本報告已在2011年07月19日停止出版。
由於嚴格的法律規範領域擴大，因此就技術層面來說，歐洲醫學影像相關企業要發展高層級製品的困難度也隨之提高。
專門在高科技領域裡從事諮詢及市場調查的美國市調公司 Frost & Sullivan (總公司: 德州)，詳盡地調查與分析歐洲 X 光診斷的法律規範的影響，並有系統地出版綜合報告書 “Strategic Analysis of the Impact of Regulations on the Radiology Practice in Europe”。
此報告書除了分析歐洲 X 光診斷的法律規範之影響，還說明了法律規範對醫學影像產業的優缺點；同時強調單一市場的法律規範之必要及探討歐洲醫學影像產業的疾病分類（DRG） 之影響等。此報告書的概略架構如下所示。
1. 歐洲 X 光診斷的法律規範影響
- 調查範圍及方法論
- 介紹與背景
- 歐洲主要法律規範環境
- 主要安全規範
- 主要患者的資料保密規定
- 工作流程規範
- 健康管理計畫
- 疾病分類–德式
- 歐洲醫學用影像產業的疾病分類影響
- 歐洲其他疾病分類的影響
- 歐洲的規範差異
- 醫學用影像產業的影響
- 技術性規範的影響
- 對於醫學用影像產業的規範影響
- 對於顧客的規範影響
- 技術性規範的影響
- 對於裝置價格的影響
- 對於競爭的規範影響
- 對於製品化的規範影響
- 產業心聲
- 邁向未來
- 主要規範組織及產業關係者
Abstract
Complicated Regulatory Procedures Challenge Medical Imaging Companies
European medical imaging companies are finding it increasingly difficult to
develop technologically advanced products and expand their reach in a stringent
regulatory environment. In addition to the Medical Device Directive, numerous
multi-layered and diffused local legislatives complicate regulatory compliance
thereby, increasing the time to market. Companies also face rising costs due to
constant alterations required in product specifications to meet the varying
technical standards in different locations.
This Frost & Sullivan research analyses the impact of regulations on the
European radiology market. It provides an overview of the advantages and
disadvantages of the regulations on the medical imaging industry. This analysis
also emphasises the need for a single market regulation and discusses the effect
of Diagnostic Related Groups (DRG) on the European medical imaging industry.
Single Market Regulation to Stimulate Growth in the Medical Imaging Market
Medical imaging companies in Europe are lobbying for the implementation of a
common set of regulations as opposed to multiple national standards to govern
their radiology practice. "Single market regulations would help the
healthcare suppliers to market the same product all over Europe, which in turn
reduces production cost and increases profit margins," explains the
analyst.
The major variations in regulations are in terms of the acceptable radiation
limits, form of data storage and type of technology. Developing single market
regulations provides uniform standards that ensure consistency in the safety and
quality of products. Such regulations are also expected to remove barriers to
trade thereby, bringing in state-of-the-art medical technology that translates
into better protection of public health.
Stringent Regulations Ensure High-Value Products
"With a strict regulatory mechanism firmly in place and increasing
competition, European medical imaging companies cannot afford to become
complacent and must strive to enhance their value proposition to
customers," says the analyst. Most major companies are migrating towards
advanced technology and competitively priced products that offer better market
value to the customers.
The Diagnostic Related Groups (DRG) system encourages technological
advancements by reimbursing expenses related to innovative medical imaging
technologies. The DRG also reimburses costs related to patient examinations
based on the type of test and the group to which the patient belongs. Although
DRG generates mixed reactions from the medical imaging industry, as rising
healthcare costs combine with constant demand for quality services, comparative
financial and clinical data from important DRGs become critical.
Table of Contents
- STRATEGIC ANALYSIS OF THE IMPACT OF REGULATIONS ON THE RADIOLOGY PRACTICE IN EUROPE
- Introduction
- Research Scope and Methodology
- Research Scope & Methodology
- Introduction and Background
- Introduction and Background
- The Key Regulatory Environment in Europe
- The Regulatory Environment in Europe
- Key Safety Regulations
- Key Patient Data Security Regulations
- The Workflow Regulations
- The Healthcare Plans
- Diagnostic Related Groups - The German Way
- Impact of the Diagnostic Related Groups on the European Medical Imaging Industry
- Impact of Diagnostic Related Groups on Rest of Europe
- Disparity in Regulations in Europe
- Key Differences in Regulations among European Nations
- The Reasons for the Disparity in Regulations in Europe
- The Impact on the Medical Imaging Industry
- The Impact of Regulation on Technology
- Impact of Regulations on Medical Imaging Market
- Impact of Regulations on the Customer
- Impact of Regulations on Pricing of the Equipment
- Impact of Regulations on Competition
- Impact of Regulations on the Time to Market
- What the Industry Says
- Towards the Future
- Advantages and Disadvantages of Regulations
- Towards the Bright Future
- Need for Harmonisation
- Towards a Single Market Regulation
- The Impact of Single Market Regulation
- What Companies Should Do
- Key Regulatory Organisations and Industry Participants
- Key Regulatory Organisations and Industry Participants
- About Our Company
- The Healthcare Team
- Consulting Capabilities
