BSI-DSZ-CC-0596-V3-2023
for
Mobiles eHealth Kartenterminal ORGA 930 M
online 4.9.0: 1.0.0
from
Worldline Healthcare GmbH
BSI - Bundesamt für Sicherheit in der Informationstechnik, Postfach 20 03 63, D-53133 Bonn
Phone +49 (0)228 99 9582-0, Fax +49 (0)228 9582-5477, Infoline +49 (0)228 99 9582-111
Certification Report V1.0 CC-Zert-327 V5.45
BSI-DSZ-CC-0596-V3-2023 (*)
eHealth: Smart Card Readers
Mobiles eHealth Kartenterminal ORGA 930 M online
4.9.0: 1.0.0
from Worldline Healthcare GmbH
PP Conformance: Common Criteria Protection Profile Mobile Card
Terminal for the German Healthcare System
(MobCT), Version 1.4, BSI-CC-PP-0052-2015, 24
September 2014
Functionality: PP conformant
Common Criteria Part 2 extended
Assurance: Common Criteria Part 3 conformant
EAL 3 augmented by AVA_VAN.5, ALC_TAT.1,
ADV_TDS.3, ADV_IMP.1, ADV_FSP.4
The IT Product identified in this certificate has been evaluated at an approved evaluation
facility using the Common Methodology for IT Security Evaluation (CEM), Version 3.1
extended by Scheme Interpretations for conformance to the Common Criteria for IT
Security Evaluation (CC), Version 3.1. CC and CEM are also published as ISO/IEC 15408
and ISO/IEC 18045.
(*) This certificate applies only to the specific version and release of the product in its
evaluated configuration and in conjunction with the complete Certification Report and
Notification. For details on the validity see Certification Report part A chapter 5.
The evaluation has been conducted in accordance with the provisions of the certification
scheme of the German Federal Office for Information Security (BSI) and the conclusions
of the evaluation facility in the evaluation technical report are consistent with the
evidence adduced.
This certificate is not an endorsement of the IT Product by the Federal Office for
Information Security or any other organisation that recognises or gives effect to this
certificate, and no warranty of the IT Product by the Federal Office for Information
Security or any other organisation that recognises or gives effect to this certificate, is
either expressed or implied.
Bonn, 18 January 2023
For the Federal Office for Information Security
Sandro Amendola L.S.
Head of Division
Bundesamt für Sicherheit in der Informationstechnik
Godesberger Allee 185-189 - D-53175 Bonn - Postfach 20 03 63 - D-53133 Bonn
Phone +49 (0)228 99 9582-0 - Fax +49 (0)228 9582-5477 - Infoline +49 (0)228 99 9582-111
SOGIS
Recognition Agreement
for components up to
EAL 4
Common Criteria
Recognition Arrangement
recognition for components
up to EAL 2 and ALC_FLR
only
Certification Report BSI-DSZ-CC-0596-V3-2023
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BSI-DSZ-CC-0596-V3-2023 Certification Report
Contents
A. Certification......................................................................................................................6
1. Preliminary Remarks....................................................................................................6
2. Specifications of the Certification Procedure...............................................................6
3. Recognition Agreements..............................................................................................7
4. Performance of Evaluation and Certification................................................................8
5. Validity of the Certification Result.................................................................................8
6. Publication....................................................................................................................9
B. Certification Results.......................................................................................................10
1. Executive Summary....................................................................................................11
2. Identification of the TOE.............................................................................................12
3. Security Policy............................................................................................................14
4. Assumptions and Clarification of Scope.....................................................................14
5. Architectural Information.............................................................................................15
6. Documentation...........................................................................................................15
7. IT Product Testing.......................................................................................................16
8. Evaluated Configuration.............................................................................................17
9. Results of the Evaluation............................................................................................18
10. Obligations and Notes for the Usage of the TOE.....................................................19
11. Security Target..........................................................................................................20
12. Definitions.................................................................................................................20
13. Bibliography..............................................................................................................21
C. Excerpts from the Criteria..............................................................................................24
D. Annexes.........................................................................................................................25
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Certification Report BSI-DSZ-CC-0596-V3-2023
A. Certification
1. Preliminary Remarks
Under the BSIG1
Act, the Federal Office for Information Security (BSI) has the task of
issuing certificates for information technology products.
Certification of a product is carried out on the instigation of the vendor or a distributor,
hereinafter called the sponsor.
A part of the procedure is the technical examination (evaluation) of the product according
to the security criteria published by the BSI or generally recognised security criteria.
The evaluation is normally carried out by an evaluation facility recognised by the BSI or by
BSI itself.
The result of the certification procedure is the present Certification Report. This report
contains among others the certificate (summarised assessment) and the detailed
Certification Results.
The Certification Results contain the technical description of the security functionality of
the certified product, the details of the evaluation (strength and weaknesses) and
instructions for the user.
