双语解读丨解析《基本医疗卫生与健康促进法》二审稿新亮点

截至2017年底，我国民营医疗机构的数量已经是全国公立医院数量的1.5倍，然而与之相对的，在诊疗人次、卫生技术人员数量、床位数等数据上，却远远不及公立医院。民营医疗机构发展“多而不强”的现状，主要还是由于民营医疗机构存在“缺医生、少医保”等问题。对不以营利为目的，将营运收入用于弥补医疗服务成本的民办非营利性医疗机构而言，上述问题往往更为明显。 民办非营利性医疗机构相较于一般营利性民营医疗机构与公立医疗机构，其发展更需要政策与法律的扶持。
By the end of 2017, the number of private medical institutions in China has already been 1.5 times that of public hospitals nationwide. However, disproportionately, the number of medical treatments private hospitals conducted, medical professionals they employ, and hospital beds they own are far less than that of public hospitals. The problem of the underdevelopment of private medical institutions, “large in quantity but not quality”, may root in private medical institutions’ lack of medical professionals and support of healthcare insurance. The above problem for non-for-profit private medical institutions (“NFPPMIs”) looks more obvious. Consequently, compared with for-profit medical institutions and public medical institutions, NFPPMIs need more political and legislative support.

《一审稿》提出“以政府预算资金、捐赠资产举办或者参与举办的医疗卫生机构不得设立为营利性医疗卫生机构。……政府举办的医疗机构不得与其他组织投资设立非独立法人资格的机构。……禁止政府办公立医疗卫生机构与社会资本合作举办营利性机构。”二审稿中，在保留原有规定的基础上，增加了鼓励社会力量合作举办非经营性医疗机构的相关规定，针对该等机构在基本医疗保险定点、重点专科建设、科研教学、等级评审、实施特定医疗技术准入、医疗卫生人员职称评定等方面，将享受与公立医院同等的权利。类似规定已在上海等多地相应规范、政策中出现过，但对此问题的全国立法而言，实属首次。在医疗机构基本医疗保险定点中将民办非营利性医疗机构与公立医疗机构同等对待，在提高民办非营利性医疗机构诊疗人次的同时，也将有助减缓公立三甲医院患者数量过多、一号难求的状况；开放医疗卫生人员职称的评定，将吸引更多优秀医师、护理人员等从“体制”中跳出来，加入到民办非营利性医疗机构的建设中。
The First Draft provided that ”a medical institution organized with government funds or donated assets, in whole or in part, shall not be organized as a for-profit medical institution... a medical institution founded by the government shall neither invest in or form any institution with non-independent legal person qualification with any other organization, nor cooperate with any private investor to form any for-profit medical institution” In the Second Draft, such provisions are well-remained, and further provisions which encourages private investments to organize NFPPMIs are added into the Second Draft, e.g. NFPPMIs organized by private investments shall enjoy the same treatment as the public medical institutions in terms of the chance to be designated as medical institutions covered by basic healthcare insurance, construction of key specialties, scientific study and teaching, grade review, access for implementation of specific medical technology, and assessment of professional titles of medical professionals employed. Although similar policies have been published in some cities e.g. Shanghai, it is the first time for such provisions to be introduced into a national law. Treating NFPPMIs and public medical institutions equally in: the chance to be designated as medical institutions covered by basic healthcare insurance, will encourage patients to visit NFPPMIs for certain diseases that is covered by basic healthcare insurance, and the problem that third grade hospitals are over-crowded and outpatient service are hard to get might be alleviated to some extent, and; assessment of professional titles of medical professionals, will help NFPPMIs attract more expert physicians to join in NFPPMIs.

