DIGA REPORT 2021 - GRÜNDERATELIER
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DiGA
REPORT
2021DiGA Report 2021 A B OU T GR ÜNDER AT ELIER GründerAtelier helps young companies to scale, to fulfill their investment needs and to build strong relations. Beyond companies, we make fruitful connections. We support our clients across a broad range of objectives: our focus lies on one hand on Startups, on the other on Investors. How do we help startups? We are here to redefine and innovate the strategic operations of startups by fo- cusing on their core segments and providing useful guidelines to allow for efficient product development. We generate a solid financial plan and proposition to make sure each startup understands its future composition of inflow and outflow of cash in order to apply the right development strategies. We bring in our reliable network and lead the way in raising the capital needed. We will provide Startups with highly strategic Investors, Connections and first Customers that will enhance traction and foster business growth. How do we help investors? We work hand-in-hand with Investors to understand their investment needs and preferences. We provide updated lists that satisfy all the investment criteria set forth. The bridge between Startups and Investors is built by knowing what each side expects. Our purpose is to funnel information among the parties in a fast and reliable manner to allow for an efficient execution. We provide solid due diligence and valuation of potential target Startups in order to hand over to Investors an ove- rall view supporting them in the decision-making process. We know information is key to success, therefore we guarantee a reliable disclosing process that creates a regular and efficient exchange of information between the parties. Julian Preibsch Carlo Alberto Zucca Managing Director Senior Investment Analyst julian.preibsch@gruenderatelier.de carlo.zucca@gruenderatelier.de Lukas Anstädt Alessio Tonacchera Managing Director Investment Analyst lukas.anstaedt@gruenderatelier.de alessio.tonacchera@gruenderatelier.de Where you can find GründerAtelier Website: gruenderatelier.de Instagram: instagram.com/gruenderatelier/ LinkedIn: linkedin.com/company/gruenderatelier/mycompany/ Copyright © via GründerAtelier GmbH; Cherry Ventures Management GmbH | All rights reserved. i
DiGA Report 2021 A B OU T C HER RY VENT UR ES Cherry Ventures is an early-stage venture capital firm led by a team of entrepre- neurs with experience building fast-scaling companies such as Zalando and Spo- tify. The firm backs Europe‘s boldest founders, usually as their first institutional in- vestor, and supports them in everything from their go-to-market strategy and the scaling of their businesses. Cherry Ventures has previously invested in the seed stage of over 60 companies across Europe, including FlixBus, Auto1 Group, Infarm, Rows, Forto, and TourRadar. Cherry Ventures is based in Berlin and invests across Europe with operations in London, Paris, and Stockholm. Catherine Treyz Head of Communications & Platform press@cherry.vc Filip Dames Founding Partner Alexander Schmitt Investor alex.schmitt@cherry.vc Where you can find Cherry Website: cherry.vc Twitter: twitter.com/cherryventures LinkedIn: linkedin.com/company/cherry-ventures Copyright © via GründerAtelier GmbH; Cherry Ventures Management GmbH | All rights reserved. ii
DiGA Report 2021
TA B L E OF CONT ENTS
About GründerAtelier........................................................................................................................i
About Cherry Ventures...................................................................................................................ii
Table of Contents..........................................................................................................................iii
List of Figures.....................................................................................................................................v
List of Tables......................................................................................................................................v
Acronyms and Abbreviations.......................................................................................................vi
1. Digital HC Ecosystem Size - Europe........................................................................................1
1.1 Focus Germany........................................................................................................................3
2. DiGA - Introduction and Overview..........................................................................................5
2.1 A new Paradigm in german Healthcare - Introduction..............................................5
2.2 Legal requirements of DiGA..............................................................................................5
2.3 Standalone Software classification...............................................................................5
2.4 How the application process works................................................................................7
2.5 Initial Document Submission............................................................................................8
2.6 Criteria needed to be eligible to be filed into the DiGA Directory.......................10
2.7 Deadlines and fees..............................................................................................................12
3. Adjustments needed to the DiGA System........................................................................14
3.1 Higher threshold for proofs concerning medical benefit.......................................14
3.2 Price regulation concerning products or services of DiGA ap- plicants..........14
3.3 Specialized team for the crea- tion of a seamless digital expe- rience...........14
3.4 Respect of GDPR and other data protection regulations....................................14
3.5 Proven quality and uniformity of software and hardware......................................14
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4. Companies with DiGA Listing.................................................................................................16
4.1 Permanently Approved.......................................................................................................16
4.1.1 deprexis............................................................................................................................16
4.1.2 elevida..............................................................................................................................16
4.1.3 somnio.............................................................................................................................16
4.1.4 velibra...............................................................................................................................16
4.2 Temporarily Admitted.........................................................................................................17
4.2.1 Invirto................................................................................................................................17
4.2.2 Kalmeda..........................................................................................................................17
4.2.3 Mika..................................................................................................................................17
4.2.4 Vivira.................................................................................................................................17
4.2.5 zanadio...........................................................................................................................18
