Reducing bureaucracy in Germany's health care sector: Market access analysis for the medical device industry

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Thomas Bade, 21.04.2023
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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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Ausgewählte Seiten

Inhalt

Background
1994
2013
2008
Compliance Costs
Bibliography
Urheberrecht

Häufige Begriffe und Wortgruppen

according accreditation achieve activities administrative Akkreditierungsstelle GmbH DAkkS Analysis Request application areas Association of Statutory authorization basis Bundesministerium bureaucracy carried certification changes companies competent competition compliance comprehensible conformity assessment consequences considered consultation contracts costs criteria decision determine Deutsche Akkreditierungsstelle documents economic effects efficiency ensure established examination Federal Ministry framework für German goals groups Health Insurance Funds hospitals impact assessment implementation Institut intended ISO/IEC issued Joint lack legislator medical aids Medical Device medical supply stores National Association necessary norm obligations offers Office orthopedic outpatient Parliamentary participation patients prequalification bodies prequalification procedure presented professional projects provision of medical question recommendations reference regard regional regulations regulatory alternatives rehabilitation requirements rules sector sentence service providers social code five standard Statutory Health Insurance structural suitable supply technical therapeutic uniform

Autoren-Profil (2023)

Born 1955 in Berlin.

Studied Business Administration at the University of Hamburg.

Professional and life experiences were gained in very different places of residence: Berlin, Hamburg, New York, Stuttgart, Helsingborg, Bad Oldesloe and Eichstätt.

After completing his education, he held various positions in marketing in Germany and the USA. From 1989 to 1996 managing director of a medical technology company and first experience with the German health care system. European representative of the American medical technology company Rehablicare Inc. in Sweden.

For Asklepios Kliniken GmbH & Co. KGaA from 2017 to 2020 responsible for Business Development and Execution in the business areas of Discharge Management and Home Care.

From March 2021 to March 2023 Managing Director of the prequalification body HAWE-Systems GmbH in Röthenbach.

Bibliografische Informationen

QR code for Reducing bureaucracy in Germany's health care sector
TitelReducing bureaucracy in Germany's health care sector: Market access analysis for the medical device industry
Autor/inThomas Bade
VerlagThomas Bade, 2023
  
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