The "Regulations on the Management of Medical Institutions" has been overhauled again, and the social medical services are welcoming a major benefit!

The "Regulations on the Management of Medical Institutions" have been overhauled again, and the hanging heart of social medical services can finally be put down.

The author | Xu Yucai

Source| Medical Community (ID: vistamed)

In recent years, with the advent of the medical institution filing system, it has opened a convenient door for social capital to set up medical institutions. However, due to the lack of "regulations" protection, the policy is always in an "unstable" period, especially the "Medical Institution Practice License" may be revoked by the administrative law enforcement organs at every turn, which also makes some social doctors often in "fear".

Nowadays, the "Regulations on the Management of Medical Institutions" has been overhauled again, and the hanging heart of social medical services can finally be put down.

On April 7, 2022, Xinhua News Agency was authorized to issue the Decision of the State Council on Amending and Repealing Some Administrative Regulations, of which some provisions of the Regulations on the Administration of Medical Institutions have been amended and decided to take effect from May 1, 2022.

Since then, the Regulations on the Administration of Medical Institutions issued by the State Council in 1994 have once again ushered in major adjustments after the heavy revision in 2016! It is reported that a total of 18 articles have been modified this time, of which 2 have been deleted and 16 have been modified.

So, what benefits will this revision bring to social medical treatment?

The filing system was established according to law, giving the social doctor a reassuring pill

The biggest highlight of this revision is that the filing system of medical institutions has been solidified in the form of regulations. In terms of the approval of the establishment of medical institutions, the original stipulation that "the establishment of all medical institutions must be approved and obtain a letter of approval for the establishment", and now the establishment of medical institutions is the coexistence of the approval system and the filing system.

For example, Article 9 of the Regulations originally stipulated that the establishment of medical institutions by units or individuals must be examined and approved by the health administrative departments of local people's governments at or above the county level, and a letter of approval for the establishment of medical institutions must be obtained. The new regulations are revised to read: Where a unit or individual sets up a medical institution and shall handle the approval of the establishment of a medical institution in accordance with the provisions of the State Council, it shall be examined and approved by the health administrative department of the local people's government at or above the county level, and a letter of approval for the establishment of a medical institution shall be obtained.

So, what are the State Council's regulations on the approval of the establishment of medical institutions? In September 2020, the Decision of the State Council on the Cancellation and Decentralization of a Number of Administrative Licensing Matters ([2020] No. 13) clearly proposed to issue administrative licenses for the establishment of medical institutions other than tertiary hospitals, tertiary maternal and child health hospitals, emergency centers, emergency stations, clinical inspection centers, Sino-foreign joint venture cooperative medical institutions, and hong Kong, Macao and Taiwan wholly-owned medical institutions.

In fact, as early as June 2018, the National Health Commission issued the "Notice on Further Reforming and Improving the Examination and Approval of Medical Institutions and Physicians", which has proposed that medical institutions at the second level and below set up "two certificates in one" for approval and practice registration. Except for tertiary hospitals, tertiary maternal and child health hospitals, emergency centers, first aid stations, clinical laboratory centers, Sino-foreign joint venture cooperative medical institutions, and hong Kong, Macao and Taiwan-owned medical institutions, if other medical institutions are established, the health administrative department will no longer issue the "Approval Letter for the Establishment of Medical Institutions", and only issue the "Medical Institution Practice License" at the time of practice registration.

Although before, the policy has made it clear that medical institutions at the second level and below no longer need to be approved, only "filing", but because the "law" has no basis, it always makes people feel uneasy and unsteady, and now in the new regulations, clear provisions have been made, which is obviously a reassuring pill for social medical treatment.

The revocation of the permit is more prudent, but the economic penalties are increased

For social medical treatment, another concern is that the "Medical Institution Practice License" may be revoked by the relevant departments at any time because of violations. This revision of the regulations gives a positive.

For example, for the development of diagnosis and treatment activities beyond the scope of registration, the original regulations stipulate that "if the diagnosis and treatment activities exceed the scope of registration in violation of Article 27 of these Regulations, the health administrative department of the people's government at or above the county level shall give a warning and order them to make corrections, and may impose a fine of not more than 3,000 yuan according to the circumstances; if the circumstances are serious, revoke their "Medical Institution Practice License". The amendment is as follows: "Where the provisions of Article 26 of these Regulations are violated and the diagnosis and treatment activities exceed the scope of registration or filing, the health administrative department of the people's government at or above the county level shall give a warning, order them to make corrections, confiscate the illegal gains, and may impose a fine of between 10,000 and 100,000 yuan according to the circumstances; if the circumstances are serious, revoke their "Medical Institution Practice Permit" or order them to stop practicing activities." ”

For the use of non-health technical personnel to engage in medical and health technical work, the original regulations stipulate that "in violation of the provisions of Article 28 of these Regulations, the use of non-health technical personnel to engage in medical and health technical work shall be ordered by the health administrative department of the people's government at or above the county level to make corrections within a time limit and may be fined not more than 5,000 yuan; if the circumstances are serious, their "Medical Institution Practice License" shall be revoked." The amendment reads: "Whoever, in violation of article 27 of these Regulations, uses non-health technicians to engage in medical and health technical work shall be ordered by the health administrative department of the people's government at or above the county level to make corrections within a time limit and may be fined between 10,000 and 100,000 yuan; ”

In these two cases, on the one hand, the newly revised regulations add the content of "warning, ordering them to make corrections, and confiscating illegal gains" to add the content of "and may impose a fine of between 10,000 and 100,000 yuan according to the circumstances"; on the other hand, for serious cases, "or order them to stop practicing activities" after "revoking their "medical institution practice license"", indicating that in addition to revoking the certificate, they can also "order them to stop practicing activities" Option.

