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Basics

The digital MedInfo Assistant (also referred to as "Smart SmPC" / "Smart Patient Information", or "Interactive FAQ") is an application for websites. The assistant can respond to free-text questions from users about individual medicinal products with pre-formulated and fixed question-and-answer pairs. Before answering, a question is shown to the user that the assistant has recognised based on the free-text input. We call this recognition "matching". Only after the user matches the displayed question to their free-text question does the assistant output an answer. In other words, it is not the answer that is triggered by the free-text input, but a question is triggered by the user's input. All displayed questions and provided answers are based on an existing question–answer catalogue (standard question set) that is approved by the customer before use.

General operation

  • The information basis of the digital MedInfo Assistant is the publicly available product information (SmPC) for the respective medicinal products. It obtains its information exclusively from the documents made available to it. Each medicinal product is considered in isolation; therefore, every user question must relate to a single medicinal product.

  • Based on the provided documents, AI is used to create answers to uniformly and medically correctly formulated questions (standard question set) for each medicinal product. The resulting question-and- answer pairs are stored in a catalogue. Unlike generative AI systems, such as ChatGPT (see below), the answers to the questions are thus immutable and are never generated in real time.

  • All question-and-answer pairs can be viewed and reviewed by the customer at any time. New question-and-answer pairs can be created by trained personnel. However, they must be approved before being added to the catalogue.

  • When a user asks a question, the question is analysed and matched to a suitable question–answer pair from the catalogue. The user is then presented with the matched question and the approved answer. This approach prevents inappropriate answers relative to the asked question and allows the user to verify the recognised intent by displaying the detected question.

  • Because of the behaviour described above, the digital MedInfo Assistant from Xircle is not a chatbot: it does not engage in dialogue with the user, i.e., it does not ask follow-up questions, presents the same question–answer pairs to all users, cannot make diagnoses, and cannot answer follow-up questions.

Comparison with generative AI applications

  • While generative applications (such as ChatGPT) are able to create new, context-dependent answers and conduct complex dialogues, the digital MedInfo Assistant provides predefined information about medicinal products and only answers a specific scope of questions.

  • In addition, the digital MedInfo Assistant provides standardised answers that cannot be personalised by user input.

  • Generative AI models could potentially provide higher-risk information because they may give the impression of being able to answer complex medical questions, which can lead to misunderstandings or incorrect information. This risk does not exist with the digital MedInfo Assistant, because it does not make diagnoses or treatment decisions and refers unrecognised or high-risk questions to the Medical Information Service.

  • Generative applications can influence users' perceptions and decision- making through their responses. The outputs of the digital MedInfo Assistant are neutral and purely informational in order not to influence users' decisions.

Distinction from the "Medizinproduktegesetz" (MPG)

  • The digital MedInfo Assistant is aimed at the general public. It provides only publicly available information about medicinal products, without making diagnoses or recommending treatment decisions. Therefore, the assistant is offered as an information source and not as a medical device.

  • The digital MedInfo Assistant does not actively intervene in the medical process, as it does not carry out direct interventions or decisions. It merely provides information about medicines without issuing recommendations that could influence users' behaviour regarding their own health or the health of third parties.

  • The digital MedInfo Assistant does not offer personalised recommendations or diagnoses based on specific health data of users and is therefore distinct from regulated medical applications.

  • The functional scope of the digital assistant is clearly limited to answering general questions about medicinal products and offers no additional features, which distinguishes it from medical devices.