Article(id=1241036332613562763, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241036327177744706, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202504066, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1743868800000, receivedDateStr=2025-04-06, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773815719034, onlineDateStr=2026-03-18, pubDate=1757433600000, pubDateStr=2025-09-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773815719034, onlineIssueDateStr=2026-03-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773815719034, creator=13701087609, updateTime=1773815719034, updator=13701087609, issue=Issue{id=1241036327177744706, tenantId=1146029695717560320, journalId=1227665162245664772, year='2025', volume='52', issue='17', pageStart='3073', pageEnd='3264', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773815717738, creator=13701087609, updateTime=1773840080282, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241138511152206262, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241036327177744706, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241138511152206263, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241036327177744706, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=3184, endPage=3189, ext={EN=ArticleExt(id=1241036333049770388, articleId=1241036332613562763, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Research on the compliance of telemedicine services provided by third-party healthcare platforms in the post-pandemic era, columnId=1228016567846367388, journalTitle=Modern Preventive Medicine, columnName=Health Policy and Management, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the compliance of telemedicine services on third-party platforms since the release of the“Telemedicine Supervision Rules (Trial)” in 2022.

Methods

An anonymous standardized patient method was employed to assess the compliance of diagnostic behaviors on eight well-known, large-scale third-party internet healthcare platforms in China.Diagnostic scenarios were designed around five representative clinical cases. Based on the Telemedicine Supervision Rules (Trial),20 regulatory indicators were extracted across five key dimensions—clinical practice supervision, pharmaceutical services, prescription and medical record standards, identity verification, and quality and safety oversight.

Results

The platforms generally deviated from policy requirements in areas such as online first diagnosis, medication prescribed before diagnosis and prescription authenticity, with average compliance rates of 29%, 25%, and 10%, respectively. Some platforms were suspected of using artificial intelligence to replace doctors in consultations. Compliance was better in areas such as physician qualification certification and real-name authentication, patient real-name authentication, termination of online medical services, and prohibiting patients from being directed to other medical providers, with only a few cases of violations. The causes of compliance issues included the policy’s failure to adapt to industry development, low government regulatory willingness, weak regulatory effectiveness, and the profit-driven behavior of platforms and healthcare providers.

Conclusion

Third-party platforms still face varying degrees of compliance issues in medical practices, pharmaceutical services, prescription regulation, and personnel identity management. It is recommended to strengthen government regulatory functions, enforce platform accountability, improve the dynamic adjustment mechanism of policies, and enhance social supervision and industry self-regulation.

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目的

探究《互联网诊疗监管细则(试行)》2022年发布以来,第三方平台互联网诊疗行为的合规性。

方法

采用匿名标准化病人法,以国内8家知名度较高、用户规模较大的第三方互联网医疗平台为研究对象,围绕5种病例设计诊疗场景,依据《互联网诊疗监管细则(试行)》中提炼的诊疗行为监管、药事服务、处方及病历规范、人员身份监管和质量安全监管5方面,共20个监管要点进行合规性评价。

结果

各平台普遍在线上首诊、先药后方和处方真实规范性方面偏离政策要求,合规率均值分别仅为29%、25%和10%;部分平台疑似用人工智能替代医师接诊;医师资质认证和实名认证公示、患者实名认证、终止线上诊疗和不得引导至别处就诊方面,各平台合规性较好,仅有个例违规。不合规的根本原因包括政策不适应行业发展、政府监管意愿低、监管效能弱以及平台和医师的逐利性。

结论

第三方互联网医疗平台在诊疗行为、药事服务、处方规范和人员身份管理方面仍存在不同程度的合规性问题,建议强化政府监管职能、压实平台主体责任、完善政策动态调整机制并强化社会监督和行业自律。

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傅虹桥,E-mail:
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辛愿(2000—),女,硕士在读,研究方向:互联网医疗