4.2.6 M-sense Migräne.......................................................................................................19
4.2.7 Rehappy.........................................................................................................................19
4.2.8 Selfapy...........................................................................................................................19
References (APA)..........................................................................................................................20
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L IST OF F IGUR ES
Figure 1. Sequence of the DiGA Application............................................................................7
Figure 2. Application for final listing in the DiGA directory..................................................8
Figure 3. Application for provisional listing in the DiGA directory.....................................9
Figure 4. Application for an extension of the trial phase....................................................9
Figure 5. Requirements and recommendations of the BSI regarding
information security.....................................................................................................10
Figure 6. IOP for DiGA.......................................................................................................................11
L IST OF TA BLES
Table 1. Segments’ economic impact - United Kingdom ....................................................2
Table 2. Segments’ economic impact - Italy............................................................................2
Table 3. Segments’ economic impact - France......................................................................2
Table 4. Segments’ economic impact - Germany..................................................................2
Table 5. Segments’ economic impact - Spain.......................................................................3
Table 6. Segments’ economic impact - Overall......................................................................3
Keywords:
DiGA, DVG, BSI, BfArM, Healthcare, Application, Software, Digital Care,Digital Experience, Medical
Devices, eHealth, Reimbursement
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A C RONY MS A ND A BBR EVI ATI O N S
Acronyms & Definition
Abbreviations
AAL Ambient Assisted Living
BDSG Bundesdatenschutzgesetz
Federal Data Protection Act
BfArM Bundesinstitut für Arzneimittel und Medizinprodukte
Federal Institute for Drugs and Medical Devices
BSI Bundesamt für Sicherheit in der Informationstechnik
Federal Office for Information Security
B2C Business to Client
CAGR Compound Annual Growth Rate
CE Conformité Européenne
Business to Client
CBT Cognitive Behavioural Therapy
DiGA Digitale Gesundheitsanwendungen
Digital Health Applications
DiGAV Digitale-Gesundheitsanwendungen-Verordnung
Digital Health Applications Regulation
DVG Digitale Versorgung Gesetz
Digital Healthcare Act
EEC European Economic Community
EPA Personal Health Record
EPR Electronic Patient Record
GDPR General Data Protection Regulation
IOP Internal Operating Procedure
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Acronyms & Definition
Abbreviations
ISMS Information Security Management System
ISO International Organization for Standardization
MDD Medical Device Directive
MDR Medical Device Regulation
mN Medizinischer Nutzen
Medical Benefit
Mn Million
MPG Medizinproduktegesetz
Medical Devices Act
SGB Sozialgesetzbuch
Social Code
STD Sexually Transmitted Diseases
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1 . DIGITA L HC ECOSYSTEM 3. ePharmacy: The ePharmacy and
SIZ E - EUROP E Personal Care segment contains
the online sale of medicine, cos-
If we dwell into the digital healthcare metics, and pharmaceutical and
ecosystem in Europe, we can divide it personal care products (inclusive
into different segments: of prescription drugs for the priva-
te end-user (B2C)). This segment
1. AAL: Ambient Assisted Living also includes products for private
(AAL) helps elderly people, but use (e.g. blood pressure monitors,
also people with special needs, to disinfectants, dressings).
manage their household activities
better on their own. It is ideal for 4. Heart Failure: The ‘Heart Failure’
people who require monitoring in segment covers the user and reve-
general including e.g. children and nue development for two eHealth
chronically ill people. The trend is product categories for people with
part of the eHealth sector since chronic heart failure. Hardware and
the respective devices track the software solutions for healthcare
user’s health data at home. Furt- professionals, e.g. medical equip-
hermore, it can be seen as the ment for hospitals and doctors’
smart home part of eHealth as AAL surgeries, are not included.
products usually aim at assisting
in a domestic context. 5. Diabetes: The ‘Diabetes’ segment
includes the user and revenue de-
2. Fitness: There are different ways velopment for two eHealth product
in which customers can benefit categories for people with diabe-
from Fitness wearables/trackers tes. Hardware and software solu-
and Fitness apps. Fitness weara- tions for healthcare professionals,
bles analyze physical activities or e.g. medical equipment for hospi-
body functions. They are usually tals and doctors’ surgeries, as well
combined with an app to give va- as professional health services like
luable insights into an individual’s telemedical monitoring are not in-
fitness. These insights can help cluded.
users to understand their body
better and support them in rea- 6. Hypertension: The ‘Hyperten-
ching specific fitness goals, for sion’ segment covers the user and
example losing weight, by tracking revenue development for eHealth
calories or calculating burned ca- product categories for people with
lories with a tracker. hypertension.
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All these segments have different impacts on different countries. As reported in
the table below1:
United Kingdom AAL Fitness ePharmacy Heart Diabetes Hyper-
Failure tension
Revenue in 2019 (€Mn) 70.00 660.00 6,783.00 21.00 11.00 28.00
CAGR next years 52% 4.7% 8.8% 7.8% 15.9% 8%
Market volume by
208.00 829.00 8,500.00 27.00 17.00 38.00
2022 (€Mn)
Table 1. Segments’ economic impact - United Kingdom (Source: Statista, eHealth Outlook 2020).
Italy AAL Fitness ePharmacy Heart Diabetes Hyper-
Failure tension
Revenue in 2019 (€Mn) 14.00 206.00 1,443.00 20.00 7.00 27.00
CAGR next years 41% 5% 14.8% 6.8% 9% 8%
Market volume by
33.00 263.00 2,183.00 24.00 9.00 35.00
2022 (€Mn)
Table 2. Segments’ economic impact - Italy (Source: Statista, eHealth Outlook 2020).
France AAL Fitness ePharmacy Heart Diabetes Hyper-
Failure tension
Revenue in 2019 (€Mn) 42.00 351.00 3,600.00 23.00 7.00 26.00
CAGR next years 37% 5% 8.7% 7.4% 8.4% 8.6%
Market volume by
90.00 844.00 4,623.00 28.00 9.00 36.00
2022 (€Mn)
Table 3. Segments’ economic impact - France (Source: Statista, eHealth Outlook 2020).
Germany AAL Fitness ePharmacy Heart Diabetes Hyper-
Failure tension
Revenue in 2019 (€Mn) 62.00 433.00 5,942.00 32.00 20.00 37.00
CAGR next years 32.6% 5.5% 13% 6.8% 11.3% 7.7%
Market volume by
122.00 568.00 8,573.00 38.00 28.00 47.00
2022 (€Mn)
Table 4. Segments’ economic impact - Germany (Source: Statista, eHealth Outlook 2020).
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Spain AAL Fitness ePharmacy Heart Diabetes Hyper-
Failure tension
Revenue in 2019 (€Mn) 13.00 195.00 1,510.00 13.00 8.00 17.00
CAGR next years 40% 5% 16% 7% 9.5% 10%
Market volume by
30.00 248.00 2,356.00 16.00 11.00 21.00
2022 (€Mn)
Table 5. Segments’ economic impact - Spain (Source: Statista, eHealth Outlook 2020).
