilities of intelligent equipment, create a number of agricultural intelligent sensing, intelligent control, autonomous operation and other material equipment, and focus on breaking through intelligent equipment such as agricultural robots, numerical control spraying, intelligent detection, intelligent handling, intelligent picking, and grading and sorting of fruit and vegetable products; Develop digital agricultural standards and specifications, and establish data standards, data access and services, software and hardware interfaces and other standards and specifications.

　　Construct the scientific and technological innovation system of digital agriculture and rural areas, and enhance the independent innovation ability of digital agriculture and rural areas.To accelerate the scientific and technological innovation of digital agriculture in rural areas, we should not only play the role of the government, but also mobilize the forces of all parties to form a joint force and jointly promote it. It is suggested that government departments at all levels should further increase investment, improve special facilities and R&D bases, and build a number of national digital agricultural rural innovation centers and professional sub-centers around strategic frontier technology layout, key common technology research, technology integration application and demonstration, and agricultural artificial intelligence R&D application, and build an innovation platform for technology research, equipment research and development and system integration. Take tackling key problems in digital agriculture and rural science and technology as the support focus of major national special projects and key research and development plans, establish a modern agricultural industrial technology system, and promote the deep integration of digital technology and agriculture and rural areas. Cooperate with scientific research institutions, universities, enterprises and other parties to cultivate a number of leading talents, engineers and high-level management teams in digital agriculture and rural areas. Strengthen the training of digital agriculture and rural business, carry out the activities of talents going to the countryside in the field of digital agriculture and rural areas, popularize the relevant knowledge of digital agriculture and rural areas, and improve the application and management level of digital technology for "three rural" cadres, new business entities and high-quality farmers. As a national comprehensive agricultural research institution, China Academy of Agricultural Sciences will gather the research strength and scientific and technological resources of the whole hospital and even the whole country, aim at the strategic needs of China’s digital agriculture and rural development, condense major scientific and technological propositions, and carry out collaborative innovation and joint research on major theories, key technologies and equipment of digital agriculture and rural agriculture from a higher level and a broader perspective to solve major scientific and technological problems;Focusing on the deep integration of digital technology and agricultural and rural modernization, we will effectively integrate existing advanced equipment, practical mature technologies and system achievements, carry out standardized assembly, integration, maturation and application verification, accelerate the transformation and demonstration application of digital agricultural and rural scientific research achievements, and explore the two-way integration mechanism of "innovation chain+industrial chain" to provide strong scientific and technological support for implementing rural revitalization strategy and solving China’s "three rural" problems.

　　Recently, the speculation that take-away apps may "eavesdrop" users has attracted a lot of attention and discussion. Related companies quickly denied that it was an unwarranted guess to emphasize "monitoring users’ daily conversations and doing information analysis" and there was no corresponding product setting. Even so, this kind of discussion still shows that most users love and hate online applications such as App: they want to be more convenient and "know me better", but they are worried about knowing too much private information, so that they "know me too well".

　　For such problems, China’s Cyber Security Law, which came into effect in 2017, establishes that network operators must follow the principles of legality, legitimacy and necessity when collecting and using personal information. However, with more and more opportunities for users’ personal information to be collected and stored, all kinds of violations of users’ private information are still emerging one after another, and some privacy-related user data leakage incidents also occur frequently. App’s excessive request for permission, out-of-range collection and use of personal information are repeatedly prohibited.

　　In response to such practical problems, the recently concluded National People’s Congress also reported that the Personal Information Protection Law has been put on the legislative agenda of this session of the National People’s Congress. On March 15th, the State Administration of Market Supervision and the Central Network Information Office jointly issued the Announcement on Carrying out App Security Certification and its implementation rules, so as to standardize the behavior of App in collecting and using user information, especially personal information, and strengthen the security protection of personal information.

　　However, after an interview with China Youth Daily and Zhongqing Online reporter, we learned that these regulatory policies are not only promoting the improvement of privacy protection system, but also facing considerable resistance. All parties are also looking for, besides laws and regulations, what other market and technical forces can balance the contradiction between privacy protection and data efficiency?

　　Repeatedly banned! Nearly 70% of users have experienced excessive access to privacy rights by App.

　　After checking a lot of contents about IELTS in the search engine, the homepage of shopping App in Wuhan college student Lin Hai’s mobile phone was captured by IELTS-related books and materials. "I was surprised at first, then angry, and then scared." He described his feelings after discovering this fact.

　　At present, such phenomena are not uncommon. Another college student, Yang Xiaoye, installed a mirror App on her mobile phone. Inadvertently, she found that the App actually accessed her address book "legally". Another single-function flashlight App even asked for the recording permission of the mobile phone.

　　From July 17 to August 13, 2018, the questionnaire survey on "App Personal Information Disclosure" organized by China Consumers Association showed that 85.2% of the respondents said that they had experienced the disclosure of App personal information; 67.2% of the respondents said that the App they used obtained the privacy rights in the mobile phone when its function was unnecessary.

　　The survey also shows that the permissions to read location information and access contacts are the most common situations when installing and using mobile apps, and the permissions such as call records, SMS records, camera and microphone recordings are often required by apps.

　　Zhu Wei, deputy director of the Communication Law Research Center of China University of Political Science and Law, has a deep understanding of the behavior of App’s excessive access to privacy. He once installed and used a famous App on his mobile phone, but he uninstalled it because he often sent advertisements. However, after uninstalling, he can still receive SMS advertisements from the App platform from time to time, and sometimes even push corresponding advertisements according to his city. Zhu Wei guessed that this may be because when he first used this App, he allowed him to obtain too many privacy rights in the use agreement.

　　Wang Yuwei, a partner of Guantao Zhongmao (Shanghai) Law Firm, believes that because many enterprises have long-standing disadvantages, it takes time and economic costs for their own legal compliance and government law enforcement, and the economic benefits obtained from excessive collection of information are attractive. These factors have made it difficult to implement relevant laws.

　　Huang Xiaolin, head of the Data and Privacy Center of Tencent’s Legal Department, pointed out that the problem of App obtaining too many and excessive user rights has been around for a long time, and it is inappropriate for some apps to obtain users’ sensitive rights beyond the necessary scope. However, the reason for these phenomena is that the legal risks they face may be far less than the commercial benefits they can obtain.

　　Huang Xiaolin also added that there are many apps that integrate multiple functions and even have more functions in future iterative upgrades. In order to realize these functions, apps will ask for more permissions. In this case, it is necessary to make a specific judgment on the specific functions of each App to judge whether it has obtained excessive user rights and whether it is compliant.

　　How effective is it? App security certification began to be implemented.

　　In view of the phenomenon that App has excessively obtained privacy rights, on March 15th, the International Consumer Rights Day, the State Administration of Market Supervision and the Central Network Information Office jointly issued the Announcement on App Security Certification, and designated the China Network Security Review Technology and Certification Center (ISCCC) as the official certification body to formulate technical verification specifications according to the Information Security Technology Personal Information Security Specification for App security certification.