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(In Chinese), articleTitle=Annual research and consultation report of panorama survey and investment strategy on China industry, refAbstract=null), Reference(id=1241139383701664296, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=14, authorNames=银川市卫生健康委, journalName=null, refType=null, unstructuredReference=银川市卫生健康委.关于印发《银川市互联网诊疗服务规范(试行)》的通知[EB/OL].[2025-05-28].https://www.yinchuan.gov.cn/xxgk/bmxxgkml/swjw/xxgkml_2361/ylws/202011/t20201109_2309406.html., articleTitle=关于印发《银川市互联网诊疗服务规范(试行)》的通知, refAbstract=null), Reference(id=1241139383802327598, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=15, authorNames=National Health Commission of Yin Chuan City, journalName=null, refType=null, unstructuredReference=National Health Commission of Yin Chuan City. Notice on the issuance of the trial implementation standards for the internet medical treatment services in Yin Chuan City[EB/OL]. [2025-05-28]. https://www.yinchuan.gov.cn/xxgk/bmxxgkml/swjw/xxgkml_2361/ylws/202011/t20201109_2309406.html. (In Chinese), articleTitle=Notice on the issuance of the trial implementation standards for the internet medical treatment services in Yin Chuan City, refAbstract=null), Reference(id=1241139383902990901, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, doi=null, pmid=null, pmcid=null, year=2020, volume=36, issue=10, pageStart=65, pageEnd=76, url=null, language=null, rfNumber=[10], rfOrder=16, authorNames=赵涛, 张智, 梁上坤, journalName=管理世界, refType=null, unstructuredReference=赵涛, 张智, 梁上坤.数字经济,创业活跃度与高质量发展--来自中国城市的经验证据[J].管理世界202036(10):65-76., articleTitle=数字经济,创业活跃度与高质量发展--来自中国城市的经验证据, refAbstract=null), Reference(id=1241139383991071291, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, doi=null, pmid=null, pmcid=null, year=2020, volume=36, issue=10, pageStart=65, pageEnd=76, url=null, language=null, rfNumber=[10], rfOrder=17, authorNames=Zhao T, Zhang Z, Liang SK, journalName=Journal of Management World, refType=null, unstructuredReference=Zhao T, Zhang Z, Liang SK. Digital economy, entrepreneurship, and high-quality economic development: Empirical evidence from urban China[J].Journal of Management World, 2020, 36(10): 65-76.(In Chinese), articleTitle=Digital economy, entrepreneurship, and high-quality economic development: Empirical evidence from urban China, refAbstract=null), Reference(id=1241139384062374465, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, doi=null, pmid=null, pmcid=null, year=2024, volume=null, issue=4, pageStart=149, pageEnd=162, url=null, language=null, rfNumber=[11], rfOrder=18, authorNames=徐国冲, 黄丽妹, journalName=理论与改革, refType=null, unstructuredReference=徐国冲, 黄丽妹.理解监管沙盒:理论界说、实施原则与运用策略[J].理论与改革2024(4):149-162., articleTitle=理解监管沙盒:理论界说、实施原则与运用策略, refAbstract=null), Reference(id=1241139384167232072, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, doi=null, pmid=null, pmcid=null, year=2024, volume=null, issue=4, pageStart=149, pageEnd=162, url=null, language=null, rfNumber=[11], rfOrder=19, authorNames=Xu GC, Huang LM, journalName=Theory and Reform, refType=null, unstructuredReference=Xu GC, Huang LM. Understanding regulatory sandbox: Theoretical definition, implementation principles and operational strategies[J]. Theory and Reform, 2024(4): 149-162.(In Chinese), articleTitle=Understanding regulatory sandbox: Theoretical definition, implementation principles and operational strategies, refAbstract=null), Reference(id=1241139384272089679, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, doi=null, pmid=null, pmcid=null, year=2021, volume=28, issue=5, pageStart=426, pageEnd=430, url=null, language=null, rfNumber=[12], rfOrder=20, authorNames=陈育庆, 邢烨, 廖维维, journalName=中国卫生监督杂志, refType=null, unstructuredReference=陈育庆,邢烨,廖维维,等.基于全域医疗大数据的医疗行为新型监管方式探索应用[J].中国卫生监督杂志202128(5):426-430., articleTitle=基于全域医疗大数据的医疗行为新型监管方式探索应用, refAbstract=null), Reference(id=1241139384339198549, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, doi=null, pmid=null, pmcid=null, year=2021, volume=28, issue=5, pageStart=426, pageEnd=430, url=null, language=null, rfNumber=[12], rfOrder=21, authorNames=Chen YQ, Xing Y, Liao WW, journalName=Chinese Journal of Health Inspection, refType=null, unstructuredReference=Chen YQ, Xing Y, Liao WW, et al. Exploration and application of the new supervision mode of medical organizations' diagnosis and treatment behaviors based on global medical big data[J]. Chinese Journal of Health Inspection, 2021, 28(5): 426-430.(In Chinese), articleTitle=Exploration and application of the new supervision mode of medical organizations' diagnosis and treatment behaviors based on global medical big data, refAbstract=null)], funds=[Fund(id=1241139379926790551, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, awardId=72473002, language=CN, fundingSource=国家自然科学基金面上项目(72473002), fundOrder=null, country=null), Fund(id=1241139380035842461, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, awardId=72103005, language=CN, fundingSource=国家自然科学基金青年项目(72103005), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1241139375195615372, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, xref=null, ext=[AuthorCompanyExt(id=1241139375199809678, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, companyId=1241139375195615372, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Health Policy and Management, School of Public Health, Peking University, Beijing 100191, China), AuthorCompanyExt(id=1241139375208198286, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, companyId=1241139375195615372, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=北京大学公共卫生学院卫生政策与管理学系,北京 100191)])], figs=[ArticleFig(id=1241139378509115715, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=EN, label=Table 1, caption=

