Useful Healthcare Glossary

Useful Healthcare Terms easily explained for you

Find easy explanations of some of the most common technical healthcare terms.

Adverse event	:	Any negative or unintended effect of a treatment.
Clinical Research	:	The process of studying and testing new treatments and therapies in human subjects.
Clinical Trial	:	A study in which human subjects are assigned to different interventions, such as new drugs or therapies, in order to evaluate their effects on health outcomes.
Clinical trial protocol	:	A detailed plan that outlines how a clinical trial will be conducted.
Double-blind study	:	A study in which neither the participants nor the researchers know which treatment a participant is receiving.
Healthy Volunteer	:	A person without significant health issues who participates in clinical research as a test subject for new drugs, devices, or interventions.
Inclusion/Exclusion Criteria	:	Factors used to determine eligibility for participation in a clinical trial. Inclusion criteria are the criteria that must be met for a person to be included in the study, while exclusion criteria are criteria that would prevent a person from participating.
Informed consent	:	A process in which a person is provided with information about a clinical trial and then decides whether or not to participate.
Institutional Review Board (IRB)	:	A group of experts that reviews and approves clinical trials to ensure that they are ethical and that the rights of participants are protected.
Patient Volunteer	:	A person who has a known health condition and participates in research in order to improve understanding, diagnosis, treatment, or cure of that disease or condition.
Phases of Clinical Trials	:	Clinical trials are usually regulated in several stages, each with a specific purpose and objective.
1. Phase I trials	:	The first stage of clinical trials, involving a small group of people (20-80), to test the safety and identify any side effects of an experimental drug or treatment.
2. Phase II trials	:	The second stage of clinical trials, involving a larger group of people (100-300), to evaluate the effectiveness and further assess the safety of the experimental drug or treatment.
3. Phase III trials	:	The third stage of clinical trials, involving a large group of people (1,000-3,000), to confirm the effectiveness, monitor side effects, and compare the experimental drug or treatment to standard or equivalent treatments.
4. Phase IV trials	:	The final stage of clinical trials, conducted after a drug has been licensed and approved by the FDA, to gather more information on its risks, benefits, and optimal use.
Placebo	:	A treatment that has no active ingredient and is used as a control in a clinical trial.
Power analysis	:	A statistical method used to determine the sample size needed for a study to have a certain level of statistical power.
Principal investigator (PI)	:	The person who is responsible for the overall conduct of a clinical trial.
Protocol	:	A detailed plan that outlines the procedures, methods, and guidelines to be followed in a clinical trial. It is designed to ensure the safety of participants and to address specific research questions.
Randomized controlled trial (RCT)	:	RCT is a study design in which participants randomly receive one of the multiple interventions being tested, such as a new treatment or a placebo. RCTs are considered a highly rigorous method for determining the effectiveness of a new treatment and are often considered the gold standard in clinical research.

Legal Documents

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HIPAA Declaration for US Patient Records

Last revised on 28^th December 2022, effective as of January 1, 2023.

Softbrik works hard to respect your privacy, starting with being transparent about what data we collect and how we use it. If you are a natural person in the United States, this HIPAA policy describes the information Softbrik OÜ, registry code 14597527, address Hobujaama tn 4, 10151 Tallinn, Harju County, and/or its wholly owned subsidiary. Softbrik Health S.a.rl., registry code B245839, address 21 Rue Glesener, L-1631, Luxembourg, common email id [info@softbrik.com], (“we” or “us”) collect from End Users (“you”) via our digital forms (the “Forms”) for health care purposes and the information we collect on behalf of our clients (“Controllers”) who employ our technology to use our messaging, analytics, and other services (the “Services”), in adherence to the Federal Privacy Regulations of the Government of United States.

1. General

Softbrik is required by the maintain the privacy of Protected Medical Information as stipulated in the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) by the Federal Government of the United States for health records of all United States residents. With regard to sensitive patient information, we are required to abide by the terms of this legislation so long as it remains in effect.

If all Softbrik guidelines are followed, there should never be Protected Medical Information/Private Health Information displayed on any part of the Softbrik’s public facing website. Only bona fide users from the Controller teams can get access to your health care information. To understand how the Data is processed, please refer to the comprehensive Softbrik Data Processing Agreement.

If a user belonging to any Data Controller wilfully violates our Terms of Service by sharing or posting such sensitive information, Softbrik will actively regulate such activity as appropriate and required by law, including remedial measures to address the damage.

We are committed to protecting your data, especially as it relates to your health services. Some examples of protected information include:

Information about your or a child’s health conditions;
Information about health care services you or a child have received or may receive in the future;
Information about you or a child’s healthcare benefits under an insurance plan;
Geographic information;
Demographic information;
Unique numbers that may identify you or a child; and
Other types of information that may identify an individual.

2. Your Rights

You have the following rights, subject to certain limitations, regarding protected medical information that CCF may maintain about you or a child under your guardianship:

2.1 Right to Inspect and Copy
You have the right to request and receive a copy of your protected medical information as long as that is not anonymized that may be used to make decisions about your care or payment for your care, including information contained within your electronic medical record and services where the data has been captured by our platform. Softbrik is strictly a data capture and bi-directional communication platform between you and your care-giver and has no direct or implicit role in any healthcare decision making.

Softbrik reserves the complete right to deny your request to inspect or receive copies in certain circumstances including projects with data anonymization, regulations around mass release of data, protected client insights and valid medical or clinical conclusions that are yet not prepared for external release. All requests must be made in writing, include the reason(s) for the request, and must be signed with bona fide verification of your identification. Once we have internally reviewed your request and approved, we will check if we have the necessary technical means to extract the data. If both approval and technical extraction means are available, we will query the information and send to you in a secure manner once your receiving identity has been verified against fraud or imposters.

2.2 Right to Amend and Correct
You have the right to request amendment and/or corrections to the protected medical information maintained by Softbrik subject to data consent policy set up for the project by the clients as Controllers of data. Often in most projects, depending on how clients set up Softbrik’s data capture mechanisms, you often have the ability yourself to submit updated information.

Softbrik is not obligated to make all requested amendments/corrections, but will give each request careful consideration. Requests can be denied if the protected medical information was not created by Softbrik, is not part of the protected medical information maintained by or for Softbrik; is not part of the protected medical information to which you have a right to access; and/or is accurate and complete as determined by Softbrik. All requests must be made in writing, include the reason(s) for the request, and must be signed.

2.3 Right to an Accounting of Disclosures
You have the right to receive an accounting of certain unusual disclosures made by Softbrik of your protected medical information for a time period of five years prior to the date of the request of accounting. Examples of disclosures include protected medical information to insurance departments, pursuant to valid legal proceedings or for law enforcement purposes. This does not include data captured for the specific clinical project by the client (controller). Any additional data sharing done by data controllers are in scope of their disclosure and accounting practices. All accounting disclosure requests must be in writing and signed.