Overview UK Italy France Germany Spain
Digital HC Revenue in
7,573.00 1,717.00 4,049.00 6,526.00 1,756.00
2019(€Mn)
Market volume by
9,609.00 2,547.00 5,230.00 9,376.00 2,682.00
2022 (€Mn)
Table 6. Segments’ economic impact - Overall (Source: Statista, eHealth Outlook 2020).
The United Kingdom and Germany be willing to pay for applications that
come out on top with an overall market can help them with emergencies while
revenue in 2019 of 7.5 bn and 6.5 bil- 40% of them provided useful insights
lion Euro respectively. The healthcare about their interest into applications
industry is witnessing an evolution to- that can track fitness and nutrition.
wards a new healthcare concept and Other interesting data from these sur-
these 2 countries are at the forefront veys reveal that 35% and 39% of the
of this innovation. respondents were also interested in
applications able to track their sleep
1.1 Focus - Germany quality and to aid them to quit smo-
king. In terms of what benefits these
In Germany, an ever-surging demand citizens expect, earlier detection of
for telemedicine and digital healthca- illnesses top the list with 56% of re-
re services paired up with a spreading spondents, while 13% of them have low
interest in the topic is fostering inno- expectations stating that they don’t
vation both in the public and private foresee any benefit from these appli-
sphere. According to market statistics, cations.3
86% of German citizens are familiar
with the term “eHealth” which proves In terms of digital services, on average
the awareness and the extent of inte- 38% of Germans are willing to book
rest in the subject. Moreover, 49% of their doctor appointments online. In
the respondents showed a high level particular 41% of respondents declare
of interest in the subject.2 to be more than willing to use an on-
line tool for doctors location and ap-
42% of the respondents declared to pointment scheduling. However, it is
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also essential to mention that not all real traction in the market. One of the
Germans are willing to use these ser- biggest steps in this direction is the
vices. It has been reported that 23% of signing by the government of the new
the respondents are not keen on using law for digital health applications.
any sort of digital service offered by
their doctors.4 On November 7th the German Parlia-
ment decided to pass the DVG (“Digi-
Moreover, one of the main constraints tale Versorgung Gesetz” also known
for German citizens when it comes to as “Digital Healthcare Act”). From June
subscribing to or using medical online 2020 onwards, any doctor in Germany
services is about costs and data pro- is able to prescribe digital health ap-
tection. 40% of respondents reported plications to the 72 million insured citi-
that these new services are too ex- zens. This brought numerous changes
pensive or that they are afraid these to the standard system such as the
services might have some future hid- possibility for statutory health insu-
den costs. Moreover, 35% of respon- rances to invest into VC funds to foster
dents don’t feel secure providing per- digital health innovation as well as the
sonal data to these new companies.5 creation of a statutory directory which
will allow pre-screened applications
Germany is pushing new regulations to (described in Germany as DiGA “Digital
fend off these limitations and allow the Health Applications”) to be subject to
new healthcare paradigm to achieve reimbursement.
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2. DIGA - INT RODUC TI O N
A N D OVERVIEW All these requirements are defined in
Section 33a of the German Social Act
2.1 A new Paradigm in German Book V (Fünftes Buch Sozialgesetz-
Healthcare - Introduction buch, SGB V).
The 7th November 2019 marked the Moreover, the European Commission
introduction into the healthcare sys- in consultation with the relevant aut-
tem of “app on prescription”. German horities implemented the following
residents will be able to use DiGA screening criteria in order to qualify
and be reimbursed by the health in- and classify a standalone software as
surance. such:
Digital health applications (DiGA – in ʅ It has to be a computer program
German: “Digitale Gesundheitsan- ʅ The purpose of the software needs
wendungen”) can be classified as to be other than just merely storing
patients’ digital assistants and can or communicating information
enhance the treatment and diagnosis ʅ The software has to be created for
process as well as support a healthier individual patients’ benefit
patient’s lifestyle.6 ʅ The software has to have an inten-
ded purpose listed in Article 1(2)a)
2.2 Legal requirements of DiGA7 of Directive 93/42/EEC (described
below in the Standalone Software
DiGA can be described as a CE-certi- paragraph)
fied medical device and according to
BfArM has the following holistic pro- Not every application can be defined
perties: as a DiGA. There can be apps such as
standalone software while others are
ʅ Devices of Class I or IIa, according incorporated into medical devices as
to the Medical Device Regulation well as other devices. These types of
(MDR) or the transitional regulation features will lead to a different classifi-
Medical Device Directive (MDD) cation in terms of risk according to the
ʅ The main function of the DiGA is ba- MPG (Medizinproduktegesetz, Act on
sed on digital technologies Medical Devices). Moreover, not only
ʅ The digital function is one of the the use will be taken into consideration
main features of the medical pro- but also the instructions for use, label-
duct ling or marketing material marketed by
ʅ Recognition, monitoring, treatment the manufacturer or related parties.
or alleviation of diseases, injuries
or disabilities are recognized by the 2.3 Standalone Software
DiGA classification8
ʅ The DiGA is used by the patient alo-
ne or by the patient and healthcare Standalone software can be classified
provider together as medical devices, but they need to
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be intended for human treatments and Class I (low risk), IIa, IIb to Class III (high
need to satisfy one of the following cri- risk). Class I products are furtherly di-
teria (Article 1(2)a) of Directive 93/42/ vided according to whether they requi-
EEC): re sterilisation or include a measuring
function.
ʅ Diagnosis, prevention, monitoring,
treatment or alleviation of disease The classification is based on the rules
ʅ Diagnosis, monitoring, treatment, reported in Annex IX of Council Direc-
alleviation or compensation of inju- tive 93/42/EEC. Here follows the clas-
ries or handicaps sification reported (the exceptions are
ʅ The investigation, replacement or for in-vitro diagnostic medical devices
modification of the anatomy or a and active implantable medical devi-
physiological process ces).
