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如何理解“诊疗活动”的概念(之一)

2019-05-21 09:47阅读:
【案情介绍】
某公司自称是一家“人体生态研究机构”——从事健康管理服务和咨询,通过为客户采血的方式,对客户血液中的白细胞、红细胞、血小板等进行观察分析,进而评估人体器官的健康状况,并根据评估结论,给客户服用特定食品。20169月,上海市静安卫计委对其进行监督检查。经调查,该公司未取得《医疗机构执业许可证》,根据《中华人民共和国行政处罚法》第23条,《医疗机构管理条例》第44条规定,执法机关责令该公司停止执业活动,罚款8,000元并没收施莱一次性末梢采血器4盒等。
该公司不服,提起行政诉讼。一审认为,本案的争议焦点为该公司实施的行为是否为诊疗活动。法院认为,该公司在其经营场所内,对其客户进行末梢采血,通过对人体血液中的白细胞、红细胞、血小板等进行观察分析,评估人体肝脏等器官的健康状况,并根据评估结论,给客户服用特定食品,一个月后再重复该行为进行复检,以调整客户的身体健康状况。上述整个行为过程属于诊疗活动。该公司的诉讼请求缺乏事实根据和法律依据,一审不予支持。
该公司不服上诉。二审法院认为,“诊疗活动'的定义包括三大要素,一是检查';二是方法',即使用药物、器械及手术等方法;三是目的',即对患者做出各种处理措施,如疾病判断、缓解病情、减轻痛苦等活动。本案中,该公司行为符合诊疗活动'的定义及特征。因此,该公司要求撤销被诉处罚决定的诉讼主张不能成立。
【律师解析】
如何理解 “诊疗活动”的概念,是一个非常重要的问题,因为,如果属于“诊疗活动”,则只有医疗机构才能开展,
否则将受到行政处罚,如果不属于“诊疗活动”,则非医疗机构也可以开展。实践中,与“诊疗活动”比较容易混淆的有健康管理、健康咨询等,很多健康管理公司由于区分两个概念不恰当,受到行政处罚。
典型的“诊疗活动”,大家不难判断,就是医疗机构常见的手术、治疗等,典型的“健康管理”、“健康咨询”也不难识别,比如对特定人群建立健康档案,出现异常症状、体征,协助其到医疗机构就诊等。 但是,世界的复杂就在于我们面临的问题常常并不总是典型情况,很多非典型情况下,在临界点附近,如何准确判断事物的性质,是一件不容易的事情。对于非典型的“诊疗活动”,如何准确区分,涉及市场主体的业务范围,是相关企业应当关注的问题,也涉及法律的权威和严肃,是执法、司法实务中应当妥善处理的问题。
在“中国裁判文书网”上检索“诊疗活动、行政处罚”,可以看到很多因是否构成诊疗活动而引发的行政诉讼,如本文所引用的案例,即对“诊疗活动”不同理解而引发争议的典型案例。因此,有必要对如何理解“诊疗活动”的概念进行讨论,分析。
依据《医疗机构管理条例实施细则》第88条的规定:“诊疗活动是指通过各种检查,使用药物、器械及手术等方法,对疾病作出判断和消除疾病、缓解病情、减轻痛苦、改善功能、延长生命、帮助患者恢复健康的活动。”2006年,当时的国家卫生部曾发布《医疗救护员和健康管理师纳入卫生行业特有职业范围》,其中明确健康管理师是指“从事对人群或个人健康和疾病的监测、分析、评估以及健康维护和健康促进的专业人员。”
依据以上概念,并结合目前公布的裁判文书以及文献资料,笔者将如何理解“诊疗活动”的概念从行为特征、行为目的、行为风险三个方面进行分析,与大家探讨。
一、行为特征
(未完待续)
作者系上海市联合律师事务所高级合伙人