Basic information of third-party healthcare platforms

, figureFileSmall=null, figureFileBig=null, tableContent=
平台主要业务
A在线问诊、预约挂号、诊后管理、健康科普、家庭医师
B在线问诊、预约挂号、医药零售、健康科普、会员服务
C健康科普、在线咨询、在线问诊、内容电商
D在线问诊、家庭医师、健康管理、医药零售、健康科普
E在线问诊、健康科普、门诊预约、医药零售
F家庭医师、在线问诊、医药零售、健康管理、商业保险
G在线问诊、健康管理、健康科普
H在线问诊、预约挂号、家庭医师、健康商城
), ArticleFig(id=1241139378601390410, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=CN, label=表1, caption=

第三方医疗平台基本情况

, figureFileSmall=null, figureFileBig=null, tableContent=
平台主要业务
A在线问诊、预约挂号、诊后管理、健康科普、家庭医师
B在线问诊、预约挂号、医药零售、健康科普、会员服务
C健康科普、在线咨询、在线问诊、内容电商
D在线问诊、家庭医师、健康管理、医药零售、健康科普
E在线问诊、健康科普、门诊预约、医药零售
F家庭医师、在线问诊、医药零售、健康管理、商业保险
G在线问诊、健康管理、健康科普
H在线问诊、预约挂号、家庭医师、健康商城
), ArticleFig(id=1241139378689470797, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=EN, label=Table 2, caption=

Clinical cases and compliance assessment design

, figureFileSmall=null, figureFileBig=null, tableContent=
内容框架合规性要点荨麻疹急性心梗抑郁焦虑类风湿性关节炎普通感冒
诊疗行为监管严禁首诊接诊
明确诊疗终止条件
首诊负责制
医师执业类别和范围
不得引导别处就诊
药事服务严禁先药后方
网络禁售药
高警示药品告知
严禁推荐指定药物
随诊服务
处方及病历规范处方真实规范性
医师药师签名
过程记录保存
人员身份监管医师资质公示
医师实名认证
医师本人接诊
患者本人就诊
质量安全监管风险提示和知情同意
收费公示
患者评价
), ArticleFig(id=1241139378790134100, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=CN, label=表2, caption=

病例对应合规性测试要点

, figureFileSmall=null, figureFileBig=null, tableContent=
内容框架合规性要点荨麻疹急性心梗抑郁焦虑类风湿性关节炎普通感冒
诊疗行为监管严禁首诊接诊
明确诊疗终止条件
首诊负责制
医师执业类别和范围
不得引导别处就诊
药事服务严禁先药后方
网络禁售药
高警示药品告知
严禁推荐指定药物
随诊服务
处方及病历规范处方真实规范性
医师药师签名
过程记录保存
人员身份监管医师资质公示
医师实名认证
医师本人接诊
患者本人就诊
质量安全监管风险提示和知情同意
收费公示
患者评价
), ArticleFig(id=1241139378920157535, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=EN, label=Table 3, caption=