ʅ Control of conception
As a premise:
The Indicative functions that the de-
vice would need to possess are, but ʅ Standalone software falls within the
not limited to: category of active medical device
ʅ Active therapeutic devices restore,
ʅ Decision support or decision-making replace, modify or support structu-
software (e.g. concerning therapeu- res or biological functions with the
tic measures) purpose of treatment or alleviation
ʅ Calculation (e.g. of dosing of medici- of an injury, illness or handicap
nes, as opposed to mere reproduc- ʅ Active devices supply information
tion of a table from which users can for treating, monitoring, diagnosing
deduce the dosage themselves) or detecting illnesses, physiological
ʅ Monitoring patients and collecting conditions, congenital deformities
data (e.g. by measurements if the or other states of health
results thereof have an influence on
diagnosis or therapy) Class II b:
Storage, communication or search- ʅ All active therapeutic devices that
only products do not result in a medi- might be hazardous for the human
cal device classification. body in the process of administering
Software applications must fulfil the energy to the body for monitoring or
basic requirements of Council Directive diagnosis
93/42/EEC. This includes accessories ʅ All active devices intended to control
manufactured and used in a health fa- other active therapeutic devices in
cility without being placed on the mar- Class IIb or intended directly to influ-
ket or custom-made device according ence their performance are in Class
to Section 3 numbers 21 and 22 MPG. IIb
ʅ All devices that are used as contra-
93/42/EEC also provides a list of dif- ception or prevention of STDs are
ferent risk classes. They range from also Class II b
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Class II a: According to the class of the device,
the manufacturer needs to fulfil some
ʅ These are all devices that might not prerequisite to receive a CE certifica-
be considered as a source of poten- tion. Generally speaking, certification
tial harm for the patient in case of of class I devices does not need the in-
diagnostic process alteration. In this volvement of a notified body while it is
category are allocated all the de- mandatory for the above classes.
vices that supply energy to the pa-
tient and that all their possible mea- 2.4 How the application process
surement variations do not harm the works9
patients
The process is straightforward: after
Class I: submitting the application, the BfArM
will review the claims done by the ma-
ʅ All other devices are in this class nufacturer on but not limited to quality,
usage, data protection, interoperabili-
This classification shows that most of ty, user-friendliness, and evidence of a
the medical apps on phones, tablets or positive healthcare effect.
similar devices are classified as Class I
while devices for the diagnosis and/or Below is a flow chart showing the ove-
monitoring of vital parameters might rall process.
fall within the above classes.
Admission
Into the DiGA directory
according to § 139e SGB V
Deter- Price
minati- negociations,
on of if necessary,
the arbitration
medical
Requirements
Regarding security, service
functionality, quality,
data protection,
interportability
Plausible
justification
of the positive care effects,
concept for evaluation
Manufacturer BfArM Positive Care
submits an Advises and effects Preliminary
application examines
Medical benefit, admission
structural and procedural Into the DiGA
improvements directory according Adjustment
to § 139e SGB V
EBM
3 months 12 months Rejection /
Cancellation
Figures 1. Sequence of the DiGA Application (Source: BfArM).
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We can divide this process into 4 parts: 2.5 Initial Document Submission
1. Manufacturers need to confirm that Before an application is made, the ma-
their product fulfils all the DiGA re- nufacturer of the DiGA has first to de-
quirements that are formulated in cide whether to apply provisionally or
Sections 3 to 7 of the DiGAV (or 3 to directly for the final listing in the direc-
6 in case of Provisional Listing) tory. This decision essentially depends
2. Manufacturers need to provide evi- on whether the manufacturer of the
dence that their products can ge- DiGA can already present a comparati-
nerate positive healthcare effects ve study to prove a positive healthca-
3. According to the documents provi- re effect that meets the requirements
ded we have different paths: of Sections 10 to 12 DiGAV (see also
3.1 The manufacturer provides all Chapter 4 Evidence of Positive Health-
the documents and awaits a re- care Effect of this guide).
ply from BfArM
3.2 The manufacturer provides all Before applying, the manufacturer
the documents besides the needs to decide whether to apply for
study of positive healthcare ef- the direct listing or provisional listing.
fects and it has up to 12 months
to provide the finished study for Final listing: Manufacturers that al-
the examination ready have a study that proves their
4. Listing in the DiGA directory: a DiGA products have a positive healthcare
becomes visible in the DiGA directo- effect, will be included in the DiGA Di-
ry as soon as a positive decision on rectory within 3 months from the sub-
the inclusion in the DiGA directory mission of the application and BfArM
according to Section 139e SGB V has positive decisions. Negotiation of
been issued reimbursement will follow.
Sets the scale for the
Framework agreement price negotiations
Price
Price negotiations
negotiations
Can set maximum Manufacturer GKV-SV
price for groups
of DiGA
Manufacturer‘s GKV-SV
association
Manufacturer‘s price Negotiated price
(is always valid from the 13th month, annually terminable)
DiGA is covered by statutiry health insurance nationwide and can be prescribed
Manufacturer BfArM by any doctor
Final Listing in the
Application for provisional
Application final listing DiGA directory
Notification
Notification
listing
in in thedirectory
the DiGA DiGA directory
Months 0 +3 + 12
Figures 2. Application for final listing in the DiGA directory (Source: BfArM).
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Provisional listing: In case the studies It is possible to obtain an extension of
are not present, the manufacturer has the trial phase, up to 12 months. The
to apply to the provisional listing. The condition allowing this extension is that
candidate will be given a 12 months trial the study submitted “makes it likely that
period to provide the study to the BfArM evidence will be provided later”. The ma-
for review. The candidate can’t re-apply nufacturer that needs the extension
for 12 months in case of no submission. will need to apply for it.
