1、RDPAC 数字医疗合规分项指南：与医疗卫生专业人士及医疗卫生组织的互动RDPAC Digital Health Compliance Sub-Guidance:Interactions with HCPs&HCOs 中国外商投资企业协会药品研制和开发工作委员会China Association of Enterprise with Foreign Investment R&D-Based Pharmaceutical Association Committee(RDPAC)2023 年 12 月引言I.数字化渠道特有的合规考虑因素1.数字化活动相关法规和规则2.第三方数字平台管理3.信息安全

2、、数据隐私和网络安全技术II.具体场景指导1.面向医疗卫生专业人士的虚拟医学教育活动2.数字化医患互动项目3.与相关协会的数字化互动项目4.与互联网医院的互动5.与电商平台及电商零售药店的互动6.运营数字医疗产品7.使用社交媒体工具附件0102020204050506070809101012Introduction I.Compliance Considerations Specific to Digital Channels1.Specificregulationsandrulesrelatingtodigitalactivities2.Managementofthird-partydigi

3、talplatforms3.Informationsecurity,dataprivacyandcybersecuritytechnologyII.Specific Scenario Guidance 1.VirtualmedicalinteractionprogramswithHCPs2.DigitalHCP-patientinteractionprograms3.Interactionwithassociationsondigitalprograms4.InteractionwithInternethospitals5.Interactionwithe-commerceplatformsa

4、nde-commerceretailpharmacies6.Operatingdigitaltherapeutic(DTx)products7.UseofsocialmediatoolsAppendix目录Table of Contents 0201 数字化渠道特有的合规考虑因素Compliance Considerations Specific to Digital Channels11.数字化活动相关法规和规则近年来，随着数字化工具在医药行业的兴起和广泛应用，中国政府制定了多项与数字化活动相关的法规和规则，例如与互联网诊疗、网售药品、互联网广告以及个人信息保护、数据安全和网络安全相关的法规

5、和规则。会员公司在计划并实施涉及在数字场景中与医疗卫生专业人士和医疗卫生组织进行互动的项目时，应严格遵守这些特定法规。2.第三方数字平台管理会员公司在与医疗卫生专业人士和医疗卫生组织互动时，可能需要与各类第三方数字平台接触或合作，包括但不限于在线会议平台、社交媒体平台、健康管理平台、互联网医院、电商平台、电商零售药店等。1.Specific regulations and rules relating to digital activitiesWith the emergence and wide use of digital tools in the pharmaceutical indus

6、try in recent years,the Chinese government has developed several regulations and rules related to digital activities,such as those related to Internet diagnosis and treatment,sale of medicines on the Internet,Internet advertising,as well as protection of personal information,data security and cybers