2.4 Right to Request Restrictions
You have the right to request a restriction or limitation on the protected medical information that we use or disclose for treatment, payment or medical care initiatives. This does not include data captured for the specific clinical project by the client (controller) as the patient wilfully gives data for such project with prior knowledge. Any usage of the data prior to the request cannot be overturned and will not be retrospectively seen by this clause as a violation of the clause. All requests to restrict information must be in writing and signed.

2.5 Right to Request Confidential Communications
You have the right to request how we communicate with you about your protected medical information in a certain way or at a certain location. For example, you can ask that we contact you only by mail or at work. We will accommodate reasonable requests. Requests for confidential communications must be made in writing and signed.

2.6 Notification of Privacy Practices
You can read Softbrik’s entire privacy practices in the Legal Document section of the website. We are also always happy to answer questions using our voice message link [Below the menu on the left hand side of the website].

2.7 Use and/or Disclosure of Your Protected Medical Information

As Softbrik is a Data Capture and Communication platform used by clients for different project, it is the Controller who decides on shareability and disclosure of your Protected Medical Information. Kindly read the Privacy Policy of the Project to ascertain and consent to the Controller’s Data Disclosure mechanisms. Some usual practices of information disclosure are:

Treatment: Controller may use or disclose your protected medical information to arrange for your treatment or the coordination of your care. For example, a treating physician/psychiatrist at another facility may request your protected medical information to ensure continuity of care (i.e., transferring of service supports).

Health Care Operations: Controller may use and disclose your protected medical information for certain facility operations. These uses/disclosures are necessary to manage the facility and to monitor and improve our quality of care. For example, Controller may use/disclose your protected medical information for quality reviews, accounting, legal, risk management, insurance services, and compliance and audit functions.

Study Results: As Softbrik is a data capture platform for many different types of clinical / direct patient activities, controllers use the platform for clinical data capture and sharing. Kindly read the privacy document or consent form available with the project to understand exactly how your data will be used, stored ands shared by the controllers.

Reminders and Other Information: Softbrik may use your protected medical information to contact you to remind you about giving timely health feedback, diarisation of health routines, appointments, tracking and other necessary and convenient tasks.

Softbrik may also use or disclose your protected medical information, in most cases without your permission for the following reasons listed below:

Required by Law: Softbrik may use or disclose your protected medical information when and to the extent we are required by local, state and federal law to do so for United States based natural person residents.

Victims of Abuse/Neglect/Domestic Violence: If Softbrik participates in a project that has a component of abuse, safety or domestic violence tracking and is working with a client who is a mandated reporting agency, and therefore required by law to disclose protected medical information of any client whom we reasonably believe is a victim of abuse or neglect.

Judicial and Administrative Proceedings: Softbrik may disclose your protected medical information in response to a court order, subpoena or administrative request. Efforts will be made to contact you about the request or to obtain an order agreement protecting the information.

Commitment Proceedings: As part of any involuntary commitment proceedings, the judge may direct that the court or mental medical review officer assigned under the Mental Medical Procedures Act have access to your protected medical information for purposes of conducting the hearing.

To Avert Serious Threat to Medical/Safety: Softbrik may use or disclose information when necessary to prevent a serious threat to your or a child’s medical/safety or the medical/safety of another person or the public. Any disclosure, however, will be made to someone who may be able to help prevent the threat.

Public Health Activities: Softbrik may disclose your protected medical information for public health purposes to an authority (i.e., Centres for Disease Control, Food and Drug Administration) that is legally authorized to collect or receive your protected medical information for the purpose of preventing or controlling disease, injury or disability, including but not limited to the reporting of a communicable disease, births, and deaths.

Health Oversight Activities: Softbrik may disclose your protected medical information to a health oversight agency for activities authorized by law such as audits, investigations, licensing, and inspections. These activities are necessary for government oversight of the health care system, government payment or regulatory programs, and compliance with civil rights laws.

Research: Softbrik may use or disclose your protected medical information for research purposes provided that the researcher adheres to certain privacy protections and only after special approval process that protects safety/confidentiality.

Coroners, Funeral Directors and Organ Donation: Softbrik may disclose your protected medical information to a coroner or medical examiner for identification purposes, cause of death determinations, organ donation, and related reasons. Protected medical information may also be disclosed to funeral directors as needed to in order that may carry out their duties.

Disaster/Emergency Relief: Softbrik may disclose your protected medical information to an organization assisting in a disaster/emergency relief effort(s) to assist in notification and general condition to family as others involved in your care (i.e., Red Cross, City of New York Emergency Management Team).

De-identifying Information: CCF may use your medical health information by removing any information that could be used to readily identify you.2

2.8 Use and Disclosures that Require Your Written Consent

Softbrik will not use or disclose any of your protected medical information unless you sign a written authorization for a particular client who as the Data Controller gives us, the Data Processor, permission to do so, with the exception of those instances listed above. The following list contains the types of uses and disclosures that require your written authorization:

Marketing Communications: Softbrik will not disclose your protected medical information for marketing purposes to 3rd parties or sell your protected medical information without your authorization. Softbrik will use and disclose protected medical information other than described in this Notice only with your written authorization. In some situations, federal and state laws provide special protection for certain kinds of health information such as information about drug and/or alcohol abuse treatment, mental health or illness, HIV/AIDS, and sexually transmitted diseases. Softbrik will not use or disclose that specifically protected information without your written consent as required by law.

2.9 Revocation of Authorization

You may revoke your prior authorizations to use or disclosed protected medical information in writing, at any time, depending on the Privacy clause of that project. If you revoke your authorization, the Data Controller will no longer use or disclose your protected medical information with the exception of information has already been used or disclosed or any action taken before receipt of the revocation. Authorization for purposes related to obtain insurance may not be revoked.

2.10 Exercising Your Rights

If you have questions about this HIPAA declaration, or wish to exercise any of the rights outlined herein, please contact us via voice message from the left tab or email at safety@softbrik.com. If you believe your privacy rights have been violated, you may file a complaint with Softbrik within 180 days of a violation of your rights on the email mentioned above.

All complaints must be made in writing. There will be no retaliation for filing a complaint.

You can further submit your complaint to:
U.S. Department of Health and Human Services
Office of Civil Rights
200 Independence Avenue,
Washington, D.C. 20201
1-877-696-6775
www.hhs.gov/ocr/privacy/hipaa/complaints

3. Which Other Privacy Laws do we cover?

Softbrik covers a host of European and international Privacy best practices.

3.1 Applicable data protection legislation – any applicable legislation relating to data protection and security, including the

European Directive on Privacy and Electronic Communications (Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector)
General Regulation on the Protection of Personal Data or GDPR (Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC) and their amendments, replacement, or extensions (hereinafter together referred to as “EU legislation”), These include health care related provisions and patient rights as termed as ‘Medical GDPR’.
All binding national laws within European Union implementing EU law and other binding data protection or data security directives, laws, regulations, and decisions in force at the relevant time for general and healthcare specific situations.
Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) – As per the Federal Government of the United States pertaining to healthcare data and patient rights for natural persons residing in the United States.

3.2 Softbrik participates in and complies with the EU-U.S. Privacy Shield Framework and the Swiss-U.S. Privacy Shield Framework. Softbrik’s accountability for personal data that it receives under the Privacy Shield and subsequently transfers to a third party is described in EU-U.S. Privacy Shield and Swiss-U.S. Privacy Shield Frameworks.

