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Table of contents

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1 Introduction—the digital transformation of medicine

2 I don’t have time for this! An overview

3 A turning point for the German healthcare system

4 Hello, I am new here, how does the German healthcare system work?

5 Pathways for digital solutions to enter the statutory (regulated) healthcare market

6 Development of digital health tools

6.1 Involvement of care expertise—ask a doctor or …

6.2 Involvement of patient expertise

6.3 Hospitals—digital health tools

6.4 Interoperability and data formats—the interaction of people and systems

6.5 Data protection and information security “by design”

6.6 Regulation of medical devices

7 The DiGA Fast-Track

7.1 The definition of a DiGA

7.2 Basic requirements

7.3 Positive care effects

7.4 Application for inclusion in the DiGA Directory

8 The DiGA is listed—now what?

8.1 And that was just the beginning: Price negotiations

8.2 And who will prescribe me now? Change of perspective: Ambulatory care

8.3 From prescription to DiGA

9 Buy my DiGA; it’s very good! Marketing of digital medical devices

9.1 Clash of cultures—modern marketing vs. the Therapeutics Advertisement Law

9.2 What could possibly go wrong?—legal consequences

9.3 The Therapeutics Advertisement Law

9.4 Advertising regulations for DiGA

10 The electronic patient record and the telematics infrastructure —a look beyond the DiGA horizon

10.1 Secure e-mail communication among healthcare providers through KIM

10.2 The electronic health card

10.3 The electronic patient record (ePA)

10.4 There was something else: The e-prescription

11 Summary and outlook

Literature

Websites

DiGA VADEMECUM

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