　　China Youth Daily Zhongqing Online reporter learned that the above-mentioned App security certification related channels were officially opened on March 21st. Certification adheres to the principle of voluntariness and follows the mode of "technical verification+on-site verification+post-certification supervision". Search platforms and App stores will be encouraged to give priority to the recommendation of certified apps. The specific technical verification specifications for personal information security in App have been formulated and will be made public to the institutions involved in the verification.

　　As a privacy protection practitioner of Internet companies, Huang Xiaolin is relatively optimistic about the above-mentioned App certification. "It will have a more positive effect on the whole industry, on individuals and privacy protection (in this respect), and will lead enterprises to pay more attention to this aspect."

　　Huang Xiaolin also pointed out that there are a large number of apps on the market at present, and it remains to be seen whether enterprises can spend enough time and economic costs to participate. However, for apps and companies that occupy most market share, this is a process of self-correction, which may promote enterprises to be more compliant from the source. He expects that this kind of App security certification can be more automated, efficient and even as popular as anti-virus software with the help of more technical means, thus further promoting the compliance operation of App.

　　As a lawyer who has long been concerned about the field of privacy protection, Wang Yuwei said that the practice of App security certification belongs to the governance method of market regulation, which will make the means of privacy governance more diversified. However, he also pointed out that although the framework of the App security certification has been set, there are still many places where the boundaries are not clear enough. For example, the concept of major information security incident appeared in the detailed rules, but the current law has no clear provisions on how to define major information security incidents.

　　Relevant personnel of China Cyber Security Review Technology and Certification Center (ISCCC) told China Youth Daily and Zhongqing Online reporter that there is no clear definition of the above concepts at present, and some personal information security-related assessment guidelines will be used as the criteria for judging. Judging from the open rules, the main supervision means for certified apps are still self-inspection by enterprises, supplemented by social supervision, but the supervision by third parties is very limited. At the same time, because the certification is voluntary, how to manage the apps that have not passed the certification has not been completely and effectively solved.

　　Encourage checks and balances! The technical community seeks solutions.

　　For the privacy protection problem brought by the development of big data technology, the technical community is also paying attention to and studying the corresponding solutions.

　　On March 23rd, at the china computer federation Youth Computer Science and Technology Forum (CCF YOCSEF), "In the era of artificial intelligence, must privacy and efficiency be irreconcilable?" During the special discussion, some technicians said that privacy protection based on blockchain technology has been tried in Hangzhou and other places. The general idea is to use public chain to carry out data transactions and alliance chain to carry out data encryption protection.

　　For the application of blockchain technology in the field of privacy protection, Meng Xiaofeng, a professor at China Renmin University, pointed out that decentralized and traceable blockchain technology is a direction of privacy protection that can be studied, which is conducive to traceability and accountability after privacy disclosure. However, due to the immature technology and low efficiency, the application of blockchain technology in the field of privacy protection is still in the exploratory stage, and the use cost of blockchain is also high, so it is uncertain whether the regulatory authorities or enterprises will adopt it.

　　As a practitioner in the technical field, Pei Zhiyong, director of the 360 Industry Security Research Center, believes that it is technically feasible to use blockchain or big data technology to monitor privacy leaks, but in practice, it faces the problem of high cost and still needs a lot of human resources.

　　At the above-mentioned symposium, Pei Zhiyong put forward an idea to introduce the "three-way principle of checks and balances" currently applied in the field of cloud computing into App security supervision: separate the owner, operator and manager of personal data related to privacy, avoid a subject being both a referee and an athlete, commercialize this ability of checks and balances, and encourage the rapid development of an industry that can check and balance enterprises’ use of user data, thus forming a long-term and sustained market-oriented supervision.

　　As a legal scholar, Zhu Wei recognized the above viewpoints put forward by Pei Zhiyong. "You can’t be an athlete and a referee alone, neither can the government nor the enterprise." He believes that the upcoming personal information protection law needs to make a bottom line, so that the protection of personal information can truly return to the individual rights itself. On this basis, through mutual competition and checks and balances between enterprises, more and more feasible methods can be found. (Reporter Wang Lin Intern Sun Ji)

　　21st century business herald reporter Zheng Zhiwen Intern Wang Qingwei Shanghai Report

　　On November 25th, Chengdu Longquanyi Public Security Bureau reported a traffic accident on Chengluo Avenue in the district. When a small car was driving in the direction of Xihe River at the Shiling Interchange ramp of Chengluo Avenue, it collided with the vehicle in front at the intersection of Shiling subway station. Three people were slightly injured in the accident and all were treated in the hospital.

　　According to the video taken by the driving recorder of the rear vehicle, all the vehicles were waiting for the traffic lights at the intersection, and a white Tesla car suddenly rushed out and hit more than a dozen cars in a row. The scene of the accident was a mess, car parts were scattered all over the place, and many cars were seriously damaged.

　　On November 27th, Tesla responded to the cause of the accident. Tesla said that by checking the background data, it was found that when the collision occurred in the video, the accelerator pedal of the accident vehicle was depressed at a depth of 100%, and the vehicle speed increased from 54km/h to 132km/h at the time of collision. However, the brake light was not turned on because the driver stepped on the brake pedal, but because the collision in the video was not the first collision. After the first collision, the "multi-collision braking" function of the vehicle was triggered, so the brake light was turned on in the video. The background data also shows that the driver did not step on the brake pedal within 2 seconds after the collision in the video.

　　In view of the fact that the vehicle did not stop in time, Tesla said that by checking the background data, the driver stepped on the brake pedal 2 seconds after the collision in the video. However, combined with the background data and the damaged state of the vehicle, after the first collision, the front wheel of the vehicle has fallen off, the braking system pipeline has been damaged, and the vehicle has been unable to brake normally.

　　It is worth noting that this accident is not the first storm in Tesla’s braking, and related "brake failure" incidents have emerged in an endless stream in recent years.

　　The whole story of "Shanghai Auto Show Roof Rights Protection Event"

　　At the 2021 Shanghai Auto Show, two Tesla owners dressed in "brake failure" made a big fuss about Tesla booth demanding rights protection. Since then, Tesla has been shrouded in the suspicion of "brake failure".

　　On the afternoon of the auto show, Tao Lin, vice president of Tesla China, responded to this matter: Tesla had no way to compromise. The next morning, Weibo, the official of Qingpu Branch of Shanghai Public Security Bureau, issued a notice saying: Zhang, a woman involved in the "Tesla Auto Show Encountered Owners’ Rights Protection" incident, was sentenced to administrative detention for five days for disturbing public order, and Li was given an administrative warning for disturbing public order.

　　Since then, the two sides have opened the curtain of going to court, and whether Tesla has "brake failure" has also attracted much attention.

