| Notice by the National Health Commission and the State Administration of Traditional Chinese Medicine for Issuing the Measures for the Administration of Internet Diagnosis and Treatment (for Trial Implementation) and Other Two Documents | | 国家卫生健康委员会、国家中医药管理局关于印发互联网诊疗管理办法（试行）等3个文件的通知 |
| (No. 25 [2018] of the National Health Commission) | | （国卫医发〔2018〕25号） |
| The health and family planning commissions and administrations of traditional Chinese medicine of all provinces, autonomous regions, municipalities directly under the Central Government, and Xinjiang Production and Construction Corps: | | 各省、自治区、直辖市及新疆生产建设兵团卫生计生委、中医药管理局： |
| For the purposes of implementing the relevant requirements of the Opinions of the General Office of the State Council on Promoting the Development of “Internet plus Health Care,” further regulating the conduct of Internet diagnosis and treatment, maximizing the active role of remote medical services, improving the efficiency of medical services, and guaranteeing the medical service quality and medical safety, the National Health Commission and the State Administration of Traditional Chinese Medicine have organized the drafting of the Measures for the Administration of Internet Diagnosis and Treatment (for Trial Implementation), the Measures for the Administration of Internet Hospitals (for Trial Implementation), and the Specifications for the Administration of Remote Medical Services (for Trial Implementation), which are hereby issued for your compliance and implementation. | | 为贯彻落实《国务院办公厅关于促进“互联网＋医疗健康”发展的意见》有关要求，进一步规范互联网诊疗行为，发挥远程医疗服务积极作用，提高医疗服务效率，保证医疗质量和医疗安全，国家卫生健康委员会和国家中医药管理局组织制定了《互联网诊疗管理办法（试行）》、《互联网医院管理办法（试行）》、《远程医疗服务管理规范（试行）》，现印发给你们，请遵照执行。 |
| Annexes: | | 附件： |
| 1. Measures for the Administration of Internet Diagnosis and Treatment (for Trial Implementation) | | 1.互联网诊疗管理办法（试行） |
| 2. Measures for the Administration of Internet Hospitals (for Trial Implementation) | | 2.互联网医院管理办法（试行） |
| 3. Specifications for the Administration of Remote Medical Services (for Trial Implementation) | | 3.远程医疗服务管理规范（试行） |
| National Health Commission | | 国家卫生健康委员会 |
| State Administration of Traditional Chinese Medicine | | 国家中医药管理局 |
| July 17, 2018 | | 2018年7月17日 |
| Annex 1 | | 附件1 |
| Measures for the Administration of Internet Diagnosis and Treatment (for Trial Implementation) | | 互联网诊疗管理办法（试行） |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of implementing the Opinions of the General Office of the State Council on Promoting the Development of “Internet plus Health Care,” regulating the Internet diagnosis and treatment, promoting the sound and rapid development of Internet medical services, and guaranteeing the medical service quality and medical security, these Measures are developed according to the Law on Medical Practitioners, the Regulation on the Administration of Medical Institutions, and other laws and regulations. | | 第一条 为落实《国务院办公厅关于促进“互联网＋医疗健康”发展的意见》，规范互联网诊疗活动，推动互联网医疗服务健康快速发展，保障医疗质量和医疗安全，根据《执业医师法》、《医疗机构管理条例》等法律法规，制定本办法。 |
| Article 2 For the purposes of these Measures, “Internet diagnosis and treatment” means the practice whereby medical institutions use physicians registered therein to provide subsequent visits for some common diseases and chronic diseases and contract signing for “Internet plus” family doctors through the Internet and other information technologies. | | 第二条 本办法所称互联网诊疗是指医疗机构利用在本机构注册的医师，通过互联网等信息技术开展部分常见病、慢性病复诊和“互联网＋”家庭医生签约服务。 |
| Article 3 The state implements access management of Internet diagnosis and treatment activities. | | 第三条 国家对互联网诊疗活动实行准入管理。 |
| Article 4 The health administrative department of the State Council and the competent departments of Chinese medicine shall be responsible for the supervision and administration of the Internet diagnosis and treatment activities across the country. The local health administrative departments at all levels (including the competent departments of Chinese medicine, here and below) shall be responsible for the supervision and management of Internet diagnosis and treatment activities within their respective jurisdictions. | | 第四条 国务院卫生健康行政部门和中医药主管部门负责全国互联网诊疗活动的监督管理。地方各级卫生健康行政部门（含中医药主管部门，下同）负责辖区内互联网诊疗活动的监督管理。 |
