The basic medical law covers basic medical and health services, medical and health institutions, medical and health personnel, drug supply guarantee, health promotion, funding guarantee, supervision and management, legal responsibilities and so on.
The Basic Medical Law will bring new changes and new requirements to the management of medical institutions.
New changes in medical notification
Thirty-second citizens to receive medical and health services, according to the law, enjoy the right to informed consent of the illness, diagnosis and treatment plan, medical risks, medical expenses and other matters.
If surgery, special examination and special treatment are needed, medical and health personnel shall promptly explain the medical risks and alternative medical programs to patients and obtain their consent; If it is impossible or inappropriate to explain it to the patient, it shall explain it to the patient's close relatives and obtain their consent. Where there are other provisions in the law, those provisions shall prevail.
In particular, the notice of "medical expenses" was clearly defined.
In the previous laws, neither the Tort Liability Law nor the Civil Code (Draft) listed medical expenses as the content of notification. The Basic Medical Law is singled out here, which shows the importance and necessity of "informing medical expenses" and deserves attention.
Increase the requirement of "timely notification"
Compared with the previous laws, the word "timely" has been added in this regulation, which is worth noting. Therefore, it can be considered that the timing of notification should not be too early or too late. If it is not "timely", it may be used as unfavorable evidence in the future.
Does the notice of operation require the patient's "written" consent?
Article 55 of Tort Liability Law stipulates that the notification of operation, special examination and special treatment requires the patient's written consent, and oral notification is invalid. However, the word "written" was deleted from Article 32 of the Basic Medical Law, which is a major change in medical notification. This revision increases the ways and means of doctors' notification, which is more flexible than just "written" notification and meets the needs of social development.
It is worth noting that article 12 19 of the draft civil code changes the notification of surgery, special examination and special treatment in Article 55 of the Tort Liability Law from "written consent" to "express consent", and also deletes "written consent".
Protecting medical staff with "the power of rule of law"
Article 46 The practice place of a medical and health institution is a public place providing medical and health services, and no organization or individual may disturb its order.
Article 57 The whole society should care for and respect medical and health personnel, maintain a good and safe medical and health service order, and build a harmonious doctor-patient relationship.
The personal safety and dignity of medical and health personnel are inviolable, and their legitimate rights and interests are protected by law. It is forbidden for any organization or individual to threaten or endanger the personal safety of medical and health personnel and infringe on their personal dignity.
The state takes measures to ensure the practice environment of medical and health personnel.
It is forbidden to threaten or endanger the personal safety of medical and health personnel
In many places, the Basic Medical Law clarifies the protection of medical personnel by the state. For example, any organization or individual is prohibited from threatening or endangering the personal safety of medical and health personnel; The whole society should care about and respect medical and health personnel.
In addition, after the hospital was formally included in the scope of public places, the public security subject of the hospital rose from "public security" to "public security", and the judicial organs had the right to intervene in medical disputes. This is a further emphasis on the seriousness of the "medical trouble" incident, pushing it from administrative law to criminal law, and strengthening the crackdown on medical-related violations. It is also a legislative response to the current lax and passive law enforcement.
New changes in overtreatment.
Article 54 Medical and health personnel shall abide by the laws of medical science, relevant technical specifications for clinical diagnosis and treatment, operating specifications and medical ethics, adopt appropriate technologies and drugs, make reasonable diagnosis and treatment, treat diseases and refrain from overtreatment.
"Don't over-examine" is extended to "Don't over-treat"
Medical treatment includes all links in the process of diagnosis and treatment, such as examination, treatment and nursing. Article 63 of the Tort Liability Law stipulates that "medical institutions and their medical personnel shall not carry out unnecessary inspections in violation of the norms of diagnosis and treatment."
This basic medical law directly stipulates that "over-medical treatment is not allowed", and its scope has been comprehensively expanded.
New regulations related to medical ethics
Thirty-second to carry out clinical trials of drugs and medical devices and other medical research should abide by medical ethics, pass ethical examination according to law and obtain informed consent.
Article 43 Medical and health institutions shall, in accordance with the clinical diagnosis and treatment guidelines, clinical technical operation specifications, industry standards, medical ethics specifications and other relevant requirements, rationally check, use drugs, make diagnosis and treatment, strengthen the prevention of medical and health safety risks, optimize services, and continuously improve the quality of medical and health services.
Forty-fourth medical and health institutions to carry out the clinical application of medical and health technology, should be adapted to its functions and tasks, follow the principles of science, safety, standardization, effectiveness and economy, and conform to ethical norms.
Article 102 In violation of the provisions of this Law, medical and health personnel who commit any of the following acts shall be given administrative punishment by the competent health department of the people's government at or above the county level in accordance with the provisions of laws and administrative regulations on the management of medical practitioners and nurses and the prevention and handling of medical disputes:
Violate medical ethics or legal responsibility
The Basic Medical Law stipulates medical ethics in four articles, and stipulates the legal liability of medical institutions and medical personnel for violating medical ethics. It can be seen that it is equally important that the future medical behavior conforms to the medical ethics norms and the technical norms of diagnosis and treatment.
Regarding the requirements of medical ethics, we need to pay attention to two points in practice:
First, from the procedural point of view, medical behavior should be reviewed ethically according to regulations; Second, in essence, the treatment of medical behavior conforms to the norms of diagnosis and treatment, and also requires medical ethics.
Clarify the security of personal health information
Article 92 The state protects citizens' personal health information and ensures the safety of citizens' personal health information. No organization or individual may illegally collect, use, process or transmit citizens' personal health information, or illegally buy, sell, provide or disclose citizens' personal health information.
