The State Council issued a document!

Since the new crown epidemic, social medical services have entered the stormy season

As of the end of March 2021, the number of medical and health institutions nationwide has reached 1.

However, some fine-tuning of policies has also left social medical practitioners in a state of entanglement and wait-and-see.

Streamline administration and delegate power! Welcome to the big reform from July 1st

This "separation of licenses and licenses" reform is actually a "deepening" on the basis of the nationwide rollout of the "separation of licenses and licenses" reforms in 2018

The reform requirements are to continue to deepen the reform of "delegation, control and service", coordinate the reform of the administrative examination and approval system and the reform of the commercial system, promote the reduction of licenses and simplify the examination and approval in a wider range and more industries, innovate and strengthen supervision during and after the event, and further optimize The business environment will stimulate the development vitality of market players, and accelerate the construction of a new development pattern in which domestic and international cycles are the mainstay and the domestic and international dual cycles promote each other

The reform goal is to implement the management of a full coverage list of business license matters related to enterprises across the country from July 1, 2021.

Promote the reform of the examination and approval system according to the four methods of direct cancellation of examination and approval, change of examination and approval to filing, implementation of notification commitments, and optimization of examination and approval services.

According to preliminary statistics, the reform of "Separation of Licenses and Licenses" involves 31 medical and health matters, and the "National Edition" involves a total of 24 medical and health industry matters

The following is an explanation of the issues that are good for the society to run a doctor

The approval of the clinic setting has been cancelled!

The five canceled approvals include the approval of the establishment of clinics, the practice license of family planning technical service institutions, the approval of setting up medical institutions, the certificate of qualification of occupational health technical service institutions, and the certificate of qualification of occupational health technical service institutions

The focus is on the approval of setting up clinics and the approval of setting up medical institutions for clinics that are closely related to the society

According to the "Regulations on the Management of Medical Institutions", the health administrative department of the local people's government at or above the county level shall formulate a plan for the establishment of medical institutions in the administrative area based on the population, medical resources, medical needs, and the distribution of existing medical institutions in the administrative area

Therefore, according to the “Regulations”, the establishment of medical institutions such as clinics must first comply with the plan and obtain the “Approval for the Establishment of Medical Institutions” before they can be constructed in accordance with the items specified in the “Approval for the Establishment of Medical Institutions”, including location and scale , Equipment purchase and installation, etc.

On February 6, 2016, State Council Order No.

On February 28, 2017, the National Health and Family Planning Commission issued the "Administrative Measures for Physician Practice Registration" on February 28, 2017 and decided to formally implement it on April 1.

In June 2018, the notice on further reform and improvement of medical institutions and physician approval work stipulated that before the end of June, electronic registration management will be fully implemented nationwide

On April 28, 2019, the National Health Commission and other five ministries jointly issued a notice (Guoweiyifa [2019] No.
39) on the implementation of the pilot proposal for promoting the development of clinics.
It was first proposed in a national official document to change the approval of clinic setting to Record system management, if a clinic is held, it shall be reported to the local county (district) health administrative department for record, and after the "Medical Institution Practicing License" is issued, practice activities can be carried out
.
Chained and group clinics operating across administrative regions shall be filed by the higher-level health administrative department, and those operating across provincial administrative regions shall be filed separately by the health administrative department of the province where they are located
.
But only in 10 cities including Beijing, Shanghai, Shenyang, Nanjing, Hangzhou, Wuhan, Guangzhou, Shenzhen, Chengdu and Xi'an
.

This time, the "Notice" of the State Council proposed to directly cancel the approval of clinic setting and the approval of setting medical institutions.
Obviously, it will be implemented in all regions of the country
.
The cancellation of the approval of the clinic setting means that the establishment of a clinic will no longer apply to the health administrative department for approval of the setting, but directly go through the setting record and obtain the setting record form to open the business
.

The cancellation of the "Approval for the Establishment of Medical Institutions" refers to the establishment of other medical institutions except for tertiary hospitals, tertiary maternity and child care hospitals, emergency centers, first aid stations, clinical testing centers, Sino-foreign joint venture medical institutions, and Hong Kong, Macao and Taiwan wholly-owned medical institutions.
The health administrative department will no longer issue the "Approval for the Establishment of Medical Institutions", and only issue the "Medical Institution Practicing Permit" at the time of practice registration
.
This is in fact consistent with the requirements of the 2018 Guowei Medical Fa [2018] No.
19 "Notice on Further Reforming and Improving Medical Institutions and Physician Approval Work"
.

