{"$schema":"https://www.lobbyregister.bundestag.de/json-schemas/R2.22/Lobbyregister-Registereintrag-schema-R2.22.json","source":"Deutscher Bundestag, Lobbyregister für die Interessenvertretung gegenüber dem Deutschen Bundestag und der Bundesregierung","sourceUrl":"https://www.lobbyregister.bundestag.de","sourceDate":"2026-04-22T17:28:15.092+02:00","jsonDocumentationUrl":"https://www.lobbyregister.bundestag.de/informationen-und-hilfe/open-data-1049716","registerNumber":"R002263","registerEntryDetails":{"registerEntryId":70237,"legislation":"GL2024","version":4,"detailsPageUrl":"https://www.lobbyregister.bundestag.de/suche/R002263/70237","pdfUrl":"https://www.lobbyregister.bundestag.de/media/7d/50/677380/Lobbyregister-Registereintraege-Detailansicht-R002263-2026-01-05_14-24-41.pdf","validFromDate":"2026-01-05T14:24:41.000+01:00","fiscalYearUpdate":{"updateMissing":true,"lastFiscalYearUpdate":"2024-06-30T13:55:21.000+02:00"}},"accountDetails":{"activeLobbyist":false,"activeDateRanges":[{"fromDate":"2024-06-30T13:55:21.000+02:00","untilDate":"2026-01-05T14:24:41.000+01:00"}],"inactiveDateRanges":[{"fromDate":"2026-01-05T14:24:41.000+01:00"}],"inactiveLobbyistStartDate":"2026-01-05T14:24:41.419+01:00","firstPublicationDate":"2022-02-28T16:48:28.000+01:00","lastUpdateDate":"2026-01-05T14:24:41.000+01:00","registerEntryVersions":[{"registerEntryId":70237,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R002263/70237","version":4,"legislation":"GL2024","validFromDate":"2026-01-05T14:24:41.000+01:00","activeUntilDate":"2026-01-05T14:24:41.000+01:00","versionActiveLobbyist":false},{"registerEntryId":39149,"jsonDetailUrl":"https://www.lobbyregister.bundestag.de/sucheJson/R002263/39149","version":3,"legislation":"GL2024","validFromDate":"2024-06-30T13:55:21.000+02:00","validUntilDate":"2026-01-05T14:24:41.000+01:00","versionActiveLobbyist":true}],"accountHasCodexViolations":false},"lobbyistIdentity":{"identity":"ORGANIZATION","name":"Ada Health GmbH ","legalFormType":{"code":"JURISTIC_PERSON","de":"Juristische Person","en":"Legal person"},"legalForm":{"code":"LF_GMBH","de":"Gesellschaft mit beschränkter Haftung (GmbH)","en":"Limited liability company (GmbH)"},"contactDetails":{"phoneNumber":"+493040367390","emails":[{"email":"office@ada.com"}],"websites":[{"website":"https://ada.com/de/"}]},"address":{"type":"NATIONAL","street":"Neue Grünstraße ","streetNumber":"17","zipCode":"10179","city":"Berlin","country":{"code":"DE","de":"Deutschland","en":"Germany"}},"capitalCityRepresentationPresent":false,"legalRepresentatives":[{"lastName":"Nathrath","firstName":"Daniel","function":"Geschäftsführer","recentGovernmentFunctionPresent":false,"entrustedPerson":false,"contactDetails":{}}],"entrustedPersonsPresent":true,"entrustedPersons":[{"academicDegreeBefore":"Professor ","lastName":"Hirsch","firstName":"Martin","recentGovernmentFunctionPresent":false},{"lastName":"Idris","firstName":"Anisa","recentGovernmentFunctionPresent":false},{"lastName":"Lemarié","firstName":"Vanessa","recentGovernmentFunctionPresent":false}],"membersPresent":false,"membershipsPresent":true,"memberships":[{"membership":"Spitzenverband Digitale Gesundheitsversorgung e.V. "}]},"activitiesAndInterests":{"activity":{"code":"ACT_ORGANIZATION_V2","de":"Sonstiges Unternehmen","en":"Other company"},"typesOfExercisingLobbyWork":[{"code":"SELF_OPERATED_OWN_INTEREST","de":"Die Interessenvertretung wird in eigenem Interesse selbst wahrgenommen","en":"Interest representation is self-performed in its own interest"},{"code":"CONTRACTS_OPERATED_BY_THIRD_PARTY","de":"Die Interessenvertretung wird in eigenem Interesse durch die Beauftragung Dritter wahrgenommen","en":"Contracts are awarded to third parties to represent own interests of the company"}],"fieldsOfInterest":[{"code":"FOI_OTHER","de":"Sonstige Interessenbereiche","en":"Other areas","fieldOfInterestText":"Künstliche Intelligenz"},{"code":"FOI_WORK_OTHER","de":"Sonstiges im Bereich \"Arbeit und Beschäftigung\"","en":"Other in the field of \"Work and employment\""},{"code":"FOI_WORK_POLICY","de":"Arbeitsmarkt","en":"Job