Article 102 In violation of the provisions of this Law, medical and health personnel who commit any of the following acts shall be given administrative punishment by the competent health department of the people's government at or above the county level in accordance with the provisions of laws and administrative regulations on the management of medical practitioners and nurses and the prevention and handling of medical disputes:
(a) taking advantage of his position to ask for, illegally accept property or seek other illegitimate interests;
(2) divulging citizens' personal health information;
(three) in the process of carrying out medical research or providing medical and health services, failing to fulfill the obligation of informing or violating medical ethics.
The protection of personal health information is incorporated into the law.
The protection of personal health information in the Basic Medical Law has begun to take shape as early as the first draft, which is not only the embodiment of China's personal information protection legislation, but also an inevitable measure under the trend of "Internet+medical care".
From medical big data analysis to commercial medical insurance customization to intelligent medical diagnosis, it is based on personal health information. Therefore, personal health information is information with commercial value and the possibility of being infringed, which needs special protection at the legislative level.
Clarify the "public welfare" of medical and health undertakings
Article 27 The State shall establish and improve the pre-hospital first aid system to provide timely, standardized and effective first aid services for critically ill patients.
The emergency center (station) shall not refuse or delay to provide emergency services for critically ill patients on the grounds of unpaid fees.
Fortieth medical and health institutions run by the government should adhere to the public welfare nature, all revenues and expenditures should be included in the budget management, and the scale should be set and controlled reasonably according to the medical and health service system planning.
The state encourages medical and health institutions run by the government to cooperate with social forces to set up non-profit medical and health institutions.
Medical and health institutions run by the government shall not invest with other organizations to set up medical and health institutions without independent legal personality, and shall not cooperate with social capital to set up profit-making medical and health institutions.
Medical and health undertakings must be "public welfare"
The principle of public welfare is of great significance and one of the biggest highlights of this law. This principle is the most important reform experience from the new round of medical and health system reform, and its important value lies in making it clear in the form of legislation that medical and health undertakings must be "public welfare" and that medical and health services must aim at citizens' health.
In this regard, Wang Yue, a professor at Peking University College of Medical Humanities, believes that "the new law will fundamentally return public hospitals to public welfare, more accurately, welfare."
Professor Wang Yue said that hospitals must truly establish the concept of "patient-centered", conform to the development trend of international medical concepts, respect and protect patients' interests, put patients' interests first, and change the medical practice goal of "saving lives" into the medical practice goal of "helping patients" as soon as possible. "Only in this way can our medical staff be safe, and we can't just look at' illness' instead of' people'.
Can you refuse or delay the free first aid service?
In this regard, the author believes that as long as medical institutions (especially public medical institutions) are not allowed to refuse or delay providing emergency services for critically ill patients on the grounds of unpaid fees.
In addition to the "public welfare of medical institutions" mentioned above, Article 3 of the Basic Medical Law also stipulates that "medical and health undertakings should adhere to the people-oriented principle and serve people's health."
In addition, many laws have mentioned this issue.
Article 31 of the Regulations on the Administration of Medical Institutions stipulates that "medical institutions should immediately rescue critically ill patients."
Article 24 of the Law on Medical Practitioners: Doctors should take emergency measures to diagnose and treat critically ill patients; Don't refuse first aid.
Article 30 of the Code of Conduct for Employees in Medical Institutions stipulates that medical personnel should be rigorous, cautious and independent, and be responsible for their own practice. If the patient is found to be in critical condition, the doctor should be informed immediately; In an emergency, in order to save the lives of dying patients, necessary emergency rescue should be implemented in time.
Article 45 of the Measures for the Management of Medical Quality clearly stipulates that doctors and nurses practicing in medical institutions "delay the rescue and diagnosis of critically ill patients due to irresponsibility" shall be handled by the local health and family planning administrative department at or above the county level in accordance with the provisions of the Law on Medical Practitioners, the Nurses Regulations and other relevant laws and regulations; If a crime is constituted, criminal responsibility shall be investigated according to law.
Encourage and support social forces to run schools.
Fortieth medical and health institutions run by the government shall not invest with other organizations to set up medical and health institutions without independent legal personality, and shall not cooperate with social capital to set up profit-making medical and health institutions.
Article 41 The state shall take various measures to encourage and guide social forces to establish medical and health institutions according to law, and support and standardize the cooperation between medical and health institutions organized by social forces and medical and health institutions organized by the government in various medical services, discipline construction and personnel training.
The red line of cooperation with social capital to run a doctor
Articles 40 and 41 of the Basic Medical Law stipulate that "encourage and guide social forces to set up medical and health institutions according to law."
But there are three points to note:
1. It is forbidden for public hospitals to cooperate with social capital to set up for-profit medical and health institutions.
2. Public hospitals shall not invest with other organizations to set up medical and health institutions without independent legal personality for profit.
3. Public hospitals can cooperate with medical institutions organized by social forces in medical services, discipline construction and personnel training. However, it is not clear whether profit-oriented cooperation (such as medical business cooperation) can be realized.
In short, whether it is a medical institution run by social capital or a medical institution run by social forces, cooperation with public hospitals must be approved by relevant departments, and the evaluation and audit of state-owned assets should be conducted in a proper procedure to avoid disputes in the future.
Legal basis:
People's Republic of China (PRC) Basic Medical Care and Health Promotion Law Article 10 The state focuses on the grassroots, rationally plans and allocates medical and health resources, and adopts various measures to give priority to supporting the development of medical and health institutions below the county level and improve the medical and health service capacity.
Article 11 The state shall increase financial input into medical and health undertakings, and give priority to supporting the development of medical and health undertakings in old revolutionary base areas, ethnic minority areas, border areas and economically underdeveloped areas by increasing transfer payments.