How to understand the concept of diagnosis and treatment activities
one
[Introduction to the case]
A company claiming to be a “human body environmental protection research institution” – was engaged in health management services and consultation, through observing and analyzing of the white blood cells, red blood cells and platelets in the blood by means of collecting blood for customers to evaluate the health status of human organs. According to the evaluation conclusion, the customer was then recommended specific food. In September 2016, Shanghai Jing'an Health and Family Planning Commission supervised and inspected it. According to the investigation, the company did not obtain the 'Certificate of Practice for Medical Institutions'. According to Article 23 of the Administrative Punishment Law of the People's Republic of China and Article 44 of the Regulations on the Administration of Medical Institutions, the law enforcement agency ordered the company to stop practicing activities and fined 8,000 yuan. 4 boxes of disposable peripheral blood collection device were also confiscated.
The company refused to accept and filed an administrative lawsuit. In the first instance, the focus of the dispute in this case was whether the behaviors carried out by the company were diagnosis and treatment activities. The court held that the company carried out peripheral blood collection for its customers in its business premises, and evaluated the health status of human liver and other organs by observing and analyzing white blood cells, red blood cells and platelets in human blood, and according to the evaluation conclusions, recommended the customers to take specific food. Repeat the behavior for review after one month to adjust the health of the client. The above whole course of behaviors is within the scope of diagnosis and treatment activities. The company’s claim lacked factual basis and legal basis and was not supported by the first instance.
The company refused to accept the judgment and appealed to the court of second instance. The court of second instance held that the definition of 'diagnosis and treatment activities' includes three major factors, one is 'inspection'; the other is 'method', that is, the use of drugs, equipment and surgery; the third is 'purpose', such as disease judgment, relief of the disease, relief of pain and other activities. In this case, the company's behavior is consistent with the definition and characteristics of “diagnosis and treatment activities”. Therefore, the company’s claim to revoke the decision of the alleged punishment cannot be established.
[Lawyer analysis]
How to understand the concept of 'diagnosis and treatment activities' is a very important issue, because if it is a 'diagnosis and treatment activity', only medical institutions can carry out, otherwise it will be subjected to administrative punishment. If it is not a 'diagnosis and treatment activity', then it can be carried out by non-medical institutions. In practice, health management and health consultation are more likely to be confused with “diagnosis and treatment activities”. Many health management companies are subjected to administrative penalties for inaccurately distinguishing between two concepts.
The typical 'diagnosis and treatment activities' are not difficult to judge, such as the common surgery and treatment in medical institutions. The typical 'health management' and 'health consultation' are not difficult to identify. For example, establishing a health record for a specific group of people, assisting them to visit a medical institution. However, the complexity of the world lies in the fact that the problems we face are often not always typical. In many atypical cases, it is not easy to accurately judge the nature of things near the critical point. For atypical “diagnosis and treatment activities”, how to accurately distinguish between “diagnosis and treatment activities” and “non-diagnosis and non-treatment activities” is closely related to the business scope of market participants. It is a problem that relevant enterprises should pay attention to, as well as the authority and seriousness of the law. Therefore, it is also the issue that should be properly handled in law enforcement and judicial practice.
Searching for “diagnosis and treatment activities, administrative punishment” on the “Chinese Judgment Document Network” can reveal much administrative litigation caused by whether or not they constitute”diagnosis and treatment activities”. For example, the case cited in this article is a typical case about different understanding of “diagnosis and treatment activities” and causes controversy. Therefore, it is necessary to discuss and analyze how to understand the concept of “diagnosis and treatment activities”.
According to the provisions of Article 88 of the Regulations for the Administration of Medical Institutions: “Diagnosis and treatment activities refers to through various examinations, and use of drugs, instruments and surgery, In order to make judgments and eliminate diseases, alleviate the disease, alleviate pain and improve function, prolong life and help patients recover from health”. In 2006, the Ministry of Health issued the “Medical Ambulance and Health Managers into the Specific Occupational Areas of the Health Industry”, in which it is clear that health manager is a professional who is involved in the monitoring, analysis, evaluation, and health maintenance and health promotion of people or individuals.
Based on the above concepts, combined with the current published judgment documents and literature materials, I will analyze the concept of “diagnosis and treatment activities” from three aspects: behavioral characteristics, behavioral goals, and behavioral risks.
First, the behavior characteristics

(To be continued)

The author is a senior partner of Shanghai United Law Firm
May 20 , 2019


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