market"},{"code":"FOI_EU_OTHER","de":"Sonstiges im Bereich \"Europapolitik und Europäische Union\"","en":"Other in the field of \"European politics and the EU\""},{"code":"FOI_LAW_OTHER","de":"Sonstiges im Bereich \"Recht\"","en":"Other in the field of \"Law\""},{"code":"FOI_WORK_RIGHT","de":"Arbeitsrecht/Arbeitsbedingungen","en":"Work right"},{"code":"FOI_EU_DOMESTIC_MARKET","de":"EU-Binnenmarkt","en":"EU internal market"},{"code":"FOI_SS_HEALTH","de":"Krankenversicherung","en":"Health insurance"},{"code":"FOI_HEALTH_OTHER","de":"Sonstiges im Bereich \"Gesundheit\"","en":"Other in the field of \"Health\""},{"code":"FOI_SCIENCE_RESEARCH_TECHNOLOGY","de":"Wissenschaft, Forschung und Technologie","en":"Science, research and technology"},{"code":"FOI_SS_LONGTERM","de":"Pflegeversicherung","en":"Long term care"},{"code":"FOI_HEALTH_SUPPLY","de":"Gesundheitsversorgung","en":"Health supply"},{"code":"FOI_HEALTH_PROMOTION","de":"Gesundheitsförderung","en":"Health promotion"},{"code":"FOI_EU_LAWS","de":"EU-Gesetzgebung","en":"EU legislation"},{"code":"FOI_ECONOMY_SAM_BUSINESS","de":"Kleine und mittlere Unternehmen","en":"Small and medium business"}],"activityDescription":"-Digitalisierung der Gesundheitsversorgung \r\n-Wirtschaftliches Umfeld für Start-Ups in Deutschland \r\n-Vereinheitlichung der Rahmenbedingungen der Branche innerhalb der EU z.B. zum Einsatz von Technologien, die künstlicher Intelligenz zugeordnet werden"},"employeesInvolvedInLobbying":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2023-01-01","relatedFiscalYearEnd":"2023-12-31","employeeFTE":0.2},"financialExpenses":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2023-01-01","relatedFiscalYearEnd":"2023-12-31","financialExpensesEuro":{"from":60001,"to":70000}},"mainFundingSources":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2023-01-01","relatedFiscalYearEnd":"2023-12-31","mainFundingSources":[{"code":"MFS_ECONOMIC_ACTIVITY","de":"Wirtschaftliche Tätigkeit","en":"Economic activity"}]},"publicAllowances":{"publicAllowancesPresent":true,"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2023-01-01","relatedFiscalYearEnd":"2023-12-31","publicAllowances":[{"name":"Bundesministerium für Bildung und Forschung ","type":{"code":"GERMAN_PUBLIC_SECTOR_FEDERAL","de":"Deutsche Öffentliche Hand – Bund","en":"German Public Sector – Federal"},"location":"Deutschland ","publicAllowanceEuro":{"from":60001,"to":70000},"description":"The PATH project is funded by the Federal Ministry of Education and Research as part of the framework program for information security entitled “Digital. Sicher. Souverän” (Digital. Secure. Sovereign). Project partners: Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Institute of International Law, Intellectual Property and Technology Law, Chair of Digital Cultures, Carl Gustav Carus University Hospital Dresden, Leipzig University Hospital, Center for Evidence-Based Healthcare (ZEGV), Ada Health GmbH, Una Health GmbH, movisens GmbH.\r\n\r\nIn the project \"Personal Mastery Health & Wellness Data\" (PATH), the researchers are pursuing the goal of creating a privacy-compliant platform to link personal health data from patient records with data from home health systems. One aspect is the simple and user-friendly access to health data in a graphical overview, which creates the necessary transparency for effective control by users. "}]},"donators":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2023-01-01","relatedFiscalYearEnd":"2023-12-31","totalDonationsEuro":{"from":0,"to":0}},"membershipFees":{"relatedFiscalYearFinished":true,"relatedFiscalYearStart":"2023-01-01","relatedFiscalYearEnd":"2023-12-31","totalMembershipFees":{"from":0,"to":0},"individualContributorsPresent":false,"individualContributors":[]},"annualReports":{"annualReportLastFiscalYearExists":true,"lastFiscalYearStart":"2023-01-01","lastFiscalYearEnd":"2023-12-31","annualReportPdfUrl":"https://www.lobbyregister.bundestag.de/media/c4/ce/677335/Ada_JAP_31-12-23_TE-final_24-000535.pdf"},"regulatoryProjects":{"regulatoryProjectsPresent":true,"regulatoryProjectsCount":1,"regulatoryProjects":[{"regulatoryProjectNumber":"RV0010495","title":"EU KI Verordnung ","printedMattersPresent":false,"printedMatters":[],"draftBillPresent":false,"description":"Durch den Einsatz von KI befinden wir uns in einer grundlegenden Transformation von Untersuchungs- und Behandlungsmethoden im Gesundheitswesen.