1、RDPAC 数字医疗合规分项指南：与患者及患者组织的互动RDPAC Digital Health Compliance Sub-Guidance:Interactions with Patients&Patient Organizations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.互动原则1.非推广性质2.科学、公正且客观的信息传播3.服务报酬4

2、.合理的招待5.患者互动项目：使患者受益6.无诊疗活动7.独立性及隐私8.患者安全；履行药物警戒义务II.具体场景指导1.面向患者的虚拟互动项目2.与患者组织的数字化互动项目01020203030404050506060608Introduction I.Principles of Interaction1.Non-promotionalinnature2.Scientific,fairandobjectiveinformationcommunication3.Remunerationforservices4.Reasonablehospitalities5.Patientinteractio

3、nprograms:benefitingpatients6.Nodiagnosisandtreatmentactivities7.Independenceandprivacy8.Patientsafety;fulfilmentofpharmacovigilanceobligationsII.Specific Scenario Guidance 1.Virtualinteractionprogramswithpatients2.Interactionwithpatientorganizationsondigitalprograms目录Table of Contents 014 RDPAC 认识到

4、与患者和患者组织的互动对了解患者的经历与认知，帮助塑造并推动未来医疗发展，提高患者护理质量，造福个人及全社会具有重要意义。根据RDPAC数字医疗合规指南（“数字医疗指南”）的原则，RDPAC 现发布本数字医疗合规分项指南：与患者及患者组织的互动（本“分项指南”），为会员公司设计并实施通过数字化渠道与患者（在适用的情况下包括护理人员）和患者组织的互动，提供不具约束力的指导。我们同时鼓励会员公司将本分项指南的一般原则用于线下场景中与患者和患者组织的互动。本分项指南应依据数字医疗指南进行解读，会员公司应始终遵守RDPAC 行业行为准则（2022年修订版）（“RDPAC准则”）开展相关活动。此外，在开

5、展相关活动时，会员公司还必须遵守适用于这些活动的所有中国法律法规，包括但不限于药品管理、反不正当竞争、反贿赂与反腐败、广告和商业宣传、数据保护及药物警戒报告相关法律法规。The RDPAC recognizes the importance of interacting with patients and patient organizations to understand their experiences and knowledge to help shape and develop the future of healthcare,thereby improving the quali

6、ty of patient care for the benefit of individuals and society as a whole.In accordance with the principles under the RDPAC Digital Health Compliance Guidance(the“Digital Health Guidance”),the RDPAC now issues this Digital Health Compliance Sub-Guidance:Interactions with Patients&Patient Organization