4. Contact US

For further understanding kindly read our Privacy Policy in details and contact us with any further questions by email: safety@softbrik.com.

Datenschutzerklärung

Datenschutzerklärung

Die für das Forschungsprojekt „Telemedizin und Acne inversa – TeleVersa” (im Folgenden „Forschungsprojekt”) unter Ziffer 1 aufgeführten Verantwortlichen (im Folgenden „Verantwortliche”) legen großen Wert auf den Datenschutz. Daher erheben und verarbeiten die Verantwortlichen Ihre personenbezogenen Daten ausschließlich in Übereinstimmung mit den einschlägigen gesetzlichen Bestimmungen, insbesondere der EU-Datenschutzgrundverordnung (DSGVO). Diese Datenschutzerklärung beschreibt, welche Arten von personenbezogenen Daten von Ihnen im Rahmen und im Zusammenhang mit dem Forschungsprojekt verarbeitet werden.

Neben der in dieser Datenschutzerklärung beschriebenen Datenverarbeitung durch die Verantwortlichen erfolgt ebenfalls eine eigenständige Erhebung und Verarbeitung Ihrer personenbezogenen Daten (einschließlich Gesundheitsdaten) durch die ADA Health GmbH, Karl-Liebknecht-Str. 1, D-10178 Berlin, Telefon +493040367390, E-Mail legal_ext@ada.com (im Folgenden „ADA Health”). Dies betrifft die Symptomanalyse über das von ADA Health bereitgestellte und betriebene Symptomanalyse Tool. Diese Datenverarbeitung durch ADA Health ist Gegenstand einer gesonderten, zusätzlichen Einwilligung von Ihnen gegenüber ADA Health auf Grundlage der Datenschutzrichtlinie (https://ada.com/de/privacy-policy/raw/) und der Allgemeinen Geschäftsbedingungen von ADA Health (https://ada.com/de/terms-and-conditions/raw/).

1. Die in dieser Datenschutzerklärung beschriebenen Abläufe und Datenverarbeitungen beziehen sich ausschließlich auf Ihre personenbezogenen Daten (einschließlich Gesundheitsdaten) aus den Fragebögen (Patient*innen- und Ärzt*in-Fragebögen) und den von ADA Health mit Ihrer Zustimmung bereitgestellten Fallbericht, nicht jedoch auf die Datenverarbeitung durch ADA Health im Rahmen der Leistungserbringung beim ADA Health Symptomanalyse Tool. An dieser Datenverarbeitung sind die Verantwortlichen nicht beteiligt und sie haben auch keinen Zugriff auf diese personenbezogenen Daten.

1.1 Die Datenverarbeitung im Rahmen der Durchführung des Forschungsprojektes steht nach Maßgabe der in Ziffer 3 beschriebenen Zuständigkeits- und Verantwortungsbereiche in der jeweiligen Verantwortung

des Initiators und Organisators des Forschungsprojektes, die Novartis Pharma GmbH, Roonstr. 25, D-90429 Nürnberg (im Folgenden „Novartis”); sowie
Ihrer/Ihres in der datenschutzrechtlichen Einwilligungserklärung und Schweigepflichtentbindung aufgeführten Hautärztin/ Hautarztes .

Als Initiator und Organisator des Forschungsprojektes agiert Novartis gemeinsam mit der*dem Hautärzt*in als gemeinsam Verantwortliche (Art. 26 in Verbindung mit Art. 4 Nr. 7 DSGVO).

1.2 Die Datenschutzbeauftragten der Verantwortlichen können Sie unter den folgenden Kontaktdaten erreichen:

Novartis Pharma GmbH: Data Privacy, Roonstr. 25, D-90429 Nürnberg, E-Mail datenschutz@novartis.com.
Hautärzt*in: Siehe die Angaben in der von Ihnen erteilten datenschutzrechtlichen Einwilligungserklärung.

2. Was ist der Grund für die gemeinsame Verantwortung zwischen Novartis und der*dem Hautärzt*in.

2.1 Novartis arbeitet beim Forschungsprojekt in arbeitsteiliger Weise eng mit der*dem Hautärzt*in zusammen. Dies betrifft auch die Verarbeitung Ihrer personenbezogenen Daten in pseudonymisierter Form. Novartis hat mit der*dem Hautärzt*in die Reihenfolge der Verarbeitung Ihrer personenbezogenen in den einzelnen Projektabschnitten festgelegt (siehe hierzu Ziffer 3). Vor diesem Hintergrund sind Novartis und die*der Hautärzt*in innerhalb der nachfolgend beschriebenen Prozessabschnitte Ihnen gegenüber gemeinsam für den Schutz Ihrer personenbezogenen Daten verantwortlich (Art. 26 DSGVO).

2.2 Im Rahmen ihrer gemeinsamen datenschutzrechtlichen Verantwortlichkeiten haben Novartis und die*der Hautärzt*in eine Vereinbarung gemäß Art. 26 DSGVO abgeschlossen, in der insbesondere geregelt ist, welche Partei welche Pflichten gemäß der EU-Datenschutzgrundverordnung (DSGVO) erfüllt. Dies betrifft insbesondere die Wahrnehmung Ihrer datenschutzrechtlichen Rechte im Sinne der Art. 15 ff. DSGVO (vgl. Ziffer 7) sowie die Erfüllung der datenschutzrechtlichen Informationspflichten im Sinne von Art. 13 DSGVO (vgl. Ziffer 3.2).

3. Zuständigkeiten und Verantwortungsbereiche für die Datenverarbeitung

3.1 Die Zuständigkeiten und die Verantwortung für die Datenverarbeitung sind wie folgt zwischen den Verantwortlichen festgelegt:

	Datenverarbeitung	Zuständigkeit und Verantwortung
(a)	Erhebung Ihrer personenbezogenen Daten im Rahmen der Arztfragebögen und die Einholung Ihrer schriftlichen Einwilligungserklärung in die Verarbeitung der personenbezogenen Daten für die Zwecke des Forschungsprojektes nach Maßgabe der Patienteninformation und dieser Datenschutzerklärung.	Alleinige Verantwortung der/des Hautärztin/Hausarztes.
(b)	Erhebung Ihrer personenbezogenen Daten im Rahmen der Patienten-Fragebögen	Alleinige Verantwortung von Novartis.
(c)	Speicherung des von ADA Health bereitgestellten pseudonymisierten Fallberichtes in der Projektdatenbank.	Alleinige Verantwortung von Novartis.
(d)	Verschlüsselte Übermittlung und Speicherung Ihrer pseudonymisierten Angaben aus dem Ärztin- und Patientinnen-Fragebögen in der Projektdatenbank.	Alleinige Verantwortung von Novartis.
(e)	Die Bereitstellung, der Betrieb und die Nutzung der Projektdatenbank für die Durchführung des Forschungsprojektes.	Alleinige Verantwortung von Novartis.
(f)	Die Analyse und Auswertung der pseudonymisierten Daten für Zwecke des Forschungsprojektes und die anschließende Verwendung anonymisierter Auswertungen und Auswertungsergebnisse zur wissenschaftlichen Dokumentation und Auswertung sowie zur Verwendung von anonymisierten Fachpublikationen (z.B. auf Fachkongressen oder in Fachzeitschriften).	Alleinige Verantwortung von Novartis.