Framework agreement Sets the scale for the
price negotiations
Price
Price negotiations
negotiations
Can set maximum
Manufacturer GKV-SV
price for groups
of DiGA
Manufacturer‘s GKV-SV
association
Manufacturer‘s price Negotiated price
(is always valid from the 13th month, annually terminable)
DiGA is covered by statutiry health insurance nationwide and can be prescribed by any doctor
Manufacturer BfArM Provisional listing in Final Listing in the
the DiGA directory DiGA directory
Application for provisional
Application final listing
Notification
Notification Trial Notification
listing
in in thedirectory
the DiGA DiGA directory
Months 0 +3 max. + 12 +3
Figures 3. Application for provisional listing in the DiGA directory (Source: BfArM).
Framework agreement Sets the scale for the
price negotiations
Price
Price negotiations
negotiations
Can set maximum
Manufacturer GKV-SV
price for groups
of DiGA
Manufacturer‘s GKV-SV
association
Manufacturer‘s price Negotiated price
(is always valid from the 13th month, annually terminable)
DiGA is covered by statutiry health insurance nationwide and can be prescribed by any doctor
Manufacturer BfArM 3 months prior to
Provisional listing in Final Listing in the
expiration: Application
the DiGA directory DiGA directory
for extension
Application for provisional
Application final listing
Notification
Notification Trial Trial Notification
listing
in in thedirectory
the DiGA DiGA directory
Months 0 +3 max. + 12 +3
Figures 4. Application for an extension of the trial phase (Source: BfArM).
This depends mainly on the presen- the product has a positive healthcare
ce of studies that already prove that effect.
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2.6 Criteria needed to be eligible the manufacturer and its processes.
to be filed into the DiGA Directory Moreover, DiGA manufacturer needs
to consent to data processing for the
The product needs to satisfy the follo- listing.
wing criteria:
Information Security: The specificati-
Safety and Suitability of use: Need a ons are based on the recommenda-
certificate of conformity tion of the BSI and can be summari-
zed in the following. However, even
Data Protection: Compliance with the though DiGA manufacturers are not
GDPR, BDSG and other data protec- yet required to implement an ISMS ac-
tion regulations according to the na- cording to the ISO 27000 series or BSI
ture of the company. The checklist to Standard 200-2 by 2022, Annex 1 to
be completed by the manufacturer of the DiGAV requires the establishment
the DiGA for the application contains of a series of processes for all DiGA in
40 statements that take into account order to anchor the basic idea outli-
both the technical implementation of ned above of security as a process at
the DiGA (e.g. technical and organiza- the manufacturer and to ensure the
tional measures in accordance with Ar- continuation of a security level once
ticle 32 GDPR) and the organization of achieved.
BSI Standards for Information Security IT-Grundschutz Compendium
Information Security and IT-Grundschutz
BSI Standard 200-1 Chapter 1
Introduction
Information Security Management System (ISMS)
Chapter 2
Layer Model and Modelling
BSI Standard 200-2 Elementary Threats
IT-Grundschutz Methodology
Layer Model
Process oriented Modules:
- ISMS (Information Security Management System)
BSI Standard 200-3 - ORP (Organisation and Personnel)
- CON (Concepts)
Risk Analysis based on IT-Grundschutz - OPS (Operations)
- OCR (Detection and Reaction)
System oriented Modules:
- IND(Industrial IT)
- APP(Applications)
BSI Standard 100-4 - SYS OT(Systems)
- NET(Networks and Communication)
Business Continuity Management
- IT#(Infrastructure)
Figures 5. Requirements and recommendations of the BSI regarding information security (Source:
BSI-Standard).
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Interoperability: The manufacturer of a ble, interoperable format so that the
DiGA must prove that it is interoperable insured person or a third party aut-
regarding three selected issues: horized by the insured person can
further process this data via other
ʅ The DiGA has to allow the insured digital products. In future, it should
person to export therapy-relevant also be possible to connect this in-
extracts of the data collected via the terface to the EPA.
DiGA in human-readable and printa- ʅ If the DiGA obtains data from medical
ble form so that he can use them for devices used by the insured person
his own purposes or pass them on to or sensors worn by the insured per-
a physician. son for the measurement and trans-
ʅ The DiGA has to allow the insured mission of vital signs (wearables), it
person to export the data collected may also address these devices via
from the DiGA in a machine-reada- an interoperable interface.
Infrastructure of the supplier Services by other providers Personal health record (ePA)
- Human-readable Legend
and printable
Export
Import Other apps Interoperability
DiGA interfaces which must
Device be implemented
Export
or Sensor
- Vesta profiles
- KBV MIO
- Int. Standard
Future extensions
Profitability
- Open profile
Mobile which have already
phone/ been set
Mobile Plattform/ Aggregator Sensor
Other DiGA Optional interfaces
Figures 6. IOP for DiGA (Source: BfArM)
Evidence of positive healthcare effect: disease, Definition: Medical bene-
The medical benefit (medizinischer fit Evidence of Positive Healthcare
Nutzen, mN) is defined in the DiGAV Effect
(based on the corresponding stan- ʅ The prolongation of survival
dards for the evaluation of drugs) as ʅ An improvement in the quality of life
patient-relevant effect(s), particularly
regarding: Those who claim a medical benefit for
a DiGA must show that patient-rele-
ʅ The improvement of the state of vant endpoints, in particular morbidity,
health mortality or quality of life, are positively
ʅ The reduction of the duration of influenced.
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Further quality requirements: DiGA DiGA in the DiGA directory that invol-
needs to also meet the following re- ves physicians and other healthcare
quirements providers in the usage of the DiGA by
the insured person.
