2023数字医疗合规指南

2023.06.30 China Association of Enterprise with Foreign InvestmentR&D-Based Pharmaceutical Association Committee 使命宣言01 Mission Statement 概述：与医疗卫生专业人士及患者互动过程中使用的数字化工具04 Overview of Digital ToolsUsed in Interactions withHCPs and Patients 1. VirtualmedicaleducationprogramsforHCPs2. Virtualdiseaseawareness/patienteducationprograms3. DigitalHCP-patientinteractionplatforms4. CollaborationwithInternethospitals5. Collaborationwithe-commerceretailpharmacies6. Operatingdigitaltherapeuticproducts7. Useofsocialmediatools 1. 面向医疗卫生专业人士的虚拟医学教育活动04 2. 虚拟疾病认知 / 患者教育活动05 3. 医患互动数字平台05 6. 运营数字医疗产品07 指导原则10 Guiding Principles 1.信息应公平且平衡2. 无虚假或误导性宣传3. 不做超说明书推广；对说明书外科学交流实施健全的管理4. 不得发布非法药品、医疗器械及医疗广告5. 不得对医疗卫生专业人士处方进行不当影响6. 不得对患者的用药决定及治疗决定进行不当影响7. 支付服务费8. 数据收集9. 隐私保护10. 遵守网络安全要求；数据跨境传输11. 数字记录的保留12. 对供应商或业务合作伙伴的适当管理专题指南附件1. Fairandbalancedinformation2. Nofalseormisleadingpromotion3. Nooff-labelpromotion;robustmanagementofoff-labelscientificcommunication4. Noillegaldrug,deviceandmedicaltreatmentadvertisement5. NoundueinfluenceonHCPprescriptions6. Noundueinfluenceonpatient'sdruguseandmedicaltreatmentdecisions7. Paymentofservicefees8. Collectionofdata9. Protectionofprivacy10. Compliancewithcybersecurityrequirements;cross-bordertransferofdata11. Retentionofdigitalrecords12. PropermanagementofvendorsorbusinesspartnersSubject Matter GuidelinesAppendix1011111112141415171718182021 使命宣言 当今全球医疗卫生事业面临重重挑战，制药公司需采用创新工具提高疾病治疗质量，提升与医师的医学及科学交流的有效性，加强与患者及公众的信任关系。我们已看到制药公司正为此逐步加强在医疗卫生领域使用数字技术，并相信这一趋势将在未来多年保持强劲势头。 To d ay ’s g l o b a l h e a l t h ca re c h a l l e n ge s re q u i repharmaceutical companies to employ innovative tools toenhance the quality of disease treatment, upgrade theeffectiveness of medical and scientific communicationswith physicians, and strengthen the trust-based tieswith patients and the general public.For this purpose,we have seen the increasing use of digital technologiesin the healthcare sector by pharmaceutical companies,and believe that such a trend will continue with strongmomentum for the many years to come. “数字医疗”一词没有固定定义，在通常理解中一般包括：（1）数字技术驱动的医疗解决方案，例如移动医疗（mHealth），以及可利用数字化数据的各类技术（例如，数据科学与人工智能（AI）技术），包括可穿戴设备及医疗器械独立软件（SaMD）；（2）远程医疗，即基于数据（包括通过电信系统传输的语音和图像、文件及其他信息等）实施医疗干预、提供诊疗决策与建议的远距离医疗活动；以及（3）使用数字技术提供健康与医疗卫生服务及相关信息，包括使用数字化工具与医疗卫生专业人士（HCP）及患者进行互动。 The term “digital health” does not have a fixeddefinition, and is commonly understood to include,among others: (i) digital-driven health solutions, suchas mobile health (mHealth), and technologies thatallow the utilization of digital data (e.g., data scienceand artificial intelligence (AI)), including wearables andsoftware as a medical device (SaMD); (ii) telemedicine,i.e., practice of medicine over a distance, in whichinterventions, diagnostics and treatment decisionsand recommendations are based on data, includingvoice and images, documents and other informationtransmitted through telecommunication systems; and(iii) the use of digital technology to deliver health andhealthcare services and information, including using ofdigital tools in interactions with healthcare professionals(HCP) and patients. 为此，全球制药行业已制定了多项相关原则及指导文件，以供制药公司在考虑数字医疗技术应用时参考。上述原则及指导文件包括但不限于《生物制药行业数字医疗全球政策原则》（国际制药企业协会联盟（IFPMA）、日本制药企业协会（JPMA）与欧洲制药企业协会联盟（EFPIA）共同制定）、《社交媒体与数字化渠道指南联合说明》（IFPMA 与 EFPIA 共同制定）以及《教育活动及远程医疗行业支持指南联合说明》（IFPMA 与 EFPIA 共同制定）。 In this regard, the global pharmaceutical industry hasformulated several principle and guidance documentsfor pharmaceutical companies when considering theirapplication of digital health technologies, including butnot limited to the Biopharmaceutical Industry’s GlobalPolicy Principles on Digital Health (co-authored byIFPMA, JPMA and EFPIA), the Joint Note for Guidanceon Social Media and Digital Channels (co-authored byIFPMA and EFPIA), and the Joint Note for Guidanceon Industry Support for Education and Access toTelemedicine (co-authored by IFPMA and EFPIA). 在中国，RDPAC 观察到数字化工具在与医疗卫生专业人士、患者以及公众等外部利益相关者进行广泛沟通交流中的应用。RDPAC 始终鼓励会员公司与这些外部利益相关者保持有效互动，提升医疗卫生专业人士的科学及医学知识与疾病治疗能力，以及提高患者和公众对疾病的认识及健康管理与疾病管理能力。 In China, RDPAC has observed the emergence of theuse of digital tools in communications with externalstakeholders, ranging from healthcare professionals topatients as well as the general public. RDPAC has alwaysencouraged its member companies to maintain effectiveinteractions with such external stakeholders, so as toadvance the scientific and medical knowledge anddisease treatment capabilities of HCPs, as well as thedisease awareness knowledge and health managementand disease management capabilities of patients andthe general public at large. 在过去几年间，数字化工具的出现及广泛使用已使中国制药行业与医疗卫生专业人士及患者的互动模式发生了改变。这一改变大大提高了互动的覆盖面、效率和有效性，但同时也在法律及监管合规、内部控制、风险管理及医学伦理等方面给会员公司带来了挑战。 In the past few years, the emergence and wideuse of digital tools has transformed the model ofsuch interactions with HCPs and patients in thepharmaceutical industry in China. On one side, it hassignificantly increased the coverage, efficiency andeffectiveness of the interactions. At the same ti