3.2 Bei Erhebung Ihrer personenbezogenen Daten ist für die Erfüllung der Informationspflichten (Art. 13 DSGVO) die*der Hautärzt*in zuständig. Zu diesem Zweck wird Ihnen die*der Hautärzt*in gemeinsam mit dem Einwilligungsformular die Patient*innen-Information sowie diese Datenschutzerklärung zur Verfügung stellen.

4. Art der Daten, Ablauf und Zweck der Datenverarbeitung

4.1 Im Rahmen des Forschungsprojektes werden in pseudonymisierter Form folgende Datenarten verarbeitet: Geschlecht, Alter, Größe, Gewicht, Diagnosen, Informationen zur Dauer und Ausprägung assoziierter Symptome zur Acne inversa bzw. Ihrer Hautkrankheit, Krankheitshistorie (Dauer der Erkrankung, Anzahl der Arztkontakte, Therapien und Schmerzen), Lebensqualität, Auswirkung Ihrer gesundheitlichen Probleme auf Ihre Fähigkeit zu arbeiten und Ihre Alltagsaktivitäten zu bewältigen sowie Informationen zu emotionalen Aspekten und dem Wohlempfinden im Rahmen der Ärzt*in-Patient*innen-Beziehung.

4.2 Die Datenverarbeitung unterliegt dem nachfolgend aufgeführten Ablauf:

(a) Nach Durchführung der eigenständigen ADA Health Symptomanalyse über die von ADA Health bereitgestellte Webapplikation über das Tablet, die in der alleinigen Verantwortung von ADA Health erfolgt, wird mit Ihrer Veranlassung ein Fallbericht von ADA Health erstellt und bereitgestellt. Des Weiteren werden Sie gebeten, die in der Patient*innen-Information im Einzelnen aufgeführten Patient*innen-Fragebögen zu beantworten. Dies erfolgt über ein Tablet, das Ihnen im Auftrag von Novartis durch deren Dienstleister Institut Dr. Schauerte GmbH, Finkenstr. 7, D-80333 München (im Folgenden „IDS”) zur Verfügung gestellt wird. Zuletzt führt die*der Hautärzt*in eine routinemäßig dermatologische Untersuchung bei Ihnen durch und beantwortet ebenfalls die in der Patient*innen-Information im Einzelnen aufgeführten Ärzt*in-Fragebögen über eine Webapplikation.

(b) Im Rahmen Ihrer Beantwortung der Patient*innen-Fragebögen über das von IDS bereitgestellte Tablet erfasst der Webserver aus technischer Notwendigkeit ferner bestimmte Verkehrsdaten von Ihnen (z.B. IP-Adresse, Datum und Uhrzeit der Durchführung des jeweiligen Patient*innen-Fragebogens, der verwendete Browser, das verwendete Betriebssystem, Domainname und Adresse des Internet- Providers). Diese Verkehrsdaten werden ausschließlich für die Durchführung des jeweiligen Patient*innen-Fragebogens über das bereitgestellte Tablet verarbeitet.

(c) Sämtliche der im Rahmen des Forschungsprojektes erhobenen personenbezogenen Daten von Ihnen (Patient*innen- und Ärzt*innen-Fragebögen sowie ADA Health Fallbericht) werden über eine verschlüsselte Verbindung und ausschließlich in pseudonymisierter Form an die Projektdatenbank, die im Auftrag von Novartis von IDS bereitgestellt und betrieben wird, übermittelt und dort gespeichert. Pseudonymisiert bedeutet, dass Ihr Name durch ein Pseudonym (d.h. einen Nummerncode) ersetzt wird. Infolgedessen ist die Zuordnung Ihrer Angaben, Werte und Informationen zu Ihnen ohne zusätzliche Informationen ausgeschlossen. Über diese zusätzlichen Informationen verfügt nur Ihr*e Hautärzt*in, nicht jedoch Novartis oder IDS.

(d) Die pseudonymisierten Daten sämtlicher Teilnehmer*innen (einschließlich Ihnen) in der Projektdatenbank werden anschließend von IDS im Auftrag von Novartis wissenschaftlich analysiert und ausgewertet. IDS ist hierbei als Auftragsverarbeiter (Art. 4 Nr. 8 DSGVO) für Novartis tätig. Nach Abschluss der Auswertung anonymisiert IDS die Auswertungen und Auswertungsergebnisse und übergibt diese an Novartis.

4.3 Die Verantwortlichen verarbeiten Ihre pseudonymisierten Daten (einschließlich Gesundheitsdaten) aus den Patient*innen- und Ärzt*in-Fragebögen sowie aus dem Fallbericht von Ada Health für die Zwecke der wissenschaftlichen Dokumentation und Auswertung sowie der Erstellung von anonymisierten Auswertungen und Auswertungsergebnissen aller Teilnehmer*innen (einschließlich Ihnen) für Zwecke der Veröffentlichung im Rahmen von Publikationen (z.B. Beiträge auf Fachkongressen und in Fachzeitschriften). Die Sie betreffenden Informationen helfen den Verantwortlichen, ein besseres Verständnis über die Acne inversa Erkrankung und die damit einhergehenden Einschränkungen im Alltag zu erlangen mit dem Ziel, Erkenntnisse zu erhalten, um die aktuelle Gesundheitsversorgungssituation von Acne inversa Patient*innen verbessern zu können.

4.4 Ferner sind zuständige Überwachungsbehörden sowie von Novartis beauftragte Monitorinnen/Monitore berechtigt, Ihre bei der*dem Hautärzt*in vorhandenen personenbezogenen Daten (insbesondere Gesundheitsdaten) ausschließlich zum Zwecke der Überprüfung der ordnungsgemäßen Durchführung dieses Forschungsprojektes einzusehen (z.B. Überprüfung der wirksam erteilten Einwilligungserklärung oder Überprüfung der ordnungsgemäßen Übertragung in die Projektdatenbank). Diese Monitorinnen/Monitore, die als Auftragsverarbeiter (Art. 4 Nr. 8 DSGVO) für Novartis tätig sind, sind vertraglich zur Verschwiegenheit verpflichtet. Eine Weitergabe der eingesehenen personenbezogenen Daten (einschließlich Gesundheitsdaten) an Novartis oder IDS findet nicht statt.

4.5 Die Verarbeitung Ihrer pseudonymisierten Daten (einschließlich Gesundheitsdaten) erfolgt ausschließlich innerhalb der Europäischen Union (EU) bzw. des Europäischen Wirtschaftsraums (EWR).

4.6 Rechtsgrundlage für die Verarbeitung Ihrer personenbezogenen Daten – einschließlich Ihrer Gesundheitsdaten – für die in Ziffern 4.3 und 4.4 genannten Zwecke ist Ihre erteilte ausdrückliche Einwilligung (Art. 6 Abs. 1 Buchst. a, Art. 9 Abs. 2 Buchst. a DSGVO).