Large-scale deployment of Class B medical equipment for social medical services

The approval was changed to 3 items for the record, including 3 items including clinic practice registration, social medical institution type B large-scale medical equipment configuration license, and public place sanitation license
.
The clinic is also the same as mentioned above, so I won't repeat it here
.

This article mainly talks about the licensing of Class B large-scale medical equipment in social medical institutions
.

In May 2018, the National Health Commission and the State Food and Drug Administration jointly issued the large-scale medical equipment configuration and use management measures (for trial implementation) stipulated that the large-scale medical equipment catalogue was proposed by the National Health Commission in consultation with relevant departments of the State Council, and announced after being approved by the State Council Execute
.
The state implements hierarchical and classified configuration planning and configuration license management for large-scale medical equipment in accordance with the catalog
.

Medical equipment disposed administration table into A, B categories
.
The National Health Commission is responsible for the configuration and management of Class A large-scale medical equipment and the issuance of configuration licenses; Class B large-scale medical equipment is responsible for configuration management and the issuance of configuration licenses by the provincial health and health administrative department
.
Violation of regulations, ultra-planning, ultra vires or illegal implementation of large-scale medical equipment configuration permits shall be dealt with in accordance with the "Administrative Licensing Law", "Regulations on the Supervision and Administration of Medical Devices" and other relevant regulations
.
This means that no matter who pays, there is no configuration permission, and no medical institution is allowed to configure Class B large-scale equipment without the approval of the provincial health administrative department
.

At present, Class B medical equipment includes: 1.
X-ray computer tomography (CT)
.
2.
Medical MRI equipment (MRI)
.
3.
Digital subtraction angiography X-ray machine (DSA)
.
4.
Medical electron linear accelerator (LA)
.
5.
Single-photon emission electronic computed tomography (SPECT)
.

On January 17, 2018, the executive meeting of the State Council decided that in the Pudong New Area of ​​Shanghai, approvals such as the issuance of licenses for large-scale medical equipment configuration of Class B medical institutions will be cancelled
.
Subsequently, the State Council formally announced the "Decision on Temporarily Adjusting and Implementing Relevant Administrative Regulations and Regulations in Pudong New Area, Shanghai" (Guofa [2018] No.
29), and decided to temporarily adjust the regulations in Pudong New Area, Shanghai from now until December 31, 2018.
Implement the provisions of Article 34, Paragraph 2 of the Regulations on the Supervision and Administration of Medical Devices concerning the issuance of large-scale medical equipment allocation licenses, and do not implement licensing management for the allocation of Class B large-scale medical equipment by social medical institutions in the pilot area
.

This is a temporary policy for Shanghai Pudong New Area
.

Since the establishment of Shanghai's first pilot free trade zone in September 2013, China has set up pilot free trade zones in more than 20 provinces in September 2020
.
Therefore, this "Notice" decided to cancel the management of the allocation of Class B medical equipment for social medical institutions in the pilot free trade zone and replace it with the record management.
Although it has not decided to implement it nationwide, it is actually a trial implementation of the Shanghai Free Trade Zone.
The promotion of the policy on a larger scale will surely benefit more medical institutions in the free trade zone
.

In addition, 4 notification commitments have been implemented, including a public place sanitation license and a social medical institution type B large-scale equipment configuration license, a disinfection product manufacturer license, anesthetic drugs and a first-class psychoactive drug purchase seal card
.

Optimized 16 items of examination and approval services, mainly including sanitation licenses for drinking water units, examination and approval of units producing disinfection products for the prevention and control of infectious diseases, qualification certificates of radiological health technical service institutions, radiological diagnosis and treatment licenses, and medical institutions practicing licenses (for drug rehabilitation services) ), Human Assisted Reproductive Technology License Approval, Maternal and Child Health Care Technical Service License, Organ Transplantation Diagnosis and Treatment Subject Registration, Medical Institution Establishment Approval (referring to medical institutions that are still needed), Medical Institutions (excluding clinics) practice registration, professional technical services Institutional level B qualification license, immediate practice registration for the establishment of blood stations, approval of the establishment of a single plasma collection station, namely the issuance of the license, the approval certificate of the human sperm bank, the stamp card for the purchase of anesthetic drugs, which is the first category of psychotropic drugs, and the social medical institution category A License for large equipment configuration
.