Main clinical documentation of each case

, figureFileSmall=null, figureFileBig=null, tableContent=
病例病历结构病历描述
荨麻疹主诉医生,我运动后皮肤发红起包,很痒。
病史近几个月,较剧烈运动后皮肤发红发痒起包。部位包括肩颈、手臂和前胸后背,无摩擦和受压。无疼痛、恶心、呕吐、腹痛、腹泻、胸闷及喉梗阻等症状。瘙痒感严重,影响日常生活。未吃药、未线下就诊。
结束语医生,我用做什么检查吗?我这到底是什么病呀?我要吃或者抹什么药吗?
急性心梗主诉最近几周,时不时感觉胸前疼痛。
病史近半个月,散步后自觉胸前闷痛,持续几分钟,可自行缓解。近期工作压力大,饮食不规律,睡眠质量差。重要既往病史:10年高血压,平日规律服用沙库巴曲缬沙坦。(主动台词)医生,胸痛还是不缓解,感觉更难受了。
病情变化(被动台词)疼痛性质为持续性、针扎样、压榨样疼痛,疼痛位置为心前区和胸骨后区,安静状态下可持续半个小时。伴随有左肩放射性痛和恶心反胃。
结束语医生,我用做什么检查吗?我这到底是什么病呀?我要服用什么药吗?
抑郁焦虑主诉医生,给我开点百忧解和罗拉。
病史近一月,情绪低落,容易焦虑紧张,对事物丧失兴趣。有时胃疼,体重减轻,失眠。严重影响工作生活。重要既往病史:2年前确诊抑郁和焦虑障碍,服用盐酸氟西汀和罗拉西泮好转后自行停药。
结束语医生,我还用做什么检查吗?我应该是复发?还给我开百忧解和罗拉吧?
类风湿性关节炎主诉半年前诊断为类风湿性关节炎,申请开甲氨蝶呤和叶酸片。
病史半年前诊断为类风湿性关节炎,规律服用甲氨蝶呤和叶酸,甲氨蝶呤片一周一次三片,用药后第二天服用叶酸片两片,肝肾功能、血沉、C反应蛋白指标检测正常。
结束语医生,我还用做什么检查吗?我这个药就正常吃是吧?
普通感冒主诉医生,我这两天发烧、鼻塞、咳嗽。
病史一周前流鼻涕、鼻塞;2天前咳嗽,嗓子痒,无痰;昨晚发烧38.5度。无头痛、腹痛腹泻。因鼻塞憋气睡眠差。未自行服药或线下就诊。
结束语医生,我还用做什么检查吗?我这是什么感冒呀?能给我开点泰诺酚麻美敏片吗?
), ArticleFig(id=1241139379092124006, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=CN, label=表3, caption=

各病例主要病历描述

, figureFileSmall=null, figureFileBig=null, tableContent=
病例病历结构病历描述
荨麻疹主诉医生,我运动后皮肤发红起包,很痒。
病史近几个月,较剧烈运动后皮肤发红发痒起包。部位包括肩颈、手臂和前胸后背,无摩擦和受压。无疼痛、恶心、呕吐、腹痛、腹泻、胸闷及喉梗阻等症状。瘙痒感严重,影响日常生活。未吃药、未线下就诊。
结束语医生,我用做什么检查吗?我这到底是什么病呀?我要吃或者抹什么药吗?
急性心梗主诉最近几周,时不时感觉胸前疼痛。
病史近半个月,散步后自觉胸前闷痛,持续几分钟,可自行缓解。近期工作压力大,饮食不规律,睡眠质量差。重要既往病史:10年高血压,平日规律服用沙库巴曲缬沙坦。(主动台词)医生,胸痛还是不缓解,感觉更难受了。
病情变化(被动台词)疼痛性质为持续性、针扎样、压榨样疼痛,疼痛位置为心前区和胸骨后区,安静状态下可持续半个小时。伴随有左肩放射性痛和恶心反胃。
结束语医生,我用做什么检查吗?我这到底是什么病呀?我要服用什么药吗?
抑郁焦虑主诉医生,给我开点百忧解和罗拉。
病史近一月,情绪低落,容易焦虑紧张,对事物丧失兴趣。有时胃疼,体重减轻,失眠。严重影响工作生活。重要既往病史:2年前确诊抑郁和焦虑障碍,服用盐酸氟西汀和罗拉西泮好转后自行停药。
结束语医生,我还用做什么检查吗?我应该是复发?还给我开百忧解和罗拉吧?
类风湿性关节炎主诉半年前诊断为类风湿性关节炎,申请开甲氨蝶呤和叶酸片。
病史半年前诊断为类风湿性关节炎,规律服用甲氨蝶呤和叶酸,甲氨蝶呤片一周一次三片,用药后第二天服用叶酸片两片,肝肾功能、血沉、C反应蛋白指标检测正常。
结束语医生,我还用做什么检查吗?我这个药就正常吃是吧?
普通感冒主诉医生,我这两天发烧、鼻塞、咳嗽。
病史一周前流鼻涕、鼻塞;2天前咳嗽,嗓子痒,无痰;昨晚发烧38.5度。无头痛、腹痛腹泻。因鼻塞憋气睡眠差。未自行服药或线下就诊。
结束语医生,我还用做什么检查吗?我这是什么感冒呀?能给我开点泰诺酚麻美敏片吗?
), ArticleFig(id=1241139379188593009, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=EN, label=Table 4, caption=

