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Reducing bureaucracy in Germany's health care sector

Market access analysis for the medical device industry

Thomas Bade

Business & Economics / Industries / Healthcare

The first edition of the book, published in April 2023, gives durable medical equipment companies and those interested in social policy an in-depth insight into the legally prescribed procedure.

The book highlights the deficits in the legislative process and in the implementation and application of legal requirements. The legislative execution around the practiced prequalification procedure for durable medical equipment is so poor that business and administration find it difficult to comprehend the content of the rules.

Five chapter describe the flawed and non-transparent standardization of the prequalification procedure. It is based on a GAP analysis in order to critically question and evaluate statutory, legal and regulatory requirements for the prequalification procedure by means of available literature, laws and guidelines (best practice analysis).

In chapter “Prognosis & Solutions”, the emerging need for legislative changes is described to eliminate all deficits and different legal opinions, as well as to enable the way to a health technology assessment for durable medical equipment.

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