| Chapter II Access to Internet Diagnosis and Treatment Activities | | 第二章 互联网诊疗活动准入 |
| Article 5 Internet diagnosis and treatment activities shall be provided by the medical institutions that have obtained a “Practicing License for a Medical Institution.” | | 第五条 互联网诊疗活动应当由取得《医疗机构执业许可证》的医疗机构提供。 |
| Article 6 A medical institution that files a new application for formation and intends to carry out Internet diagnosis and treatment activities shall mention it in the application for formation and mention the Internet diagnosis and treatment activities in the feasibility study report. To cooperate with a third-party institution to establish an Internet diagnosis and treatment service information system, it shall submit a cooperation agreement. | | 第六条 新申请设置的医疗机构拟开展互联网诊疗活动，应当在设置申请书注明，并在设置可行性研究报告中写明开展互联网诊疗活动的有关情况。如果与第三方机构合作建立互联网诊疗服务信息系统，应当提交合作协议。 |
| Article 7 After accepting an application, the health administrative department shall, in accordance with the relevant provisions of the Regulation on the Administration of Medical Institutions and the Detailed Rules for the Implementation of the Regulation on the Administration of Medical Institutions, conduct an examination, and make a written reply of approval or disapproval within the prescribed time limit. Where approval for formation is granted and agreement for providing Internet diagnosis and treatment is granted, approval of its carrying out Internet diagnosis and treatment activities shall be indicated in the Approval for Formation of a Medical Institution. A medical institution shall apply for practicing registration in accordance with the relevant laws, regulations and rules. | | 第七条 卫生健康行政部门受理申请后，依据《医疗机构管理条例》、《医疗机构管理条例实施细则》的有关规定进行审核，在规定时间内作出同意或者不同意的书面答复。批准设置并同意其开展互联网诊疗的，在《设置医疗机构批准书》中注明同意其开展互联网诊疗活动。医疗机构按照有关法律法规和规章申请执业登记。 |
| Article 8 A medical institution that has obtained a Practicing License for a Medical Institution and intends to carry out Internet diagnosis and treatment activities shall file an application for practicing registration of Internet diagnosis and treatment activities with the authority issuing the Practicing License for a Medical Institution and file the following materials: | | 第八条 已经取得《医疗机构执业许可证》的医疗机构拟开展互联网诊疗活动，应当向其《医疗机构执业许可证》发证机关提出开展互联网诊疗活动的执业登记申请，并提交下列材料： |
| (1) The application form in which the legal representative or primary person in charge of the medical institution signs the consent, and the reasons for applying for carrying out Internet diagnosis and treatment activities. | | （一）医疗机构法定代表人或主要负责人签署同意的申请书，提出申请开展互联网诊疗活动的原因和理由； |
| (2) The cooperation agreement shall be filed, where an Internet diagnosis and treatment service information system is established in cooperation with a third-party institution. | | （二）如果与第三方机构合作建立互联网诊疗服务信息系统，应当提交合作协议； |
| (3) Other materials required by the registration authority to be filed. | | （三）登记机关规定提交的其他材料。 |
| Article 9 The practicing registration authority shall examine the application materials for the registration of medical institutions in accordance with relevant laws, regulations and rules. Where the examination is passed, registration shall be conducted, and “Internet diagnosis and treatment” shall be added to the service mode in the duplicate of the Practicing License for a Medical Institution. Where it fails the examination, the applicant shall be notified of the examination result in writing. | | 第九条 执业登记机关按照有关法律法规和规章对医疗机构登记申请材料进行审核。审核合格的，予以登记，在《医疗机构执业许可证》副本服务方式中增加“互联网诊疗”。审核不合格的，将审核结果以书面形式通知申请人。 |
| Article 10 A cooperation agreement between a medical institution and a third-party institution shall specify the rights and responsibilities of all parties in medical services, information security, privacy protection and other respects. | | 第十条 医疗机构与第三方机构的合作协议应当明确各方在医疗服务、信息安全、隐私保护等方面的责权利。 |
| Article 11 A medical institution shall carry out Internet diagnosis and treatment activities consistent with its diagnostic and treatment items. It shall not carry out Internet diagnosis and treatment activities under the diagnostic and treatment items that have not been approved by the health administrative department. | | 第十一条 医疗机构开展互联网诊疗活动应当与其诊疗科目相一致。未经卫生健康行政部门核准的诊疗科目，医疗机构不得开展相应的互联网诊疗活动。 |
