Nachfolgend wird für verschiedene Begriffe jeweils die männliche Form verwendet. Alle Aussagen gelten jedoch für alle Geschlechter gleichermassen.
Der angebotene Dienst (Software)
MedicalGuide, COVID-Guide, SmED, concordiaMed Check, WELL Symptom-Checker sind Handelsnamen des Medizinprodukts SMASS.
SMASS (Structured Medical Assessment System) ist eine webbasierte Softwarelösung (hiernach auch als „Software“ bezeichnet). SmED (Strukturierte medizinische Ersteinschätzung in Deutschland) ist die auf das Deutsche Gesundheitssystem adaptierte Software innerhalb der generischen Produktegruppe SMASS.
Der Hersteller ist für die Richtigkeit der medizinischen Inhalte der Software verantwortlich. Der angebotene Dienst ist jedoch explizit keine telemedizinische Beratung.
Rollen
Hersteller der Software SMASS im Sinne der MDD ist die
in4medicine AG
Monbijoustrasse 23
3011 Bern
CHE-114.317.142
tellme.in4medicine.ch
In der Europäischen Union wird die In4medicine AG repräsentiert durch
HCQS Health Care Quality Systems GmbH
Maschmühlenweg 8 – 10
37073 Göttingen
DE237838407
info(at)hcqs.de
Das Impressum gibt zusätzlich Auskunft über den Anbieter des jeweiligen Dienstes. Keine der erwähnten Rolleninhaber ist eine ambulante oder stationäre Behandlungseinrichtung und keine Arztpraxis.
Zur Verfügung gestellter Dienst
Zweck der Software
Allgemein
SMASS ist eine webbasierte Software, die bezweckt, Gesundheitsfachpersonen und Laien bei der strukturierten Dokumentation und Einschätzung von Gesundheitsproblemen zu unterstützen und die Nutzenden zu möglichen medizinischen Abklärungsschritten, Behandlungen und Massnahmen zu informieren. SMASS weist zwei unterschiedliche User-Interfaces auf: SMASSPathfinder für Laienpersonen und SMASSProfessional für Gesundheitsfachpersonen. Die beiden User-Interfaces unterscheiden sich lediglich in der Assessmentführung (Benutzerführung). SMASS beinhaltet verschiedene Anwendungsmodule, welche auf einer oder mehreren medizinischen Wissensdatenbanken beruhen.
Intended medical purpose
SMASSProfessional assists health professionals with documentation of:
• the anamnesis
• the initial assessment
• of diagnostic steps
and informs them about:
• possible clarification steps (e.g. physical, laboratory examinations),
• possible measures (e.g. going to a pharmacy, making an appointment with the family doctor in the next few days) and treatments (e.g. physical treatment principles, simple painkillers).
The medical content is based on medical literature and expert knowledge. The system is based on the International Classification of Primary Care (ICPC2) as a principle of order of medical content.
The software is multilingual and currently available in German, French, Italian and English.
SMASS has a responsive web design. Data can be entered by users via forms and dynamic masks (e.g. chatbot). The content can be displayed on different devices (mobile, tablet, PC) with any common browser.
Characterisation of the users
SMASSProfessional is used by health professionals with formal medical training (e.g. practice assistants, pharmacists, telemedicine consultants).
SMASSProfessional is used in Germany, Austria, Italy and Switzerland. Users must be familiar with the use of simple web applications. The use and user guidance are intuitive. The use of SMASSProfessional requires 2-6 hours of training (depending on the initial level of knowledge of the training participants).
Use of the software
The use of the software has to be in accordance with the conditions laid down in the contract. Any use that deviates from that stipulated in the contract may result in the withdrawal of the right of use. The right to take further legal action is reserved.
If the software is made available via a third party, it is the user's responsibility to inquire with the third party provider about the contractually agreed use, unless this information has been provided in advance by the third party.
Characterisation of the environment of use
SMASSProfessional is used in medical practices, pharmacies, in the context of triage training, hospitals/emergency rooms, rescue services and in the medical call centre environment. Basically, the environments of use can be divided into:
• Telemedicine use (patient calls telemedicine centre, the health professional on the phone is the user of the software)
• Use at the counter (patient comes in person to a counter, the health worker at the counter is the user of the software)
• Mobile use (health professional is a user of the software and carries out an assessment on the move on a mobile device for a patient)
Exclusions in the Intended medical purpose
SMASSProfessional does not provide a direct diagnosis.
SMASSProfessional makes a recommendation with appropriate justification based on the questions asked and information entered. A final decision is always made by the health professional based on the SMASS recommendation and their own assessment and experience.
Risks
Analogous to other sources of information in real or digital world, the software can only provide instructions for action. The instructions for action must be assessed by the user in the individual context and appropriate measures derived from them on their own responsibility. If the instructions are ignored or not interpreted correctly or inadequate measures are derived from them, it can lead to suboptimal medical care and consequently, to a risk to the user (medical overuse or underuse).
Medical device
The software is a medical device and has been developed in accordance with the European Medical Device regulation (93/42/EEC MDD) and has been registered with the relevant authorities as conforming to the directive under the generic product group SMASS.
Electronic delivery of documents
The user has the possibility to save the medical anamnesis data (questions and entered symptoms) as well as the recommendation as a PDF at the end of the use of the software. It is also possible that a communication service is offered at the end of use to send the initial assessment. If this data is not saved directly, it cannot be retrieved later. In this case, the assessment must be carried out again with the software.