Basic information of interviewees

, figureFileSmall=null, figureFileBig=null, tableContent=
特征数量占比(%)
性别男性1973.08
女性726.92
年龄分组(岁)25~34415.38
35~44830.77
45~541142.31
55~64311.54
身份背景公立医院医师1038.46
平台用户/患者311.54
第三方平台负责人934.61
政府监管人员27.69
专家学者27.69
), ArticleFig(id=1241139379293450615, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=CN, label=表4, caption=

受访者信息表

, figureFileSmall=null, figureFileBig=null, tableContent=
特征数量占比(%)
性别男性1973.08
女性726.92
年龄分组(岁)25~34415.38
35~44830.77
45~541142.31
55~64311.54
身份背景公立医院医师1038.46
平台用户/患者311.54
第三方平台负责人934.61
政府监管人员27.69
专家学者27.69
), ArticleFig(id=1241139379486388609, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241036332613562763, language=EN, label=Table 5, caption=

Compliance rate of anonymous standardized-patient assessment (%)

, figureFileSmall=null, figureFileBig=null, tableContent=
内容框架合规性要点平台A平台B平台C平台D平台E平台F平台G平台H
医疗行为严禁首诊接诊4045252520151050
明确诊疗终止条件100801008080100100100
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后新冠疫情时代第三方互联网医疗平台诊疗行为合规性研究
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辛愿 , 傅虹桥
现代预防医学 | 卫生政策与管理 2025,52(17): 3184-3189
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现代预防医学 | 卫生政策与管理 2025, 52(17): 3184-3189
后新冠疫情时代第三方互联网医疗平台诊疗行为合规性研究
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辛愿, 傅虹桥
作者信息
  • 北京大学公共卫生学院卫生政策与管理学系,北京 100191
  • 辛愿(2000—),女,硕士在读,研究方向:互联网医疗

通讯作者:

傅虹桥,E-mail:
Research on the compliance of telemedicine services provided by third-party healthcare platforms in the post-pandemic era
Yuan XIN, Hong-qiao FU
Affiliations
  • Department of Health Policy and Management, School of Public Health, Peking University, Beijing 100191, China
出版时间: 2025-09-10 doi: 10.20043/j.cnki.MPM.202504066
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目的

探究《互联网诊疗监管细则(试行)》2022年发布以来,第三方平台互联网诊疗行为的合规性。

方法

采用匿名标准化病人法,以国内8家知名度较高、用户规模较大的第三方互联网医疗平台为研究对象,围绕5种病例设计诊疗场景,依据《互联网诊疗监管细则(试行)》中提炼的诊疗行为监管、药事服务、处方及病历规范、人员身份监管和质量安全监管5方面,共20个监管要点进行合规性评价。

结果

各平台普遍在线上首诊、先药后方和处方真实规范性方面偏离政策要求,合规率均值分别仅为29%、25%和10%;部分平台疑似用人工智能替代医师接诊;医师资质认证和实名认证公示、患者实名认证、终止线上诊疗和不得引导至别处就诊方面,各平台合规性较好,仅有个例违规。不合规的根本原因包括政策不适应行业发展、政府监管意愿低、监管效能弱以及平台和医师的逐利性。

结论

第三方互联网医疗平台在诊疗行为、药事服务、处方规范和人员身份管理方面仍存在不同程度的合规性问题,建议强化政府监管职能、压实平台主体责任、完善政策动态调整机制并强化社会监督和行业自律。

互联网医疗  /  合规性  /  第三方平台  /  标准化病人
Objective

To explore the compliance of telemedicine services on third-party platforms since the release of the“Telemedicine Supervision Rules (Trial)” in 2022.

Methods

An anonymous standardized patient method was employed to assess the compliance of diagnostic behaviors on eight well-known, large-scale third-party internet healthcare platforms in China.Diagnostic scenarios were designed around five representative clinical cases. Based on the Telemedicine Supervision Rules (Trial),20 regulatory indicators were extracted across five key dimensions—clinical practice supervision, pharmaceutical services, prescription and medical record standards, identity verification, and quality and safety oversight.