　　On May 6, 2021, Ms. Zhang formally sued Tesla (Shanghai) Co., Ltd., Tesla (Beijing) Co., Ltd. and Tao Lin, global vice president of Tesla. Ms. Zhang believes that after the rights protection incident at the Shanghai Auto Show, some remarks made by Tao Lin and Tesla officials were intended to create a negative image of the plaintiff’s unreasonable troubles and professional car troubles, which violated their reputation and caused troubles to their lives. These remarks include "all the recent negatives are her contribution", "only willing to pay high compensation" and the so-called "there is a team from Beijing". Ask the defendant to stop the infringement of the plaintiff’s reputation right, apologize to him and pay 50 thousand yuan for mental damage.

　　Two years later, Tesla issued a document in response to the failure of the female car owner of Tesla’s roof rights protection: the female car owner of Shanghai Auto Show advocated that the woman sued Tesla’s reputation right dispute case and personal information protection dispute case. After trial, the court of first instance decided to reject all the claims of Ms. Zhang in the two cases. On November 22, 2023, Tesla v. the case of infringement of the reputation right of female car owners in Xi ‘an "Shanghai Auto Show Incident", the court made a first-instance judgment, and found that Ms. Li in Xi ‘an was guilty of reputation infringement, and she had to publicly apologize to Tesla and compensate for the losses, and at the same time bear the vehicle appraisal fee.

　　Recently, according to Tesla’s news, the court made the latest judgment in the case of Tesla v. another female car owner in Xi ‘an, who was involved in the right to defend the roof of Shanghai Auto Show, and found that Ms. Li in Xi ‘an was guilty of reputation infringement, and she had to apologize to Tesla publicly and pay 2,000 yuan, and at the same time bear the vehicle appraisal fee of 20,000 yuan. After identification, there is no braking problem in the vehicle involved.

　　It is reported that before this, the judgment was made in December 2021, and the result was that Ms. Li won the case. Tesla then filed an appeal, and the Xi ‘an Intermediate People’s Court ruled that the case was sent back for retrial. On November 9, 2023, the weiyang district court made a new judgment, and the verdict was that Ms. Li lost the case. For the result of Tesla’s victory in the first instance, Ms. Li said that she respected the court’s decision, but she would appeal again.

　　It is worth noting that in March 2021, Weibo, the "Tesla Customer Support", said that the accident liability certificate issued by the traffic police showed that Mr. Zhang (the owner’s father) was found to have violated the relevant laws on safe driving and keeping a safe distance from the vehicle in front, and should bear full responsibility for the accident.

　　After the "Shanghai Auto Show Rights Protection" took place, Tesla provided the data one minute before Ms. Zhang’s vehicle accident, and made a written explanation, which stated that when the driver stepped on the brake pedal for the last time, the data showed that the vehicle speed was 118.5 kilometers per hour. Within 2.7 seconds after the driver stepped on the brake pedal, the maximum brake master cylinder pressure was only 45.9bar. After that, the driver stepped on the brake pedal more, and the brake master cylinder pressure reached 92.7bar. Then, the forward collision warning and automatic emergency braking function started (the maximum brake master cylinder pressure reached 140.7bar) and played a role, reducing the collision amplitude. 1.8 seconds after the ABS action, the system recorded the collision. After the driver stepped on the brake pedal, the vehicle speed continued to decrease, and before the collision, the vehicle speed decreased to 48.5 kilometers per hour. Through the inspection and analysis of vehicle data and on-site photos, it is found that ABS works normally during the braking period of the vehicle, and the functions of forward collision warning and automatic emergency braking are started and played a role, and no abnormality is found in the vehicle braking system.

　　At this point, the dispute over rights protection at the Shanghai Auto Show has also come to an end for the time being. Although Tesla won the rights protection, the price it paid was also heavy. In the face of rights-defending car owners, Tesla CEO Musk dissolved the public relations department and showed a tough attitude of refusing to apologize. Tao Lin, global vice president of Tesla, publicly told the media that Tesla had no way to compromise and asked consumers to strengthen education and study. This attitude caused dissatisfaction among many car owners in China, which made Tesla’s share price plummet at that time, and its market value evaporated by hundreds of billions of dollars overnight.

　　In the lawsuit with Ms. Li, Tesla asked Ms. Li to pay 5 million yuan in the first instance, but the amount of compensation awarded was only 2,000 yuan. On November 27th, Tesla said that it would continue to appeal. The incident caused huge losses to it, and the loss of Tesla’s orders and goodwill was as high as 100 million yuan as assessed by the judicial evaluation agency.

　　Give up the "single pedal" mode

　　In the storm of Tesla’s "brake failure", the "single pedal" mode seems to have become the target of public criticism.

　　This year, Tesla recalled 1.1 million Tesla cars around the world. The announcement on the website of the General Administration of Quality Supervision, Inspection and Quarantine once said that drivers were not allowed to choose the energy recovery braking strategy for vehicles within the scope of this recall; At the same time, it may not provide enough reminder for the driver to step on the accelerator pedal for a long time. The superposition of the above factors may increase the probability of mistakenly stepping on the accelerator pedal for a long time, which may increase the risk of collision and pose a safety hazard.

　　In the analysis of professionals, Tesla’s kinetic energy recovery technology is the strongest in the industry. Through kinetic energy recovery, it can save about 20% of energy and improve the endurance by about 15%-20%. Moreover, Tesla’s energy recovery mode is mandatory default mode, and the owner can’t set it by himself and can’t choose to turn it off. Most of the energy recovery modes of other electric vehicles on the market give the owners the freedom to choose.

　　Many users reported to 21st century business herald that the "single pedal" mode was not suitable for use at first, but it was really "fragrant" after being used to it, but some users still could not accept the "single pedal" mode.

　　Tesla said that the "single pedal" mode is more convenient and efficient. However, there are also risks. A survey report in 2021 showed that the National Highway Traffic Safety Administration (NHTSA) had investigated 246 cases of Tesla’s runaway acceleration, and all 246 cases were caused by stepping on the wrong pedal.

　　"There is no evidence that there is any fault in the accelerator pedal assembly, motor control system or braking system that leads to accidents, and there is no evidence that design factors will increase the possibility of pedal misuse." NHTSA said.

　　The so-called "single pedal" mode, in simple terms, can realize starting, accelerating, decelerating (braking) and other operations only by controlling the switch pedal. In this mode, kinetic energy recovery can not only save electricity, but also reduce the use of brakes, which can improve the cruising range of electric vehicles. Although the "single pedal" mode is not only equipped with one pedal, it is still equipped with a brake pedal. However, in this mode, users put their feet on the accelerator pedal instead of the brake pedal for a long time, which changes the way users are used to driving traditional fuel vehicles, but there may be potential safety hazards in an emergency.

　　Tesla has cancelled the "Kinetic Energy Recovery Adjustment Option" since the beginning of 2021, that is, on Tesla cars, this function is mandatory, not a switchable option. According to Tesla, after the OTA recall, car owners who like energy recovery braking can continue to choose the "standard" mode, and control the speed by "foot feeling", while improving the endurance of the vehicle by 10%-20% and reducing the wear of brake discs and pads. Car owners who are not used to this function can now choose the "low" mode to transition.