2. Specifications of the Certification Procedure
The certification body conducts the procedure according to the criteria laid down in the
following:
● Act on the Federal Office for Information Security1
● BSI Certification and Approval Ordinance2
● BMI Regulations on Ex-parte Costs 3
● Special decrees issued by the Bundesministerium des Innern und für Heimat (Federal
Ministry of the Interior and Community)
● DIN EN ISO/IEC 17065 standard
● BSI certification: Scheme documentation describing the certification process (CC-
Produkte) [3]
● BSI certification: Scheme documentation on requirements for the Evaluation Facility, its
approval and licencing process (CC-Stellen) [3]
● Common Criteria for IT Security Evaluation (CC), Version 3.14
[1] also published as
ISO/IEC 15408
1
Act on the Federal Office for Information Security (BSI-Gesetz - BSIG) of 14 August 2009,
Bundesgesetzblatt I p. 2821
2
Ordinance on the Procedure for Issuance of Security Certificates and approval by the Federal Office for
Information Security (BSI-Zertifizierungs- und -Anerkennungsverordnung - BSIZertV) of 17 December
2014, Bundesgesetzblatt 2014, part I, no. 61, p. 2231
3
BMI Regulations on Ex-parte Costs - Besondere Gebührenverordnung des BMI für individuell
zurechenbare öffentliche Leistungen in dessen Zuständigkeitsbereich (BMIBGebV), Abschnitt 7 (BSI-
Gesetz) - dated 2 September 2019, Bundesgesetzblatt I p. 1365
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BSI-DSZ-CC-0596-V3-2023 Certification Report
● Common Methodology for IT Security Evaluation (CEM), Version 3.1 [2] also published
as ISO/IEC 18045
● BSI certification: Application Notes and Interpretation of the Scheme (AIS) [4]
3. Recognition Agreements
In order to avoid multiple certification of the same product in different countries a mutual
recognition of IT security certificates - as far as such certificates are based on ITSEC or
CC - under certain conditions was agreed.
3.1. European Recognition of CC – Certificates (SOGIS-MRA)
The SOGIS-Mutual Recognition Agreement (SOGIS-MRA) Version 3 became effective in
April 2010. It defines the recognition of certificates for IT-Products at a basic recognition
level and, in addition, at higher recognition levels for IT-Products related to certain SOGIS
Technical Domains only.
The basic recognition level includes Common Criteria (CC) Evaluation Assurance Levels
EAL 1 to EAL 4. For "Smartcards and similar devices" a SOGIS Technical Domain is in
place. For "HW Devices with Security Boxes" a SOGIS Technical Domains is in place, too.
In addition, certificates issued for Protection Profiles based on Common Criteria are part of
the recognition agreement.
The current list of signatory nations and approved certification schemes, details on
recognition, and the history of the agreement can be seen on the website at
https://www.sogis.eu.
The SOGIS-MRA logo printed on the certificate indicates that it is recognised under the
terms of this agreement by the related bodies of the signatory nations. A disclaimer
beneath the logo indicates the specific scope of recognition.
This certificate is recognized according to the rules of SOGIS-MRA, i.e. up to and including
CC part 3 EAL 4 components. The evaluation contained the component AVA_VAN.5 that is
not mutually recognised in accordance with the provisions of the SOGIS MRA. For mutual
recognition the EAL 4 components of these assurance families are relevant.
3.2. International Recognition of CC – Certificates (CCRA)
The international arrangement on the mutual recognition of certificates based on the CC
(Common Criteria Recognition Arrangement, CCRA-2014) has been ratified on 08
September 2014. It covers CC certificates based on collaborative Protection Profiles (cPP)
(exact use), CC certificates based on assurance components up to and including EAL 2 or
the assurance family Flaw Remediation (ALC_FLR) and CC certificates for Protection
Profiles and for collaborative Protection Profiles (cPP).
The current list of signatory nations and approved certification schemes can be seen on
the website: https://www.commoncriteriaportal.org.
The Common Criteria Recognition Arrangement logo printed on the certificate indicates
that this certification is recognised under the terms of this agreement by the related bodies
of the signatory nations. A disclaimer beneath the logo indicates the specific scope of
recognition.
4
Proclamation of the Bundesministerium des Innern und für Heimat of 12 February 2007 in the
Bundesanzeiger dated 23 February 2007, p. 3730
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Certification Report BSI-DSZ-CC-0596-V3-2023
This certificate is recognized according to the rules of CCRA-2014, i. e. up to and including
CC part 3 EAL 2 and ALC_FLR components.
4. Performance of Evaluation and Certification
The certification body monitors each individual evaluation to ensure a uniform procedure, a
uniform interpretation of the criteria and uniform ratings.
The product Mobiles eHealth Kartenterminal ORGA 930 M online, 4.9.0: 1.0.0 has
undergone the certification procedure at BSI. This is a re-certification based on BSI-DSZ-
CC-0596-V2-2018. Specific results from the evaluation process BSI-DSZ-CC-0596-V2-
2018 were re-used.
The evaluation of the product Mobiles eHealth Kartenterminal ORGA 930 M online, 4.9.0:
1.0.0 was conducted by TÜV Informationstechnik GmbH. The evaluation was completed
on 11 January 2023. TÜV Informationstechnik GmbH is an evaluation facility (ITSEF)5
recognised by the certification body of BSI.
For this certification procedure the applicant is: Worldline Healthcare GmbH.
The product was developed by: Worldline Healthcare GmbH.
