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Digital Health Innovation for the German Healthcare system
DVG Fast Track
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12 experienced expertsin the fields of:
Financed by Federal Ministry of Health
Mission ends 31.12.2021.
Our goal:
Realising benefits of digital
health care for patients
In- & Outpatient Medicine |
Big Data | A.I. | Digital Health |
Interoperability | HTA | MedLaw
hih at a glance
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The hih-Team:Sparring Partner & Think Tank
Prof. Dr. med. Jörg Debatin
Chairman
Dr. Henrik Matthies
Managing Director, DiGA
Dr. med. Philipp Stachwitz
Outpatient care
Dr. med. Kai
Heitmann
Interoperability
Julia Hagen
Regulatory & political
affairs
Lars Roemheld
AI & Data
Dr. Philipp Kircher
Privacy, IT-security,
MedLaw
Jan B. Brönneke
HTA, Medical Devices,
MedLaw
Claudia Dirks
Communications
Ecky Oesterhoff
Hospital
Ralf König
Pharmacy
Nataliya Bogdanova-Dochev
Events
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Our topics
Electronic Health Record
DiGA-Fast-Track
Digitalization Long Term Care
Digitalization Hospitals
Data-“donation“
AI Regulation
Value-Based-Medicine
National Healthcare Portal
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Digital Health Applications (DiGA)
DVG FastTrack
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Until 2020: No specific pathway into GKV for digital solutions
Quelle: © Caption Health, © Butterfly
§§ 20 ff.
Primary Prevention
§ 32
Heilmittel
§ 33
Medical Aids
§§ 63 ff.
Pilot Schemes
... §§
§ 137f
DMP
§ 140a
Integrated care
§ 291g
Telecounseling
§ 291a
Applications TI/eGK
§ 137e
Trial of methods
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Definition: DiGA (digital health application)
Classes I and IIa MDR
(+ provisional rules MDR)
Medical Device
Relies on digital technologies
Main function
Centered on patients,
possibly including treating
doctors
Intended use
Detection (monitoring),
treatment, palliation /
abatement of pain,
compensation of diseases,
injuries, disabilities
Functionalities
DiGA acc.
§ 33a SGB V
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The Fast Track according to DVG (1/2)
Consulting
(remunerated)
BfArM
On registration in DiGA-registryaccording to §139e SGB V
Application of producer
Examines and decides within 3
months (net)
BfArM
General requirementssafety | quality | functionality |
privacy | data security
Positive care effectsmedical benefit | structural &
procedural effects
✓
?
✓
Listing in DiGA-registry
Preliminary listing & 12 months trial period
x
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The Fast Track according to DVG (2/2)
Preliminary listing
& trial period of 12
months
• Plausible
hypothesis
• Evaluation
concept by
independent
scientific
institution
• Producer bears
costs
DiGA
12-months trial in first
healthcare market
Standard Care
Producer sets price
Preliminary reimbursement
of physicians if applicable
Price negotiations with
GKV-SV
Arbitration if negotiations
stuck after 1 year
Prescription by physicians and
psychotherapists
Permission by health insurance fund (with
corresponding indication)
Adaption of physician‘s
reimbursement scheme if
applicable
Decides on final
listing
BfArM
✓Positive care
effects
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Further specification of requirements
of positive care effects – within 12-
months trial period where applicable
Proof
Structural and procedural effects
Medical benefit
of compliances with general
requirements
Proof
SafetyFunctionality
Quality
PrivacyData-/IT-Security
and/or+→ Further specification by DIGAV by BMG and guideline by BfArM
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General requirements
Proof of
Privacy & Data-Security
InteroperabilityRobustness
Consumer protection
User friendliness(Patients & Physicians)
Quality ofmedical content
Patient safety
CE-Marking
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Positive care effects (1/3)
SGB V and DiGAV
§ 10 para. 1 & 2 DiGAV
Retrospective controlled trials,
showing that the use of DiGA is
superior to care without DiGA.
Prospective controlled trials
possible.
§ 139e para. 9 SGB VProof of positive care effects is based on the principles of evidence based medicine.
§ 11 para. 1 DiGAV
Prospective controlled trials
mandatory when lack of
signifcant data or comparability.
§ 12 DiGAV
Trials for diagnostic devices
Trials, showing sensitivity and
specificity of DiGA.
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Positive care effects (2/3)
Reduction of BoI in daily life
Securing standard of care
Health literacy
Access to care
Adherence
Patient safety…
Coordination of care
Structural and procedural effects Medical benefit
Morbidity
Quality of Life
Mortality
Adverse effects
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Positive care effects (3/3)
Healthcareresearch
Systematic reviews
Randomised controlled trials
Cohort-studiesCase-control-studies
Behaviouralresearch
Epide-miology
etc.Data
Science
Structural and procedural effects Medical benefit
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Possible Data Sources
• ProspectiveTrial-Data
RWD:
• Claims-Data
• Treatment Data (eHR)
• Register Data
• Patient Generated Data
That‘s
new!
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BfArM Guideline (English version in progress)
Details DiGA-definition
Software-Hardware-combo
Content of registry
Software-Service-combo
Details requirements
Further obligations
Details consulting
Procedural questions
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After Trial Period
Negotiated price
Trial Period
Producer sets price
Claim
Quality of Evidence?
Proven effects?
Prices within EU?
Prices of self-payers?
§ 139 para. 4 –Framework agreement
Federal associations of GKV and DiGA-producers
Intended use (MDR)
Pricing
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Potential prescription and reimbursement procedure
1. Physician
prescribes DiGA via
standard prescription
2. Patient downloads DiGA
3. Uploads precription in
health insurance app /
hotline / mail
3. Receives activation code
4. Provider sends code to health insurance fund
5. Health insurance fund reimburses provider
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What’s next?
mid July, tba
International DiGA Summit
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See you soon.
www.hih-2025.de
hih2025
health innovation hub (hih)
Further information on DiGA-procedure including guideline and application-form on
https://www.bfarm.de/DE/Medizinprodukte/DVG/_node.html (German)
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