ʅ Robustness: The device needs to ʅ Quality of Medical Content: The pro-
be used by insured persons as far as cedure implemented by DiGA and
possible without interference, loss of the content presented must be ba-
data, transmission errors or difficulties sed on sound medical knowledge
in connection with devices, power fai- and take into account recognized
lure, interruptions in internet connec- professional standards. Health in-
tions, malfunctioning that cause data formation provided to the insured
falsification among others. must be up-to-date and appropria-
ʅ Consumer Protection: The manu- tely prepared for the focus group.
facturer of a DiGA must supply he- ʅ Patient Safety: The manufacturer of
althcare providers and insured per- a DiGA must ensure by appropriate
sons with transparency regarding organizational and technical mea-
the purpose and functionality of the sures that the risks of use of the
DiGA. Moreover, insured persons application are as low as possible.
must be able to determine to what While the CE marking ensures the
extent the application fits their own basic technical safety of the DiGA,
requirements, ideas and (technical) the measures required here are ai-
circumstances. It is possible to ins- med at conscious handling of exis-
tall paid functions on the application ting residual risks for the insured
but in this case, the user will have person.
to pay for them by him/herself. Ho-
wever, according to section 5 Para-
graph 4, Digital health applications 2.7 Deadlines and fees
in the DiGA directory must be free of
advertising. The application procedure begins
when the manufacturer has filled out
ʅ Ease of Use: The operating instruc- all the mandatory information in the
tions implemented or supported in application portal and attached the
the DiGA must consider the areas necessary attachments, clicked on the
of vision, hearing and motor skills. button that triggers the transmission
Exceptions are only permitted if this of the application to the BfArM who re-
can be justified based on the target ceives the application online.
group or the purpose of the DiGA.
From January 1st .2020 all DiGA listed The candidate will receive a reply from
in the register must either include BfArM within 14 days from submission.
operating aids for people with disa- On the day of receipt of the complete
bilities or support the operating aids documents by the BfArM, the legal-
offered by the platform. ly prescribed maximum three-month
ʅ Support for healthcare providers: evaluation period of the application by
The DVG also allows the listing of a the BfArM begins.
Copyright © via GründerAtelier GmbH; Cherry Ventures Management GmbH | All rights reserved. 12DiGA Report 2021 If a manufacturer wishes to have a to any preconditions however it bears DiGA deleted from the directory, he a fee (reported below). can submit an application for delisting to the BfArM via the electronic applica- The BfArM charges fees for the proces- tion portal. This deletion is not bound sing of applications and notifications: Application for final listing in the DiGA directory: € 3,000 to € 9,900 Application for provisional listing in the DiGA directory: € 3,000 to € 9,900 Assessment of the proof of positive effect (provisional): € 1,500 to € 6,600 Application for extension of the trial phase: € 1,500 to € 4,900 Notification of significant changes to the DiGA: € 1,500 to € 4,900 Notification of the need for changes in the DiGA directory: € 300 to € 1,000 Removing of a DiGA from the DiGA directory: € 200 Copyright © via GründerAtelier GmbH; Cherry Ventures Management GmbH | All rights reserved. 13
DiGA Report 2021
3 . A DJUST MENTS NEEDED (Section 12(1) sentence 1 SGB V pro-
TO T H E DIGA SYST EM vides as follows: “Treatments must be
adequate, fit for purpose and econo-
Regardless of the innovative push mically efficient; they must not exceed
that Germany created concerning the dimension of the necessary.”).
digital healthcare, the system it has Therefore, it would be advisable to ne-
established needs to be fine-tuned gotiate a price between all the prices
in order to avoid opportunistic beha- and develop a clear pricing strategy
viours and to protect users. over the years according to the evolu-
tion of the market.
3.1 Higher threshold for proofs
concerning medical benefit 3.3 Specialized team for the crea-
tion of a seamless digital expe-
As of January 2021, access to the DiGA rience
directory is allowed for companies that
deliver studies proving positive me- DiGA applicants are required to provide
dical benefits for the final user of the a service to the end-user which delivers
product. The positive medical bene- a positive healthcare effect. However,
fits are not clearly defined and they not enough emphasis is conveyed to
are compared to a non-use scenario. the creation process of the application
Medical benefits would need to be as- itself. An application that is not custo-
sessed taking into consideration the mer-friendly would suffer from pheno-
services provided nowadays by the go- mena of incorrect usage and also pro-
vernment to understand how the re- vide a low retention rate and therefore
sults of the applicant pair up with exis- would impact in a limited way on the
ting services. Allowing companies to country‘s healthcare system.
be lifted into the directory, regardless
of the quality of the medical benefit, 3.4 Respect of GDPR and other
might create the multiplication of the data protection regulations
same type of service without bringing
any value to the end-user. The program shall provide users full
protection against data loss and full
3.2 Price regulation concerning privacy according to the latest GDPR
products or services of DiGA ap- regulation. Data protection should be
plicants guaranteed from the manufacturer to
the user of the application. Data pro-
DiGA admitted companies have the tection evidence should be deemed
possibility to set prices over the first mandatory since self-declaration is
years since their inclusion into the di- not enough.
rectory. This possibility has led to ex-
cessive pricing with companies over- 3.5 Proven quality and uniformity
charging 400% to 500% more than in of software and hardware
the self-payer market, compromising
the principle of economic efficiency Besides data protection, the manufac-
Copyright © via GründerAtelier GmbH; Cherry Ventures Management GmbH | All rights reserved. 14DiGA Report 2021 turer should also provide proof of the ther with a common interface for EPR. quality of the hardware and software A simple and common interface shall of the product. Moreover, interopera- be used in order to simplify data col- bility would need to be provided toge- lection to improve the system. Copyright © via GründerAtelier GmbH; Cherry Ventures Management GmbH | All rights reserved. 15
DiGA Report 2021
4 . COMPANIES WIT H DI GA cialist). elevida is based on establis-
L IST ING 1 0 (AS OF 16.04.2021) hed psychotherapeutic approaches
and procedures, especially cognitive
The following companies are divided behavioural therapy (CBT).