5. Risiken der Datenverarbeitung und Weitergabe Ihrer personenbezogenen Daten

5.1 Bei jeder Datenverarbeitung können Vertraulichkeitsrisiken (z.B. die Möglichkeit, die betreffende Person zu identifizieren) trotz aller Bemühungen nicht vollständig ausgeschlossen werden. Derartige Risiken steigen in der Regel, je mehr Daten miteinander verknüpft werden können. Die Verantwortlichen werden alle angemessenen und nach dem Stand der Technik möglichen Maßnahmen zum Schutz Ihrer Privatsphäre ergreifen und Daten nur an Dritte weitergeben, die ein geeignetes Datenschutzkonzept vorweisen können. Medizinische Risiken sind mit der Datenverarbeitung nicht verbunden.

5.2 Ihre in der Projektdatenbank eingestellten pseudonymisierten Daten werden nicht an Dritte weitergegeben, es sei denn, dies ist zur Erfüllung des Forschungsprojektes erforderlich, sonst aufgrund einschlägiger gesetzlicher Bestimmungen zulässig oder Sie haben den Verantwortlichen Ihre Einwilligung in die Weitergabe erteilt.

5.3 Die Verantwortlichen sind berechtigt, die Verarbeitung Ihrer pseudonymisierten Daten im Rahmen der datenschutzrechtlichen Vorgaben ganz oder teilweise an externe Dienstleister auszulagern, die für den jeweiligen Verantwortlichen als Auftragsverarbeiter (Art. 4 Nr. 8 DSGVO) tätig sind.

Novartis setzt folgende externe Dienstleister als Auftragsverarbeiter im Rahmen des Forschungsprojektes ein:

Dienstleister	Beschreibung des Dienstes	Empfängerland und angemes-senes Datenschutzniveau
Dienstleister Institut Dr. Schauerte GmbH, Finkenstr. 7, D-80333 München	Bereitstellung, Betrieb und Hosting der Projekt¬daten¬bank, Durchführung der Analyse und Auswertung der pseudonym-isierten Daten der Teilnehmer und Erstellung von entsprechenden Auswertungen und Auswertungsergebnissen	Deutschland (EU)

6. Dauer der Speicherung Ihrer personenbezogenen Daten

Ihre personenbezogenen Daten werden von den Verantwortlichen nur so lange gespeichert, wie dies für die Erreichung der Zwecke, für die diese personenbezogenen Daten erhoben wurden, erforderlich ist oder – soweit darüberhinausgehende gesetzliche Aufbewahrungsfristen bestehen – für die Dauer der gesetzlich vorgegebenen Aufbewahrung. Im Anschluss werden Ihre personenbezogenen Daten gelöscht.

Ihre pseudonymisierten Daten werden von IDS nach Abschluss des Forschungsprojektes anonymisiert und Novartis ausschließlich in Form von anonymisierten Auswertungen und Auswertungsergebnisse aller Teilnehmer*innen zur Verfügung gestellt. Anschließend werden diese Daten bei IDS gelöscht.

7. Ihre Betroffenenrechte

7.1 Ihnen stehen nach Maßgabe des geltenden Datenschutzrechts insbesondere die folgenden Rechte gegenüber den Verantwortlichen zu. Bitte wenden Sie sich an die unter Ziffer 1 angegebenen Kontaktmöglichkeiten der Verantwortlichen.

Bitte üben Sie Ihre in dieser Ziffer 7 beschriebenen Betroffenenrechte vorrangig gegenüber der*dem Hautärzt*in bzw. deren*dessen Personal aus, da nur diese in der Lage sind, Ihnen die entsprechenden pseudonymisierten Daten zuzuordnen. Novartis (einschließlich ihres Auftragsverarbeiters IDS) ist eine Zuordnung der pseudonymisierten Daten zu Ihnen nicht möglich (Art. 11 DSGVO).

7.2 Als betroffene Person im Sinne der EU-Datenschutzgrundverordnung (DSGVO) haben Sie grundsätzlich das Recht auf Auskunft über die Verarbeitung Ihrer personenbezogenen Daten (Art. 15 DSGVO). Sie haben ggf. das Recht, die Berichtigung (Art. 16 DSGVO), Löschung (Art. 17 DSGVO) oder Einschränkung der Verarbeitung (Art. 18 DSGVO) Ihrer personenbezogenen Daten zu verlangen und je nach Sachlage haben Sie das Recht auf Datenübertragbarkeit (Art. 20 DSGVO).

7.3 Soweit die Verarbeitung auf Ihrer Einwilligung beruht, haben Sie das Recht, diese Einwilligung jederzeit zu widerrufen. Durch den Widerruf wird die Rechtmäßigkeit, der aufgrund der Einwilligung bis zum Widerruf erfolgten Verarbeitung nicht berührt. Bitte beachten Sie, dass die Verwendung der anonymisierten Auswertungen und Auswertungsergebnisse aller Teilnehmer*innen von Ihrem Widerruf unberührt bleibt, da es sich hierbei um anonyme Daten handelt.

7.4 Sie haben zudem das Recht, sich bei der zuständigen Datenschutzaufsichtsbehörde über die Verarbeitung Ihrer personenbezogenen Daten zu beschweren.

Zuständige Datenschutzaufsichtsbehörde für Novartis: Bayerisches Landesamt für Datenschutzaufsicht, Postfach 606,
D- 91511 Ansbach, Telefon +49 981 180093-0, Fax +49 981 180093-800, E-Mail poststelle@lda.bayern.de.
Zuständige Datenschutzaufsichtsbehörde für die*den Hautärzt*in: Siehe die Angaben in der datenschutzrechtlichen Einwilligungserklärung und Schweigepflichtentbindung.

Sie können sich aber auch an eine andere Datenschutzaufsichtsbehörde – etwa an Ihrem Wohnsitz – wenden. Weitere Datenschutzaufsichtsbehörden finden Sie auf der Website der Bundesbeauftragten für den Datenschutz und die Informationsfreiheit unter www.bfdi.bund.de/DE/Infothek/Anschriften_Links/anschriften_links-node.html.

7.5 Die Verantwortlichen informieren sich unverzüglich gegenseitig über die von Ihnen geltend gemachten datenschutzrechtlichen Rechtspositionen. Die Verantwortlichen stellen einander sämtliche für die Beantwortung von Auskunftsersuchen oder anderen datenschutzrechtlichen Anfragen notwendigen Informationen zur Verfügung.

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Softbrik Terms of Service

Thanks for using Softbrik! These are our Terms and Conditions for using the Softbrik services. We would encourage you to take a few minutes and read through them. In case of any questions, you can always reach out to us at info@softbrik.com.

The Agreement must be accepted as a necessary condition without any exception to signing up for our services.

For setting up various Softbrik subscription(s), you will have to provide certain information about your business, individuals in the organisation as well as provide certain payment information. The Agreement applies whether you are signing up as a company or as an individual.

