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商品編碼

1410095

醫療保健電子同意市場：2023 年至 2028 年預測

eConsent in Healthcare Market - Forecasts from 2023 to 2028

出版日期: 2023年12月11日 | 出版商:

Knowledge Sourcing Intelligence | 英文 150 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

2021年全球醫療保健電子同意市場規模達405,431,000美元。

醫療保健市場的電子同意預計將在整個預測期內穩定成長。在醫療保健領域，以電子方式獲得患者知情同意的過程稱為電子同意。這涉及透過軟體應用程式和網路平台等電子技術向患者提供有關醫療程序、治療、研究計劃和其他醫療保健干預措施的資訊，並獲得患者以電子方式表示同意。醫療保健市場中電子同意的主要成長動力是醫療保健領域的多重相關優勢和日益數位化。此外，技術進步和有利的政府法規預計將導致更多產品的推出和 eConsent 的採用，這有望擴大醫療保健領域的 eConsent 市場。

多項相關好處

eConsent 具有多種優勢，將擴大醫療保健領域的 eConsent 市場。電子同意平台經常包含互動元素，以增加患者的理解和參與。醫療保健組織可以透過數位化授權流程而不是列印、儲存和管理紙本同意書來節省時間、成本和資源。電子健康記錄(EHR) 系統和 eConsent 平台通常協同工作，提供無縫記錄和同意資料搜尋，從而節省時間和資源。此外，eConsent 允許患者在舒適的家中電子簽章同意書，無需進行體檢或文書工作，並簡化了遠端同意流程。

擴大數位科技的引進

醫療保健產業正在經歷一場數位革命，重點是利用科技來改善患者照護並加快流程。 eConsent 以電子技術替代了紙本同意書，使醫療保健組織能夠數位化和自動化同意流程，從而推動了醫療保健領域的 eConsent 市場。 2019 年 3 月，世衛組織發布了《2020-2025 年數位衛生全球策略》，解決衛生系統面臨的主要挑戰。世界計劃鼓勵適當使用數位技術作為數位公共產品，可客製化用於不同情況，以提供對數位資源的公平存取。此外，2023 年 6 月，歐盟委員會和世界衛生組織 (WHO) 宣佈建立歷史性合作夥伴關係，提供一系列數位產品來改善所有人的健康。

有利的政府法規

世界各國政府都在推動醫療保健產業的數位化，其中包括電子同意，這正在推動醫療保健領域的電子同意市場。例如，提供有關在 HHS 監管的人類受試者研究和 FDA 監管的臨床研究中可能使用多種電子媒體獲得知情同意的電子系統和流程的使用建議。已與 HHS 和 OHRP 合作發布使用指南電子同意在臨床研究中的應用。

提高臨床試驗效率

由於電子同意書能夠有效捕捉患者偏好，因此在臨床試驗中的採用正在迅速增加，並且它們的採用正在推動醫療保健領域的電子同意書市場。根據Signant Health 2019 年行業電子同意調查，65% 的CRO 受訪者和85% 的贊助商受訪者表示，他們將在未來12 個月內對某些考試採用電子同意；76% 的受訪者和71% 的贊助商受訪者表示，他們將在以下領域採用電子同意：未來三年及以後的大部分考試。研究顯示，患者的理解和參與是臨床試驗中採用電子同意的最受歡迎的業務促進因素，佔總數的 91%。

市場抑制因素

預計很少有因素會限制醫療保健市場的電子同意。例如，實施 eConsent 需要電子健康記錄(EHR) 和臨床試驗管理系統之間的兼容性，而醫療保健組織可能很難將 eConsent 平台與其目前的IT基礎設施整合。 eConsent 對外部供應商進行設計和編程的依賴可以延長實施和運作線時間。此外，老年人、電腦程度較低的人或弱勢群體可能很難理解和使用電子同意系統。電子同意系統的設計應涵蓋可訪問性的元素，並為需要幫助或喜歡數位同意以外的方法的患者提供替代選擇。

北美地區預計將大幅成長

預計北美地區將在醫療保健市場中佔據電子同意的重要佔有率。造成這一佔有率的因素包括醫療保健領域擴大採用數位技術、臨床試驗的增加以及醫療設施的改善。例如，根據 Signant Health 的 2019 年產業電子同意調查，北美是電子同意實施率最高的地區（72%）。此外，Veeva Systems 和 Florence Healthcare 等主要市場參與者的存在也有望透過提高該地區電子同意的可及性和實施的便利性來推動醫療保健市場的電子同意。

主要市場參與者

Veeva Systems 是雲端基礎的軟體供應商，專注於為醫學科學領域提供技術解決方案。生命科學公司可以使用雲端基礎的內容管理工具 Veeva Vault 管理受監管的材料。此外，Veeva OpenData 還提供有關醫療機構和專業人員的完整且檢驗的資訊。 Florence Healthcare 成立於 2014 年，提供專門適合臨床研究的電子文件工作流程管理平台。 Florence eBinders 平台提供雲端基礎的解決方案，用於管理電子臨床實驗主文件 (eTMF) 和臨床實驗網站文件 (eISF)。 Wellbeing Software（Citadel Group）是一家致力於提供軟體解決方案和服務以促進臨床資訊管理和改善患者治療效果的組織。來自不同組織的患者記錄透過該公司開發的 Stratus Shared Records 連接起來。

新興市場的主要發展

2022 年 11 月，YPrime 宣布推出 eConsent 平台。該平台使研究團隊能夠以高度可見且易於理解的方式向患者呈現日益複雜的研究訊息，以增進理解並提高參與度。 2022 年 1 月，SMART-TRIAL 發布了新的 eConsent附加元件，讓您可以完全控制您的設定和同意收集。 2021 年 7 月，Castor 宣布推出可擴展的病患登記和 eConsent 平台，以增強目前的病患登記流程並提高試驗參與度。

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

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