Part I General Knowledge of Health Law
I. Overview of health law: the definition of health law, the characteristics and adjustment of the object, the role of health law, the health legal relationship.
Second, the development of health law: the concept of health law development, development authority, development procedures, sources and systems of health law.
Three, the implementation of health law: the concept of health law implementation, functions and characteristics, role and significance, the scope of effectiveness of health law.
Four, health administrative license: health administrative license concept, features and principles, license setting, license form, license setting procedures, license effectiveness, license change and renewal, license revocation, cancellation and suspension.
V, health administrative inspection and investigation and evidence collection: health administrative inspection concepts and features, inspection methods, investigation and evidence collection concepts and principles, investigation and evidence collection methods, evidence preservation, review and application.
VI, health administrative law enforcement: health administrative law enforcement concepts, principles, subject of law enforcement, law enforcement behavior, law enforcement means.
VII, health violations and legal responsibility: health violation conditions, health legal responsibility, the concept and characteristics of health administrative punishment, principles, jurisdiction of administrative punishment, the application of administrative punishment, the types and forms of health administrative punishment, health administrative punishment procedures, administrative coercive measures to implement the program, administrative coercive enforcement procedures, administrative case transfer procedures.
VIII, health legal remedies: the concept and meaning of health legal remedies, administrative review, administrative litigation, administrative compensation.
Part II Communicable Disease Supervision
I. Overview: the concept and characteristics of communicable disease supervision, legal basis, subject and scope, characteristics of infectious diseases, legal infectious diseases, common and important infectious diseases, outbreaks of classification and disposal.
Second, preventive supervision: regular preventive measures, key preventive measures, monitoring system, early warning system, immunization planning, vaccine circulation and vaccination management.
Three, control and supervision: dissemination and epidemic infectious diseases control measures, outbreaks of infectious diseases control measures, epidemic reporting, notification and publication, supervision and management of content.
Four, disinfection and isolation of health supervision: supervision of infectious sources, places, objects and medical waste disinfection and disposal, disinfection and isolation of protective measures, legal responsibility, infectious disease prevention and control of disinfection products, disinfection products manufacturer supervision.
V. Pathogenic microorganisms laboratory supervision: classification of pathogenic microorganisms, pathogenic microorganisms laboratory biosafety level, laboratory set up and infection control, bacteriological (virulent) reservoirs, sample collection, transportation, storage.
Part III public **** health supervision
I, drinking water and water-related products health supervision: legal basis, drinking water and health, centralized water supply, secondary water supply, pipeline quality water supply, water-related products, water-related products manufacturers and other health supervision and management points.
Second, public **** place health supervision: legal basis, public **** place concept and types, public **** place supervision concept and significance, preventive health supervision content, recurrent health supervision content, public **** place hygienic surveillance, public **** place control of tobacco use, framework convention on tobacco control.
Three, school health and health supervision of child care institutions: the legal basis, school health concept and content, school health supervision concept and meaning, preventive health supervision content, recurrent health supervision content, school drinking water supervision, health supervision of child care institutions content.
Four, occupational health supervision: legal basis, occupational health concepts, occupational hazards, occupational health testing and health standards, occupational protection measures, occupational health supervision, occupational diseases, definition and types of occupational diseases, occupational disease diagnosis, preventive occupational health supervision, regular occupational health supervision.
V. Radiation hygiene supervision: legal basis, basic knowledge of ionizing radiation, radiation protection system, radiation protection principles and methods, the concept of radiation hygiene supervision, radiation hygiene and protection standards, radioisotopes, radiation devices, radiation source analysis, radioactive products and protective equipment, radiation workers, radiation accident handling.
The fourth part of the supervision of medical services
I. Supervision of medical institutions: legal basis, definition of medical institutions, classification, organizational structure, medical institutions, diagnostic and therapeutic subjects and service modalities, the layout of the medical institutions, set up the approval of the registration, practice registration, inspection, supervision and inspection of the content and methods.
Second, large medical equipment supervision: the legal basis, the concept and classification of large-scale medical equipment, configuration planning, configuration permits, large-scale equipment supervision content and methods.
Three, the supervision of clinical application of medical technology: the legal basis, the basics of medical ethics, the basics of clinical research, the definition of clinical medical technology, classification, restriction of medical technology for the record and management, the supervision of clinical application of medical technology content.
Four, blood health supervision: legal basis, basic knowledge of blood and blood transfusion, basic knowledge of clinical blood use, blood collection and supply institutions, service content, set up and practice permits, blood collection and supply institutions to monitor the content of the clinical use of blood supervision.
V. Supervision of maternal and child health care and human assisted reproduction technology services: legal basis, premarital medical examination, prenatal diagnosis, midwifery, birth control and termination of pregnancy, human assisted reproduction technology, human sperm bank basics, definitions, management requirements, technical service licensing, supervision content.
Sixth, supervision of medical services in Chinese medicine: legal basis, basic knowledge of Chinese medicine, Chinese medicine medical institutions, classification and characteristics of Chinese medicine, Chinese medicine heritage and development requirements, Chinese medicine medical institutions licensing, Chinese medicine clinic for the record, Chinese medicine practitioner qualifications, Chinese medicine practice supervision content.