More preferential policies in the Free Trade Zone

One is the "Administrative Measures for Radioactive Drugs
.
" Article 21 of the Measures stipulates that the use of radiopharmaceuticals by medical units must comply with the national regulations on the safety and protection of radioisotopes
.
Local provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with the level of nuclear medical technicians and equipment conditions of medical units, issue corresponding levels of "Radiopharmaceutical Use License", and medical units without a license shall not use radiopharmaceuticals clinically
.

Article 23 stipulates that medical units holding the License for the Use of Radioactive Drugs must be responsible for conducting clinical quality inspections of the radioactive drugs used, collecting adverse drug reactions and other tasks, and regularly reporting to the local drug supervision and management and health administration.
Department report
.
After being collected by the drug regulatory and health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government, they shall be reported to the drug regulatory and health administrative departments of the State Council respectively
.
This "Notice" clarified that the use of radioactive drugs (Class I and II) by medical units will be directly cancelled
.

The second is the medical device supervision and management regulations
.
Article 34 of the Regulations stipulates that the deployment of large-scale medical equipment by medical device users shall comply with the large-scale medical equipment configuration plan formulated by the health and family planning department of the State Council, meet its functional positioning and clinical service needs, and have corresponding technical conditions and supporting facilities.
And professional and technical personnel with corresponding qualifications and abilities, and approved by the health and family planning department of the people's government at or above the provincial level, to obtain a large-scale medical equipment configuration license
.

Article 63 stipulates that if large-scale medical equipment is deployed and used without permission, the health and family planning department of the people's government at or above the county level shall order it to stop the use, give a warning, and confiscate the illegal income; if the illegal income is less than 10,000 yuan, a penalty shall be imposed.
A fine of more than 10,000 yuan and less than 50,000 yuan; if the illegal income is more than 10,000 yuan, a fine of 5 times to 10 times the illegal income will be imposed; if the circumstances are serious, the application for large-scale medical equipment configuration licenses submitted by the relevant responsible persons and units will not be accepted within 5 years
.
Since the "Notice" has clarified that the purchase of Class B large-scale equipment by social medical institutions in the Free Trade Zone has been changed from approval to filing, the two articles in the regulations have been temporarily adjusted accordingly
.

The third is the regulations on sanitation management in public places
.
The regulations stipulate that the state implements a "hygiene permit" system for public places
.
This "Notice" adjusts and decides to change the public health approval approval of "concert halls; exhibition halls, museums, art galleries, libraries; bookstores, video halls (rooms)" to the record
.

After deregulation, supervision will also be strengthened!

In recent years, governments at all levels have actively promoted the reform of decentralization, management, and service.
In many places, unified administrative examination and approval departments have been established to implement centralized examination and approval
.
However, there is a disconnect between approval and supervision.
This "Notice" clearly requires that the regulatory responsibilities should be clarified to meet the reform requirements
.
It is proposed to implement the requirements of combining decentralization and regulation with equal emphasis, in accordance with the principle of "who approves, who supervises, who is in charge, who supervises", to earnestly perform regulatory duties, and resolutely correct the problems of "management by approval" and "regardless of approval" to prevent the occurrence of supervision Vacuum
.

If the examination and approval is directly cancelled, and the examination and approval is changed to the filing, the original examination and approval department shall assume the supervisory duties according to law
.
In the case of implementing notification promises and optimizing examination and approval services, the examination and approval department shall be responsible for supervising and punishing unlicensed business operations in accordance with the law
.
In areas where relatively centralized administrative licensing reforms or comprehensive administrative law enforcement reforms are implemented, supervisory responsibilities shall be determined in accordance with the reform plan formulated by the provincial-level people's government, and the review and management linkage mechanism shall be improved
.

For special industries and key areas directly related to public safety and people's life and health, implement full coverage and key supervision, strengthen the quality management of the whole process, and keep the bottom line of safety
.

Judging from the recent epidemic situation in Guangdong, although the new crown virus has mutated rapidly and spread faster, a large number of medical institutions, especially private hospitals and clinics, have been suspended from practicing due to poor epidemic prevention and control.
All costs depend on their own social medical institutions.
From a standpoint, it seems that the situation is not optimistic, but judging from the general trend of national policies, the future is still bright, mainly because only social medical services can meet the diverse medical service needs of the people
.
After wind and rain, you will see a rainbow
.