The certification is concluded with the comparability check and the production of this
Certification Report. This work was completed by the BSI.
5. Validity of the Certification Result
This Certification Report applies only to the version of the product as indicated. The
confirmed assurance package is valid on the condition that
● all stipulations regarding generation, configuration and operation, as given in the
following report, are observed,
● the product is operated in the environment described, as specified in the following report
and in the Security Target.
For the meaning of the assurance components and assurance levels please refer to CC
itself. Detailed references are listed in part C of this report.
The Certificate issued confirms the assurance of the product claimed in the Security Target
at the date of certification. As attack methods evolve over time, the resistance of the
certified version of the product against new attack methods needs to be re-assessed.
Therefore, the sponsor should apply for the certified product being monitored within the
assurance continuity program of the BSI Certification Scheme (e.g. by a re-assessment or
re-certification). Specifically, if results of the certification are used in subsequent evaluation
and certification procedures, in a system integration process or if a user's risk
management needs regularly updated results, it is recommended to perform a re-
assessment on a regular e.g. annual basis.
In order to avoid an indefinite usage of the certificate when evolved attack methods would
require a re-assessment of the products resistance to state of the art attack methods, the
maximum validity of the certificate has been limited. The certificate issued on 18 January
2023 is valid until 17 January 2028. Validity can be re-newed by re-certification.
The owner of the certificate is obliged:
5
Information Technology Security Evaluation Facility
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BSI-DSZ-CC-0596-V3-2023 Certification Report
1. when advertising the certificate or the fact of the product's certification, to refer to
the Certification Report as well as to provide the Certification Report, the Security
Target and user guidance documentation mentioned herein to any customer of the
product for the application and usage of the certified product,
2. to inform the Certification Body at BSI immediately about vulnerabilities of the
product that have been identified by the developer or any third party after issuance
of the certificate,
3. to inform the Certification Body at BSI immediately in the case that security relevant
changes in the evaluated life cycle, e.g. related to development and production sites
or processes, occur, or the confidentiality of documentation and information related
to the Target of Evaluation (TOE) or resulting from the evaluation and certification
procedure where the certification of the product has assumed this confidentiality
being maintained, is not given any longer. In particular, prior to the dissemination of
confidential documentation and information related to the TOE or resulting from the
evaluation and certification procedure that do not belong to the deliverables
according to the Certification Report part B, or for those where no dissemination
rules have been agreed on, to third parties, the Certification Body at BSI has to be
informed.
In case of changes to the certified version of the product, the validity can be extended to
the new versions and releases, provided the sponsor applies for assurance continuity (i.e.
re-certification or maintenance) of the modified product, in accordance with the procedural
requirements, and the evaluation does not reveal any security deficiencies.
6. Publication
The product Mobiles eHealth Kartenterminal ORGA 930 M online, 4.9.0: 1.0.0 has been
included in the BSI list of certified products, which is published regularly (see also Internet:
https://www.bsi.bund.de and [5]). Further information can be obtained from BSI-Infoline
+49 228 9582-111.
Further copies of this Certification Report can be requested from the developer6
of the
product. The Certification Report may also be obtained in electronic form at the internet
address stated above.
6
Worldline Healthcare GmbH
Konrad-Zuse-Ring 1
24220 Flintbek
Deutschland
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Certification Report BSI-DSZ-CC-0596-V3-2023
B. Certification Results
The following results represent a summary of
● the Security Target of the sponsor for the Target of Evaluation,
● the relevant evaluation results from the evaluation facility, and
● complementary notes and stipulations of the certification body.
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BSI-DSZ-CC-0596-V3-2023 Certification Report
1. Executive Summary
The Target of Evaluation (TOE) is the Mobile Card Terminal “ORGA 900” with integrated
smart card readers. The TOE fulfills the requirements to be used with the German
electronic Health Card (eHC) and the German Profession Card (HPC) based on the
regulations of the German healthcare system.
The Security Target [6] is the basis for this certification. It is based on the certified
Protection Profile Common Criteria Protection Profile Mobile Card Terminal for the German
Healthcare System (MobCT), Version 1.4, BSI-CC-PP-0052-2015, 24 September 2014 [8].
The TOE Security Assurance Requirements (SAR) are based entirely on the assurance
components defined in Part 3 of the Common Criteria (see part C or [1], Part 3 for details).
The TOE meets the assurance requirements of the Evaluation Assurance Level EAL 3
augmented by AVA_VAN.5, ALC_TAT.1, ADV_TDS.3, ADV_IMP.1, ADV_FSP.4.
The TOE Security Functional Requirements (SFR) relevant for the TOE are outlined in the
Security Target [6], chapter 6. They are selected from Common Criteria Part 2 and some of
them are newly defined. Thus the TOE is CC Part 2 extended.
The TOE Security Functional Requirements are implemented by the following TOE
Security Functionality:
TOE Security Functionality Addressed issue
SF_1 Secure Identification & Authentication
The TOE provides several authentication mechanisms for the roles
administrator, medical supplier and developer and associates users with
roles. Each user has to be successfully identified and authenticated before
being allowed to perform any TSF-mediated action.
