China: 远程医疗的法律概念和内容浅析

Last Updated: 9 August 2019
Article by DeHeng Law Offices
Most Read Contributor in China, July 2019

在我国,远程医疗的概念和实践存在已久,本文旨在通过对远程医疗的法律概念和服务内容的发展变化进行研究,厘清远程医疗的内容和范围,同时浅析境内医疗机构与境外医疗机构远程医疗合作(以下笔者称"跨境远程医疗")的法律适用问题,供远程医疗的推广和发展予以借鉴。

一、远程医疗的概念和内容

在我国相关法律文件中,远程医疗的概念和内容主要发展过程如下:

1.原卫生部于1999年1月4日发布的《卫生部关于加强远程医疗会诊管理的通知》("《1999年通知》")中规定:"三、远程医疗会诊是应用计算机及网络、通讯技术进行异地医疗咨询活动,属于医疗行为,必须在取得《医疗机构执业许可证》的医疗机构内进行。各级卫生行政部门依据管理权限,审定入网医疗机构;医疗机构应在能够取得清楚影像资料的条件下,方可开展远程医疗会诊工作。七、会诊医师与申请会诊医师之间的关系属于医学知识的咨询关系,而申请会诊医师与患者之间则属于通常法律范围内的医患关系。对病人的诊断与治疗的决定权属于收治病人的医疗机构。若出现医疗纠纷仍由申请会诊的医疗机构负责。"

《1999年通知》提出了"远程医疗会诊"的概念,远程医疗会诊是应用计算机及网络、通讯技术进行异地医疗咨询活动,属于医疗行为,必须在取得《医疗机构执业许可证》的医疗机构内进行。

2. 国务院2013年《关于促进健康服务业发展的若干意见》("《2013年意见》")中规定:"以面向基层、偏远和欠发达地区的远程影像诊断、远程会诊、远程监护指导、远程手术指导、远程教育等为主要内容,发展远程医疗。"

《2013年意见》提出了"远程医疗"的概念,根据《2013年意见》,远程医疗包括远程影像诊断、远程会诊、远程监护指导、远程手术指导、远程教育等。


3.原国家卫生计生委2014年8月21日发布的《国家卫生计生委关于推进医疗机构远程医疗服务的意见》(以下简称"《远程医疗意见》")中规定:"远程医疗服务是一方医疗机构(以下简称邀请方)邀请其他医疗机构(以下简称受邀方),运用通讯、计算机及网络技术(以下简称信息化技术),为本医疗机构诊疗患者提供技术支持的医疗活动;医疗机构运用信息化技术,向医疗机构外的患者直接提供的诊疗服务,属于远程医疗服务。远程医疗服务项目包括:远程病理诊断、远程医学影像(含影像、超声、核医学、心电图、肌电图、脑电图等)诊断、远程监护、远程会诊、远程门诊、远程病例讨论及省级以上卫生计生行政部门规定的其他项目。"

《远程医疗意见》明确了远程医疗的概念和内容,即远程医疗既包括医疗机构之间运用信息化技术提供的技术支持医疗活动,也包括医疗机构运用信息化技术向医疗机构外的患者直接提供的诊疗服务,具体内容包括远程病理诊断、远程医学影像(含影像、超声、核医学、心电图、肌电图、脑电图等)诊断、远程监护、远程会诊、远程门诊、远程病例讨论等。

4.原国家卫生计生委办公厅2014年12月10日发布的《远程医疗信息系统建设技术指南》(以下简称"《指南》")规定:"远程医疗业务包括基本业务、高端业务和延伸业务。其中基本业务包括远程会诊、远程影像诊断、远程心电诊断、远程中医经络诊断、远程中医体质辨识、远程医学教育、远程预约、远程双向转诊等;高端业务包括远程重症监护、远程病理诊断、远程手术示教、远程宏观微观舌相诊断等;延伸业务包括各医疗专业远程应用和向患者个人、家庭等医疗机构之外的医疗健康服务。"

《指南》明确提出远程医疗包括的业务内容为远程会诊、远程影像诊断、远程心电诊断、远程中医经络诊断、远程中医体质辨识、远程医学教育、远程预约、远程双向转诊、远程重症监护、远程病理诊断、远程手术示教、远程宏观微观舌相诊断等,且对每项业务内容均进行了详细定义。

5.国家卫生健康委员会、国家中医药管理局于2018年7月17日颁布的《远程医疗服务管理规范(试行)》规定:"远程医疗服务包括以下情形:

(一)某医疗机构(以下简称邀请方)直接向其他医疗机构(以下简称受邀方)发出邀请,受邀方运用通讯、计算机及网络技术等信息化技术,为邀请方患者诊疗提供技术支持的医疗活动,双方通过协议明确责权利。

(二)邀请方或第三方机构搭建远程医疗服务平台,受邀方以机构身份在该平台注册,邀请方通过该平台发布需求,由平台匹配受邀方或其他医疗机构主动对需求做出应答,运用通讯、计算机及网络技术等信息化技术,为邀请方患者诊疗提供技术支持的医疗活动。邀请方、平台建设运营方、受邀方通过协议明确责权利。"