　　Although Tesla returned the option of kinetic energy recovery to the public, there are still other doubts that not recognizing the wrong operation of the owner can explain all the accidents of Tesla vehicles out of control and brake failure. Tesla’s roof rights car advocates that the top of Ms. Weibo is the video of Tesla Hainan accident released by another well-known Tesla rights car owner. The car owner can’t step on the brakes, but the staff will open the video that still can’t step on the brakes. In its latest Weibo, it forwarded a video recorded by another Tesla owner who obviously stepped on the brake system but mistook the owner for stepping on the accelerator.

　　There is also a question about whether Tesla’s data is reliable. "All data collection is based on Tesla’s unilateral provision, and Tesla only records the data collected by itself in the background. Is this data record objective? For example, if the owner steps on the brake, but can’t step on it, is it recorded in the background that he didn’t step on it? The owner did not step on the acceleration, and the vehicle automatically accelerated. Will the background also be recorded as acceleration, which means that the owner is stepping on the switch? "

　　Regarding the data problem, industry experts also said that there is no institution in China that has the professional ability to detect the data of smart electric vehicles. Zhang Xiang, a member of the automotive industry expert think tank of the Ministry of Industry and Information Technology, said in an interview with the media: "Now the institutions on the market basically only test mature and long-developed technologies, that is, mainly test traditional cars. As a smart car, Tesla can’t be tested according to the standards of traditional cars. Moreover, Tesla’s time to market is not long, and the technical iteration is changing with each passing day. Our regulations and industry standards have not kept up. "

　　There have been different opinions about the real cause of Tesla accident. Whether it is the owner’s "habitual thinking" or the quality of car design, the result of frequent vicious traffic accidents is unacceptable. At the moment of rapid development of new energy vehicles, car safety is the most important issue, and it needs the joint efforts of many parties to form effective supervision.

All relevant units:

　　The Measures for the Rapid Review and Approval of Medical Devices in Beijing have been deliberated and adopted at the 5th Director’s Office Meeting of Beijing Food and Drug Administration in 2018, and are hereby issued, please follow them.

Beijing Food and Drug Administration

February 9, 2018

Measures of Beijing Municipality for the Examination and Approval of Rapid Review of Medical Devices

　　the first　According to the requirements of the Notice of the General Office of the State Council City, the General Office of the Central Committee of the CPC on Printing and Distributing Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Medicines and Medical Devices (Z.Z. [2017] No.42), according to the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of the Registration of Medical Devices, the Measures for the Administration of the Registration of In-vitro Diagnostic Reagents and the Policy Matters of the Food and Drug Administration on Supporting the Supervision and Industry Development of Zhongguancun, In order to encourage innovation, encourage the transformation of scientific and technological achievements, improve the efficiency of examination and approval of medical devices in Beijing, and promote the rapid development of medical device industry in Beijing, these measures are formulated.

　　the second　For Beijing medical device products that meet one of the following circumstances, the applicant may apply to Beijing Food and Drug Administration for approval of innovative medical devices:

　　(1) Having relevant national and Beijing scientific research projects, and the patents of core technology inventions involved have been made public or authorized.

　　(2) The invention patent of the core technology, which is the first in Beijing, has the leading product technology in China, has great clinical application value and is involved, has been made public or authorized.

　　(3) Patents for core technology inventions produced by key enterprises in Beijing, such as the 100-thousand-cultivation project and the Beijing Biomedical Industry Leap-forward Development Project (G20), have been made public or authorized.

　　(four) included in the national or Beijing major science and technology projects, key research and development plans;

　　Article　For the implementation of innovative medical devices in accordance with the provisions of Article 2 of these Measures, the person in charge shall be responsible, and early intervention, whole-process counseling, priority registration and testing, priority review and approval, priority registration quality system verification and priority production license matters shall be handled. See Annex 1 for the application requirements of innovative medical devices in Beijing.

　　Article 4　According to the application of the enterprise, Beijing Medical Device Technology Evaluation Center provides pre-consulting services for innovative clinical trial schemes of medical devices that meet the requirements of Article 2 of these Measures.

　　Article 5　For innovative medical devices that meet the requirements of Article 2 of these Measures, enterprises may entrust Beijing medical device manufacturing enterprises to produce products, and the medical device production license of the entrusted party shall obtain the corresponding production scope.

　　Article 6　For innovative medical devices, a cross-disciplinary joint evaluation method can be implemented.

　　Article 7　For innovative medical devices in Beijing that have been listed in the first registration cycle, all adverse medical device events of the product shall be reported and a summary report on monitoring, analysis and evaluation of adverse medical device events shall be submitted to the Beijing medical device adverse event monitoring technical institution and the food and drug administration department in the jurisdiction every year.

　　Article 8　For Beijing medical device products that meet one of the following circumstances, the applicant may apply to Beijing Food and Drug Administration for priority approval of medical devices:

　　(1) It is urgently needed in clinic, and there is no product of the same variety approved for registration in China;

　　(two) the varieties of medical devices belonging to the Beijing medical materials reserve unit and the unique and frequently-occurring diseases of children or disabled people;

　　(3) Diagnosing or treating rare diseases with obvious clinical advantages;

　　(four) for the treatment of serious life-threatening diseases and there is no effective treatment, as well as public health and other urgent needs;

　　(5) Intelligent rehabilitation apparatus;

　　(six) Beijing innovative medical device products to improve the production process.

　　Article 9　For medical device products that meet the requirements of Article 8 of these Measures, priority shall be given to registration and testing, priority shall be given to review and approval, priority shall be given to the verification of registration quality system, and priority shall be given to the handling of production licensing matters. Please refer to Annex 2 for the application requirements for priority approval of medical devices in Beijing.

　　Article 10　For the change of medical device registration license matters, the specification of product name, product technical requirements, scope of application, etc. does not involve substantial content changes, which can be combined with the renewal of registration.

　　Article 11　If the recommended standards, the guiding principles of registration technology review and the norms of registration technology review change in the renewal registration of medical devices, the enterprise may not change the licensing matters.

　　Article 12　If the specifications and models of medical devices are reduced, they can be handled in accordance with the registration procedures.

　　Article 13　For in vitro diagnostic reagent products, it is not necessary to submit analytical performance evaluation data, risk analysis data related to product changes, product technical requirements, product specifications and label samples by increasing the packaging specifications with different loading quantities (only the loading differences) and adding the changes of licensing items for applicable models with the same degree of automation. The time limit for registration review was shortened to 30 working days.

　　On the basis of strictly implementing the requirements of the quality system, the enterprise completes relevant risk analysis, performance evaluation, design changes, etc., and keeps records for future inspection.

　　Article 14　Those who fail to apply for registration renewal six months before the expiration of the validity period shall be registered for the first time. If the product has not changed, the latest registered clinical data, registration test report and system verification results may be submitted.