SF_2 Secure Residual
The TOE terminates an authenticated session and thereby delete all
unencrypted sensitive information from the memory: On dropping of the
authenticated state, power loss and deallocation of the resource from
temporary data in the persistent storage of the TOE and in the volatile
memory of the TOE.
SF_3 Secure Self-Tests
The TOE performs self-tests at initial start-up and are able to be started
manually via management. The selftests check the TOE's functionality by
evaluating the integrity of the stored data. This includes the integrity of the
firmware in processor flash (loader and application) and integrity of TSF
SFLASH-Page with configuration data.
SF_4 Secure Data Protection
The TOE encrypts health insurance data stored in the persistent storage of
the TOE with the cryptographic algorithm AES-GCM and cryptographic key
size of 256 bits and with a symmetric cryptographic key. The generation of
the symmetric cryptographic key is initiated and performed by the
authorised card of the user.
SF_5 Secure Management
The TOE grants access to the management functions i.e. installing
firmware, import of cross CVCs, management of time settings, resetting to
factory defaults, management of the administrator login credentials, and
printer control, to the administrator who has to authenticate himself by PIN
entry or for the latter perform a successful Challenge & Response operation
with the TOE.
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Certification Report BSI-DSZ-CC-0596-V3-2023
TOE Security Functionality Addressed issue
SF_6 Secure Card Communication
When an authorised card is put into one of the TOE's slots, the TOE will
read out the card’s X.509 certificate and check: whether the card claims to
be an authorised card, whether the X.509 certificate of this authorised card
is mathematically correct, and whether the current date is given by the TOE
falls within the validity period of the certificate before permitting any other
interaction with a card.
The Card holder PIN entered via the PIN pad is only sent to the card slot
where the authorised card is plugged in. No PIN is sent to the card slot
where the eHC is plugged in.
SF_7 Secure DMS Communication
The TOE enables the medical supplier to transfer data records from the
persistent storage to the DMS only. The transmission takes place via error
detection code (EDC).
After the data record has been transferred to the DMS successfully it is
been deleted from the devices.
SF_8 Secure Firmware-Update
On firmware update the TOE can be securely updated with new firmware.
The secure update guarantees that only authentic firmware electronically
signed by the manufacturer will be accepted by the TOE and installed on
the TOE. For signature verification purposes the TOE firmware contains the
public cryptographic key and the TOE performs a signature verification for
firmware updates with cryptographic algorithms SHA and RSA and
cryptographic key sizes of: SHA-512 and RSA-4096.
Table 1: TOE Security Functionalities
For more details please refer to the Security Target [6], chapter 7.
The assets to be protected by the TOE are defined in the Security Target [6], chapter 1.4.7.
Based on these assets the TOE Security Problem is defined in terms of Assumptions,
Threats and Organisational Security Policies. This is outlined in the Security Target [6],
chapter 3.3.
This certification covers the configurations of the TOE as outlined in chapter 8.
The vulnerability assessment results as stated within this certificate do not include a rating
for those cryptographic algorithms and their implementation suitable for encryption and
decryption (see BSIG Section 9, Para. 4, Clause 2).
The certification results only apply to the version of the product indicated in the certificate
and on the condition that all the stipulations are kept as detailed in this Certification
Report. This certificate is not an endorsement of the IT product by the Federal Office for
Information Security (BSI) or any other organisation that recognises or gives effect to this
certificate, and no warranty of the IT product by BSI or any other organisation that
recognises or gives effect to this certificate, is either expressed or implied.
2. Identification of the TOE
The Target of Evaluation (TOE) is called:
Mobiles eHealth Kartenterminal ORGA 930 M online, 4.9.0: 1.0.0
The following table outlines the TOE deliverables:
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BSI-DSZ-CC-0596-V3-2023 Certification Report
No Type Identifier Release Form of Delivery
1 a) HW+FW ORGA 930 M online
HW and Firmware Image
“orga_930_130_PU_PK_sig.dfu”
(SHA-256:
8d62b2d83c8a16085b1888b6bbbc40270e71107
90c69092618d615fccd24c35f)
4.9.0:1.0.0 TOE delivered by the
Secure delivery chain.
Firmware Image
initially included in the
TOE.
1 b) FW ORGA 930 M
Firmware Image Package
“ORGA_930_M_online_FW_4.9. 0.ppu”
(SHA-256:
25019f3c55bd632bf5b44e8bdd2e83664a4809ae
67745eac6cc62b1f52dc1fe5)
4.9.0:1.0.0 Provided by the
developer on its
homepage.
2 DOC Bedienungsanleitung Mobiles eHealth
Kartenterminal ORGA 930 M online mit
Firmware- Version 4.9.0
(SHA-256:
a5709a5d4f979b88fdb7a84f071147b0919e2d16
8fd3acca599af61fad04c75b)
22.9.1 Provided by the
developer on its
homepage.
3 DOC Kurzanleitung Mobiles eHealth Kartenterminal
ORGA 930 M online mit Firmware-Version 4.9.0
(SHA-256:
1792aae9950454d88630151b297235a7ebf14e8
61f7662c617678422e761a309)
22.9.2 Provided by the
developer on its
homepage.