into companies that already obtai-
ned the approval and those that are ʅ Target patients: Between 18 and 65
temporarily added to the directory. years old and above 65 years old
ʅ Disease/Condition: Multiple sclero-
4.1 Permanently Approved sis (Encephalomyelitis disseminata)
4.1.1 deprexis 4.1.3 somnio
deprexis is an interactive online self- somnio is a digital application for the
help programme to support the the- treatment of sleep onset and sleep
rapy of patients with depression and maintenance disorders (insomnia).
depressive moods who are at least 18 The application teaches evidence-ba-
years old. The programme is intended sed and guideline-compliant content
to be used in addition to an otherwise from the field of cognitive behavioural
usual treatment (for example with a therapy for insomnia (CBT-I). Users
general practitioner, specialist or psy- learn, for example, to optimise their
chotherapist). sleep times, to follow an individually
coordinated sleep-wake rhythm, to
ʅ Target Patients: Between 18 and 65 deal with thoughts that prevent sleep
years old and above 65 years old or to bring themselves into a sleep-
ʅ Disease/Condition: Mild depressive promoting state by means of relaxa-
episode, moderate depressive epi- tion techniques.
sode, severe depressive episode
without psychotic symptoms, re- ʅ Target Patients: Between 18 and 65
current depressive disorder, present years old
mild episode, recurrent depressive ʅ Disease/Condition: Non-organic in-
disorder, current moderate episode, somnia
recurrent depressive disorder, cur-
rent major episode without psycho- 4.1.4 velibra
tic symptoms velibra is a web-based program for
patients with generalized anxiety di-
4.1.2 elevida sorder, panic disorder with or without
elevida is a digital health app for peo- agoraphobia or social anxiety disorder.
ple with multiple sclerosis who also velibra teaches established methods
have fatigue and are at least 18 years and exercises of Cognitive Behavio-
old. Fatigue is when there is persistent ral Therapy - a very well scientifically
tiredness or exhaustion. elevida aims studied form of psychotherapy. The
to reduce fatigue and its programme is program is intended as a supplement
supposed to be used in addition to an to an otherwise usual treatment (for
otherwise usual treatment (for exam- example by the family doctor) for pa-
ple by a general practitioner or spe- tients who are at least 18 years old.
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ʅ Target patients: Between 18 and 65 ʅ Target patients: Between 18 and 65
years old years old and above 65 years old
ʅ Disease/Condition: Agoraphobia, ʅ Disease/Condition: Tinnitus aurium
Panic disorder, social phobias, panic
disorder (episodic paroxysmal an- 4.2.3 Mika
xiety), generalised anxiety disorder The Mika App is a digital health ap-
plication to support the alleviation
4.2 Temporarily Admitted of psychological and psychosomatic
consequences of diagnoses and the-
4.2.1 Invirto rapies of malignancies. The application
Invirto enables people with agorapho- achieves relief through documentation
bia, panic disorder or social phobia to of distress, symptoms and side effects
treat their anxiety disorder from home. in the course as well as resource-ac-
Patients learn from therapists or doc- tivating patient education in the areas
tors accompanied by an app and vir- of health literacy, stress management,
tual reality glasses in order to better exercise and nutrition.
understand their anxiety, to cope with
high levels of tension, manage anxious ʅ Target patients: Between 18 and 65
thoughts and to revisit anxious situa- years old and above 65 years old
tions. ʅ Disease/Condition: Malignant neo-
plasm of the cervix uteri, Malignant
ʅ Target patients: Between 18 and 65 neoplasm of the uterus, part unspe-
years old and above 65 years old cified, Malignant neoplasm of the
ʅ Disease/Condition: Agoraphobia: ovary
without indication of panic disorder,
agoraphobia: With panic disorder, 4.2.4 Vivira
Social phobias, Panic disorder (epi- Vivira is a digital health application for
sodic paroxysmal anxiety) treating back, knee and hip pain in non-
specific low back pain, osteoarthritis of
4.2.2 Kalmeda the spine (osteochondrosis), osteo-
Kalmeda offers patients (who have arthritis of the knees (gonarthrosis),
reached the age of 18) with chronic tin- non-specific knee pain, osteoarthritis
nitus a guideline-based, behavioural of the hip (coxarthrosis) and non-spe-
therapy. The structured programme is cific hip pain.
supplemented by relaxation instructi- The Vivira App for movement thera-
ons, soothing nature and background py offers 4 exercises daily, which are
sounds as well as a knowledge sec- continuously adjusted in intensity
tion. The behavioural therapy pro- and complexity based on the patient‘s
gramme, which lasts several months, feedback. The daily exercises are sup-
consists of 5 levels with 9 stages each plemented by weekly health queries,
and shows patients step by step the visualization of progress, monthly
way to a self-determined handling of movement tests and educational con-
the tinnitus and to a reduction of the tent. Vivira supports the implementa-
tinnitus burden. tion of the training elements provided
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for in guidelines for non-specific low and somatic dysfunction: thoracic
back pain, knee arthrosis and hip arth- (thoracolumbar) region, segmental
rosis, as well as the implementation of and somatic dysfunction: lumbar re-
the Remedies Directive. gion (lumbosacral), segmental and
somatic dysfunction: sacral region
ʅ Target patients: Between 18 and 65 (sacrococcygeal, sacroiliac), other
years old and over 65 years old biomechanical dysfunctions: tho-
ʅ Disease/Condition: Primary coxar- racic region (thoracolumbar), other
throsis bilateral, other primary co- biomechanical dysfunctions: lumbar
xarthrosis, coxarthrosis as a result of region [lumbosacral], other biome-
dysplasia bilateral, other dysplastic chanical dysfunctions: Sacral region
coxarthrosis, post-traumatic coxar- (sacrococcygeal, sacroiliac), other
throsis, bilateral, other post-trauma- biomechanical dysfunctions: Pelvic
tic coxarthrosis, other secondary co- region (hip or pubic region), other
xarthrosis bilateral, other secondary biomechanical dysfunctions: lower
coxarthrosis, unidentified coxarthro- extremity, biomechanical dysfunc-
sis, Primary gonarthrosis bilateral, ot- tion, unspecified: thoracic region
her primary gonarthrosis, post-trau- (thoracolumbar), biomechanical dys-
matic gonarthrosis bilateral, other function, unspecified: lumbar region
post-traumatic gonarthrosis, other (lumbosacral), biomechanical dys-
secondary gonarthrosis bilateral, ot- function, unspecified: sacral region
her secondary gonarthrosis, gonar- (sacrococcygeal, sacroiliac), biome-
throsis unspecified, joint pain: pelvic chanical dysfunction, unspecified:
region and thigh (pelvis, femur, but- pelvic region (hip or pubic region),
tocks, hip, hip joint, sacroiliac joint), biomechanical dysfunction, unspe-
joint pain: lower leg (fibula, tibia, knee), cified: lower limb.
