在欧洲采用数字治疗方法
Amelie Fassbender1, Shaantanu Donde2, Mitchell Silva3
1Medical Affairs DM, Viatris, Hoeilaart, Belgium.
Therapeutics and clinical risk management
|January 1, 2025
概括
数字疗法 (DTx) 提供经济效益和减少医疗负担,但由于监管和认识差距,在欧洲面临着不同的采用. 建议制定战略,以改善整个非洲大陆的一致的DTx使用.
科学领域:
- 数字健康数字健康
- 医学创新 医学创新
- 欧洲的医疗保健系统
背景情况:
- 数字疗法 (DTx) 是针对各种疾病的基于证据的,经监管批准的干预措施.
- DTx显示出降低医疗保健系统负担并提供经济效益的潜力.
- 目前,欧盟没有针对DTx的具体法规,这导致欧洲各国的采用情况各不相同.
研究的目的:
- 审查欧洲数字疗法 (DTx) 的采用水平.
- 探索增强DTx采用和在整个大陆范围内一致使用的战略.
- 提出一个框架,以改善DTx在欧洲市场的普及.
主要方法:
- 欧洲当前的DTx景观的叙述性回顾.
- 对监管和偿还框架的分析.
- 探索采用驱动器,挑战和患者观点的探索.
主要成果:
- 在欧洲,DTx的采用程度有很大差异.
- 主要障碍包括缺乏监管协调,报销问题以及医疗保健专业人员和患者之间有限的认识.
- 人工智能验证,数据标准和互操作性也带来了挑战.
结论:
- 协调的法规,明确的报销途径和提高认识对于广泛采用DTx至关重要.
- 共同设计,以生态系统为中心的发展,以及解决道德问题至关重要.
- 一项拟议的框架旨在指导改善DTx在欧洲医疗保健中的采用和整合.
相关概念视频
Electroconvulsive Therapy
16
Electroconvulsive therapy (ECT), or shock therapy, remains a critical biomedical intervention for severe, treatment-resistant depression. While its origins can be traced back to Hippocrates' observations that malaria-induced convulsions alleviated mental illness, modern ECT has evolved significantly from its earlier, more primitive applications. First introduced in 1938 by Ugo Cerletti and his colleagues, ECT involves inducing controlled seizures using electrical currents. In its early...
16
Drug Therapy
23
The advent of drug therapy has profoundly shaped modern mental health care, providing targeted treatments for a range of psychological disorders. Psychotherapeutic drugs, classified into antianxiety, antidepressant, and antipsychotic medications, address symptoms across anxiety disorders, mood disorders, and schizophrenia. While these medications have transformed patient outcomes, they require careful management due to their potential side effects and limitations.
Antianxiety Medications
Antianxiety Medications
23
Issues And Trends In Healthcare Delivery System
5.5K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.5K
Clinical Trials: Overview
2.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.4K
Preclinical Development: Overview
4.0K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.0K
Clinical Trials
6.6K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.6K