For the issuance of false certification documents, the original regulations stipulate that "in violation of the provisions of Article 32 of these Regulations, if a false certification document is issued, the health administrative department of the people's government at or above the county level shall give a warning; if the harmful consequences are caused, a fine of less than 1,000 yuan may be imposed; and the directly responsible personnel shall be given administrative sanctions by the unit or higher-level organ." The amendment reads, "Whoever violates the provisions of Article 31 of these Regulations and issues false certification documents shall be warned by the health administrative department of the people's government at or above the county level; for those who cause harmful consequences, a fine of between 10,000 and 100,000 yuan may be imposed; and the directly responsible personnel shall be given administrative sanctions by their units or higher-level organs." Obviously, after the revision of the regulations, the amount of punishment for causing harmful consequences will be adjusted from less than 1,000 yuan to a fine of between 10,000 yuan and 100,000 yuan, which is a large range.

For those who practice without obtaining the "Medical Institution Practice License", the new regulations will clearly punish them in accordance with the "Basic Medical Care and Health Promotion Law of the People's Republic of China". The original regulations stipulate that "whoever violates the provisions of Article 24 of these Regulations and practices without obtaining a Medical Institution Practice License" shall be ordered by the health administrative department of the people's government at or above the county level to stop his professional activities, confiscate the illegal gains, drugs and equipment, and may impose a fine of not more than 10,000 yuan according to the circumstances." Amended to read: "Whoever violates the provisions of Article 23 of these Regulations and practices without obtaining a Medical Institution Practice Permit shall be punished in accordance with the provisions of the Basic Medical Care and Health Promotion Law of the People's Republic of China." In violation of Article 23 of these Regulations, if a clinic practices without filing for the record, the health administrative department of the people's government at or above the county level shall order it to make corrections, confiscate the illegal gains, and impose a fine of not more than 30,000 yuan; if it refuses to make corrections, it shall be ordered to stop its practice activities. ”

The penalties for practicing without obtaining a medical institution practice license in the Basic Medical Care and Health Promotion Law are: the competent health department of the people's government at or above the county level shall order the suspension of practice activities, confiscate the illegal gains and drugs and medical devices, and impose a fine of five times to twenty times the illegal gains, and if the illegal gains are less than 10,000 yuan, it will be calculated according to 10,000 yuan, that is, a penalty of 50,000 yuan to 200,000 yuan. Obviously, the penalties have been greatly increased.

For the sale, transfer or lending of the "Medical Institution Practice License", the original regulations stipulate that "whoever, in violation of Article 23 of these Regulations, sells, transfers or lends the "Medical Institution Practice License" shall confiscate the illegal gains by the health administrative department of the people's government at or above the county level and may impose a fine of not more than 5,000 yuan; if the circumstances are serious, the "Medical Institution Practice License" shall be revoked." The new regulations are revised to read: "Whoever, in violation of Article 22 of these Regulations, sells, transfers or lends the Medical Institution Practice License shall be punished in accordance with the provisions of the Basic Medical Care and Health Promotion Law of the People's Republic of China." "The punishment provided for in the Law of the People's Republic of China on Basic Medical Care and Health Promotion is: the competent health department of the people's government at or above the county level shall order corrections, confiscate the illegal gains, and impose a fine of not less than five times but not more than fifteen times the illegal gains, and if the illegal gains are less than 10,000 yuan, it shall be calculated as 10,000 yuan; if the circumstances are serious, the medical institution practice license shall be revoked. Obviously, the sale, transfer and lending of the "Medical Institution Practice License" will not only be subject to huge economic penalties, but also the medical institution practice license will be revoked.

Standardized practice is still the eternal theme of social medicine

Judging from the newly revised Regulations on the Administration of Medical Institutions, although a filing system has been established in the establishment of approvals, that is, there is a trend of liberalization of access, the supervision will be greater. From the perspective of regulatory liberalization, it is easy not to say that the certificate is revoked, but the economic punishment will be significantly on the next level, and all kinds of signs show that the social medical service must still be more standardized.

In particular, it is not allowed to carry out diagnosis and treatment activities beyond the scope of registration; use non-health technicians to engage in medical and health technology work; issue false certification documents; practice without obtaining a "Medical Institution Practice License"; and sell, transfer or lend the "Medical Institution Practice License". Social medical institutions must carefully study these five pits, and really understand the details of each of the "pits" and very specific "clinical manifestations", because, even if they do not speak lightly, the severe economic penalties are enough to make them difficult to bear, remember! Remember! (This article is published by "Seeing the Medical Community", reprinted with permission, and the author and source are indicated at the beginning of the article.) ）

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