other specified joint diseases: pelvic
region and thigh (pelvis, femur, but- 4.2.5 zanadio
tocks, hip, hip joint, sacroiliac joint), zanadio is an application that helps
other specified joint diseases: lower users to reduce their weight in the
leg (fibula, tibia, knee joint), joint di- long term by changing their habits in
sease, unspecified: pelvic region and the areas of exercise, nutrition and
thigh (pelvis, femur, buttocks, hip, hip other behaviour. The DiGA is based on
joint, sacroiliac joint), joint disease, the scientific concept of multimodal,
unspecified: lower leg (fibula, tibia, conservative obesity therapy, which
knee joint), juvenile osteochondro- addresses the various relevant areas
sis of the spine, osteochondrosis of and thereby brings about long-term,
the spine in adults, osteochondrosis permanent weight reduction. The
of the spine, unspecified, Instability program implements this established
of spine, other specified diseases of treatment approach digitally.
the spine and back, disease of spine
and back, unspecified, low back pain, ʅ Target patients: Between 18 and 65
thoracic spine pain, other back pain, years old
back pain, unspecified, segmental ʅ Disease/Condition: Obesity
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4.2.6 M-sense Migräne Intracerebral haemorrhage, other
M-sense Migräne offers a compre- non-traumatic intracranial haemorr-
hensive digital treatment programme hages, cerebral infarction, stroke
for migraine patients. The application not classified as haemorrhage or
includes a digital headache diary and infarction, other cerebrovascular di-
guideline-compliant procedures for sease, consequences of cerebrova-
migraine prophylaxis and acute treat- scular disease
ment of attacks. Migraine patients
can access customised knowledge 4.2.8 Selfapy
transfer, animated physiotherapeutic Selfapy offers sufferers of depression
exercises, instructions for endurance an individual online course based on
sports as well as audio files for relaxa- evidence-based theories and tech-
tion and imagination exercises. niques of Cognitive Behavioural The-
rapy. The therapeutic content can be
ʅ Target patients: Between 18 and 65 worked on independently by the per-
years old and above 65 years old son affected via the internet-based
ʅ Disease/Condition: Migraine course. The course is divided into in-
dividual lessons, each of which deals
4.2.7 Rehappy with one topic, such as dealing with
Rehappy supports the aftercare of negative thoughts, creating a posi-
stroke patients. The support takes tive daily structure, relaxation tech-
the form of an individually compiled niques, sleep problems, and relapse
supply of motivation and knowledge prevention strategies. The contents
with a mobile app, an activity tracker are taught with the help of audio and
and a web portal. The patients are ac- video clips, texts and exercises. The
tivated, informed and accompanied in contents are individually adapted to
order to be able to tackle their path the personal situation of the person
to recovery in a sustained, self-de- concerned.
termined, competent and confident
manner. The support is based on edu- ʅ Target patients: Between 18 and 65
cational information and positive rein- years old
forcement for the perception of per- ʅ Disease/Condition: Mild depressive
sonal responsibility and an increase in episode, moderate depressive epi-
therapy adherence as well as intrinsic sode, other depressive episodes,
motivation. depressive episode, unspecified, re-
current depressive disorder, current
ʅ Target patients: Between 12 and 17 mild episode, recurrent depressive
years old, 18 and 65 years old and disorder, current moderate episode,
above 65 years old recurrent depressive disorder, cur-
ʅ Disease/Condition: Cerebral tran- rently remitted, other recurrent de-
sient ischaemia and related syndro- pressive disorder, recurrent depres-
mes, subarachnoid haemorrhage, sive disorder
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R E F E RENC ES ( A PA )
1. Statistica, eHealth Outlook 2020, November 2020.
2. Statista, Survey Digital Health 2017, November 2020.
3. Statista, Survey Digital Health 2017, November 2020.
4. Statista, Global Consumer Survey 2020, November 2020.
5. Statista, Survey Digital Health 2017, November 2020.
6. BfArM, Digital Health Applications (DiGA), December 2020.
Retrieved from:
www.bfarm.de/EN/MedicalDevices/DiGA/_node.html [26.04.2021]
7. BfArM, Guidance on “Medical Apps”, December 2020.
Retrieved from:
www.bfarm.de/EN/MedicalDevices/Differentiation/MedicalApps/_node.
html;jsessionid=6DE15EFB5D3F64AA02BF575FF3BE60D5.1_cid354.
[26.04.2021]
8. Official Journal of the European Communities, COUNCIL DIRECTIVE 93/42/
EEC of 14 June 1993 concerning medical devices, December 2020.
Retrieved from:
eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042
[26.04.2021]
9. BfArM, The Fast-Track Process for Digital Health Applications (DiGA) accor-
ding to Section 139e SGB V, December 2020.
Retrieved from:
www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.
pdf;jsessionid=6DE15EFB5D3F64AA02BF575FF3BE60D5.1_cid354?__
blob=publicationFile&v=2 [26.04.2021]
10. BfArM, DiGA-Verzeichnis, April 2021.
Retrieved from:
diga.bfarm.de/de/verzeichnis [26.04.2021]
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