　　Article 15　Formulate the technical guidelines for clinical evaluation of medical devices in Beijing, study the comparison methods of similar medical devices, and simplify the clinical evaluation data of the same variety of medical devices.

　　Article 16　Beijing Medical Device Technology Evaluation Center has established a communication mechanism for enterprises to solve the difficult problems encountered by enterprises in the registration and evaluation stage of medical devices.

　　Article 17　Integrate the on-site inspection of the registered quality system verification and the on-site inspection of the production license. In principle, after the on-site inspection of the new product registration quality system verification has passed and the medical device registration certificate has been obtained, the products added to the Medical Device Production License can be exempted from the on-site inspection.

　　Article 18　For enterprises that have obtained production licenses, applying for the registration of Class II medical devices that do not involve new methodology or new technology may be exempted from on-site inspection or optimization of on-site inspection items and processes in the process of registration quality system verification.

　　Article 19　If the contents of the change of medical device registration license items do not involve the change of production process, the on-site inspection may be exempted or the on-site inspection items and processes may be optimized in the process of registration quality system verification.

　　Article 20　For those who have passed the on-site inspection of registered quality system verification at least once in two years, and the products applied for inspection this time have the same or similar working principles and expected uses compared with those that have passed the inspection, and have basically the same structural composition, production conditions and production processes, they are exempted from on-site inspection or optimized on-site inspection items and processes in the process of registered quality system verification.

　　Article 21　If the production address is reduced and the production process changes are not involved, the on-site inspection can be exempted or the on-site inspection items and processes can be optimized during the approval of the production license.

　　Article 22　In principle, on-site re-inspection is not required if no key project defects are found in the on-site inspection of the registered quality system, and the number of general project defects accounts for less than 10% of the total number of general projects that should be inspected.

　　Article 23　If the on-site inspection of the production license requires the enterprise to carry out rectification, the enterprise may be required to submit rectification report and rectification data according to the situation of the on-site inspection and the rectification items, and the on-site re-inspection is not required if it can be verified through the data.

　　Article 24　Optimize the registration examination and approval procedures, and cancel the following examination and review links in the administrative examination and approval of medical device registration:

　　(1) First registration of Class II medical device products (including in-vitro diagnostic reagents) that fully implement the guiding principles of product registration technology review issued by china food and drug administration or the product registration technology review norms issued by Beijing Food and Drug Administration;

　　(two) the second class of medical devices (including in vitro diagnostic reagents) continued registration;

　　(three) the second kind of medical devices (excluding in vitro diagnostic reagents) product description changes;

　　(four) the second kind of medical devices (including in vitro diagnostic reagents) product registration certificate error correction.

　　Article 25　These Measures shall not apply to domestic applicants who apply for approval of innovative medical devices to Beijing Food and Drug Administration according to the Notice of the General Administration of Food and Drug Administration on Printing and Distributing Special Approval Procedures for Innovative Medical Devices (Trial) (No.13 [2014] of the Food and Drug Administration).

　　Article 26　These Measures shall be interpreted by the Beijing Food and Drug Administration.

　　Article 27　These Measures shall come into force as of the date of promulgation. The Measures for the Examination and Approval of Medical Devices in Beijing (Trial) issued on August 11, 2016 (Beijing Food and Drug Administration [2016] No.36) was abolished at the same time.

　　Attachment: 1. Requirements for reporting innovative medical devices in Beijing.

　　 　 　 　2. Requirements for priority examination and approval of medical devices in Beijing

Annex 1

Requirements for reporting innovative medical devices in Beijing

　　In order to standardize the application for innovative medical devices in Beijing and improve the quality of application materials, this application requirement is formulated in accordance with the Measures for the Examination and Approval of Rapid Medical Devices in Beijing.

　　I. Application materials for innovative medical devices in Beijing

　　(a) Beijing innovative medical device review application form (Annex 1)

　　The applicant shall truthfully fill in all the contents.

　　The contents filled in the product performance structure and composition, main working principle/action mechanism and expected use should reflect all the important information of product characteristics, be concise and to the point, use standardized and professional terms, and avoid ambiguity.

　　(2) Relevant information of previous applications for innovative medical device approval (approval) (if applicable)

　　If the product has applied for innovative medical device products from china food and drug administration or Beijing Food and Drug Administration, for the innovative medical devices that have been applied for again, copies of previous notices shall be provided, and explanations on product changes and improvement of application materials shall be submitted.

　　(3) A photocopy of the business license of the enterprise to which it applies.

　　(four) the intellectual property rights of the products and the supporting documents.

　　1. Provide a description of the intellectual property rights of the core technology of the innovative medical device applied for. If there are many invention patents, it is suggested to display the information such as the name of the invention patent, the patentee and the patent status in a list.

　　2. Provide relevant intellectual property documents.

　　(1) If the applicant has obtained the patent right for invention, it is required to provide the original copy of the patent power of attorney, the patent claim, the specification and the copy of the patent register signed by the applicant.

　　(2) If the applicant has obtained the right to use the invention patent in China through the transferee according to law, in addition to submitting the copy of the patent authorization, patent claim, specification and patent register held by the patentee, it is also necessary to provide the original Certificate of Filing the Patent License Contract issued by the patent administrative department.

　　(3) If the application for a patent for invention has been made public by the patent administration department of the State Council and is not authorized, it is necessary to provide a copy of the proof document of the publication of the invention patent signed by the applicant (such as the notice of publication of the application for a patent for invention, the notice of publication of the application for a patent for invention and the notice of entry into the substantive examination stage, etc.) and a copy of the published version of the claim and specification. In the process of examining an application for a patent for invention, if the patent claim and specification are modified at the request of the patent examination department, the modified text shall be submitted; Where the patentee changes, the certifying documents issued by the competent patent department, such as a copy of the notice of conformity, shall be submitted.

　　(V) Summary of product development process and results

　　Summarize the original intention of product research and development, laboratory research, animal experimental research, clinical research and results, and submit a comprehensive report on product research and development including design input, design verification and design output. Information on patient selection criteria, as well as parameters to be monitored and factors to be considered during use.

　　(6) Product technical documents, which shall at least include:

　　1. The intended use of the product;

　　(1) It should be made clear that the treatment and diagnosis expected to be provided by the product conform to the purpose defined in Article 76 of the Regulations on the Supervision and Administration of Medical Devices, and the applicable medical stage (such as monitoring and rehabilitation after treatment) can be described;

　　(2) explain whether the product is used once or repeatedly;

　　(3) A description of the equipment expected to be used in combination with it;

　　(4) Information of the target patient population (such as adults, children or newborns).

　　2. Working principle/action mechanism of the product;

　　Elaborate the working principle/mechanism of the product to achieve its expected use, and provide relevant basic research data.

　　3. Make clear the main technical indexes of products and the basis for determination, the index requirements of main raw materials and key components, the main production process and flow chart, and the inspection methods of main technical indexes.

