Technical Proposal

Provision and Operation of a Digital Platform for Teledermatology Consultation for AOK Sachsen-Anhalt

Introduction: A Partnership for Advanced Dermatological Care

AI Labs Group S.L. is pleased to present this technical proposal in response to tender AOK SAN 2025-0028 Teledermatologie, detailing our premier solution, Legit.Health Plus, for establishing an innovative teledermatology service for AOK Sachsen-Anhalt's members. Our overarching goal is to present Legit.Health Plus as the premier solution for establishing an innovative, efficient, and reliable teledermatology service. This proposal details how our platform will empower participating dermatologists and deliver exceptional care to AOK's insured members, in full alignment with the objectives of special care contracts under § 140a SGB V.

Understanding of AOK Sachsen-Anhalt's Objectives

We clearly understand that the core mission of this tender is to provide AOK Sachsen-Anhalt's insured members with rapid, location-independent specialist assessment of skin conditions. The central objective is to implement a digital platform that not only facilitates expert telemedical consultations but also ensures a seamless transition between telemedical consultation and standard outpatient care ("nahtlosen Übergang zwischen der telemedizinischen Konsultation und der ambulanten Regelversorgung"). Our proposal is designed to directly address this critical requirement by offering a solution that is technologically advanced, clinically validated, and built for interoperability within the German healthcare ecosystem.

Proposed Solution: Legit.Health Plus

To meet and exceed the tender's requirements, we propose Legit.Health Plus, our state-of-the-art teledermatology platform. Legit.Health Plus is not merely software; it is a certified Class IIb Medical Device under EU Medical Device Regulation (MDR) 2017/745. It is purpose-built to empower dermatologists with objective data and advanced analytical tools, thereby enhancing diagnostic confidence and delivering superior patient outcomes.

This proposal will now provide a detailed explanation of the Legit.Health Plus platform's clinical capabilities, technical architecture, and regulatory standing, demonstrating its suitability as the optimal solution for AOK Sachsen-Anhalt.

Legit.Health Plus: A Clinically Advanced and Certified Solution

The strategic selection of a teledermatology platform requires a focus on solutions that are not only technologically capable but also medically certified and clinically effective. An AI-driven platform must serve as a trusted co-pilot for the clinician, offering reliable, objective data that enhances, rather than complicates, the care process. This section details the core functionalities of Legit.Health Plus, demonstrating how its design philosophy prioritizes clinical utility, robust diagnostic support, and tangible, user-centric benefits for all stakeholders.

Solution Overview and Intended Purpose

Legit.Health Plus is a software-only medical device that leverages advanced computer vision algorithms to process images of the skin and its associated structures. Its principal function is to provide healthcare practitioners with a wide range of clinical data extracted from these images. By transforming visual information into objective metrics and probabilistic insights, the device enhances the efficiency and accuracy of care delivery, supporting clinicians in their professional evaluations and decision-making processes.

Core Diagnostic Support Capabilities

The platform delivers two primary analytical functions that work in tandem to provide a comprehensive, data-rich view of a patient's condition.

AI-Powered Clinical Sign Quantification

Legit.Health Plus provides quantifiable data on the intensity, count, and extent of visible clinical signs. This transforms subjective visual assessment into objective, repeatable measurements, which is invaluable for both initial assessment and longitudinal monitoring of treatment efficacy. The platform can identify and quantify a wide range of signs, including but not limited to:

Sign Category Examples Inflammation Erythema, Swelling (Oedema), Induration Surface Changes Desquamation, Crusting, Xerosis, Lichenification Lesions & Tissue Papule, Nodule, Pustule, Necrotic Tissue, Granulation Tissue

Interpretative ICD Category Analysis

The platform provides an interpretative probability distribution across possible International Classification of Diseases (ICD) categories based on the visual information contained in an image. It is critical to understand that this is an advanced decision-support tool, not a standalone diagnostic test.

Unlike a simple diagnostic test that yields a binary true/false result, Legit.Health Plus provides a full spectrum of probabilities across all relevant skin-related ICD categories. This sophisticated output is designed to complement a dermatologist's expertise by presenting a data-driven overview of possibilities. The nature of this probability distribution provides further insight: in ambiguous cases, the output may be platykurtic, with probabilities spread flatly across many potential conditions. Conversely, when visual evidence is strong, the distribution becomes leptokurtic, with a sharp peak concentrating the probability on a few likely ICD categories. This nuanced output broadens the differential diagnosis and supports a more informed clinical judgment, while the final diagnostic decision always remains with the healthcare professional.

Clinical Benefits for All Stakeholders

The implementation of Legit.Health Plus offers distinct advantages to each group involved in the care pathway.

• For AOK Insured Members:
  • Rapid Access: Enables fast, specialist consultations for skin conditions, reducing wait times and anxiety.
  • Convenience: Provides location-independent care, offering access to specialists regardless of the member's geographical location.
  • Continuity: Facilitates consistent monitoring of chronic conditions through objective data tracking.
• For Participating Dermatologists:
  • Objective Data: Offers precise, quantifiable measurements of clinical signs for more accurate assessments.
  • Enhanced Decision Support: Provides an AI-generated probability distribution of potential ICD categories to aid in clinical reasoning.
  • Efficient Monitoring: Streamlines the tracking of a patient's condition over time with consistent data points, improving follow-up consultations.
  • Improved Workflow: Automates the measurement of clinical signs, freeing up valuable clinician time.
• For AOK Sachsen-Anhalt:
  • Successful Contract Implementation: Delivers a certified and reliable platform to successfully execute the special care contract under § 140a SGB V.
  • Operational Efficiency: Streamlines the teledermatology workflow, from consultation to data management.
  • Data-Driven Insights: Gathers structured data that can be used to optimize dermatological care pathways and resource allocation.