4 DOC Endnutzer-Ckeckliste „Sichere Lieferkette“
(SHA-256:
65ffff99a99b641502d859fc4ea980aa1158250ea
08ff1020fd655abffbecf53)
22.9.1 Provided by the
developer on
itshomepage.
5 DOC Prüfung der Versandverpackung durch den
Empfänger
(SHA-256:
a41f6c4aed6468cc6f246ae9a96ae85103262f86
4e72289a5cc76706d2c6bc8e)
22.10.3 Provided by the
developer on its
homepage.
Table 2: Deliverables of the TOE
The TOE is delivered to the end user in such a way as defined by the secure delivery
chain.
The first option is, to do a secure delivery of the TOE from the developer Worldline to the
company CGM (CompuGroup Medical Deutschland AG), T-Systems or a participant of the
Konnektor delivery chain. From this point, the secure delivery chain is identical to the
certified secure delivery chain with the Cert.-ID.: BSI-DSZ-CC-0950-V2-2018 (CGM) or
BSI-DSZ-CC-0928 (T-Systems).
The direct transport to the end user is the second allowed transport of the secure delivery
chain. The service technician or the end user installs the product Mobile Card Terminal
ORGA 900 within the premises of the end user. The guidance defines all steps the end
user has to perform to check, if the secure delivery chain was correctly used and to check
that the TOE is not manipulated or replaced and therefore the integrity and authenticity of
the TOE is guaranteed.
The TOE can be identified within the management menu \Service\Status\. There, the
product version 4.9.0:1.0.0 is displayed.
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Certification Report BSI-DSZ-CC-0596-V3-2023
3. Security Policy
The Security Policy is expressed by the set of Security Functional Requirements and
implemented by the TOE. It covers the following issues:
• Cryptographic Support
• User Data Protection
• Identification and Authentication
• Security Management
• TOE Access
• Protection of the TSF
4. Assumptions and Clarification of Scope
The Assumptions defined in the Security Target and some aspects of Threats and
Organisational Security Policies are not covered by the TOE itself. These aspects lead to
specific security objectives to be fulfilled by the TOE-Environment. The following topics are
of relevance:
• OE.MEDIC: The medical supplier shall be non hostile, always act with care, and
read the existing guidance documentation of the TOE.
• OE.ADMIN: The administrator shall be non hostile, always act with care, knows the
existing guidance documentation of the TOE and adhere to the rules of the TOEs
environment.
• OE.Developer: The developer is assumed to be non hostile, always act with care
and knows the existing guidance documentation of the TOE.
• OE.CARDS: The authorised cards and the eHC are smart cards that comply with
the specification of the gematik.
• OE.DMS: The TOE shall only be connected to a Data Management System for a
practice or hospital that is trusted by the medical supplier.
• OE.PHYSICAL: The secure TOE environment shall protect the TOE against
physical manipulation.
• OE.ENVIRONMENT: While the TOE is in use by either the medical supplier or the
administrator, they shall always keep the TOE under their control. This applies to its
authenticated as well as its unauthenticated state.
Details can be found in the Security Target [6], chapter 4.2.
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BSI-DSZ-CC-0596-V3-2023 Certification Report
5. Architectural Information
The figure presents the main building blocks of the TOE and their relation to the
environment.
The TSF is broken down into the following 5 subsystems:
• Loader: This subsystem contains the bootloader of the TOE, which executes the
start-up process.
• Application: This subsystem involves the applications of the device.
• Loader Driver: This subsystem includes the drivers of the hardware from the TOE
for the interaction with subsystem “Loader”.
• Application Driver: This subsystem includes the drivers of the hardware from the
TOE for the interaction with subsystem “Application”.
• Hardware: The hardware contains all electronic and mechanical components of the
main processor and the connected peripherals.
6. Documentation
The evaluated documentation as outlined in table 2 is being provided with the product to
the customer. This documentation contains the required information for secure usage of
the TOE in accordance with the Security Target.
Additional obligations and notes for secure usage of the TOE as outlined in chapter 10 of
this report have to be followed.
15 / 26
Figure 1: TOE Architecture
Certification Report BSI-DSZ-CC-0596-V3-2023
7. IT Product Testing
There is only one evaluated configuration (with 2 variants) of the TOE.
7.1. Developer’s Testing
TOE test configurations
The Security Target [6] has identified two configurations of the TOE, which are identical
except their configuration ID. Therefore, only one configuration need to be tested.
The test setup comprises a laptop with the test suite Qumate, a TOE and two virtual.card
kits and real smart cards (eGK, HBA, SMC-B). The virtal.card kits are used to simulate
special situation, for example, a smart card with wrong/invalid certificate.
Testing approach
• Coverage and depth tests are done together.
• Tests considering the different roles that can access the TOE.
• Tests covering all TSF subsystems in the TOE design.
• Developer provides mappings to the tested TSFI(s), SFR(s), subsystem(s), SFR-
enforcing modules and use cases.
• Different testing approaches are used:
◦ Code analysis,
◦ Test suite (automatic and manual test).
• The test descriptions comprise (inter alia):
◦ Pre conditions: Preparative steps,
◦ Test steps: Core test steps,
◦ Post conditions: Clearance steps to tidy up before the next test.
