月度归档： 2025 年 4 月

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.

On Monday, April 16, 2018, the State Council Press Office held a regular briefing on the State Council policy, and invited Ceng Yixin, deputy director of the National Health and Wellness Committee, to introduce the relevant information on the Opinions on Promoting the Development of "Internet+Medical Health" and answer questions from reporters.

Jiao Yahui, Deputy Director of Medical Administration and Hospital Authority:

There are two modes in the document of Internet hospital: one mode is that medical institutions are the main providers, and medical institutions use Internet information technology to expand service time and space, and take Internet hospital as the second name of medical institutions. There is a very important principle that the services to be provided by Internet hospitals should be consistent with the relevant diagnosis and treatment subjects of entity medical institutions approved by us, that is to say, our hospital is a three-level general hospital, which subject is approved, and what content can Internet hospitals provide accordingly. The second is that some Internet companies and enterprises have applied for Internet hospitals. They have the resources of some high-quality experts, such as doctors in the north and the south of China, who use the platform provided by this Internet company to provide some services for patients. In this document, we require that Internet hospitals must be located in physical medical institutions, with consistent supervision online and offline, and must rely on physical medical institutions to provide patients with telemedicine services such as remote clinics through the Internet platform. Generally speaking, it is such a form.

The Internet hospital you mentioned just now, we are talking about not only Internet hospitals, but also Internet medical services are divided into two categories:

First, around our core business, that is, treating patients, it is generally said that whether the disease needs the next diagnosis, whether to propose a treatment plan and prescribe some prescriptions, this is called Internet diagnosis and treatment service, which is a kind of content of Internet service. We say it is the core business of medical care, and this Internet diagnosis and treatment service, as mentioned by Director Zeng and Director Yu just now, we are drafting and formulating management measures for Internet diagnosis and treatment. This is also a very important supporting document authorized by the National Health and Wellness Committee in the the State Council document. In this document, we will define the bottom line and boundary of Internet diagnosis and treatment, and within this boundary, we can provide some services. For example, as proved by practice now, it also includes internationally mature and recognized telemedicine services. In addition, there are family doctors who provide some health management and online consultation services for the patients he signed. It is stipulated in the document that some common diseases and chronic diseases can be followed up online, and the online follow-up service can also be provided through the Internet, and doctors can prescribe prescriptions for these patients online when they have mastered some basic case data of these patients, which is part of the Internet diagnosis and treatment service.

Second, non-core business, that is, we should provide some auxiliary services to take advantage of the convenience and convenience of the Internet. In this field, Internet technology has great room and great potential. Moreover, in practical application, it has been applied in many practices now, and patients in many places have enjoyed the convenience and bonus in this respect. For example, for example, many patients go to the hospital to see a doctor now, and they can register online and make appointments with a mobile phone, and when they come to the hospital, they can provide some reminders through the mobile phone when they arrive, and they can also pay by mobile phone without queuing up at the window. In addition, some inspection and inspection results can be queried online. This is a great bonus that patients can enjoy in the hospital, and everyone has personal experience. At the same time, we use the internet to sink the good resources of high-quality medical care. For example, the economy and medical care in remote and poverty-stricken areas are not very developed. Through telemedicine or remote outpatient service, some patients in some counties and some patients in remote and poverty-stricken areas can also see experts from these big hospitals in Beishangguang without leaving their place of residence, and they can enjoy this convenient service. We also have some decision-making assistance activities supported by artificial intelligence, including some grassroots doctors and doctors in county and city hospitals, which can greatly improve their medical service level and efficiency, and indirectly serve more patients.

We are now using it in family doctor contract service. For example, we have some rural patients, community patients, elderly people in the community and village clinics at home or at home, and contracted doctors can consult some questions online or at his place. For some problems, village doctors or contracted family doctors can’t solve them, and they can also seek help from the doctors in the superior hospital of this team through the Internet, so that patients can enjoy more convenient, daily health management and safe and appropriate diagnosis and treatment services at home, so I think these are what we say Internet hospitals or Internet diagnosis and treatment can provide.