If one of the offered communication services is used, it is the user’s responsibility to ensure that they have the patient’s authorisation to use the communication service for the transmission of the initial assessment data. The service provider assumes no responsibility for the use of the communication service or any data protection risks.
Duties of the user
Responsibility and duty of care of the user for himself and third parties
The user is responsible for all actions performed via the software and derived from the information in the software, both for themselves and for third parties. The user confirms that they have all necessary data and information about themselves and the third party. The user ensures that all data and information provided by the user and third parties in the context of the use of the software are complete and correct. If the user is acting on their own behalf or on behalf of a third party, they must ensure that they have all the necessary consents and authorisations. By using the software, the user confirms their authorisation to perform actions both for themselves and for third parties. The responsibility for the use of the software by third parties lies exclusively with the user. The user is solely responsible for the consequences of incomplete or incorrect data and information. The user shall ensure that the third parties are aware of and comply with the liability and warranty limitations of these terms of use.
If a third party asserts claims against the service provider because the user has performed actions via the software without the authority to represent the third party or knowledge of the third party, the user shall fully indemnify the service provider.
The user is obliged to report any illegal use of the software by third parties (e.g. hackers) to the service provider without delay.
Validity of the terms of use
The Terms of Use are available to the user in the same languages in which the software is offered. The German version shall prevail.
By agreeing to the terms of use, the user declares that they have read, understood and accepted the terms of use.
The user must accept the terms of use before each new use of the software. If the terms of use change, the user accepts the validity of the new terms of use.
Minimum age
The functionalities of the software are available to natural persons who are at least 16 years old and capable of judgement at the time of using the software. If the user is not 18 years old yet, the consent of the legal representative is required for the use of the software.
Use for or by a third person
The user may use the software both for themselves and for third parties. A third party is any natural person who is not identical to the user and for whom the user enters the information for the purposes in the software. The responsibility for the use of the software for the third party lies solely with the user.
Liability and rights
The software is made available to the user exclusively for the declared purposes of use as it is. The use of the software is at the user's own risk. Any implicit and explicit guarantee for the software is rejected. Furthermore, no other (implicit or explicit) promises, guarantees or assurances are made in regard to the software or the transmitted data, as long as these are not explicitly listed in these terms of use. In particular, no warranty is given for the functionality or constant availability without error or interruption, that errors will be corrected or that the transmitted data is correct and complete.
However, liability is assumed for possible culpably caused damage arising from or in connection with the software and for possible damage arising from the use of the software in accordance with the applicable legal provisions.
References to external content
The software may contain hyperlinks to websites on the World Wide Web which are not maintained by the service provider and which have no connection with the provider (hereinafter referred to as "third-party websites"). The use of such hyperlinks is at the user's own risk. This also includes checking for malware. The hyperlinks are provided as a courtesy to the user. The service provider is not responsible or liable. The responsibility for reviewing or evaluating the content of such third-party websites rests with the user. The content of third-party websites does not necessarily reflect the opinion of the service provider. Any liability or responsibility for the content of such third-party websites, in particular for their accuracy and completeness, is rejected.
Use from abroad
For any use outside the approved areas, all liability is disclaimed and the user is responsible for compliance with the laws in force in the country concerned.
Property rights and intellectual property
All worldwide rights (in particular all intellectual property rights and rights to know-how) relating to the software and the associated documentation belong in their entirety to the manufacturer in4medicine AG, subject to deviating legal or contractual regulations. All elements of the software are protected by copyright and/or trademark law. The complete or partial reproduction, transmission (electronically or by other means), modification or linking of the software with other applications is prohibited without the prior written consent of in4medicine AG.
The user refrains from any use or modification of the respective name, trademarks and/or logo of the service provider without the prior written consent of the service provider. These obligations are valid for an indefinite period of time.
Other subjects
Security
During the development of the software, special emphasis was placed on security. The contents are transmitted using state-of-the-art encryption procedures. Absolute security cannot be guaranteed even with all security precautions, which are also state of the art.
The user's terminal device (computer, mobile phone, etc.) and/or network are part of the system. They are beyond the control of the service provider and can therefore become a weak point in the system.
The user accepts the risks involved in the use of the software? It behoves them to inform themselves in detail about the necessary security measures corresponding to the current state of the art and to take suitable protective measures.
Data security and data protection
The software is always operated on servers in Switzerland or the EU.
Changes to the terms of use/deactivation of the software
The service provider reserves the right to change the terms of use and the scope of the software at any time and without prior notice or to adapt them to technical or legal developments.
The service provider may deactivate the software globally or in certain regions at any time without prior notice and without stating reasons. There is no entitlement to the continued use of the software.
Subject to the legal provisions
Any mandatory legal provisions governing the content, operation and/or use of the software remain reserved.
Salvatory clause
Should any provision of these Terms of Use be or become invalid, the validity of the remaining Terms of Use shall not be affected. The invalid provision shall be replaced by a provision that comes as close as possible to the economic purpose of the invalid provision.
Applicable law and place of jurisdiction
All legal disputes arising from or in connection with the Terms of Use or the use of the software shall be governed exclusively by German law, excluding the rules of private international law and the Vienna Sales Convention.
The exclusive place of jurisdiction for all disputes arising out of or in connection with the Terms of Use or the use of the Software shall be the registered office of HCQS (Göttingen), except where mandatory jurisdiction is provided by law .