| Chapter III Practicing Rules | | 第三章 执业规则 |
| Article 12 A medical institution carrying out Internet diagnosis and treatment activities shall satisfy the requirements of medical management and develop rules and regulations on medical service quality and medical safety. | | 第十二条 医疗机构开展互联网诊疗活动应当符合医疗管理要求，建立医疗质量和医疗安全规章制度。 |
| Article 13 To carry out Internet diagnosis and treatment activities, a medical institution shall have the facilities and equipment, information systems, technical personnel and information security systems that satisfy the requirements of Internet technology, and implement Grade III graded protection of information security. | | 第十三条 医疗机构开展互联网诊疗活动，应当具备满足互联网技术要求的设备设施、信息系统、技术人员以及信息安全系统，并实施第三级信息安全等级保护。 |
| Article 14 Physicians and nurses carrying out Internet diagnosis and treatment activities shall be able to be found in the national electronic registration system of physicians and nurses. A medical institution shall conduct electronic real-name verification for the medical staff members carrying out Internet diagnosis and treatment activities, and encourage qualified medical institutions to strengthen the management of medical staff members through face recognition and other human body characteristics recognition technologies. | | 第十四条 开展互联网诊疗活动的医师、护士应当能够在国家医师、护士电子注册系统中查询。医疗机构应当对开展互联网诊疗活动的医务人员进行电子实名认证，鼓励有条件的医疗机构通过人脸识别等人体特征识别技术加强医务人员管理。 |
| Article 15 The grassroots health care and medical institutions shall enter into agreements with “Internet plus” family doctors through the Internet, notify in the contracts patients of the service contents, processes, responsibilities and rights of both parties and the possible risks, among others, and sign letters of informed consent. | | 第十五条 基层医疗卫生机构实施“互联网＋”家庭医生签约服务，在协议中告知患者服务内容、流程、双方责任和权利以及可能出现的风险等，签订知情同意书。 |
| Article 16 When a medical institution provides subsequent visits for some common diseases and chronic diseases online, the physician shall understand the patient's medical records and provide subsequent visits for the same diagnosis, after a patient is specifically diagnosed in a physical medical institution to have a common disease or chronic disease or several common diseases or chronic diseases. When diagnosis and examination need to be conducted by medical staff members in the event of change in the disease of a patient, the medical institution and its medical staff members shall immediately stop Internet diagnosis and treatment activities and direct patients to receive medical treatment in a physical medical institution. | | 第十六条 医疗机构在线开展部分常见病、慢性病复诊时，医师应当掌握患者病历资料，确定患者在实体医疗机构明确诊断为某种或某几种常见病、慢性病后，可以针对相同诊断进行复诊。当患者出现病情变化需要医务人员亲自诊查时，医疗机构及其医务人员应当立即终止互联网诊疗活动，引导患者到实体医疗机构就诊。 |
| Internet diagnosis and treatment activities shall not carried out for any patient receiving initial diagnosis. | | 不得对首诊患者开展互联网诊疗活动。 |
| Article 17 A medical institution carrying out Internet diagnosis and treatment activities shall, in accordance with the requirements of the Provisions on the Administration of Medical Records in Medical Institutions, and the Basic Specifications for Electronic Medical Records (for Trial Implementation), etc., create electronic medical records for patients and conduct management according to the provisions. | | 第十七条 医疗机构开展互联网诊疗活动应当按照《医疗机构病历管理规定》和《电子病历基本规范（试行）》等相关文件要求，为患者建立电子病历，并按照规定进行管理。 |
| Article 18 A medical institution carrying out Internet diagnosis and treatment activities shall strictly comply with the Measures for the Administration of Prescriptions and other provisions on the administration of prescriptions. After understanding the medical records of patients, a physician may issue prescriptions online for patients of some common diseases and chronic diseases. The electronic signature of a physician must be affixed to a prescription issued online. After examination by the pharmacist, the medical institution and the drug business enterprise may entrust a third-party institution meeting the conditions to deliver the drugs. | | 第十八条 医疗机构开展互联网诊疗活动应当严格遵守《处方管理办法》等处方管理规定。医师掌握患者病历资料后，可以为部分常见病、慢性病患者在线开具处方。在线开具的处方必须有医师电子签名，经药师审核后，医疗机构、药品经营企业可委托符合条件的第三方机构配送。 |