　　(seven) certification documents of product innovation, which shall at least include:

　　1. Novelty retrieval report issued by information or patent retrieval institutions.

　　It should be a sci-tech novelty report issued by information retrieval institutions in China or a novelty report issued by patent retrieval institutions. The contents of the report should be able to prove the innovation point, innovation level and reasons of the product. The novelty retrieval report is valid for one year.

　　2. Summary of academic papers, monographs and documents published in core journals that can fully explain the clinical application value of products (if any)

　　Can provide product literature, but also provide overseas literature of similar products.

　　3. Analysis and comparison of the application of similar products listed at home and abroad.

　　(1) Provide a description of the retrieval of similar products that have been listed in China. Generally, it should include the retrieval database, retrieval date, retrieval keywords and the results retrieved by each keyword, and analyze the differences between the applied innovative medical devices and similar products on the market in terms of working principle/mechanism.

　　(2) Provide an explanation of the application of similar products listed overseas, compare and analyze the similarities and differences with this product, and provide comparative analysis data to support this product to be at the international leading level in technology.

　　4. The innovative content of the product and its remarkable value in clinical application.

　　(1) Overview of innovative medical devices applied for.

　　This paper expounds the innovative contents of the applied medical device, and discusses that the device has been significantly improved in terms of safety, effectiveness and economy compared with the existing products or treatment methods through innovation, and has significant clinical application value.

　　(2) Provide relevant supporting materials.

　　(eight) product safety risk management report.

　　1. Based on the research results of the risk management process carried out by the product.

　　2. Prepared according to YY/T 0316 "Application of Medical Device Risk Management to Medical Devices".

　　(9) Product description (sample draft).

　　It shall comply with the relevant requirements in the Regulations on the Administration of Instructions and Labels of Medical Devices (Order No.6 of the General Administration).

　　(ten) other documents that prove that the product conforms to Article 2 of the Measures for the Examination and Approval of Medical Devices in Beijing.

　　1. If the product or its core technology has won national and Beijing municipal science and technology awards, please explain and submit copies of relevant supporting documents;

　　2. The approval certificate of key supporting enterprises in Beijing, such as the 100 thousand cultivation project and the Beijing biomedical industry leap-forward development project (G20).

　　3 included in the national or Beijing major science and technology projects, key research and development plan documents.

　　(eleven) the self-assurance statement of the authenticity of the submitted materials.

　　Second, the format requirements

　　(a) the application materials shall be compiled by the applicant, and the documents shall be printed on A4 paper, arranged in the order specified in this acceptance requirement and bound into a book.

　　(two) there should be a list of submitted materials, including the first and second titles of the application materials. The data corresponding to each secondary heading shall be separately numbered.

　　(3) Unless otherwise specified, the application materials for the review of innovative medical devices in Beijing shall be original and signed by the applicant. "Signature" refers to the seal of the enterprise, or the signature of its legal representative and responsible person plus the seal of the enterprise.

　　(four) if the application materials are in photocopy, the photocopy shall be clear and consistent with the original. Color pictures and charts shall be provided with color copies. If the original application materials have been submitted in the previous application for examination of innovative medical devices, a copy signed by the applicant can be provided, and the applicant will issue a document stating the acceptance number of the application materials where the original application materials are located.

　　(5) The application materials shall be in Chinese. If the original text is in a foreign language, there should be a Chinese translation.

　　Third, the review process

　　To apply for innovative medical device products in our city, after the above materials are prepared, they shall be reported to the Medical Device Registration and Supervision Department of the Municipal Bureau (hereinafter referred to as the "Device Department"), and the Device Department shall formally review the application materials, and issue a receipt document (Annex 2) within 5 working days; The device will be reviewed by relevant experts within 40 working days, and the applicant and product name will be publicized on the website of Beijing Food and Drug Administration for 10 working days for the varieties to be included in Beijing’s innovative medical devices. If there is no objection after the publicity period, a final review opinion will be issued, and a notice of review of innovative medical devices in Beijing (Annex 3) will be made to inform the applicant in writing.

　　Attachment: 1. Application Form for Review of Innovative Medical Devices in Beijing

　 　 　 　　2. Beijing Innovative Medical Devices Review Receipt Certificate

　 　 　 　　3. Notice of Review Opinions on Innovative Medical Devices in Beijing

Annex 1 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Annex 2 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Beijing Innovative Medical Device Review Receiving Material Voucher

(first copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of innovative medical devices in Beijing. After formal examination, the application materials are complete and it is decided to accept it. A total of _ _ pieces of materials were received.

　　Tel: 010-83979525

　　Receiver’s signature: year month day

Beijing Innovative Medical Device Review Receiving Material Voucher

(second copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of innovative medical devices in Beijing. After formal examination, the application materials are complete and it is decided to accept it. A total of _ _ pieces of materials were received.

　　Tel: 010-83979525

　　Signature of the applicant: year month day

Annex 3 of Beijing Municipality’s Declaration Requirements for Innovative Medical Devices

Notice of Beijing Municipality on Review Opinions of Innovative Medical Devices

　　(No.:_ _ _ _ _)

　　The application for examination of innovative medical devices in Beijing submitted by your company (receiving material number:)

　　Performance structure and composition:

　　Main working principle/mechanism:

　　The conclusion of the review is:

.

　　I hereby inform you.

(Seal)

Date:

Annex 2

Requirements for Priority Approval and Declaration of Medical Devices in Beijing

　　In order to standardize the application for priority approval of medical devices and improve the quality of application materials, this application requirement is formulated in accordance with the Measures of Beijing Municipality for Rapid Review and Approval of Medical Devices (Revised).

　　First, Beijing gives priority to the examination and approval of medical device application materials.

　　(1) Application Form for Priority Approval of Medical Devices (Annex 1)

　　Clearly explain the circumstances specified in Article 14 of the Measures for the Rapid Review and Approval of Medical Devices in Beijing (Revised), and briefly describe the reasons for priority approval.

　　(two) a copy of the application form for registration of medical devices.

　　(three) in accordance with the "Beijing medical device rapid review and approval measures" eighth cases of medical device priority approval application, should provide information according to the following requirements:

　　1 clinical needs, and there is no product of the same variety approved for registration in China.

　　(1) Summary of the clinical treatment status of the indications of this product, explaining the reasons for urgent clinical need;

　　(2) The overseas approval and clinical use of this product and similar products;

　　(3) Provide a description of the search, which proves that there are no related products of the same variety approved for registration in China at present, and there is no equivalent alternative diagnosis or treatment method at present.

　　2. The medical device reserve varieties belonging to the Beijing medical material reserve unit and the medical device varieties used by children or disabled people with unique and multiple diseases.

　　(1) the certificate of entering the catalogue of medical material reserve units in Beijing;

　　(2) The indication of this product belongs to the supporting data of unique and frequently-occurring diseases of children or disabled people;

　　(3) Summary of the clinical treatment status of this indication;

　　(4) Description and relevant supporting materials proving that the product is specially used for diagnosing or treating unique and frequently-occurring diseases of children or disabled people, and has obvious clinical advantages compared with existing products or treatment methods.