Verdict for the activity
The developer’s testing efforts have been proven sufficient to demonstrate that the TSFIs
and subsystems perform as expected.
7.2. Independent Testing
TOE test configurations
The evaluation body used the same test configurations and test environment as the
developer during functional testing.
Testing approach
The evaluation body chose to cover the existing interfaces broadly without specific
restrictions. All interfaces were considered during testing.
The evaluation body chose to inspect all developer tests. They also chose to repeat all
tests, except for nine tests that were not repeated due to their duration and additional
hardware requirements.
The evaluator conducted independent testing covering the stationary mode and guidance
testing.
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BSI-DSZ-CC-0596-V3-2023 Certification Report
Verdict for the sub-activity
No deviations were found between the expected and the actual test results.
7.3. Penetration Testing
Test Configurations
The configuration defined in the ST was tested. Furthermore, different TOE variants were
used during penetration testing to verify different mechanisms.
The overall test result is that no deviations were found between the expected and the
actual test results; moreover, no attack scenario with the attack potential High was actually
successful.
The TOE was delivered by the developer in different configurations: This includes a final
operational and a special AVA variant. The AVA configuration provides debugging outputs,
which allow the evaluator to have a look at the running system.
Testing approach
The evaluation body conducted penetration testing based on Functional Areas of Concern
derived from SFRs and architectural mechanisms. The areas were prioritized with regards
to various factors, e.g. attack surface, estimated flaw likelihood, developer testing
coverage, detectability of flaws during developer testing.
The penetration testing activities were performed as tests and as analytical tasks.
Whenever an analysis was estimated to yield better results, the evaluator chose the
analytical approach.
Attack scenarios
The evaluation body considered security analysis and penetration testing in the following
areas:
o Handling of HPC / eHC / KVK smart cards,
o Update,
o Authentication,
o Secure encryption / decryption,
o Leakage.
The evaluator ensured that all areas listed above are tested. The penetration testing was
then conducted based on priorities as described above. Therefore, a complete coverage of
security functional testing based on Functional Areas of Concern is performed.
Verdict for the sub-activity
The overall test result is that no deviations were found between the expected and the
actual test results. No attack scenario with the attack potential High was actually
successful in the TOE’s operational environment provided that all measures required by
the developer are applied.
8. Evaluated Configuration
This certification covers the following configurations of the TOE: There is only one
evaluated configuration (with 2 variants) of the TOE.
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ORGA 930 M online, mobile card terminal, graphical display, 2 full size slots (eHC / KVK
and HPC / SMC-B). This involves the delivery of new ORGA 930 M online devices.
• TOE Version: 4.9.0:1.0.0
The TOE version includes the following versions:
• Version Hardware: 1.0.0
• Manufacturing code: HC 00 04 00 00
• Version Loader: 7.5.1
• Version Application: 4.9.0
• Version Configuration: 1.0.0/930MONLINE
ORGA 930 M: This product is identical to ORGA 930 M online except for ALC_DEL and the
configurations after updating the application and the loader to the same version of ORGA
930 M online.This is just the delivery of updates to existing ORGA 930 M eGK devices.
• TOE Version: 4.9.0:1.0.0
• Version Configuration: 1.0.0/930M
9. Results of the Evaluation
9.1. CC specific results
The Evaluation Technical Report (ETR) [7] was provided by the ITSEF according to the
Common Criteria [1], the Methodology [2], the requirements of the Scheme [3] and all
interpretations and guidelines of the Scheme (AIS) [4] as relevant for the TOE.
The Evaluation Methodology CEM [2] was used.
As a result of the evaluation the verdict PASS is confirmed for the following assurance
components:
● All components of the EAL 3 package including the class ASE as defined in the CC (see
also part C of this report)
● The components AVA_VAN.5, ALC_TAT.1, ADV_TDS.3, ADV_IMP.1, ADV_FSP.4
augmented for this TOE evaluation.
As the evaluation work performed for this certification procedure was carried out as a re-
evaluation based on the certificate BSI-DSZ-CC-0596-V2-2018, re-use of specific
evaluation tasks was possible. The focus of this re-evaluation was on minor changes of
the TOE as product optimizing and Updates of the Open Source components. The Secure
Delivery Chain was improved, as it is now independent from the forwarder with new
security measures.
The evaluation has confirmed:
● PP Conformance: Common Criteria Protection Profile Mobile Card Terminal for the
German Healthcare System (MobCT), Version 1.4, BSI-CC-PP-
0052-2015, 24 September 2014 [8]
● for the Functionality: PP conformant
Common Criteria Part 2 extended
● for the Assurance: Common Criteria Part 3 conformant
EAL 3 augmented by AVA_VAN.5, ALC_TAT.1, ADV_TDS.3,
ADV_IMP.1, ADV_FSP.4
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The results of the evaluation are only applicable to the TOE as defined in chapter 2 and
the configuration as outlined in chapter 8 above.
9.2. Results of cryptographic assessment
The strength of the cryptographic algorithms was not rated in the course of this certification
procedure (see BSIG Section 9, Para. 4, Clause 2). But cryptographic functionalities with a
security level of lower than 100 bits can no longer be regarded as secure without
considering the application context. Therefore, for these functionalities it shall be checked
whether the related crypto operations are appropriate for the intended system. Some
further hints and guidelines can be derived from the 'Technische Richtlinie BSI TR-02102'
(https://www.bsi.bund.de).
