Оглавление
Jörg F. Debatin. DiGA VADEMECUM
DiGA VADEMECUM. How to Launch Digital Health Apps in the German Healthcare System
The Authors
Acknowledgements and Foreword
The Authors
Jan B. Brönneke, LL.M
Prof. Jörg F. Debatin, M.D
Julia Hagen
Philipp Kircher, Dr. jur
Henrik Matthies, Ph.D
Kai Heitmann, M.D
Ecky Oesterhoff
Philipp Stachwitz, M.D
Prof. Ariel D. Stern, Ph.D
Table of contents
1. Introduction —the digital transformation of medicine. My diagnosis, my therapy, my DiGA = My health!
Increased patient sovereignty
Quantum leaps in digital technology
Digital health applications in standard medical care
DiGA VADEMECUM
2. I don’t have time for this! An overview
Chapter 3 A turning point in the German healthcare system
Chapter 4 Hello, I’m new here. How does the German healthcare system work?
Chapter 5 Assistive technologies, methods, digital health application— pathways to statutory healthcare for digital solutions
Chapter 6 Development of digital health tools
Chapter 7 The Digital Health Application (DiGA) Fast-Track
Chapter 8 The DiGA is listed—now what?
Chapter 9 Buy my DiGA; it‘s really good! Marketing of digital medical devices
Chapter 10 Electronic patient record and telematics infrastructure—a look beyond the DiGA horizon
Chapter 11 Summary and outlook
3. A turning point for the German healthcare system
Previous story/History/Prehistory
A new reality thanks to digital health applications
The digital health application environment
Health insurers
Physicians
Psychotherapists
Hospitals
Patients
Important digitalisation projects beyond the Fast-Track
4. Hello, I am new here, how does the German healthcare system work?
Dual insurance system
Parallel worlds/pillars in the healthcare system
Self-governance in the healthcare system
Cost-effectiveness requirement
Remuneration structures
5. Pathways for digital solutions to enter the statutory (regulated) healthcare market
Diagnostic and therapeutic services
Medical aids, therapeutic methods provided by non-physicianss (e.g., physiotherapy, speech therapy), medicinal products, and DiGA—What is what?
6. Development of digital health tools
6.1Involvement of care expertise—ask a doctor or …
6.1.1Understanding medicine
6.1.2Understanding care processes
6.1.3Understanding economics
6.1.4Who can help me?
6.2Involvement of patient expertise
6.3Hospitals—digital health tools
6.3.1DiGA and the hospital
6.3.2Digital Future—also in the Hospital
6.3.3Digital tools in the hospital
6.4Interoperability and data formats—the interaction of people and systems
6.5Data protection and information security “by design”
6.6Regulation of medical devices
6.6.1 Is (my) software a medical device?
6.6.2Best in class! Or rather not?
6.6.3Classified—what’s next?
7. The DiGA Fast-Track
7.1The definition of a DiGA
7.1.1Class I or IIa medical device
7.1.2Intended use
7.1.3Target group: Patients
7.1.4Digital main function
7.2Basic requirements. 7.2.1Safety and functional capability
7.2.2Data protection and data security by design
Legal framework
General Data Protection Regulation (GDPR)
Data Protection Impact Assessment (DPIA)
Technical and organisational measures
Data Protection Officer
Federal Data Protection Act (BDSG)
DiGA manufacturers are non-public bodies
No statutory processing power in the BDSG
Extended requirements for technical and organisational measures
SGB V
Applicability and relationship to other data protection law(s)
Data protection regulations for DiGA in the SGB V
Requirements under DiGAV
Admissibility of data processing—restriction of consent
Processing abroad and involvement of third-party service providers
Data transfers to third countries and the Privacy Shield
Obligation to maintain confidentiality
Requirements for data security
Meaning of Technical Guideline TR-03161 of the Federal Office for Information Security
Summary: Data protection must-haves
7.2.3Quality and interoperability
7.3Positive care effects
7.3.1Defining positive care effects
7.3.2And how are such effects demonstrated?
7.3.3Plausible justification and evaluation concept
7.4Application for inclusion in the DiGA Directory
7.4.1Information on the digital health application
7.4.2Information on the positive care effect
7.4.3Advice from the BfArM
7.4.4Declaration of the manufacturer for publication of information
8. The DiGA is listed—now what? 8.1And that was just the beginning: Price negotiations
8.1.1Price negotiations: General conditions and pricing models
8.1.2Pricing models: Pay for Activation, Pay for Active Use, Pay for Performance
Pay for Active Use
Pay for Performance
8.2And who will prescribe me now? Change of perspective: Ambulatory care
8.3From prescription to DiGA
8.3.1Prescription by physicians and psychotherapists
8.3.2Authorisation procedure by the health insurer
8.3.3Obtaining the prescription code to activate the DiGA
8.3.4DiGA with hardware components
9. Buy my DiGA; it’s very good! Marketing of digital medical devices. 9.1Clash of cultures—modern marketing vs. the Therapeutics Advertisement Law
9.2What could possibly go wrong?—legal consequences
9.3The Therapeutics Advertisement Law
9.3.1UWG
9.3.2The Theapeutics Advertisement Law (HWG)
What actually constitutes advertising?
What are the restrictions?
9.4Advertising regulations for DiGA
10. The electronic patient record and the telematics infrastructure —a look beyond the DiGA horizon
10.1Secure e-mail communication among healthcare providers through KIM
10.2The electronic health card
10.2.1Insured individuals’ master data management (VSDM)
10.2.2Emergency data mananagement (NFDM)
10.2.3Electronic medication plan (eMP)
10.3The electronic patient record (ePA)
10.4There was something else: The e-prescription
11. Summary and outlook
Literature
Websites