　　3 diagnosis or treatment of rare diseases, and has obvious clinical advantages.

　　(1) Incidence data of the indications of this product and relevant supporting data;

　　(2) Supporting data to prove that the indication is a rare disease;

　　(3) Summary of the clinical treatment status of this indication;

　　(4) Description of the obvious clinical advantages of this product compared with the existing products or treatment methods and relevant supporting materials.

　　4 for the treatment of serious life-threatening diseases and there is no effective treatment, as well as public health and other urgent needs.

　　(1) To prove that the indication belongs to the urgently needed supporting information for treating diseases that are seriously life-threatening and have no effective treatment methods, and public health;

　　(2) Summary of the clinical treatment status of this indication;

　　(3) the product has obvious clinical advantages over the existing products or treatment methods, and relevant supporting materials.

　　5. Intelligent rehabilitation apparatus

　　(1) Medical devices that meet the definition of intelligent rehabilitation devices in the "Thirteenth Five-Year Plan for Scientific and Technological Innovation of Health Industry" (No.149 [2017] of National Science and Technology Development Agency);

　　(2) Summary of the clinical treatment status of this indication;

　　(3) the product has obvious clinical advantages over the existing products or treatment methods, and relevant supporting materials.

　　6. Improve the production process of innovative medical device products in Beijing.

　　(1) Notice of Review Opinions on Innovative Medical Devices in Beijing;

　　(2) Description of production process changes of new and old products.

　　(4) A self-assurance statement on the authenticity of the submitted materials.

　　Second, the format requirements

　　(a) the application materials shall be compiled by the applicant, and the documents shall be printed on A4 paper, arranged in the order specified in this acceptance requirement and bound into a book.

　　(two) there should be a list of submitted materials, including the first and second titles of the application materials. The data corresponding to each secondary heading shall be separately numbered.

　　(3) Unless otherwise specified, the application materials for the examination and approval of priority medical devices in Beijing shall be original and signed by the applicant. "Signature" refers to the seal of the enterprise, or the signature of its legal representative and responsible person plus the seal of the enterprise.

　　(four) if the application materials are in photocopy, the photocopy shall be clear and consistent with the original. Color pictures and charts shall be provided with color copies. If the original application materials have been submitted in the previous priority examination and approval of the medical device application, a copy signed by the applicant can be provided, and the applicant will issue a document stating the acceptance number of the application materials where the original application materials are located.

　　(5) The application materials shall be in Chinese. If the original text is in a foreign language, there should be a Chinese translation.

　　Third, the review process

　　To apply for the priority approval of medical device products in our city, after the above materials are prepared, they shall be reported to the Medical Device Registration and Supervision Department of the Municipal Bureau (hereinafter referred to as the "Device Department"), and the Device Department shall conduct a formal review of the application materials, and issue a receipt document (Annex 2) within 5 working days; The device shall be reviewed by relevant experts within 40 working days, and the applicant and product name shall be publicized on the website of Beijing Food and Drug Administration for 10 working days for the varieties of medical devices to be approved in Beijing. If there is no objection after the publicity period, a final review opinion will be issued, and a notice (Annex 3) for the review of medical devices with priority approval in Beijing will be made, and the applicant will be informed in writing.

　　Attachment: 1. Application Form for Priority Approval of Medical Devices in Beijing

　 　 　 　　2. Beijing Municipality gives priority to the examination and approval of medical devices, and receives the certificate of materials.

　　 　 　 　3. Notice of Beijing Municipality on Priority Examination and Approval of Medical Devices

Annex 1 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Annex 2 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Beijing Municipality gives priority to the examination and approval of medical devices.

(first copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of medical devices with priority approval in Beijing. After formal examination, the application materials are complete and it is decided to accept it. Total materials received　Pieces.

　　Tel: 010-83979525

　　Receiver’s signature: year month day

Beijing Municipality gives priority to the examination and approval of medical devices.

(second copy)

　　(Receiving material number: _ _ _ _ _)

　　：

　　Your company applied for the examination of medical devices with priority approval in Beijing. After formal examination, the application materials are complete and it is decided to accept it. Total materials received　Pieces.

　　Tel: 010-83979525

　　Signature of the applicant: year month day

Annex 3 of the Declaration Requirements for Priority Approval of Medical Devices in Beijing

Notice of Beijing Municipality on Priority Examination and Approval of Medical Devices

　　(No.:_ _ _ _ _)

　　Your application for the examination of medical devices in Beijing with priority approval (receiving material number:)

　　Performance structure and composition:

　　Main working principle/mechanism:

　　The conclusion of the review is:

.

　　I hereby inform you.

(Seal)

Date:

　　People’s Daily Online, Beijing, January 4 (Zhu Jiang) "China is one of the countries most seriously affected by marine disasters in the world." The reporter learned from the Ministry of Natural Resources that according to the statistics of the Marine Early Warning and Monitoring Department, in the past 10 years, the average annual direct economic loss of marine disasters was 11.7 billion yuan, with an average annual death (including missing) of 93 people. In recent 30 years, the average sea level rise rate in China is 3.3 mm/year, which is higher than the global average. Under the background of global climate change, the risk of major marine disasters along the coast is becoming increasingly prominent. With the rapid increase of marine economic activities, the offshore waters are seriously polluted and the marine ecological environment is destroyed.

　　During the institutional reform of the central and state organs, the Ministry of Natural Resources set up a marine early warning and monitoring department to fulfill the responsibilities of marine disaster prevention and mitigation, whose main responsibilities include "formulating policies and systems for marine observation and forecast and marine scientific investigation and supervising their implementation. To carry out marine ecological early warning and monitoring, disaster prevention, risk assessment and hidden danger investigation and management, and issue warnings and bulletins. Construction and management of the national global ocean stereoscopic observation network, and organization of marine scientific investigation and survey. Participate in emergency response to major marine disasters. "

　　Wang Hua, deputy director of the Marine Early Warning and Monitoring Department, made it clear that it provided an important organizational guarantee for the effective implementation of the principles, policies and decision-making arrangements of the CPC Central Committee and the State Council on the prevention and control of natural disasters. The first task of the Marine Early Warning and Monitoring Department is to do a good job in the top-level design of marine observation and forecast and marine scientific investigation, and the second is to continuously improve the basic capabilities of marine observation, monitoring and investigation, and further improve the marine early warning and monitoring business system. At the same time, it is necessary to make overall plans for the connection between marine disaster prevention and mitigation, land space planning and ecological protection and restoration.

　　At present, marine early warning and monitoring work faces five problems.