The following table gives an overview of the cryptographic functionalities inside the TOE to
enforce the security policy and outlines its rating from cryptographic point of view. Any
Cryptographic Functionality that is marked in column 'Security Level above 100 Bits' of the
following table with 'no' achieves a security level of lower than 100 Bits (in general context)
only.
Purpose Cryptographic
Mechanism
Standard of
Implementation
Key Size
in Bits
Security Level
above 100 Bits
Cryptographic operation for
signature verification of
firmware updates
RSASSA-PKCS1-
v1_5 with RSA-4096
and SHA-512
[PKCS#1]
[RFC6234]
4096 Yes
Challenge & Response
mechanism
SHA-1 [RFC3174] 160 No
Integrity of the TSF SHA-512 [RFC6234] 512 Yes
The following table gives an overview of the cryptographic functionalities inside the TOE to
enforce the security policy and outlines the standard of application where its specific
appropriateness is stated.
Purpose Cryptographic
Mechanism
Standard of
Implementation
Key Size in Bits Standard of
Application
Encryption / decryption
of health insurance data
AES-256 in GCM
mode
[18] 256 with a tag-
length of 256
[FIPS197]
[NIST800- 38D]
Table 3: TOE cryptographic functionality
The strength of the these cryptographic algorithms was not rated in the course of this
certification procedure (see BSIG Section 9, Para. 4, Clause 2).
According to the application standards in the table above, especially the standards issued
by gematik, the algorithms are suitable for the intended purposes listed above. An explicit
validity period is not given.
10. Obligations and Notes for the Usage of the TOE
The documents as outlined in table 2 contain necessary information about the usage of the
TOE and all security hints therein have to be considered. In addition all aspects of
Assumptions, Threats and OSPs as outlined in the Security Target not covered by the TOE
itself need to be fulfilled by the operational environment of the TOE.
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The customer or user of the product shall consider the results of the certification within his
system risk management process. In order for the evolution of attack methods and
techniques to be covered, he should define the period of time until a re-assessment of the
TOE is required and thus requested from the sponsor of the certificate.
The limited validity for the usage of cryptographic algorithms as outlined in chapter 9 has
to be considered by the user and his system risk management process, too.
If available, certified updates of the TOE should be used. If non-certified updates or
patches are available the user of the TOE should request the sponsor to provide a re-
certification. In the meantime a risk management process of the system using the TOE
should investigate and decide on the usage of not yet certified updates and patches or
take additional measures in order to maintain system security.
In addition, the following aspects need to be fulfilled when using the TOE: For the certified
use as a mobile card terminal, the stationary mode “stationäre Betriebsart” is not allowed.
As described in the installation manuals [10] and [11], the administrator is however
required to temporarily change the mode to “stationäre Betriebsart” for the duration of an
update of the TOE to a newer certified version.
11. Security Target
For the purpose of publishing, the Security Target [6] of the Target of Evaluation (TOE) is
provided within a separate document as Annex A of this report.
12. Definitions
12.1. Acronyms
AES Advanced Encryption Standard
AES-GCM AES in Galois Counter Mode (GCM)
AIS Application Notes and Interpretations of the Scheme
BSI Bundesamt für Sicherheit in der Informationstechnik / Federal Office for
Information Security, Bonn, Germany
BSIG BSI-Gesetz / Act on the Federal Office for Information Security
CCRA Common Criteria Recognition Arrangement
CC Common Criteria for IT Security Evaluation
CEM Common Methodology for Information Technology Security Evaluation
cPP Collaborative Protection Profile
EAL Evaluation Assurance Level
eGK elektronische Gesundheitskarte
eHC electronic Health Card
eHCT Electronic Health Card Terminal
ETR Evaluation Technical Report
HPC Health Professional Card
IT Information Technology
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ITSEF Information Technology Security Evaluation Facility
PP Protection Profile
SAR Security Assurance Requirement
SFP Security Function Policy
SFR Security Functional Requirement
SM-KT Sicherheitsmodul Kartenterminal
ST Security Target
TOE Target of Evaluation
TSF TOE Security Functionality
12.2. Glossary
Augmentation - The addition of one or more requirement(s) to a package.
Collaborative Protection Profile - A Protection Profile collaboratively developed by an
International Technical Community endorsed by the Management Committee.
Extension - The addition to an ST or PP of functional requirements not contained in CC
part 2 and/or assurance requirements not contained in CC part 3.
Formal - Expressed in a restricted syntax language with defined semantics based on well-
established mathematical concepts.
Informal - Expressed in natural language.
Object - A passive entity in the TOE, that contains or receives information, and upon which
subjects perform operations.
Package - named set of either security functional or security assurance requirements
Protection Profile - A formal document defined in CC, expressing an implementation
independent set of security requirements for a category of IT Products that meet specific
consumer needs.
Security Target - An implementation-dependent statement of security needs for a specific
identified TOE.
Semiformal - Expressed in a restricted syntax language with defined semantics.
Subject - An active entity in the TOE that performs operations on objects.