Results

The platforms generally deviated from policy requirements in areas such as online first diagnosis, medication prescribed before diagnosis and prescription authenticity, with average compliance rates of 29%, 25%, and 10%, respectively. Some platforms were suspected of using artificial intelligence to replace doctors in consultations. Compliance was better in areas such as physician qualification certification and real-name authentication, patient real-name authentication, termination of online medical services, and prohibiting patients from being directed to other medical providers, with only a few cases of violations. The causes of compliance issues included the policy’s failure to adapt to industry development, low government regulatory willingness, weak regulatory effectiveness, and the profit-driven behavior of platforms and healthcare providers.

Conclusion

Third-party platforms still face varying degrees of compliance issues in medical practices, pharmaceutical services, prescription regulation, and personnel identity management. It is recommended to strengthen government regulatory functions, enforce platform accountability, improve the dynamic adjustment mechanism of policies, and enhance social supervision and industry self-regulation.

Telemedicine  /  Compliance  /  Third-party platform  /  Standardized patient
辛愿, 傅虹桥. 后新冠疫情时代第三方互联网医疗平台诊疗行为合规性研究. 现代预防医学, 2025 , 52 (17) : 3184 -3189 . DOI: 10.20043/j.cnki.MPM.202504066
Yuan XIN, Hong-qiao FU. Research on the compliance of telemedicine services provided by third-party healthcare platforms in the post-pandemic era[J]. Modern Preventive Medicine, 2025 , 52 (17) : 3184 -3189 . DOI: 10.20043/j.cnki.MPM.202504066
近年来,我国互联网+医疗健康服务快速发展。特别是新冠疫情以来[1],公众对互联网+医疗健康服务的接受度显著增加,国家政策支持力度不断加大,互联网+医疗健康服务已成为我国医疗健康服务的重要组成部分[2]。但随着互联网医疗服务量不断增大,线上首诊、先药后方以及医师资质等不合规现象逐渐凸显[3-5]。为此,国家卫生健康委和国家中医药局于2022年5月正式发布了《互联网诊疗监管细则(试行)》[6](简称《细则》),旨在进一步规范诊疗行为、明确责任主体、完善监管手段。
目前,较少研究评估《细则》发布后互联网诊疗行为的合规性,特别是第三方互联网医疗平台诊疗行为合规性。鉴于第三方平台是我国互联网医疗服务的主体[7],研究其合规性对推动互联网+医疗健康行业规范发展具有重要意义。为此,本研究将通过匿名标准化病人测试和半结构化访谈,探究《细则》发布以来我国头部第三方平台诊疗合规性现况,并基于既往研究[5]结果分析合规性变化,总结原因并提出建议。
经调研和专家咨询,选择八家知名度较高、用户规模较大的第三方互联网医疗平台作为匿名标准化病人法的研究对象。这八家平台共占据超65%的市场份额[8],在企业类型、主营业务、商业模式等方面具备代表性,能较好体现我国互联网医疗行业现状,各平台基本情况见表1