　　"What we are facing is a situation where challenges and opportunities coexist." On November 7, 2018, in a series of interview programs with the Director of the Department of Natural Resources, Wang Hua said that after years of development, marine observation, early warning and disaster reduction have formed a good working foundation. In 2012, the State Council promulgated the Regulations on the Administration of Marine observation and forecast, which filled the legal gap in the work of marine observation and forecast in China. After decades of development, the ocean observation business system has gradually formed, which consists of ocean station network, buoy network, radar network, volunteer ship, satellite remote sensing and so on, basically covering China’s inshore, offshore and some key sea areas. Established a marine forecasting system from national to local. The focus of disaster prevention and mitigation has been constantly moving forward, and the business system of marine disaster risk prevention has basically taken shape.

　　Wang Hua believes that the current marine early warning and monitoring work faces five problems. First, the laws, regulations and institutional standards of marine observation and forecast and related fields of disaster prevention and mitigation are not yet complete. Second, the basic ability still needs to be strengthened. The ocean view monitoring system needs to be further optimized, the ability of deep-sea observation is insufficient, the independent research and development of ocean forecasting and the application level of key technologies need to be improved, and the work of marine disaster risk assessment and hidden danger investigation has not been fully carried out. Third, the information resource sharing mechanism needs to be established. The sharing of information resources in disaster-related fields and the management and coordination of ocean observation activities still need to be strengthened. Fourth, the level of science and technology and the ability of global governance need to be improved, and the participation and voice of international ocean affairs governance are not enough. Fifth, it is necessary to further stimulate the vitality of the market and give full play to the role of market mechanisms and social forces in marine disaster prevention and mitigation.

　　The marine early warning and monitoring department should perform three responsibilities.

　　According to the data of China Organization Network, the main responsibilities of the Marine Early Warning and Monitoring Department are: to formulate policies and systems for marine observation and forecast and marine scientific investigation and supervise their implementation. To carry out marine ecological early warning and monitoring, disaster prevention, risk assessment and hidden danger investigation and management, and issue warnings and bulletins. Construction and management of the national global ocean stereoscopic observation network, and organization of marine scientific investigation and survey. Participate in emergency response to major marine disasters.

　　Wang Hua mentioned that the Marine Early Warning and Monitoring Department should perform three responsibilities: First, implement the important arrangements of the CPC Central Committee and the State Council for the prevention and control of natural disasters, and do a good job in the top-level design of marine observation and forecast and marine scientific investigation; The second is to continuously improve the basic capabilities of marine observation, monitoring and investigation, and strengthen the construction of marine ecological early warning and monitoring system; The third is to fully connect with relevant departments and make overall plans for marine disaster prevention and mitigation, land and space planning, ecological protection and restoration.

　　Wang Hua pointed out that in the past, China’s marine observation, forecasting and early warning, disaster reduction and other work were mainly aimed at the physical environment of the ocean and the process of natural disasters. In the future, we should focus more on the principle of realizing "two unifications" (that is, "the Ministry of Natural Resources uniformly exercises the duties of the owner of all natural resources assets of the whole people, and uniformly exercises the duties of controlling all land use and ecological protection and restoration"). For example, accelerate the construction of marine ecological early warning system to provide support for the effective protection of important, sensitive and fragile marine ecosystems; Efforts will be made to strengthen the connection between marine early warning and monitoring, national spatial planning and ecological protection and restoration.

　　The marine early warning and monitoring department will focus on three aspects.

　　Wang Hua said that in the field of marine early warning and monitoring, it is the basic work to dynamically monitor the state of marine resources and environment and grasp the basic situation. It is necessary to find problems through long-term series monitoring, and judge whether the carrying capacity of resources and environment is in a normal state through statistical analysis and evaluation of data, and issue early warning in time. At the same time, put forward some suggestions for specific problems.

　　In this regard, Wang Hua demanded that the next step should focus on three aspects: First, further rationalize the business system, make a good connection with other disaster-related ministries at the national level, and give full play to the supporting role of marine early warning and forecasting under the new emergency management framework to promote comprehensive disaster reduction; At the local level, strengthen guidance, coordination and supervision, and actively play the role of local authorities. At the same time, further clarify the responsibilities of the agencies in the sea area, and form a unified and orderly, reasonable division of labor, coordinated and efficient institutional mechanism.

　　Second, actively implement the requirements of the third meeting of the Central Financial and Economic Committee on the prevention and control of marine disasters, implement coastal zone restoration projects, build ecological seawalls, and improve the ability of ecosystems to defend against marine disasters.

　　The third is to implement the main responsibility and continuously improve business capabilities. In the "Sanding" plan issued by the Ministry, for the first time, the task of building and operating the national global marine stereoscopic observation network and carrying out marine ecological early warning and monitoring was clearly defined. As the competent department of business, the marine early warning and monitoring department should adhere to the scientific development concept and implement every link of the business chain in a down-to-earth manner.

　　To this end, the Marine Early Warning and Monitoring Division will focus on the following four aspects in the near future:

　　— In the observation business, do a good job in top-level design and accelerate the construction of the global marine stereoscopic observation network. Optimize the observation layout. In 2019, we will start to compile a new national ocean observation network plan, fully integrate the observation, monitoring and investigation services, and form a trinity business layout. From the aspects of observation means, observation elements and quality control, we will further strengthen the operational management of marine observation. Promote the sharing of marine observation data, improve the level of data services, strengthen the management of relevant industries of local and departmental departments, and carry out a general survey of marine observation capabilities and resources to achieve full integration.

　　Second, in the forecasting business, we should speed up the revision of emergency plans, and consider the respective characteristics of marine natural disasters and ecological disasters to study how to form a plan system. Reorganize the forecasting organization and business system, comprehensively consider the characteristics of administrative area management, and build a forecasting business system with up-and-down linkage and clear division of labor. Make full use of numerical forecasting, cloud platform, artificial intelligence and other information technologies, carry out the construction of marine intelligent grid forecasting business system and the "Maritime Silk Road" marine environmental protection system, explore the development of marine ecological early warning services, and improve the efficiency of early warning services.

　　Third, in disaster reduction, we will continue to do a good job in preventing and controlling natural disasters such as storm surges, tsunamis and sea ice. At the same time, we will promote ecological disaster reduction, select red tide and green tide-prone areas for pilot prevention and control, and give full play to the ability of mangroves, tamarisk, reeds, seagrass beds and other ecosystems to resist moisture and waves and consolidate dikes and revetments. Guide coastal areas to continue to carry out marine disaster risk assessment and delineation of key defense areas, and promote the investigation and management of potential risks. Strengthen the information application of disaster prevention and mitigation achievements, and integrate background information, observation data, early warning and pre-judgment information in coastal high-risk areas into one system in real time. Intensify publicity and education, popularize knowledge of disaster prevention and mitigation, and actively participate in international governance.

　　Fourth, in terms of ecological monitoring and scientific investigation, optimize the top-level design and system layout of marine ecological monitoring and early warning, establish a technical standard system, and start special research on typical ecosystems. Establish management norms, and institutions and ships engaged in marine survey and monitoring should have unified management requirements. Strengthen the use of volunteer ships, remote sensing and other equipment and means, and integrate development in monitoring, observation and investigation.