As for the application procedure of Internet hospitals, because it is a new format, we will seriously solve the problems about the conditions that this kind of medical institutions should have, how to apply, and at which level for examination and approval, in line with the principles and requirements of "streamline administration, delegate power, strengthen regulation and improve services", and will make clear provisions in our management measures for Internet diagnosis and treatment. Thank you.

　　Is aspirin taken on an empty stomach or after meals??

　　Some patients taking aspirin for a long time may cause digestive tract damage. Aspirin-induced digestive tract injury is the result of local and systemic effects. The local effect is that aspirin directly stimulates the digestive tract mucosa, directly damages the gastric mucosa, and also damages the intestinal mucosal barrier. The systemic effect is that it reduces prostaglandin synthesis, and prostaglandin is a substance that can regulate gastrointestinal blood flow, stimulate the synthesis and secretion of mucus and bicarbonate, and protect gastric mucosa.

　　If you take aspirin enteric-coated tablets, there is an acid-resistant coating outside it, and the environment in the stomach is acidic. The acid-resistant coating can protect the acidic environment in the stomach from being dissolved and released, and then it can be slowly released and absorbed in the alkaline environment of the small intestine, thus reducing the direct stimulation to the gastric mucosa and the adverse reactions of the gastrointestinal tract. Therefore, aspirin enteric-coated tablets are recommended to be taken on an empty stomach. Furthermore, taking it on an empty stomach can shorten the retention time in the stomach, and then reach the absorption site of the small intestine smoothly, thus avoiding the gastrointestinal adverse reactions caused by the prolonged retention time in the stomach. However, if you use ordinary aspirin tablets instead of enteric-coated aspirin tablets, there is no such protective mechanism, and such aspirin should be taken after meals.

　　What time do you mean by fasting and after meals??

　　Taking medicine on an empty stomach actually means 1 hour before eating or 2 hours after eating. Taking medicine after meals does not mean taking medicine immediately after meals, but taking it 15-30 minutes after eating.

　　Should aspirin be taken in the morning or at night??

　　This issue is still inconclusive. Some experts believe that the viscosity of platelets at night is higher and the risk of thrombosis is higher, so aspirin should be taken at night to play its antiplatelet role; Some experts also believe that the risk of cardiovascular risk events in the morning is high, so it should be taken in the morning to prevent cardiovascular risk events.

　　Aspirin exerts its antiplatelet effect by irreversibly inhibiting cyclooxygenase, which can exist in the whole life cycle of platelets (about 10 days). Once it takes effect, its antiplatelet effect is persistent. Therefore, aspirin can be taken at any time of the day (morning, noon or evening), and it is important to take it regularly at the same time every day.

　　Can aspirin be taken apart??

　　In most cases, aspirin enteric-coated tablets can’t be opened for use, because the outer coating plays a protective role in gastric mucosa. If you take it open, it will destroy the surface coating and lose the protective effect of enteric-coated tablets. If the dosage is relatively large, aspirin enteric-coated tablets with smaller specifications can be replaced.

　　When can I chew it??

　　You need to chew it when you save yourself from myocardial infarction. Correct pre-hospital first aid is one of the key factors to reduce the mortality rate of myocardial infarction. If there are elderly people over 50 years old or patients with coronary heart disease at home, you should always keep aspirin and take it with you when you go out.

　　The typical symptoms of myocardial infarction are pain in the middle or left part of the sternum, feeling of dying and oppression, accompanied by sweating and nausea. When a patient is suspected of having a myocardial infarction, he can immediately chew up 300 mg of aspirin and call 120. At this time, chewing aspirin enteric-coated tablets can make the drug disintegrate quickly, accelerate the absorption of the drug, and make it play an anti-platelet role more quickly. In addition, before coronary stent surgery, you can also take chewing aspirin to play a quick role.

　　(Peng Wenxing is the pharmacist in charge of the Pharmaceutical Department of Beijing anzhen hospital affiliated to Capital Medical University.)