主要依据国家重点监管文件《细则》,同时结合地方监管规范《银川市互联网诊疗服务规范(试行)》[9](简称《规范》)作为评价依据,共纳入20个合规性要点。见表2
病例的选取主要基于该病例是否能满足合规性测试需求,在此基础上选择线上诊疗常见疾病并参考同类研究设计。本研究评价的部分合规性要点需通过特定的诊疗场景测试,例如:针对“严禁首诊接诊”,设置线上首诊病例如过敏和感冒,测试医师是否接诊;针对“明确诊疗终止条件”,设置危急重症病例如急性心梗,测试医师能否及时终止线上诊疗建议线下就医;针对“首诊负责制”,设置皮肤科病例测试医师能否遵循线上线下一致原则,要求患者提供皮肤照片后才进行诊断;针对“严禁先药后方”,设置主诉为开具处方药的病例,测试医师是否先问诊再开方;针对“高警示药品告知”和“网络禁售药”,设置申请开具高危药品和网络禁售药品的病例,如申请开具甲氨蝶呤的类风湿性关节炎和申请开具劳拉西泮的抑郁症,测试平台有无警示告知、用户能否购买到网络禁售药。
基于上述考量,选择荨麻疹、急性心梗、焦虑抑郁、类风湿性关节炎和普通感冒五个病例进行测试。不同病例在合规性要点的审查上各有侧重,各病例对应的合规性测试要点见表2。病例描述见表3
研究对每个平台使用每个病例各选择五位医师进行测试,八个平台共测试200位医师。通过两种方法选择医师:先通过“极速问诊”选择平台推荐的医师诊疗;若平台推荐医师重复则搜索相应科室,手动选择排名靠前的医师。如此可涵盖平台自雇医师和公立医院多点执业医师两种医师类型,全面反映合规性现况。
研究者作为匿名标准化病人按照上述流程在各平台选择医师申请图文问诊,依据表3扮演患者完成诊疗,按照表2对相应病例的合规性要点进行评价。各平台完成所有病例的测试后,汇总各测试点的评价结果。
研究对互联网平台诊疗的各利益相关方进行一对一、半结构化深入访谈,主要探究重点合规性问题、分析不合规原因并探索优化建议。受访者包括医师、用户、平台负责人、监管者和专家。以目的抽样原则选择访谈对象,选择标准为(1)医师:主治医师及以上职称,平台接诊人次数大于1 000;(2)用户:近两年至少使用五次线上问诊服务;(3)平台负责人:熟悉平台管理制度和实际运营的业务负责人;(4)监管者:参与制定或执行《细则》的国家和地方卫生监管人员;(5)专家:互联网医疗领域资深学者。最终纳入26位访谈对象,人口学特征见表4
经匿名标准化病人测试,20个合规性要点在八个平台的测试结果见表5。平台整体在质量安全监管方面合规性较好,但在诊疗行为监管、药事服务、处方及病历规范、人员身份监管四方面均存在突出问题:诊疗行为监管方面,平台普遍违反“严禁首诊接诊”,未设置制度管理,仅依靠医师自主判断患者是否适合线上诊疗,而测试医师中多半也不要求患者提供线下就诊凭证。只有平台D对精神心理科疾病严格履行了首诊要求。对于“危急重症患者终止线上诊疗”,绝大部分医师直接建议线下就诊,但平台D一医师误诊胃肠道疾病、平台B一医师未引导至线下就诊。对于“首诊负责制”,部分医师不要求荨麻疹患者提供病损部位照片,仅凭文字描述就进行首诊诊断,但所有医师诊断均正确。对于“医师执业类别和范围”,个别平台由于接诊医师数量和专科较少而不设分诊,导致医患错配。对于“不得引导别处就诊”,各平台合规性良好,仅发现平台H自雇医师会引导购买处方药的用户添加企业微信并进行后续用药随访。
药事服务方面,平台A和C无直接购药通道,其他六个平台都未遵守“严禁先药后方”规定,患者可以先买药后补方。患者可在平台B、G先药后方购买盐酸氟西汀(精神科处方药)和甲氨蝶呤(高警示药物);在平台F可先药后方购买盐酸氟西汀(精神科处方药);在平台D、E、H可先药后方购买甲氨蝶呤(高警示药物)。值得注意的是,所有可先药后方的六个平台均支持患者自主选择诊断疾病生成处方。其中在平台G购买甲氨蝶呤时,患者只能选择“肺炎”这一疾病诊断,但甲氨蝶呤同时有癌症、类风湿性关节炎等多个适应症,推测平台为规避处方诊断显示高危疾病,限制患者如实填写诊断,导致处方与实际不符。“网络禁售药”方面各平台均合规,所有平台无法购买劳拉西泮和酚麻美敏片。“高警示药品告知”方面,五个平台无高警示药品风险提示,部分医师也未主动提醒。“推荐指定药品”方面普遍合规,仅平台H某位医师在荨麻疹病例问诊中发送药品链接,并反复催促用户购买,营销性可能较大。“随诊服务”方面,除H外所有平台,问诊服务结束后患者在按照处方和医嘱用药过程中,平台不提供免费随访服务,患者若需进一步咨询则需额外付费。
处方及病历规范方面,“处方真实规范性”各平台普遍不合规,大部分平台在预问诊阶段不收集用药信息、接诊医师也未主动询问,因此广泛存在处方上药品规格和用法用量与患者实际不符的情况。“处方签字盖章”大部分平台合规,但平台B所有处方缺少互联网医院电子章;平台E的二位医师因平台无法开具精神科药品和高警示药品,上传手写处方照片并嘱患者到其他平台或药店凭照片购买。
人员身份监管方面,“医师资质公示和实名认证”整体合规性良好,但平台E所有医师无实名认证和资质认证公示、平台F、G、B、D部分医师无身份认证。“医师本人接诊”方面,平台B、F、H在诊疗环节存在疑似AI回复,平台D、G在买药补方环节疑似系统自动开方审方。“患者本人就诊”方面,患者在平台D、E、F、H上通过问诊开具非处方药无需实名认证,其他平台无论患者购买的是否为处方药均需实名认证。