1. Acceptance of the Agreement

1.1 The Agreement applies to Softbrik OÜ, Hobujaama 4, 10151 Tallinn, Estonia, business reg. no. 14597527 and/or its wholly owned subsidiary Softbrik Health S.a.rl., registry code B245839, address 21 Rue Glesener, L-1631, Luxembourg, with common email id info@softbrik.com, (‘Softbrik’) and the customer (‘Customer’).

As a customer, you can be a legal entity or a natural person. If you are a natural person, you represent and warrant to Softbrik that as an individual (i.e., not a corporation or a registered entity) you are at least 18 years of age. You also represent and warrant that you are legally permitted to use the Services and access the Site from your current and foreseeable jurisdiction. If you are entering into this Agreement on behalf of a company or any other legal entity of whatever shape or form, you represent and warrant that you have the authority to bind such entity to this Agreement on behalf of the entity and its affiliates, in which case the terms “you” or “your” will refer to such entity and all its affiliates as relevant. This Agreement is void where prohibited by law, and the right to use the Services is revoked in such jurisdictions.

1.2 The Agreement covers the Customers use of the Softbrik services, client software and any other services launched by Softbrik (Services).

1.3 This Agreement is fully and unconditionally accepted by you without any prejudice when ticking off the “I hereby accept the Softbrik OÜ Subscription, Terms & Conditions” box upon signing up for the Softbrik OÜ services.

2. Duration of the Agreement

2.1 The Agreement becomes legally binding and effective upon both parties on the date of signing up for the Services by ticking off the “I hereby accept the Softbrik’s Subscription, Terms & Conditions” box (‘Effective Date’).

2.2 When signing up for the Services, you will immediately be granted access to our freemium platform. This does not require any payment details. If you want to subscribe to paid Softbrik services at a later stage, you will be asked for further company/person and payment details. After successful payment (see below under Section 3.2.), you will receive an email with a link to your private Softbrik environment and login information.

2.3 You can at any given time, choose to upgrade or downgrade your Softbrik subscription. Any change will be pro-rated from the next invoicing period taking already made payments into account. Should you which to cancel your subscription, you will only be invoiced for the remaining number of days left in that invoicing period. The account will as such remain open until the end of the invoiced period. Should you wish reconsider your decision and continue using Softbrik services, kindly send us an e-mail at support@softbrik.com with the specific details.

2.4 An Enterprise Agreement may be terminated as follows:

Termination by the Enterprise account holder: Should you wish to terminate your company’s Softbrik account permanently (including any analytics dashboard), please send us an e-mail at support@softbrik.com and we will terminate the account. An account can be terminated only to the end of an invoicing period applying 2 weeks of written notice. In case the request to terminate a company, account is received later than 2 weeks prior to the end of an invoicing period, the termination will only be effective as of the following invoicing period, for which an invoice will be issued. The termination of an Enterprise account is non-reversible, and no company data will be retained. Should you wish to use Softbrik services in the future, a new company account will have to be set up.

Termination by Softbrik: In case of violation of the Agreement (see section 7), your account will first be suspended after which you will receive a written notice to contact Softbrik (support@softbrik.com). If a solution has not been found within 2 weeks after the notice, the account will be terminated. The termination of an Enterprise account is non-reversible, and no company data will be retained.

3. Payment & Invoices

3.1 A Softbrik subscription may or may not entail special offers such as a.) a free trial period or free usage of features on the Softbrik platform b.) time bound discounts on the subscription c.) referrals and other bonuses. If you, as the Customer, are eligible for any such time bound schemes and activities, they will automatically be announced upon the execution of your subscription and entering your payment information. Please note that offering and implementation of any such

3.2 You are invoiced for the first month when you sign up for the paid subscription services. Subsequent invoices are issued and to be paid upfront monthly. As an example, if you sign up on 12 December then the next invoice will be issued for upfront payment on 12 January and so forth. You can cancel the Agreement at any given time, see above under Duration of the Agreement.

3.3 The total payment is calculated based on the subscription chosen and potential add-ons.

3.4 All payment details, including VAT specifications, appear on your monthly invoice.

3.5 Invoices are e-mailed directly to the email address used to setup the Softbrik account ( henceforth called ‘Administrator’ or ‘Admin’ in abbreviation) as well as accessible inside the Softbrik Platform. If you do not receive an invoice or if you need to have the invoice(s) send to another email address, make sure to contact us using either our contact form on the website or email us directly at support@softbrik.com.

3.6 If you which to change the timing of your invoice, please contact our support team at support@softbrik.com.

3.7 The credit card you enter during the registration is used for the subscription. It is possible to update the credit card information in the Admin panel. Softbrik accept payment on any valid credit card (VISA or MASTERCARD) through our approved and licensed payment partners. All payments are executed in EURO. In case your credit card is not supported, please contact us using either our contact form or email us directly at support@softbrik.com.

3.8 If an invoice is not paid, for whatever reason, within 3 banking days calculated as of the first day of a new invoicing period, see above under 3.2., you will receive a reminder to pay the invoice within 10 banking days calculated as of the date of receiving the reminder. In case the invoice is not paid in due time within the 10 banking days, the company account will be terminated, and all Services stopped, see above under 2.b.ii for what happens when a company account is closed. A new company account may be opened upon payment of any outstanding amount.

3.9 You, the Customer, explicitly and unequivocally agree that Softbrik will never be liable or responsible for any loss, of whatever nature, amount, or any other impact it may have, that a company incurs, directly or indirectly, due to the closing, for whatever reason, of a company account. The same applies to a company’s use of the Services, Softbrik cannot, may not and will never accept to be made responsible for any loss, of whatever nature, amount, or any other impact it may have, that a company incurs, directly or indirectly, by using the Services.

4. Your Information, Site Submissions & Your Permissions

4.1 When you use our Services, you provide, upload, share or generate to us a range of information and data including but not limited to your files, content, messages, contacts, customer identities, financial information and so on (‘Your Information’). Your Information remains your legal ownership throughout the course of your Softbrik Services usage. The Agreement does not give us any legal ownership rights to Your Information except for the limited rights that enable us to provide the Services. The security, confidentiality and privacy of your information is our priority. For further details please read our Privacy Policy and the FAQs on Security and Privacy.

4.2 By signing this Agreement, you are permitting us to conduct activities like, but not limited to, hosting Your Information, backing it up completely or partially, and sharing it completely or partially as needed to perform our Services. Our Services also provide you with features like, but not limited to, photo thumbnails, document previews, commenting, easy sorting, editing, sharing, and searching. These and other present or future features may require our systems to access, store, and scan Your Information to provide quality Services. You give us explicit permission without any prejudice to do those tasks and more as we decide the most appropriate way to provide our services. Furthermore, you explicitly and unequivocally agree that this permission extends to all our trusted third-party services like, but not limited to, Amazon Web Services (AWS).