| Article 19 When carrying out Internet diagnosis and treatment activities, a medical institution shall not issue any prescription of narcotic drugs, psychotropic drugs, or any other drugs under special control. To issue an Internet drug prescription for a young child (under 6 years of age), it shall be confirmed that the child is accompanied by a guardian and a relevant professional physician. | | 第十九条 医疗机构开展互联网诊疗活动时，不得开具麻醉药品、精神药品等特殊管理药品的处方。为低龄儿童（6岁以下）开具互联网儿童用药处方时，应当确认患儿有监护人和相关专业医师陪伴。 |
| Article 20 The medical institutions shall strictly implement the relevant laws and regulations on information security and confidentiality of medical data, and appropriately keep patients' information, and shall not illegally trade or disclose patients' information. After patients' information and medical data are disclosed, a medical institution shall report to the competent health administrative department in a timely manner and immediately take effective response measures. | | 第二十条 医疗机构应当严格执行信息安全和医疗数据保密的有关法律法规，妥善保管患者信息，不得非法买卖、泄露患者信息。发生患者信息和医疗数据泄露后，医疗机构应当及时向主管的卫生健康行政部门报告，并立即采取有效应对措施。 |
| Article 21 A medical institution carrying out Internet diagnosis and treatment activities shall comply with the relevant provisions on hierarchical diagnosis and treatment, and be compatible with its functional orientation. | | 第二十一条 医疗机构开展互联网诊疗活动应当符合分级诊疗相关规定，与其功能定位相适应。 |
| Article 22 Utilization of Internet technology in the medical association shall be encouraged, realization of connection of medical resources at all levels shall be accelerated, the capacity and efficiency of grassroots medical services shall be improved, and the building of an orderly hierarchical diagnosis and treatment pattern shall be promoted. Hospitals at the third level shall be encouraged to transfer their patients to hospitals at lower levels through the Internet diagnosis and treatment information system in the medical association. | | 第二十二条 鼓励医联体内利用互联网技术，加快实现医疗资源上下贯通，提高基层医疗服务能力和效率，推动构建有序的分级诊疗格局。鼓励三级医院在医联体内通过互联网诊疗信息系统向下转诊患者。 |
| Article 23 Hospitals at the third level shall give priority to the development of Internet medical services between hospitals at the second level and grassroots health care and medical institutions, and provide technical support for the Internet diagnosis and treatment activities carried out by the grassroots health care and medical institutions. | | 第二十三条 三级医院应当优先发展与二级医院、基层医疗卫生机构之间的互联网医疗服务，为基层医疗卫生机构开展的互联网诊疗活动提供技术支持。 |
| Chapter IV Supervision and Administration | | 第四章 监督管理 |
| Article 24 Medical institutions shall strengthen the management of their Internet diagnosis and treatment activities, establish and improve the relevant management rules and service procedures, ensure whole-process tracking and trackability of the Internet diagnosis and treatment activities, and open data interfaces to the supervision departments. | | 第二十四条 医疗机构应当加强互联网诊疗活动管理，建立完善相关管理制度、服务流程，保证互联网诊疗活动全程留痕、可追溯，并向监管部门开放数据接口。 |
| Article 25 To carry out Internet diagnosis and treatment activities, a physician shall obtain corresponding practicing qualifications according to law, have not less than 3 years of independent clinical work experience, and obtain the consent of the medical institution where he or she has undergone the formalities of practicing registration. | | 第二十五条 医师开展互联网诊疗活动应当依法取得相应执业资质，具有3年以上独立临床工作经验，并经其执业注册的医疗机构同意。 |
| Article 26 A medical institutions carrying out Internet diagnosis and treatment activities shall, under the principle of localized management, be subject to supervision and administration of the local health administrative department at or above the county level. | | 第二十六条 医疗机构开展互联网诊疗活动按照属地化管理的原则，由县级及以上地方卫生健康行政部门进行监督管理。 |
| Article 27 The local health administrative departments at or above the county level shall disclose the lists of medical institutions allowed to carry out Internet diagnosis and treatment activities to the public, announce the supervision telephone numbers or other supervision methods, and accept and handle the tip-offs on Internet diagnosis and treatment services in violation of laws and regulations in a timely manner. Where the provisions of these Measures are found not be complied with, the relevant competent departments shall be notified in a timely manner. | | 第二十七条 县级及以上地方卫生健康行政部门应当向社会公布允许开展互联网诊疗活动的医疗机构名单，公布监督电话或者其他监督方式，及时受理和处置违法违规互联网诊疗服务举报。发现不符合本办法规定的，应当及时告知有关主管部门。 |