\r\nDas Zusammenspiel zwischen der KI-VO und dem bestehenden Medizinprodukterecht birgt die akute Gefahr, intransparente, überlappende und widersprüchliche Anforderungen zu schaffen, die in einem bereits angespannten Sektor zu einer innovationshemmenden bürokratischen Überlastung beitragen würden.\r\nUm dieser Gefahr entgegenzuwirken und zur Unterstützung der Arbeit der deutschen Vertreter:innen in der nationalen Gesetzgebung, in relevanten europäischen Gremien zur Gestaltung von harmonisierten Normen und der Entwicklung von Guidance-Dokumenten, schlagen wir konkrete Maßnahmen zur Lösung vor.","affectedLawsPresent":false,"affectedLaws":[],"fieldsOfInterest":[{"code":"FOI_OTHER","de":"Sonstige Interessenbereiche","en":"Other areas","fieldOfInterestText":"Künstliche Intelligenz"}]}]},"statements":{"statementsPresent":true,"statementsCount":1,"statements":[{"regulatoryProjectNumber":"RV0010495","regulatoryProjectTitle":"EU KI Verordnung ","pdfUrl":"https://www.lobbyregister.bundestag.de/media/f9/68/326944/Stellungnahme-Gutachten-SG2406250242.pdf","pdfPageCount":20,"text":{"copyrightAcknowledgement":"Die grundlegenden Stellungnahmen und Gutachten können urheberrechtlich geschützte Werke enthalten. Eine Nutzung ist nur im urheberrechtlich zulässigen Rahmen erlaubt.","text":"Exemplary application of the EU Al Act to medical device use cases \r\n\r\nIn response to the stakeholder dialogue conducted by your ministry on March 25th, 2024, we would like to present a medical device industry perspective in applying the EU Al Act to specific medical devices. \r\n\r\nThe four use cases attached have been provided by Ada Health GmbH, CADS GmbH, Carl Zeiss Meditec AG and Siemens Healthineers AG (the content of each use case is the sole responsibility of its providing company). These use cases cover a diverse range of medical device applications such as AI based software to diagnose (segmentation, classification and volume determination), to predict disease progression, to guide and to monitor therapies in the field of bones, brain and lung images as well as AI based symptom assessment. All use cases are subject to the Medical Device Regulation (MDR) or the In-vitro-Diagnostic Medical Device Regulation (IVDR).   \r\nWhile the submitted use cases differ with respect on how AI is specifically integrated in the presented medical devices, all use cases reflect the need for further details as well as more specific guidelines on the intention and interpretation of the EU AI Act in particular with respect to the following aspects:   \r\nArticle 6: Classification Rules for High-Risk AI Systems\r\nAll submitted use cases highlight the need for more precise specification regarding the classification of an AI system that is intended to be used as a safety component of a product, or that itself is a product as a high-risk system. \r\nOur current understanding of the systematic categorization of High-Risk AI Systems is summarized as follows:  \r\nBeyond the logic of classification, defining criteria such as\r\n‘the AI System is intended to improve the result of a previously completed human activity’ Article 6 (3 b) EU AI Act\r\nOR\r\n‘AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates’ Annex III 4 (a) EU AI Act \r\nOR\r\n‘AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance’ Annex III 5 (c) EU AI Act\r\nshould be further specified, too. For instance:\r\n1.\tIs an AI system to be classified as high-risk in case it is categorized as a medical device of risk class I acc. to MDR with an intended purpose of vision monitoring and that is used by an airline company for recruitment and selection of pilots (intended purpose of vision monitoring does not exclude explicitly the use case vision monitoring in pilots)?