《远程医疗新规》明确了远程医疗服务仅包括医疗机构之间(邀请方和受邀方之间)运用信息化技术,为邀请方患者提供技术支持的医疗活动,而《远程医疗意见》提及的医疗机构运用信息化技术向医疗机构外的患者直接提供的诊疗服务不再属于远程医疗的范围(属于互联网诊疗活动 [1])。同时,根据《远程医疗新规》及国家卫生健康委员会医政医管局焦雅辉副局长在2018年9月14日新闻发布会的介绍,远程医疗是指由医疗机构之间使用本机构注册的医务人员,利用互联网等信息技术开展远程会诊和远程诊断,其中远程会诊为医疗机构之间通过远程进行会诊,受邀方提供诊断治疗意见,邀请方明确诊断治疗方案;远程诊断为邀请方和受邀方建立对口支援或者形成医疗联合体等合作关系,由邀请方实施医学影像、病理、心电、超声等辅助检查,由受邀的上级医疗机构进行诊断,具体流程由邀请方和受邀方通过协议明确。

综上,我国远程医疗的概念和内容存在着不同阶段、不同政策导向的演变过程。远程医疗的概念和内容经历了从仅包括远程医疗会诊到《远程医疗意见》界定的包括医疗机构之间运用信息化技术提供的技术支持医疗活动和医疗机构运用信息化技术向医疗机构外的患者直接提供的诊疗服务再到《远程医疗新规》界定的仅限于医疗机构之间进行的远程会诊和远程诊断的过程,立法和政策逐步明晰。

值得注意的是,《远程医疗新规》明确了远程诊断的概念,在现行推行医联体政策的环境下,在医联体内利用远程诊断的方式,是国家解决基层人才缺失、平衡医疗资源的对策之一,即"基层检查,上级诊断",此情况下由邀请方和受邀方两者共同承担法律责任,而在远程会诊中,受邀请方只提供诊疗意见,最后诊断和治疗的决策权依然在邀请方,所以相应的法律责任承担由邀请方承担。

二、跨境远程医疗的法律适用


在我国相关法律文件中,提及跨境远程医疗的文件主要如下:


1.原国家卫生计生委2014年8月21日发布的《远程医疗意见》规定:"医疗机构与境外医疗机构之间开展远程医疗服务的,参照本意见执行。"

《远程医疗意见》正式提出了境内医疗机构和境外医疗机构之间开展远程医疗服务的概念。

2.原国家卫生计生委办公厅2014年12月10日发布了《指南》,《指南》提及了跨境远程医疗典型案例,笔者摘取部分如下:

中日友好医院2012年设为国家卫生计生委远程医疗管理与培训中心,和日本、美国、德国等多个国家和地区开展了远程医疗活动。目前通过远程医疗信息管理平台,统一管理与应用基于软视频的远程会诊、高清视频终端会诊、3D手术远程示教直播和远程教育培训等系统,采用数字专线、国际VPN线路和互联网等多种接入方式。开展了临床会诊、影像会诊、病理会诊、教学培训、3D手术示教、多学科病例讨论与查房、学术会议等多种远程医疗活动。

浙江大学附属第一医院国际远程医学中心已与美国加州大学洛杉矶分校(UCLA)大学、印度尼西亚大学、西澳大利亚州、美国麻省总院、美国克里夫兰医学中心等建立横跨大洋的国际远程医疗平台,开展深入的交流和广泛的合作,促进优质医疗国际共享。截至2013年底,浙江省共开展20000余例远程专家会诊、近千例远程持续监护、250余次远程教学查房、300余次基于临床案例的远程专题教学和学术研讨、350余次远程健康知识讲座,20余次远程手术直播和国际合作交流。

从《指南》提出的典型应用可见,跨境远程医疗在行业内已有实务案例,合作内容主要为远程会诊、教学培训、学术研讨等。

笔者理解,目前市场上开展的跨境远程医疗项目多为根据《远程医疗意见》中"医疗机构与境外医疗机构之间开展远程医疗服务的,参照本意见执行"的规定下进行的合作。但如本文第一部分所述,《远程医疗意见》提及的医疗机构运用信息化技术向医疗机构外的患者直接提供的诊疗服务已不再属于远程医疗的范围,《远程医疗新规》已明确远程医疗服务仅包括医疗机构之间(邀请方和受邀方之间)运用信息化技术,为邀请方患者提供技术支持的医疗活动。同时,互联网新规中没有关于境内医疗机构与境外医疗机构合作的规定,也未提及与境外医疗机构合作可以参照适用。因此互联网新规出台后,境内医疗机构与境外医疗机构远程医疗合作是否继续参照《远程医疗意见》执行,是否可以继续开展远程合作,目前没有明确的结论。

笔者认为,因《远程医疗意见》仍现行有效,跨境远程医疗应可以按照《远程医疗意见》执行,但应仅限于互联网新规下的"远程会诊"合作,即境内医疗机构作为邀请方向境外医疗机构发出远程会诊邀请,会诊受邀请方只提供诊疗意见,最后诊断和治疗的决策权在邀请方,医疗责任由境内医疗机构承担,跨境远程医疗不应包括"远程诊断",理由如下:

1.全国人民代表大会常务委员会于1999年5月1日发布的《中国人民共和国执业医师法》中规定:"医师实施医疗、预防、保健措施,签署有关医学证明文件,必须亲自诊查、调查。"(即"亲自诊查义务")《远程医疗新规》规定:"在远程医疗服务过程中发生医疗争议时,患者向邀请方所在地卫生健康行政部门提出处理申请。远程会诊由邀请方承担相应法律责任,远程诊断由邀请方和受邀方共同承担相应法律责任。"

根据上述规定,笔者认为,亲自诊查义务的立法原意为亲自诊查义务能够保证通过医师的亲自诊查确保医疗水平的完善。如在美国实施远程医疗中也存在类似的解释,全美诸州医疗委员会联盟在2002年《医疗实践中互联网恰当使用指南 (Model Guideline for the Appropriate Use if the Internet in Medical Practice)》中要求,互联网平台上开展的治疗和咨询应该达到与传统亲自面对面进行治疗和咨询时相同的临床实践标准;包括处方在内,只基于在线询问而实施的治疗达不到一个可以接受的注意标准(an acceptable standard ofcare)[2]。在境内医疗机构之间开展远程会诊,受邀方为诊疗意见的提供者,邀请方则履行亲自诊查义务。跨境远程会诊可以参照的立法逻辑也应如此。目前我国境内医疗机构间的远程医疗扩大到可以包括远程诊断,笔者认为,这存在特殊原因,即为了平衡医疗资源分配的分级诊疗及医联体等政策导向。在我国政策下,远程诊断一般为上级医疗机构作为受邀请方,对下级医疗机构难以诊治的疾病进行诊治,属于医疗资源的下沉,提高下级医疗所在区域的医疗水准。并且,《远程医疗新规》规定,远程诊断由邀请方与受邀方共同承担责任,其共同实施诊断义务。据此,共享医疗资源的立法用意也可见一斑。由于远程诊断的特殊性,这种模式无法被参照应用于跨境医疗机构之间,笔者认为其原因为:一是主管部门很难对境外医疗机构的医疗水平予以判断,二是难以实现对境外医疗机构追究责任。

2.原卫生部1992年10月7日《外国医师来华短期行医暂行管理办法》(2016年1月19日修订)中规定:"'外国医师来华短期行医',是指在外国取得合法行医权的外籍医师,应邀、应聘或申请来华从事不超过一年期限的临床诊断、治疗业务活动。外国医师来华短期行医必须经过注册,取得《外国医师短期行医许可证》。"

根据上述规定,如果外国医师来华从事短期临床诊断、治疗业务的情况下,应该取得《外国医师短期行医许可证》,其立法逻辑为对于外国医师的诊断、治疗业务也应纳入我国医生执业资格许可的监管,那么笔者认为,若允许跨境远程医疗包括远程诊断,意味着通过"远程"的方式可以规避外国医师的行医许可监管,与立法本意不符。

综上,笔者认为,跨境远程医疗内容可以包括远程会诊,目前不应包括远程诊断。但结合笔者的项目经验,实践中跨境远程医疗是否可行,建议境内医疗机构进一步征询主管卫健委的意见,并根据主管卫健委的意见按其要求和指导提交说明合作内容的合作方案供其审批或备案。

目前《远程医疗新规》已经对远程医疗进行了明确定义和规范,建议进一步对跨境医疗立法进行完善。完备清晰的法律规定将促进境内远程医疗和跨境远程医疗健康有序发展。

文中备注:

[1]《远程医疗新规》颁布的同时,国家卫生健康委员会、国家中医药管理局也颁布了《互联网诊疗管理办法(试行)》和《互联网医院管理办法(试行)》(合称"《互联网新规》")。根据国家卫生健康委员会医政医管局焦雅辉副局长在2018年9月14日新闻发布会的介绍,根据使用的人员和服务方式,将"互联网+"医疗服务分为三类:第一类为远程医疗,由医疗机构之间使用本机构注册的医务人员,利用互联网等信息技术开展远程会诊和远程诊断;第二类为互联网诊疗活动,由医疗机构使用本机构注册的医务人员,利用互联网技术直接为患者提供部分常见病、慢性病复诊和家庭医生的签约服务;第三类为互联网医院,包括作为实体医疗机构第二名称的互联网医院,以及依托实体医疗机构独立设置的互联网医院。其中,第一类远程医疗服务分为两类,一种叫远程会诊,一种叫远程诊断。其中第二类和第三类均属于医疗机构通过互联网直接为患者提供服务。

[2]The Federation of State Medical Boards,Model Policy For the Appropriate Use of Telemedicine Technologies in the Practice of Medicine,in: http: / /www. fsmb. org/Media/Default/PDF/FSMB/Advocacy/FSMB_ Telemedicine_ Policy. pdf,2018-5-6.

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Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions