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医疗保健电子同意市场：2023 年至 2028 年预测
市场调查报告书
商品编码
1410095

医疗保健电子同意市场：2023 年至 2028 年预测

eConsent in Healthcare Market - Forecasts from 2023 to 2028
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 150 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

2021年全球医疗保健电子同意市场规模达405,431,000美元。

医疗保健市场的电子同意预计将在整个预测期内稳定成长。在医疗保健领域，以电子方式获得患者知情同意的过程称为电子同意。这涉及透过软体应用程式和网路平台等电子技术向患者提供有关医疗程序、治疗、研究计划和其他医疗保健干预措施的信息，并获得患者以电子方式表示同意。医疗保健市场中电子同意的主要成长动力是医疗保健领域的多重相关优势和日益数位化。此外，技术进步和有利的政府法规预计将导致更多产品的推出和 eConsent 的采用，这有望扩大医疗保健领域的 eConsent 市场。

多项相关好处

eConsent 具有多种优势，将扩大医疗保健领域的 eConsent 市场。电子同意平台经常包含互动元素，以增加患者的理解和参与。医疗保健组织可以透过数位化授权流程而不是列印、储存和管理纸本同意书来节省时间、成本和资源。电子健康记录(EHR) 系统和 eConsent 平台通常协同工作，提供无缝记录和同意资料搜寻，从而节省时间和资源。此外，eConsent 允许患者在舒适的家中电子签章同意书，无需进行体检或文书工作，并简化了远端同意流程。

扩大数位科技的引进

医疗保健产业正在经历一场数位革命，重点是利用科技来改善患者照护并加快流程。 eConsent 以电子技术替代了纸本同意书，使医疗保健组织能够数位化和自动化同意流程，从而推动了医疗保健领域的 eConsent 市场。 2019 年 3 月，世卫组织发布了《2020-2025 年数位卫生全球策略》，解决卫生系统面临的主要挑战。世界计划鼓励适当使用数位技术作为数位公共产品，可客製化用于不同情况，以提供对数位资源的公平存取。此外，2023 年 6 月，欧盟委员会和世界卫生组织 (WHO) 宣布建立历史性合作伙伴关係，提供一系列数位产品来改善所有人的健康。

有利的政府法规

世界各国政府都在推动医疗保健产业的数位化，其中包括电子同意，这正在推动医疗保健领域的电子同意市场。例如，提供有关在 HHS 监管的人类受试者研究和 FDA 监管的临床研究中可能使用多种电子媒体获得知情同意的电子系统和流程的使用建议。已与 HHS 和 OHRP 合作发布使用指南电子同意在临床研究中的应用。

提高临床试验效率

由于电子同意书能够有效捕捉患者偏好，因此在临床试验中的采用正在迅速增加，并且它们的采用正在推动医疗保健领域的电子同意书市场。根据Signant Health 2019 年行业电子同意调查，65% 的CRO 受访者和85% 的赞助商受访者表示，他们将在未来12 个月内对某些考试采用电子同意；76% 的受访者和71% 的赞助商受访者表示，他们将在以下领域采用电子同意：未来三年及以后的大部分考试。研究显示，患者的理解和参与是临床试验中采用电子同意的最受欢迎的业务驱动因素，占总数的 91%。

市场抑制因素

预计很少有因素会限制医疗保健市场的电子同意。例如，实施 eConsent 需要电子健康记录(EHR) 和临床试验管理系统之间的兼容性，而医疗保健组织可能很难将 eConsent 平台与其目前的IT基础设施整合。 eConsent 对外部供应商进行设计和编程的依赖可以延长实施和运作线时间。此外，老年人、电脑程度较低的人或弱势群体可能很难理解和使用电子同意系统。电子同意系统的设计应纳入可访问性的元素，并为需要帮助或喜欢数位同意以外的方法的患者提供替代选择。

北美地区预计将大幅成长

预计北美地区将在医疗保健市场中占据电子同意的重要份额。造成这一份额的因素包括医疗保健领域越来越多地采用数位技术、临床试验的增加以及医疗设施的改善。例如，根据 Signant Health 的 2019 年产业电子同意调查，北美是电子同意实施率最高的地区（72%）。此外，Veeva Systems 和 Florence Healthcare 等主要市场参与者的存在也有望透过提高该地区电子同意的可及性和实施的便利性来推动医疗保健市场的电子同意。

主要市场参与者

Veeva Systems 是云端基础的软体供应商，专注于为医学科学领域提供技术解决方案。生命科学公司可以使用云端基础的内容管理工具 Veeva Vault 管理受监管的材料。此外，Veeva OpenData 还提供有关医疗机构和专业人员的完整且检验的资讯。 Florence Healthcare 成立于 2014 年，提供专门适合临床研究的电子文件工作流程管理平台。 Florence eBinders 平台提供云端基础的解决方案，用于管理电子临床实验主文件 (eTMF) 和临床实验网站文件 ​​(eISF)。 Wellbeing Software（Citadel Group）是一家致力于提供软体解决方案和服务以促进临床资讯管理和改善患者治疗效果的组织。来自不同组织的患者记录透过该公司开发的 Stratus Shared Records 连接起来。

新兴市场的主要发展

2022 年 11 月，YPrime 宣布推出 eConsent 平台。该平台使研究团队能够以高度可见且易于理解的方式向患者呈现日益复杂的研究讯息，以增进理解并提高参与度。 2022 年 1 月，SMART-TRIAL 发布了新的 eConsent附加元件，让您可以完全控制您的设定和同意收集。 2021 年 7 月，Castor 宣布推出可扩展的病患登记和 eConsent 平台，以增强目前的病患登记流程并提高试验参与度。

目录

第一章简介

  • 市场概况
  • 市场定义
  • 调查范围
  • 市场区隔
  • 货币
  • 先决条件
  • 基准年和预测年时间表

第二章调查方法

  • 调查资料
  • 先决条件

第三章执行摘要

  • 研究亮点

第四章市场动态

  • 市场驱动因素
  • 市场抑制因素
  • 波特五力分析
  • 产业价值链分析

第 5 章 医疗保健中的电子同意：依平台

  • 介绍
  • 云端基础
  • 基于网路的

第 6 章 医疗保健中的电子同意：按註册类型

  • 介绍
  • 现场
  • 偏僻的

第 7 章 医疗保健中的电子同意：按型态类型

  • 介绍
  • 普遍同意
  • 普遍同意但有具体反对意见
  • 经明确同意后一般拒绝
  • 普遍拒绝

第 8 章 医疗保健领域的电子同意：按地区

  • 介绍
  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他的
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 西班牙
    • 其他的
  • 中东/非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 以色列
    • 其他的
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 韩国
    • 印尼
    • 泰国
    • 其他的

第九章竞争环境及分析

  • 主要企业及策略分析
  • 新兴企业和市场盈利
  • 合併、收购、协议和合作
  • 供应商竞争力矩阵

第十章 公司简介

  • Veeva Systems
  • Wellbeing Software, a Citadel Group
  • Florence Healthcare
  • Concentric Health Ltd
  • 5thPort, LLC
  • Cloudbyz
  • Calysta EMR
  • Interlace Health
  • Thieme Compliance GmbH
简介目录
Product Code: KSI061615769

The global eConsent in healthcare market was valued at US$405.431 million in 2021.

The eConsent in healthcare market is anticipated to grow at a steady pace throughout the forecast period. The process of getting a patient's informed permission electronically in the healthcare sector is referred to as eConsent. It entails presenting information to patients regarding medical procedures, treatments, research projects, or other healthcare interventions through electronic technologies, such as software apps or internet platforms, and allowing them to electronically give their consent. Multiple associated benefits and increased digitalization in healthcare are major growth drivers of eConsent in healthcare market. Moreover, the technological advancements and favourable government regulations resulting in more product launches and adoption of eConsent are also contemplated to augment the eConsent in healthcare market.

Multiple Associated Benefits

There are multiple benefits associated with eConsent that are contemplated to boost the eConsent in healthcare market. Interactive elements are frequently included in eConsent platforms to improve patient comprehension and involvement. Healthcare organizations can save time, money, and resources by digitizing the permission process instead of printing, storing, and managing paper consent forms. Electronic health record (EHR) systems and eConsent platforms frequently work together to provide seamless documentation and retrieval of consent data, saving time and resources. Moreover, the use of eConsent streamlines the remote consent procedure by enabling patients to electronically sign consent forms from the comfort of their homes, eliminating the need for office visits and paperwork.

Increased Implementation of Digital Technology

The healthcare sector has been going through a digital revolution, with a growing emphasis on using technology to improve patient care and expedite processes. By substituting electronic technologies for paper-based consent forms, eConsent supports this shift by enabling healthcare organizations to digitize and automate the consent process thereby boosting the eConsent in healthcare market. WHO launched a Global Strategy on Digital Health 2020-2025 in March 2019 to address major issues facing the health system, the global plan encourages the appropriate use of digital technologies as digital public goods that may be customized for usage in various situations to provide equitable access to digital resources. Moreover, in June 2023, a historic partnership between the European Commission and the World Health Organization (WHO) was announced to provide a variety of digital items to improve everyone's health.

Favourable Government Regulations

The government of numerous nations is promoting digitalization in the healthcare industry including eConsent which is propelling the eConsent in healthcare market. For example, to provide recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for HHS-regulated human subjects research and FDA-regulated clinical investigations, the FDA, in cooperation with HHS and OHRP, published a guideline for the use of eConsent in clinical investigations.

Efficiency in Clinical Trials

The adoption of eConsent in clinical trials is booming due to its efficiency in collecting patient preferences, and comprehension therefore it propels the eConsent in healthcare market. According to Signant Health's 2019 Industry eConsent Survey, 65% of CRO respondents and 85% of sponsor respondents said to adopt eConsent for some studiens in the next 12 months while 76% of CRO and 71% of sponsor respondents reported the adoption of eConsent in the majority of studies in the coming 3 years and beyond. The most popular business driver in the adoption of eConsent in clinical trials according to this survey was patient comprehension and engagement with 91% of overall votes.

Restraints in the Market

Few factors are expected to limit eConsent in healthcare market. For example, electronic health records (EHRs) and clinical trial management systems must be compatible to implement eConsent and it may be difficult for healthcare organizations to integrate eConsent platforms with their current IT infrastructure. The eConsent's reliance on outside vendors for design and programming can prolong the time it takes to deploy and go live. Moreover, it may be difficult for older folks, people with low levels of computer literacy, or members of underprivileged populations to comprehend and use eConsent systems. The design of eConsent systems must incorporate accessibility elements and offer patients who might need assistance or prefer non-digital consent methods alternate options.

North America is Expected to Grow Significantly

The North American region is projected to hold a significant share of the eConsent in healthcare market. Various factors attributed to such a share are higher adoption of digital technology in healthcare, increased clinical trials, and well-established healthcare facilities. For instance, North America was the most popular region with a higher implementation rate (72%) of eConsent as per the 2019 Industry eConsent Survey by Signant Health. Moreover, the presence of major market players such as Veeva Systems, and Florence Healthcare are also expected to boost the eConsent in healthcare market through enhanced accessibility and easy adoption of eConsent in the region.

Major Market Players

  • Veeva Systems is a cloud-based software provider with a focus on offering technological solutions to the medical sciences sector. Life sciences organizations can manage their regulated material using the cloud-based content management tool Veeva Vault. Moreover, Veeva OpenData offers complete and verified information on healthcare organizations and professionals.
  • Florence Healthcare, founded in 2014, provides a platform for managing electronic document workflows that is especially suited for clinical research. The Florence eBinders platform offers a cloud-based solution for managing electronic Trial Master Files (eTMFs) and Investigator Site Files (eISFs).
  • Wellbeing Software, (Citadel Group) is an organization that specializes in delivering software solutions and services to facilitate the administration of clinical information and enhance patient outcomes. Patient records from various organizations are connected through Stratus Shared Records developed by the company

Key Market Developments

  • In November 2022, YPrime launched the eConsent platform to enable study teams to present increasingly complex study information to patients in highly navigable, digestible components that improve comprehension and boost engagement.
  • In January 2022, SMART-TRIAL released a new eConsent Add-On to enable the collection of consents with full control of the setup.
  • In July 2021, Castor launched scalable patient enrollment and the eConsent platform to enhance the current patient enrollment process and higher study engagement.

Segmentation:

By Platform

  • Cloud-based
  • Web-based

By Enrollment Type

  • On-site
  • Remote

By Form Type

  • General Consent
  • General Consent with Specific Denial(s)
  • General Denial with Specific Consent(s)
  • General Denial

By Geography

  • North America
  • United States
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • United Kingdom
  • Germany
  • France
  • Spain
  • Others
  • Middle East and Africa
  • Saudi Arabia
  • UAE
  • Israel
  • Others
  • Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Indonesia
  • Thailand
  • Others

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. Market Overview
  • 1.2. Market Definition
  • 1.3. Scope of the Study
  • 1.4. Market Segmentation
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

  • 2.1. Research Data
  • 2.2. Assumptions

3. EXECUTIVE SUMMARY

  • 3.1. Research Highlights

4. MARKET DYNAMICS

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porter's Five Force Analysis
    • 4.3.1. Bargaining Power of Suppliers
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis

5. ECONSENT IN HEALTHCARE, BY PLATFORM

  • 5.1. Introduction
  • 5.2. Cloud-based
  • 5.3. Web-based

6. ECONSENT IN HEALTHCARE, BY ENROLLMENT TYPE

  • 6.1. Introduction
  • 6.2. On-site
  • 6.3. Remote

7. ECONSENT IN HEALTHCARE, BY FORM TYPE

  • 7.1. Introduction
  • 7.2. General Consent
  • 7.3. General Consent with Specific Denial(s)
  • 7.4. General Denial with Specific Consent(s)
  • 7.5. General Denial

8. ECONSENT IN HEALTHCARE, BY GEOGRAPHY

  • 8.1. Introduction
  • 8.2. North America
    • 8.2.1. United States
    • 8.2.2. Canada
    • 8.2.3. Mexico
  • 8.3. South America
    • 8.3.1. Brazil
    • 8.3.2. Argentina
    • 8.3.3. Others
  • 8.4. Europe
    • 8.4.1. United Kingdom
    • 8.4.2. Germany
    • 8.4.3. France
    • 8.4.4. Spain
    • 8.4.5. Others
  • 8.5. Middle East and Africa
    • 8.5.1. Saudi Arabia
    • 8.5.2. UAE
    • 8.5.3. Israel
    • 8.5.4. Others
  • 8.6. Asia Pacific
    • 8.6.1. Japan
    • 8.6.2. China
    • 8.6.3. India
    • 8.6.4. South Korea
    • 8.6.5. Indonesia
    • 8.6.6. Thailand
    • 8.6.7. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 9.1. Major Players and Strategy Analysis
  • 9.2. Emerging Players and Market Lucrativeness
  • 9.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 9.4. Vendor Competitiveness Matrix

10. COMPANY PROFILES

  • 10.1. Veeva Systems
  • 10.2. Wellbeing Software, a Citadel Group
  • 10.3. Florence Healthcare
  • 10.4. Concentric Health Ltd
  • 10.5. 5thPort, LLC
  • 10.6. Cloudbyz
  • 10.7. Calysta EMR
  • 10.8. Interlace Health
  • 10.9. Thieme Compliance GmbH