Target of Evaluation - An IT Product and its associated administrator and user guidance
documentation that is the subject of an Evaluation.
TOE Security Functionality - Combined functionality of all hardware, software, and
firmware of a TOE that must be relied upon for the correct enforcement of the SFRs.
13. Bibliography
[1] Common Criteria for Information Technology Security Evaluation, Version 3.1,
Part 1: Introduction and general model, Revision 5, April 2017
Part 2: Security functional components, Revision 5, April 2017
Part 3: Security assurance components, Revision 5, April 2017
https://www.commoncriteriaportal.org
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[2] Common Methodology for Information Technology Security Evaluation (CEM),
Evaluation Methodology, Version 3.1, Rev. 5, April 2017,
https://www.commoncriteriaportal.org
[3] BSI certification: Scheme documentation describing the certification process (CC-
Produkte) and Scheme documentation on requirements for the Evaluation Facility,
approval and licencing (CC-Stellen), https://www.bsi.bund.de/zertifizierung
[4] Application Notes and Interpretations of the Scheme (AIS) as relevant for the TOE7
https://www.bsi.bund.de/AIS
[5] German IT Security Certificates (BSI 7148), periodically updated list published also
on the BSI Website, https://www.bsi.bund.de/zertifizierungsreporte
[6] Security Target BSI-DSZ-CC-0596-V3-2023, Version 3.33, 2022-11-02, Common
Criteria Security Target for the Evaluation of the Product ORGA 900, Worldline
Healthcare GmbH
[7] Evaluation Technical Report Summary, Version 2, 2023-01-06, TÜV
Informationstechnik GmbH, (confidential document)
[8] Common Criteria Protection Profile Mobile Card Terminal for the German
Healthcare System (MobCT), Version 1.4, BSI-CC-PP-0052-2015, 24 September
2014
[9] Configuration list for the TOE, Version 1.19.0, 2022-11-11, ConfigList Document
References Listing of CC Documents from Evaluation of the Product ORGA v 6141
online and ORGA 930 online, Worldline Healthcare GmbH (confidential document)
[10] Bedienungsanleitung Mobiles eHealth Kartenterminal ORGA 930 M online mit
Firmware-Version 4.9.0, Version 22.9.1, Worldline Healthcare GmbH
[11] Kurzanleitung Mobiles eHealth Kartenterminal ORGA 930 M online mit Firmware-
Version 4.9.0, Version 22.9.2, Worldline Healthcare GmbH
[12] Endnutzer-Checkliste „Sichere Lieferkette“, Version 22.9.1, Worldline Healthcare
GmbH
[13] Prüfung der Versandverpackung durch den Empfänger, Version 22.10.3, Worldline
Healthcare GmbH
[14] Liste der Lieferketten, Version 0.7, Worldline Healthcare GmbH
7
specifically
• AIS 1, Durchführung der Ortsbesichtigung in der Entwicklungsumgebung des Herstellers
• AIS 14, Anforderungen an Aufbau und Inhalt der ETR-Teile (Evaluation Technical Report) für
Evaluationen nach CC
• AIS 19, Anforderungen an Aufbau und Inhalt der Zusammenfassung des ETR (Evaluation Technical
Report) für Evaluationen nach CC
• AIS 23, Zusammentragen von Nachweisen der Entwickler
• AIS 34, Version 3, Evaluation Methodology for CC Assurance Classes for EAL 5+ (CCv2.3 &
CCv3.1) and EAL 6 (CCv3.1)
• AIS 41, Guidelines for PPs and STs
• AIS 45, Erstellung und Pflege von Meilensteinplänen
• AIS 46, Informationen zur Evaluierung von kryptographischen Algorithmen und ergänzende
Hinweise für die Evaluierung von Zufallszahlengeneratoren
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[15] Produktbeschreibung „Versandverpackungssiegelband“, Version 0.1, Worldline
Healthcare GmbH
[16] Produktbeschreibung „Versandverpackungssiegel“, Version 0.3, Worldline
Healthcare GmbH
[17] Übergreifende Spezifikation Verwendung kryptographischer Algorithmen in der
Telematikinfrastruktur, Version 2.21.0, 2022-01-31, gematik
[18] Spezifikation Mobiles Kartenterminal, Version 2.15.0, 2022-02-24, gematik
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C. Excerpts from the Criteria
For the meaning of the assurance components and levels the following references to the
Common Criteria can be followed:
• On conformance claim definitions and descriptions refer to CC part 1 chapter 10.5
• On the concept of assurance classes, families and components refer to CC Part 3
chapter 7.1
• On the concept and definition of pre-defined assurance packages (EAL) refer to CC
Part 3 chapters 7.2 and 8
• On the assurance class ASE for Security Target evaluation refer to CC Part 3
chapter 12
• On the detailed definitions of the assurance components for the TOE evaluation
refer to CC Part 3 chapters 13 to 17
• The table in CC part 3 , Annex E summarizes the relationship between the
evaluation assurance levels (EAL) and the assurance classes, families and
components.
The CC are published at https://www.commoncriteriaportal.org/cc/
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D. Annexes
List of annexes of this certification report
Annex A: Security Target provided within a separate document.
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Note: End of report
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