VII, health professionals supervision: the legal basis, physicians and nurses practice basic knowledge, health professionals qualifications, practice registration, regular assessment, prescription supervision, narcotic drugs and psychotropic substances, antimicrobial drugs, clinical use of foreign physicians, as well as Hong Kong, Macao and Taiwan physicians to practice the basic knowledge and practice supervision.
Part V Drug Supervision
I. Overview: definition and classification of drugs, quality of drugs, drug standard system, legal system of drug management, principles of drug administration, basic drug system, rational use of medication policy, the main body of supervision, supervision, legal responsibility.
Second, drug research and development and registration management: legal basis, drug research and development, clinical trials, drug registration, intellectual property rights, drug names and trademarks, monitoring of adverse drug reactions, post-market re-evaluation, drug information management.
Three, drug marketing license holder: definition of drug marketing license holder, rights and obligations, drug quality traceability system, drug re-evaluation system, annual report system, legal responsibility.
Four, drug production supervision and management: the legal basis, the concept of drug production, drug production license, drug production quality management standard (GMP), drug production supervision content.
Fifth, drug management supervision and management: the legal basis, drug business enterprise classification and business mode, drug business license, drug business quality management standard (GSP), drug packaging and labeling instructions, prescription drugs and non-prescription drugs, the basic requirements of drug circulation management, drug advertising management, drug Internet service management.
Sixth, medical institutions, pharmaceutical management: the legal basis, the basic knowledge of medical institutions, pharmaceutical supply management, drug management, drug classification and management regulations, preparation management, intravenous drug configuration, transfer business and prescription management regulations.
VII, special drug supervision and management: legal basis, basic knowledge of narcotic drugs and psychotropic substances, toxic drugs for medical purposes, basic knowledge of radioactive drugs, narcotic drugs, psychotropic substances, toxic substances for medical purposes, radioactive drugs, production, operation and medical institutions, such as pharmacological management, supervision and management of content and methods.
VIII, supervision and management of Chinese medicine: the concept of Chinese medicine, Chinese herbal medicines, Chinese medicine, Chinese medicine tablets, proprietary Chinese medicines management regulations, Chinese medicine varieties of protection, production and quality management of Chinese herbal medicines, supervision and management of content and methods.
Nine, supervision and management of medical devices: definition and classification of medical devices, regulatory purposes and principles, the legal system of medical device management, quality management system of medical devices, medical device research and development and registration management, supervision and management of the production of medical devices, supervision and management of medical devices, medical device business supervision and management, medical device post-market management.
Ten, supervision and management of cosmetics: cosmetic definition and classification, cosmetic raw materials management, cosmetic registration/record management and related requirements, cosmetic production licensing, cosmetic production supervision (including commissioned production), cosmetic business supervision (including the use of units, e-commerce platform operators), cosmetic labeling and advertising management, cosmetic monitoring system for adverse reactions, cosmetic risk monitoring system, recall management, legal and regulatory issues. system, cosmetics recall management, legal responsibility.
Part VI Food Safety Supervision
Overview: Definition of food safety, food safety standards, food additives, food advertising, food safety supervision of the legal basis, legal responsibility.
Second, food production safety supervision: food production license, food production process supervision, food producer supervision, food production raw materials supervision, supervision of prohibited food production, good manufacturing practice (GMP) management, hazard analysis and critical control points (HACCP) management, food recall system.
Three, food business and food service safety supervision: food circulation license, food operator safety supervision, food business process safety supervision, prohibited food supervision, food service licenses, processing and operation of premises and facilities for the supervision of food purchasing, processing and storage supervision, food service personnel safety supervision.
Four, special food safety supervision: new resources for food, health food, genetically modified food, food for infants and young children and other specific groups of primary and secondary food safety supervision.
V. Food Safety Risk Monitoring and Assessment: Foodborne Disease, Food Contamination, Harmful Factors in Food, Hazard Identification, Exposure Assessment, Principles of Preferential Selection for Food Safety Risk Monitoring, and Management of Food Safety Risk Assessment.
VI. Supervision of Major Food Safety Incidents: Grading of Major Food Safety Incidents, Grading of Emergency Response, and Management of Information Release.
Part VII Medical Security
I. Overview: Medical Security Definition and Classification, Risk and Insurance, Medical Insurance and its Principles, Medical Aid, Supplementary Insurance.
Second: medical insurance model and evaluation: different medical insurance model basics, China's medical insurance system system features, medical insurance evaluation content and methods.
Three: Demand and Supply of Medical Insurance: Basic knowledge of demand and supply of medical insurance, market failure of medical insurance, moral hazard, adverse selection, risky selection, and countermeasures of market failure.
IV. Mobilization and Management of Medical Insurance Fund: Principles of Medical Insurance Fund Measurement, Principles, Channels and Methods of Medical Insurance Fund Mobilization, Distribution and Management of Medical Insurance Fund.
V. Medical Insurance Payment and Cost Control: Scope of Coverage (Standard of Treatment), Reimbursement of Demand Side Costs, Definition, Characteristics, Advantages and Disadvantages of Supply Side Payment Methods, and Management of Agreements.
Sixth, social health insurance supervision and management: the legal basis, the main body of supervision, supervision of the object, the health insurance agency, the insured, the designated medical institutions and their medical staff, pharmaceutical enterprises and other regulatory content.