| Article 28 Where the health administrative departments at lower levels fail to manage the Internet diagnosis and treatment activities in accordance with the provisions of the Regulation on the Administration of Medical Institutions and these Measures, the health administrative departments at higher levels shall make corrections in a timely manner. | | 第二十八条 下级卫生健康行政部门未按照《医疗机构管理条例》和本办法规定管理互联网诊疗活动的，上级卫生健康行政部门应当及时予以纠正。 |
| Article 29 The local health administrative departments at or above the county level shall maximize the role of social organizations and strengthen the industry supervision and self-discipline of Internet diagnosis and treatment activities. | | 第二十九条 县级及以上地方卫生健康行政部门应当充分发挥社会组织作用，加强互联网诊疗活动的行业监督和自律。 |
| Chapter V Supplementary Provisions | | 第五章 附 则 |
| Article 30 A medical institution that has carried out Internet diagnosis and treatment activities before these Measures come into force shall, within 30 days of these Measures' coming into force, re-apply for the practicing registration in accordance with the requirements of these Measures. | | 第三十条 本办法施行前已经开展互联网诊疗活动的医疗机构，自本办法施行之日起30日内，按照本办法要求重新提出执业登记申请。 |
| Article 31 Remote medical services shall be governed by the Specifications for the Administration of Remote Medical Services (for Trial Implementation) and other relevant documents. | | 第三十一条 远程医疗服务按照《远程医疗服务管理规范（试行）》等相关文件管理。 |
| Internet hospitals shall be managed according to the Measures for the Administration of Internet Hospitals (for Trial Implementation). | | 互联网医院按照《互联网医院管理办法（试行）》管理。 |
| Article 32 These Measures shall come into force on the date of issuance. | | 第三十二条 本办法自发布之日起施行。 |
| Annex 2 | | 附件2 |
| Measures for the Administration of Internet Hospitals (for Trial Implementation) | | 互联网医院管理办法（试行） |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of implementing the Opinions of the General Office of the State Council on Promoting the Development of “Internet plus Health Care,” promoting the sustainable and sound development of Internet hospitals, regulating the management of Internet hospitals, improving the efficiency of medical services, and ensuring the medical service quality and medical security, these Measures are developed according to the Law on Medical Practitioners, the Regulation on the Administration of Medical Institutions, and other laws and regulations. | | 第一条 为落实《国务院办公厅关于促进“互联网＋医疗健康”发展的意见》，推动互联网医院持续健康发展，规范互联网医院管理，提高医疗服务效率，保证医疗质量和医疗安全，根据《执业医师法》、《医疗机构管理条例》等法律法规，制定本办法。 |
| Article 2 For the purposes of these Measures, “Internet hospitals” includes the Internet hospitals as the second names of the physical medical institutions and Internet hospitals independently established by relying on the physical medical institutions (see Annex for the Basic Standards for Internet Hospitals). | | 第二条 本办法所称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（互联网医院基本标准见附录）。 |
Article 3 The state shall implement access management to Internet hospitals in accordance with the Regulation on the Administration of Medical Institutions and the Detailed Rules for the Implementation of the Regulation on the Administration of Medical Institutions.
．．．．．． | | 第三条 国家按照《医疗机构管理条例》、《医疗机构管理条例实施细则》对互联网医院实行准入管理。
．．．．．． |
|
Dear visitor, as a premium member of this database, you will get complete access to all content.Please go premium and get more.
1. To become a premium member, please call 400-810-8266 Ext. 171.
2. Binding to the account with access to this database.
3. Apply for a trial account.
4. To get instant access to a document, you can Pay Amount 【￥1200.00】 for your single purchase. | |
您好：您现在要进入的是北大法宝英文库会员专区。
如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户；您可通过网上支付进行单篇购买，支付成功后即可立即查看本篇内容。
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail:info@chinalawinfo.com
|
| | | |
| | | |