需要注意的是，早先有不少包含类似内容的政策出台，提出“同等对待”，该等政策在不同地区的落实至今仍有明显的差异，部分地区依然存在“亲疏有别”的情况。故就鼓励社会力量合作举办非经营性医疗机构，使民办非营利性医疗机构享受同公立医院的同等权利一项，还需保证该规定可以得到完全落实，或出台相应实施细则来帮助民办非营利性医疗机构缓解甚至解决“缺医生、少医保”的困境。

It shall be noted that there used to be several local policies published which also provided “Equal Treatment” provisions, however, such local “Equal Treatment” provisions are implemented differently in different areas, and in certain areas providing “Equal Treatment” provision, NFPPMIs are still not equally treated. Hence, to encourage private investments to organize NFPPMIs, the “Equal Treatment” provision in the Basic Healthcare and Health Promotion Law should be completely implemented nationwide or be ensured by further implemental measures, and finally alleviate the difficulties NFPPMIs have come across.

多年以来，我国医患关系饱受“医闹”之困，患者家属暴力伤害甚至杀害医生的新闻屡见不鲜。对此， 2017年12月的《一审稿》便规定“扰乱医疗卫生机构秩序，威胁医疗卫生人员人身安全，构成违反治安管理行为的，由公安机关依法予以治安管理处罚；构成犯罪的，依法追究刑事责任。”《二审稿》在此基础上，增加了禁止任何组织或个人侵犯医疗卫生人员人格尊严的相关规定，对于“医闹”及侵犯医疗卫生人员人格尊严，构成违反治安管理行为的人员，将被给予治安管理处罚。
The doctor-patient relationship in China is always intense due to violent incidents taking place from time to time. We have seen a few incidents that unsatisfactory family members of the patient violently assaulted or even killed medical professionals. In order to accommodate this, the First Draft issued in December 2017 provided:” Where the order of a medical institution is disturbed, the personal safety of medical professional is threatened or damaged, and violation of public security administration is constituted in violation of Basic Healthcare and Health Promotion Law, public security administration punishment shall be imposed, and where a crime is constituted, the violator shall be held criminally liable according to the law.” The Second Draft added specific provision to protect the personal dignity of medical professionals, and where the personal dignity of medical professional is infringed and constitutes violation of public security administration, public security administration punishment will be imposed upon the violator.

《二审稿》新增对医疗卫生人员人格尊严的保护并非空穴来风，2018年1月9日发布的《中国医师执业状况白皮书》显示，2016至17年度全国66%的医师经历过不同程度的暴力伤医事件，其中51%属于侵犯人格尊严的语言暴力。该规定的出现，有望更好震慑“医闹”份子，但其中“侵犯人格尊严，构成违反治安管理行为”的界限在何处，仍有待明确、细化。如情绪失控的病人家属在医院对医生的过激言语是否构成“侵犯人格尊严，构成违反治安管理行为”？“患者家属对患者情不自禁的关切表现”与“侵犯医疗卫生人员人格尊严的医闹行为”之间，那个合乎情理又合乎法律规定的界限在哪里？这些仍需进一步明确或有待具体个案执法情况的观察。

There is a factual ground in support of the necessity of the protection of personal dignity of medical professionals. According to the White Book for Practice Status of Chinese Physicians published on 9 January 2018, in the year 2016-17, 66% of physicians in China have experienced injuries of different levels, 51% of which were psychological harm. The protection of the personal dignity of medical professionals is expected to be deterrent to the "troublemakers in hospitals", however, what will trigger the “infringing personal dignity of medical professionals and violation to public security administration” still need to be clarified. For example, whether the family members of a patient who are emotionally out of control and gave inappropriate words to the physicians would be regarded as infringing the personal dignity of medical professionals and violating public security administration? What is the reasonable and lawful boundary between “uncontrollable concern to family member” and “intentional insult that infringes personal dignity of medical professionals”? All these still need to be further clarified subject to real cases.

目前全球环境下，宏观立法对于数据、个人隐私、个人信息保护的重视程度越来越高，个人健康信息的保护也是其中非常重要的一部分。诚如我们在八月和十月发布的《中国健康数据立法保护现状评析》中所言，我国健康信息保护的实施尚处于起步阶段，关于健康信息的立法完善仍在路上。本次《一审稿》与《二审稿》中便出现了针对个人健康信息保护的相关规范。《二审稿》规定：“国家保护与公民健康有关的个人隐私，确保个人健康信息安全。除法律法规规定或本人同意外，任何组织或者个人不得获取、利用和公开公民个人健康信息。”对于非法获取、传播公民健康信息，构成违反治安管理行为的，行为人将被给予治安管理处罚；对于泄露公民健康有关的个人隐私，造成严重后果的公办医疗机构医疗卫生人员，还将受到相应处分。
From a global perspective, a lot of countries are attaching greater importance on legislation on data privacy and data protection, the protection of personal health information is also an important part of it. As we mentioned in Health Data Protection in China released in August and October, “the protection of health information in China is still at early stage, and still has a long way to go in legislation on health data protection.” The two Drafts have provided specific provisions to protect personal health information. The Second Draft provides that:” China protects the personal privacy relating to the health of patients and will ensure the security of personal health information. No organization or individual may obtain, utilize or disclose the personal health information of any patient, unless as otherwise prescribed by laws and regulations or with consent of the patient.” Where patients’ health information is illegally obtained and disseminated, and violation of public security administration is constituted in violation of Basic Healthcare and Health Promotion Law, public security administration punishment shall be imposed, for violator who is staff of medical institutions founded by the government, disciplinary actions will be imposed.

关注患者个人健康信息保护的同时，《二审稿》也新增了患者对自身健康信息的书面知情同意规则。去年底的《一审稿》中，规定“公民在接受医疗卫生服务时，对病情、诊疗方案、医疗风险、医疗费用等有关的事项依法享有知情同意的权利。”《二审稿》在保留该条文的基础上，对于需要实施手术、特殊检查、特殊治疗的，要求医疗卫生人员向患者说明风险、替代方案，取得书面同意；对于不宜向患者说明病情的情况，要求医疗卫生人员向其近亲属说明，取得其书面同意。目前《二审稿》中对书面知情同意的要求还仅限于医疗卫生人员向患者实施手术、特殊检查、特殊治疗的情况，对于是否将其推广至更多环节，如对于医疗机构采集、披露患者个人健康信息前，是否需要取得患者书面知情同意？等具体问题，可能有待进一步的廓清。

In addition, the Second Draft has added the rule of written informed consent of patients for his/her personal health information. Last year, the First Draft provides: “When receiving medical services, patients shall have the right to informed consent for the illness, diagnosis and treatment plans, medical risks, medical expenses and other relevant matters”, based on that, where surgery, special medical check and special treatment needs to be conducted, the Second Draft requires that the medical professionals shall explain the medical risks, alternative medical plans and other situation to patients in a timely manner, and obtain their written consents; and where it is inappropriate to make explanation to a patient, explanation shall be made to the close relatives of the patient, and the written consent thereof shall be obtained. So far, the rule of written informed consent is still limited to the conduct of surgery, special medical check and special treatment, it needs to be further clarified whether such rule will be further adopted in different aspects in providing the medical service.

我们发现，《二审稿》相较于《一审稿》增加了不少亮点，部分规定的可操作性有所提升，但仍存在一定需要细化、明确的地方。就目前参与《二审稿》审议与会人员的态度来看，《基本医疗卫生与健康促进法》还存在一定优化与修改的空间，我们建议相关从业者关注后续修改或相关细则规定。

Compared with the First Draft, the Second Draft has added some innovative provisions and is more practicable while there are several points still need to be specified or clarified. Based on our observation to the opinions of the participants for the review of the Second Draft, it is likely that there will be further amendments and revisions to the Basic Healthcare and Health Promotion Law, and we highly recommend practitioner to keep close attention to any follow-up changes on this draft.