2021年10月14日，FDA的数字健康卓越中心（DHCOE）举行了公必威手机APP共研讨会，讲述了人工智能/支持机器学习设备的透明度。The workshop followed the recently published list of nearly 350 AI/ML-enabled medical devices that have received regulatory approval since 1997. The workshop was aimed at moving forward the objectives of FDA’s DHCoE to “empower stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation.” The DHCoE was established in 2020 within FDA’s Center for Devices and Radiological Health (CDRH) under the leadership of Bakul Patel.
十月的研讨会以“透明度”为主题和指南，推动了适当的监管过程以及医疗保健专业人员和/或患者对此类设备的广泛采用。必威手机APP在这种情况下，透明度一词涵盖了对AI/ML的医疗设备的风险管理以及影响未来采用的其他因素，包括（但不限于）：
- Data (used to train and test the algorithm).
- “预期使用”定义和过程调整的重要性。
- 算法背后的逻辑并产生了结论（“解释性”）。
- 避免偏见（数据生成中的性别，种族和年龄多样性的整合）。
- Communication of potential adverse events.
- 成本/报销。
The workshop incorporated perspectives from the agency itself, industry, healthcare providers/systems and patients, and attracted nearly 4,000 registrants. Diverse opinions and presentations highlighted the complexity and challenge associated with risk management and the development of a suitable approval process for devices incorporating self-learning algorithms.
下面的摘要突出显示了从当前已批准的AI/ML启用医疗设备的已发布列表的分析中选择高级发现，以及作为FDA研讨会的一部分共享的观点以及对医疗设备和诊断制造商的精选含义。（要对讨论和评估的主题进行更深入的了解，请直接访问FDA记录和演示文稿。）
Current status and assessment of AI/ML-enabled medical devices
FDA批准的近350个AI/ML的医疗设备的近350个列表提供了证据，表明成像/诊断技术导致算法的整合以推动医疗保健领域的临床决策。必威官方在线必威手机APP截至2021年中期，迄今为止，有70％的批准在放射学领域，其次是心脏病学领域，占12％，血液学和神经病学应用程序分别为3％（见图）。
资源：人工智能和机器学习（AI/ML）支持的医疗设备|FDA
毫不奇怪的是，在最近的过去，批准的加速也不足为奇。在1997年至2015年之间进行了<30次批准之后，提交和批准加速了，仅在2020年就达到了大约100个个人批准。预计该数字将继续与在更广泛的疾病领域和设备类别中进一步开发基于AI/ML的应用程序和机会并行增加。从行业的角度来看，数据显示了更广泛的GE和西门子组织，迄今为止分别有22和18批准。
FDArecognizes “the need for careful oversight to ensure the benefits of these advanced technologies outweigh the risks to patients,” while collaborating with stakeholders and building “partnerships to accelerate digital health advances.” FDA references four key considerations underlying these advancements: usability, trust, equity and accountability — themes that were raised consistently throughout the workshop by various stakeholders.
可用性: Recommendations were made that guidelines and approval processes need to be adjusted based on the intended use case of the enabled device. Reimbursement for associated data analysis of such devices also remains a key factor influencing usability with HCPs, along with out-of-pocket cost considerations for patients.
Trust：医必威手机APP疗保健专业人员和患者需要“信任”该设备，需要与“正确的利益相关者”的见解和“正确信息”共享：betway必威怎么提款
Regulatory considerations: the logic behind the algorithms’ decision-making, understanding the data used to train and test, metrics behind the development, among others.
Provider considerations：验证性能（安全性和功效数据），可解释的逻辑等。
患者的考虑: transparency about adverse effects, benefits, minimized complexity but explainable logic, among others.
Equity：透明度被提升为促进健康平等，使利益相关者（患者和HCP）能够做出明智的决定。必威手机APP关于公平的讨论还基于用于培训算法的同质患者数据和缺乏多样性包容性（性别，种族，年龄等）的讨论提出了偏见的话题。访问低收入和少数族裔患者人群的试验参与被强调是对未来成功和消除偏见的关键需求。
Accountability：关于该设备的可用性和逻辑的访问，问责制和教育仍然存在疑虑，以确保适当的HCP患者通信和与AI/ML支持的医疗设备的参与度。预计对绩效后进行的持续监控将成为未来的更为严格的要求。
行业含义
参与努力通过开发AI/ML的医疗设备来改善患者护理的所有利益相关者都可以从审查FDA记录和演示文稿的细节中受益。betway必威怎么提款洞察力和发现在广泛的初始开发和应用尝试，患者反应，看法和其他考虑因素中共享。选择根据讨论的高级行业建议可以总结如下：
- 继续与FDA密切合作，以了解监管批准要求和流程的开发方面的考虑和进步。监视数字健康软件预先认证（PER-CERT）计划的输出和发现；必威手机APP在可能的情况下参与。
- Prepare for stronger demands on generating post-launch, in-market evidence of device performance. Build a process to make real world evidence (RWE) data collection and analysis core components of your ecosystem, supporting development and performance monitoring.
- Include diverse patient groups in clinical trials to produce “unbiased” data sets. Make trial participation accessible for low-income patient populations and minorities.
- Understand the importance of building trust with the provider and patient. Turn these requirements into actions driving development, data analysis and messaging.
- 认识到HCP在与患者建立和传达该设备的信任方面所扮演的角色的重要性。支持和教育过程至关重要；建立关系将再次变得重要。
根据设备，应用和预期用例，制造商将受益于彻底剖析，理解和解决每个利益相关者（FDA，付款人，提供商，患者）的“透明度”需求。患者越来越多地以新的方式参与自己的医疗保健，因此，了解和解决患者对使用AI/ML的医疗设备的担忧对于必威手机APP推动未来采用至关重要。倾听患者的强大声音以进行未来的创新和收养，这一点至关重要。
To access real world evidence and data, develop an RWE-based strategy, including post-launch performance monitoring, development and applications of AI/ML-driven data analysis and patient trial execution, contact us at IQVIA MedTech.