4.3 Please note that “Your Information”, automatically includes all the information your input, your employees, customers, vendors, stakeholders and any other individual whose data you choose to share, or they share with you via Softbrik platform as a logical extension of your business. When you grant us the permission to use Your Information, the consent naturally and logically extends to the information you have shared about your employees, customers, vendors, stakeholders, or other individuals as you have deemed appropriate. Softbrik is not responsible in anyway whatsoever to either assess, verify, gauge the appropriateness of Your Information nor to take any additional consent for Your Information shared. You are completely and unequivocally responsible and liable for Your Information, their accuracy, completeness, quality, integrity, legality, reliability, and appropriateness, including any consent from any natural person without exception.

Please Note: Softbrik does not take any legal responsibility of your content and in case of any legal enquiries by appropriate authorities satisfying grounds of reasonable evidence of illegal content, may decide to share necessary content with the authorities for due legal process. It is clearly understood that you, your team and all the users understand their own responsibility and liability and consequence of storing, retrieving any information and generally using any services related to Softbrik or its partner ecosystem. Please read the Responsibilities and Acceptable Use clauses below for further understanding of your role in fair and safe usage of the platform.

5. Your Conduct & Responsibilities

5.1 You are responsible for your conduct as the Customer. Your Information and you must comply with the Agreement. Content in the Services may be protected by others’ intellectual property rights. Please do not copy, upload, download, or share content unless you have the unconditional right to do so.

5.2 We may choose to review your conduct from time-to-time review and use of our Services to make sure they are compliant with the Agreement. With that said, we have no obligation to do so. We are not responsible for the content people post and share via the Services.

5.3 Help us keep you informed, and Your Information protected. Safeguard your password to the Services and keep your account information current. Do not share your account credentials or give others access to your account.

6. Consent & Personal Information

6.1 You (The Customer) take complete and full ownership of any your employees, customers, vendors, stakeholders, or any person’s data (including private information like email addresses, phone number, voice or textual feedback and other forms of personally identifiable information) entered on the Softbrik platform. In case of any objection, the Company must do everything possible to remove such private information from the platform. Softbrik personnel do not have access to Customer Information and hence cannot take any responsibility, directly or indirectly, under any circumstances, for any private information submitted to the system with or without prior consent. All users of Softbrik’s communication system must provide electronic consent to Softbrik Data Processing Agreement.

6.2 If you are subject to European data protection laws (General Data Protection Regulation), the California Consumer Privacy Act (CCPA), or similar data protection laws, you further represent and warrant that you have reviewed and clearly agreed to Softbrik’s Data Processing Addendum. You further acknowledge and agree that your indemnity obligation under the “Indemnity” section below applies to your disclosure of Personal Data under this Agreement.

7. Violation of the Agreement

7.1 You may use our Services only as permitted by at any time applicable law, including export control laws and regulations.

7.2 To use our Services, you must be at least 18 years old or else please check your local law for the age of digital consent. If you do not meet these age requirements, or any other relevant requirements, you may not use the Services under any condition whatsoever.

7.3 Any unlawful conduct may, partly or in full, lead to the suspension or termination of Services or the Agreement. Softbrik unconditionally reserves the right to take any legal action deemed necessary to remedy such situation irrespective of any payments made for the consumption of such Services for whatever period of time. Any possible refund of any amount after suspected or proven violation of usage terms is completely and solely up to Softbrik to decide upon. Softbrik, cannot, will not and may not, partly, or fully, be made responsible for any loss, of whatever nature, the Customer may suffer from such actions. Softbrik reserves the right to claim compensation from the Customer for any costs, loss or otherwise financial expenses incurred to ensure a lawful Customer account according to this provision.

8. Acceptable Usage

8.1 True Identity: The Customer is registered with Softbrik applying only true user identities, company details, credit card information, etc. We apply a zero tolerance for impersonation of other businesses, legal and natural persons. Any attempt to impersonate a business, legal or natural person, or provide misleading or fake information at registration or later, entitles us to stop, limit or terminate, partly or in full, without any warning and at the sole decision of Softbrik OÜ, the Service towards you. In such case, you may or may not receive a refund, partly or in full, for unfulfilled Services, a decision solely to be made by us. We reserve the right to deduct, from a possible refund to the you, any expenses incurred to investigate the incident as well as claim further compensation from you for any loss, of whatever nature and amount, we may have suffered due to such misbehavior. Softbrik OÜ bears no responsibility, of whatever nature, towards you for any loss or damage that you may claim to have or suffer from us stopping, limiting, or terminating the Services, partly or in full, according to this provision.

8.2 Malicious Usage: You are given access to our Services in good faith. Any attempt to maliciously use the out platform, hack, disrupt or use it in any way other than as intended, entitles us to stop, limit or terminate, partly or in full, the Services. In such case, you may or may not receive a refund, partly or in full, for unfulfilled Services, a decision solely to be made by Softbrik OÜ. We reserve the right to deduct, from a possible refund to you, any expenses incurred to investigate the incident as well as claim further compensation from you for any loss, of whatever nature and amount, we may have suffered due to such misbehavior on your part. We bear no responsibility, of whatever nature, towards you for any loss or damage that you may claim to or suffer from us stopping, limiting, or terminating the Services, partly or in full, according to this provision.

9. Software & Beta Services

9.1 Some of our Services may allow you to download client software (“Software”), which may be updated automatically from time to time. Through the Agreement, you are given a limited, non-exclusive, non-transferable, revocable license to use the Software, solely for the purpose of accessing the Services. To the extent any component of the Software may be offered under an open-source license, we will make that license available to you and the provisions of that license may expressly override part of the Agreement. Unless, the following restrictions are prohibited by law, you agree not to reverse engineer or decompile, partly or in full, the Software or Services, attempt to do so, or assist anyone in doing so.

9.2 We sometimes release new or updated products and features that we are still testing and evaluating. Such Services will be marked beta, preview, early access, or evaluation (or with words or phrases with similar meanings) and may not be as reliable as other Services.

10. Intellectual Property

10.1 As between Softbrik and you, Softbrik (and/or its licensors) is the sole and exclusive owner, and will retain all right, title, and interest in and to the Services. You will not own any portion of the Services in any form. You will not copy or store any portion of the Services other than for their intended fair usage without prior written permission from Softbrik, or from the copyright holder.

10.2 All trademarks, service marks, and trade names that appear on the Services are proprietary to Softbrik or third parties. You will abide by all copyright notices and restrictions contained in the Services which are protected at any time, by any applicable intellectual property rights and regulations as per European Union laws, Estonian laws and any other relevant international law as applicable from time to time. Subject to the terms and conditions of this Agreement, Softbrik grants you and your Authorized Users a nonexclusive, non-transferable right and license (without right to sublicense) to access and use the Services, solely for you and your Authorized Users’ business purposes.

10.3 Except as provided in this Section, you may not modify, publish, transmit, participate in the transfer or sale of, reproduce, create derivative works based on, distribute, perform, display, or in any way exploit, any of the Services in whole or in part. Additionally, you will not attempt to circumvent any of Softbrik’s technical measures, or decompile, reverse engineer, or disassemble the Services. The Agreement does not grant you any right, title or interest, neither partly nor fully, in the Services, Softbrik OÜ trademarks, logos or other brand features.