\r\n2.\tDoes any intended function that determines the risk of a disease or therapy progression drive the classification of the medical device as a high-risk AI system in case a private health insurance company in Europe uses the outcome of the medical device to adjust its insurance premiums?\r\nIn summary, we received several requests with respect to technical definitions as well as interpretation of the AIA regarding the categorization of high-risk AI systems. Further, guidance is needed to facilitate the intended implementation.   \r\nArticle 9: Risk Management System \r\nAll submitted use cases emphasize the need for more precise specification regarding the addressed risk according to Article 9 EU AI Act. As for medical devices, the risk management with respect to the intended purpose of the medical device is already addressed and regulated under MDR/IVDR. It should be confirmed that applying the EU AI Act’s requirements towards a risk management system to a medical device needs to be done in accordance with the medical device’s intended purpose (of which the AI system may only be a part).  \r\nArticle 14: Human Oversight \r\nThe application of Article 14 EU AI Act to the submitted use cases leads to manifold requests for more precise specification of the clause. Here, also the general intention of the regulation is not well understood. Requests of the industry that our associations received addressed the question whether Art. 14 EU AI Act is intended to determine that each individual use or manifestation of the AI system, or its component, should be subject to human oversight. In addition, provided definitions such as \r\n“High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use” Article 14 (1) EU AI Act \r\nlack specification with respect to the addressed situation. For instance, if an AI system analyzes images before experts can access a patient file, should human oversight take place at this stage in time (human oversight to the technical process) or once the results of the AI system are available for expert review (human oversight to the results). If the AI system is built in a way that the results can be reviewed by an expert, is this already fulfilling the passus “effectively overseen by natural persons during the period in which they are in use”?  Moreover, certain interruptions of the technical processes of AI systems might lead to unintended results and pose a security risk itself. In addition, typical implementations of an AI system or its components, for instance as a mobile app, do not allow for human-machine interface tools that are addressed by experts. \r\nAgain, more specific guidance including technical definitions with respect to the application of human oversight will be highly appreciated. \r\nThe undersigned associations would like to thank you for the opportunity to address the above points and appeal to the German Federal Government to address the existing challenges in implementing the EU AI Act as soon as possible and to develop solutions in agreement with the proposed mitigation measures.  \r\nAs regulatory compliance is of uttermost relevance for the future of our represented industry, we are committed to being a proactive partner and look forward to supporting this innovative framework policy.  \r\nSincerely yours"},"recipientGroups":[{"recipients":{"parliament":[],"federalGovernment":[{"department":{"title":"Bundesministerium der Justiz (BMJ) (20. WP)","shortTitle":"BMJ (20. WP)","url":"https://www.bmj.de/DE/Startseite/Startseite_node.html","electionPeriod":20}},{"department":{"title":"Bundesministerium für Gesundheit (BMG)","shortTitle":"BMG","url":"https://www.bundesgesundheitsministerium.de/","electionPeriod":20}},{"department":{"title":"Bundesministerium für Wirtschaft und Klimaschutz (BMWK) (20. WP)","shortTitle":"BMWK (20. WP)","url":"https://www.bmwk.de/Navigation/DE/Home/home.html","electionPeriod":20}}]},"sendingDate":"2024-06-11"}]}]},"contracts":{"contractsPresent":false,"contractsCount":0,"contracts":[]},"codeOfConduct":{"ownCodeOfConduct":false}}