总体来看,各平台当前存在较广泛的违规首诊、先药后方和处方内容与实际不符的合规性问题。在禁止网络销售药品、危重症患者及时终止线上诊疗等风险较高且政府易监管的问题上,以及医师实名认证、资质公示、患者实名认证、医师药师签名等平台通过设立管理制度即可完善的问题上,各平台合规性良好。
既往研究中,李妍玫等[4]学者为探究第三方平台诊疗合规性,曾依据《规范》对八家在银川市注册互联网医院的第三方平台通过标准化病人法进行诊疗合规性测试。
本研究选取的八家第三方平台与该研究一致、依据的监管文件包含《规范》、测试病例包含该研究设计,且该研究于2020年实施,探究了《细则》发布前的合规性结果。因此可通过对比两项研究结果,分析《细则》对平台诊疗服务的规范作用。结果显示,《细则》正式颁布后平台合规性变化体现在四方面。第一,违规首诊和先药后方持续存在。首诊合规性虽有提高(新增平台D针对精神科疾病严格禁止首诊),但整体仍处于无监管状态;先药后方整体合规性下降(新增平台B允许先药后方)。第二,“医师本人接诊”合规性降低,疑似存在人工智能接诊。第三,“处方药品用法用量与实际不符”及“处方签章不全”持续存在,“高警示药品告知”合规性虽有提高(新增平台D),但仍有5/8平台未设置高警示告知。第四,“医师资质认证和实名认证公示”“患者本人就诊”“危急重症患者及时终止线上诊疗”“不得引导至别处”合规性明显提高。“风险提示和知情同意”“收费公示”“患者评价”维持较高合规性水平。
通过定性访谈发现,不合规有四方面原因。第一,政策不适应行业发展。如近年备受关注的首诊问题,随着技术进步和市场需求的变化,诸如到家检测等创新诊疗模式出现,使得线上诊疗的安全边界发生了变化。而沿用至今的首诊禁令会使部分患者在安全风险可控的前提下无法获得潜在的诊疗便利,同时也对互联网诊疗的创新潜力形成制约。第二,政府监管意愿低。在促进经济增长、激发新质生产力、支持民营高新技术企业发展的中央战略背景下,国家监管部门对互联网医疗持开放发展态度[10];同时,地方政府出于税收原因,呈现宽松监管和事后监管。第三,政府监管效能低。目前,尚未形成中央层面完整统一的监管政策框架和体系,监管主体分散,相关监管部门间政策存在矛盾甚至冲突。此外,省级监管平台仅发挥了“数据搜集”和“业务统计”功能,监管方式重事前、轻事中事后,同时缺乏有专业背景的监管团队和医疗数据对外开放使用的法律法规。第四,平台和医师的逐利性。平台为持续获得业务增长,以患者需求为指引,不设首诊限制和处方购药限制;平台还以维护医师资源为运营目的,降低管理标准,默许医师推广药品以赚取回扣;平台与药企紧密的利益关联促使其推动药品销售。
为促进平台诊疗规范发展,应完善政府-平台-行业-社会多方协同治理体系。首先,建议强化政府监管职能。对高风险诊疗行为建立干预机制,对高风险药品处方设立超量预警机制;建议通过监管沙盒机制[11],向合规企业开放脱敏数据,智能化升级省级监管平台以提高监管效能。其次,压实平台主体责任。建议平台加强问诊和处方违规行为的实时识别管理;依据医师合规表现建立流量分配标准,形成促进合规的正反馈机制[12]。再次,应建立政策动态调整机制,寻求创新和质量间的平衡。如探究开放首诊的可行路径,建议综合评估诊疗风险和技术可行性,率先放开皮肤、心理等临床专科或率先准入合规性良好的互联网医院和医师。最后,需强化社会监督和行业自律。监管部门和平台应畅通渠道并及时反馈;行业协会应积极引导规范,对政策尚未覆盖的新技术或新应用,如人工智能在诊疗中的使用边界,可组织制定行业共识,督促行业共同遵守,维护行业健康发展。
  • 国家自然科学基金面上项目(72473002)
  • 国家自然科学基金青年项目(72103005)
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2025年第52卷第17期
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doi: 10.20043/j.cnki.MPM.202504066
  • 接收时间:2025-04-06
  • 首发时间:2026-03-18
  • 出版时间:2025-09-10
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  • 收稿日期:2025-04-06
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国家自然科学基金面上项目(72473002)
国家自然科学基金青年项目(72103005)
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    北京大学公共卫生学院卫生政策与管理学系,北京 100191

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2种不同金属材料的力学参数

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Number of
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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