10.4 We respect the intellectual property of others. We respond to notices of alleged copyright infringement and reserve the right to take any actions upon such notice that we deem appropriate, entitled, and necessary. If you think anyone has posted material to the Site or Services that violates any copyrights or other intellectual property right, then you can notify Softbrik at info@softbrik.com with the Subject Line: Potential Copyright Infringement. Alternately you can write the word ‘Copyright’ on an envelope, put the details inside and then courier us to Softbrik OÜ, Hobujaama 4, 10151 Tallinn, Estonia.

11. Warranty Disclaimer

11.1 Softbrik has no special relationship with or fiduciary duty to you. You acknowledge that Softbrik has no control over, and no duty to take any action regarding: which end users gain access to the Services; what results you may obtain via the Services; what effects the Services may have on you; how you may interpret or use such results; or what actions you may take because of having been exposed to the Services. You release Softbrik from all liability for your having acquired or not acquired Services and content and results through the Services. Softbrik does not manage or control any business or individual that you may interact with through the Services, and Softbrik accepts no responsibility or liability for any act or omission by such entity. You hereby waive all legal or equitable rights or remedies you have or may have against Softbrik with respect to acts and omissions by such entities.

11.2 The Services may contain, or direct you to sites containing, information that some people may find offensive or inappropriate. Softbrik makes no representations concerning any content contained in or accessed through the Services, and Softbrik will not be responsible or liable for the accuracy, copyright compliance, legality or decency of material contained in or accessed through the Services. THE SERVICES ARE PROVIDED ON AN “AS IS” BASIS, WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY, TITLE, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. SOME JURISDICTIONS DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU.

11.3 TO THE FULLEST EXTENT ALLOWED BY LAW, SOFTBRIK DISCLAIMS ANY LIABILITY OR RESPONSIBILITY FOR THE ACCURACY, RELIABILITY, AVAILABILITY, COMPLETENESS, LEGALITY OR OPERABILITY OF THE MATERIAL PROVIDED THROUGH THE SERVICES. BY USING THE SERVICES, YOU ACKNOWLEDGE THAT SOFTBRIK IS NOT RESPONSIBLE OR LIABLE FOR ANY HARM RESULTING FROM: (i) USE OF THE SERVICES; (ii) DOWNLOADING INFORMATION CONTAINED ON THE SERVICES; (iii) UNAUTHORIZED DISCLOSURE OF IMAGES, INFORMATION OR DATA THROUGH THE SERVICES; AND (iv) THE INABILITY TO ACCESS OR RETRIEVE ANY DATA FROM THE SERVICES, INCLUDING, WITHOUT LIMITATION, HARM CAUSED BY VIRUSES OR ANY SIMILAR DESTRUCTIVE PROGRAM.

12. Third Party Sites and Services

12.1 You (The Customer) of Softbrik may gain access from the Services to third-party sites on the Internet. Third-party sites or services are not within the supervision or control of Softbrik. Softbrik makes no representations or warranties about any third-party site or resource and does not endorse the products or services offered by third parties. Softbrik disclaims all responsibility and liability for content on third-party websites. Third-party providers of ancillary services may require your agreement to additional or different terms prior to your use or access of their sites or services. Any such agreement will in no way modify this Agreement.

13. Indemnification

13.1 You will indemnify and hold Softbrik, its directors, officers, employees, agents, and representatives harmless, including costs and attorneys’ fees, from any claim or demand made by any third party due to or arising out of (i) your access to or use of the Services, (ii) your violation of this Agreement, (iii) your infringement, or the infringement by any third party using your registration information, of any intellectual property, or other right of any person or entity, including but not limited to any third party claims relating to your disclosure of Personal Data to Softbrik, and (iv) the Data or any other materials provided to Softbrik.

14. Limitations of Liability

14.1 EXCEPT FOR DAMAGES AND LIABILITIES ARISING FROM: (i) A PARTY’S BREACH OF SECTION 6 (CONFIDENTIALITY); (ii) ITS VIOLATION OF APPLICABLE LAWS; (iii) ITS INDEMNIFICATION OBLIGATIONS; OR (iv) GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT, IN NO EVENT SHALL EITHER PARTY, ITS DIRECTORS, OFFICERS, SHAREHOLDERS, EMPLOYEES, MEMBERS, AGENTS AND REPRESENTATIVES BE LIABLE TO THE OTHER FOR: (i) ANY INDIRECT, INCIDENTAL PUNITIVE, OR CONSEQUENTIAL DAMAGES OF ANY KIND OR DAMAGES FOR LOSS OF USE, PROFITS, DATA, IMAGES, OR OTHER INTANGIBLES, OR IN THE CASE OF SOFTBRIK, DAMAGES FOR UNAUTHORIZED USE, NON-PERFORMANCE OF THE SERVICES, ERRORS OR OMISSIONS. SOFTBRIK’S LIABILITY UNDER THIS AGREEMENT WILL BE LIMITED TO THE GREATER OF: (A) THE AMOUNT PAID BY YOU, IF ANY, FOR ACCESSING THE SERVICES DURING THE TWELVE (12) MONTHS PRIOR TO THE DATE THE CLAIM AROSE; OR (B) $100.00 US DOLLARS. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS AND EXCLUSIONS MAY NOT APPLY TO YOU.

15. Choice of Law, Venue and Language

15.1 The Agreement will be governed by the laws of Estonia, without reference to its choice of law rules.

15.2 Exclusive jurisdiction over and venue of any suit arising out of or relating to the Agreement, will be in the court of the district of Tallinn, and each of the parties hereto consents to the personal jurisdiction of, and venue in, this court.

15.3 Any correspondence in relation to the Agreement, whether written or spoken, shall at any time, no matter what the context, only be accepted and delivered in standard UK or UK business English.

16. Miscellaneous

16.1 The failure of either party to exercise in any respect any right provided for herein will not be deemed a waiver of any further rights hereunder. If any provision of this Agreement is found to be unenforceable or invalid, that provision will be limited or eliminated to the minimum extent necessary so that this Agreement will otherwise remain in full force and effect and enforceable.

16.2 This Agreement is not assignable, transferable, or sublicensable by you except with Softbrik’s prior written consent. Softbrik may transfer, assign, or delegate this Agreement and any or all of its rights and obligations without consent.

16.3 If you are purchasing paid Services, Softbrik may request and with your consent, Softbrik may publicly disclose in writing that you purchased Services and may use your trademarks, service marks or trade name solely in connection with such disclosures.

16.4 This Agreement (including the Privacy Policy and Anti-Spam Policy) is the complete and exclusive statement of the mutual understanding of the parties and supersedes and cancels all previous written and oral agreements, communications and other understandings relating to the subject matter of this Agreement. No agency, partnership, joint venture, or employment is created as a result of this Agreement, and you do not have any authority to bind Softbrik in any respect whatsoever.

16.5 Any notice that is required or permitted by this Agreement will be in writing and will be deemed effective upon receipt, when sent by confirmed e-mail, if to you, at the email address you provide with your account, and if to Softbrik, to info@softbrik.com.

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