Medical Technology and Evaluation

所在平台: Coursera

课程主页: https://www.coursera.org/learn/healthcare-medical-technology

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课程简介

课程名称:医疗技术与评估 课程概述: 医疗技术的创新是全球经济增长的重要领域之一。这些新技术可以是药品、医疗器械、生物技术、信息技术或这些创新的组合,为私人企业和社会福祉提供了巨大的机遇。然而,这些创新并非没有成本,并需要从私营或公营的医疗保健系统获得报销,才能进入市场。本课程旨在提供批判性评估新医疗技术所需的概念、数据和方法论的知识,以实现财务投资、报销和监管合规目标,例如FDA批准。课程设计使学员能够掌握评估医疗技术所需的分析工具。 完成本课程后,学生将具备以下技能: - 理解医疗技术使用的报销系统。 - 理解政府和监管机构在新医疗技术开发和应用中的作用。 - 确定医疗技术所服务的人群。 - 使用医疗数据评估医疗技术。 - 执行新技术的成本效益和成本效果分析。 课程大纲: 1. 医疗技术评估在当前医疗保健融资及监管环境中的应用:本模块概述美国医疗保健行业,阐明医疗技术评估在行业中的重要性。讨论医疗行业独特的方面及多方利益相关者的需求,以及行业中的各种监管和支付系统。 2. 临床试验与保险索赔数据:此模块讨论两种在医疗技术评估中常用的数据类型:临床试验数据和健康保险索赔数据。分析临床试验设计的基本要素及其对技术评估可靠性的影响,同时讨论索赔数据的内容及其与临床数据的差异。 3. 医疗技术评估的要素:本模块将探讨多种医疗技术评估方法及其优势与劣势,讨论不同评估方法的适用场景,并涵盖评估的两大基本特征:成本与效益的测量。 4. 方法论的途径与考虑:第四模块整合前三个模块的内容,详细探讨在评估中可能遇到的常见定量方法。讨论如何将不确定性和时间因素纳入医疗技术评估模型,以及用于动态患者反应评估的模型类型。 通过本课程的学习,学员将能够深入理解医疗技术评估的复杂性与重要性,为未来的医疗技术创新与应用奠定坚实基础。

课程大纲

Name:Medical Technology Assessment in the Current Health Care Financing and Regulatory Environment

Description:This module includes an overview of the healthcare industry, focusing on the U.S., and provides context for why medical technology evaluations are important sources of information within the industry. The module begins by discussing the aspects of health care industry that make it unique from other industries and the many stakeholders who have interests in the results of medical technology evaluations. The remainder of the module covers the various regulation and payment systems that exist within the industry and where and how medical technology evaluations are necessary elements of those systems.

Name:Clinical Trials and Insurance Claims Data

Description:This module discusses the two most common types of data used in medical technology evaluations: clinical trial data and health insurance claims data. The discussion of clinical trial data covers the basic elements of trial design that help ensure the results will be reliable inputs to technology evaluations. The discussion of claims data covers what types of information is available in claims and how it differs from clinical data. It also covers potential sources of data. The module concludes with a few lessons that discuss general considerations and precautions when using data to ensure the validity of a technology evaluation.

Name:The Elements of Medical Technology Assessments

Description:In this module we will discuss a variety of types of medical technology evaluation approaches and the types of assessments. We will go into detail about the pros and cons of each type of assessment as a way to illustrate situations where one approach may be better than another. Finally, we will also cover the details of the two fundamental features of any evaluation: measuring costs and benefits.

Name:Methodological Approaches and Considerations

Description:Module 4 brings everything together from the first three modules. We will go into more detail about some of the more common quantitative methodologies you may encounter with an evaluation. We will talk about incorporating the effects of uncertainty and time into a medical technology evaluation model as well as the type of models that allow for the dynamic nature of patient responses to medical technology.

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课程详情

Innovations in medical technologies are one of the leading areas of economic growth in the world. Whether new technologies take the form of pharmaceutical, medical device, biotechnology, information technology of some combination of these innovations, the opportunities for both private enterprise and social welfare are substantial. However, these innovations are not without cost, and require reimbursement from either a privately or publicly financed health care delivery system to enter the marketplace. This course aims to provide knowledge of the concepts, data, and methodology required to critically evaluate new medical technologies in order to secure financial investment, reimbursement, and regulatory compliance objectives, such as FDA approval. The course is designed to provide understanding of the analytic tools needed to evaluate medical technologies. After completing this course, students will have the skills needed to: - Understand the reimbursement systems financing medical technology use. - Understand the role of government and regulatory agencies in the development and use of new medical technologies. - Identify a population to be served by a medical technology. - Use health care data to evaluate a medical technology. - Perform cost/benefit and cost/effectiveness analysis of a new technology.

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