The powerful clinical capabilities of Legit.Health Plus are made possible by its robust, modern, and interoperable technical architecture.

Technical Architecture and Seamless Integration

A robust and interoperable technical foundation is the bedrock of any successful enterprise healthcare platform. The architecture must not only be reliable and performant but also flexible enough to integrate seamlessly into existing clinical workflows and IT ecosystems. This section details the architecture, integration capabilities, and performance specifications of Legit.Health Plus, proving its readiness for deployment within the AOK Sachsen-Anhalt ecosystem and its ability to fulfill the critical requirement of seamless care transitions.

API-First Design for Maximum Interoperability

Legit.Health Plus is built as an Application Programming Interface (API) that follows the REST protocol. This modern, API-first architectural approach provides a fundamental advantage by completely separating the user interface from the server and data storage. This separation ensures maximum flexibility and adaptability, allowing AOK Sachsen-Anhalt or its partners to integrate the platform’s powerful analytical engine into any existing or future system with ease.

Adherence to Healthcare Data Standards

To ensure seamless data exchange and interoperability, the platform is designed in full compliance with the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard. Adherence to HL7 FHIR is critical for integrating with diverse healthcare systems, such as Electronic Health Records (EHRs), and is the key technical enabler for achieving the tender's objective of a smooth transition to ambulatory care. Furthermore, our platform includes a comprehensive OpenAPI Specification, providing clear and developer-friendly documentation that simplifies the integration process.

Embedded Data Integrity and Quality Assurance

The platform features multiple integrated AI models designed to ensure that only high-quality, clinically relevant data is processed, safeguarding the integrity of the system and the reliability of its outputs.

• Dermatology Image Quality Assessment (DIQA): This model functions as a crucial preliminary check. Before any clinical analysis is performed, DIQA assesses the submitted image for photographic quality parameters such as focus, exposure, and contrast. This ensures that only images of sufficient clinical utility are processed, preventing suboptimal predictions based on poor-quality inputs.
• Image Domain Check: This model acts as a security and integrity layer. It verifies that an uploaded image is, in fact, a dermatological photo. This prevents the accidental or malicious processing of out-of-domain images (e.g., photos of documents, objects, or non-skin body parts), thereby preventing misuse and ensuring the system's resources are used as intended.

Performance and Reliability Specifications

Legit.Health Plus is engineered for high availability and enterprise-grade performance. Our service level commitments ensure a reliable and responsive platform for both clinicians and patients.

Metric Specification Average Response Time 1400 milliseconds Service Availability Rate 100% (per month) Maximum Application Recovery Time (RTO) 6 hours Maximum Data Loss (RPO) None (zero data loss is permissible) Backup Frequency Every 12 hours

This robust technical architecture is governed by a strict regulatory and compliance framework, ensuring the platform operates with the highest standards of safety and efficacy.

Regulatory Compliance and Lifecycle Management

In healthcare technology, regulatory compliance is not an optional feature but a foundational requirement. It serves as the ultimate assurance of a product's safety, quality, and effectiveness. This section provides definitive proof of Legit.Health Plus's status as a certified medical device, outlines our commitment to long-term security and maintenance, and details the clear guidelines for its intended users, demonstrating a mature and responsible approach to product governance.

Medical Device Certification: EU MDR Class IIb

Legit.Health Plus is certified as a Class IIb Medical Device under the stringent European Union Medical Device Regulation (EU MDR 2017/745). This classification is based on Rule 11 of the regulation, which applies to software intended to provide information used for diagnostic or therapeutic purposes.

While a risk analysis based on the MDCG 2019-11 guidance could justify a Class IIa classification, the manufacturer, AI Labs Group S.L., has made a strategic choice reflecting a deep commitment to regulatory maturity and the highest possible safety standards. In their own words: "we have decided to classify the device as Class IIb, even though the guidance suggests Class IIa, because we prefer to err on the side of caution." This provides AOK Sachsen-Anhalt with the assurance of a rigorously vetted and compliant solution.

Platform Lifecycle and Maintenance

We guarantee the long-term viability and security of the Legit.Health Plus platform with a comprehensive lifecycle management plan. The platform has an expected operational lifetime of 5 years, a period that can be extended through ongoing development and maintenance activities. This is supported by:

• A proactive Software Change Management plan for regular updates and functional enhancements.
• Continuous security updates to mitigate emerging cybersecurity threats.
• A formal strategy for managing operating system and tool obsolescence, ensuring the platform remains secure, compatible, and effective for the full contract period and any potential extensions.

Intended User Profile and Required Competencies

To ensure the effective and safe utilization of the platform, we have defined clear profiles for its intended users. It is assumed all users possess the baseline competencies associated with their professional roles.

• Healthcare Professionals (HCPs): This group includes dermatologists, medical doctors, and registered nurses. While no additional official qualifications are required, we recommend that HCPs possess proficiency in capturing high-quality clinical images and a basic understanding of interpreting digital health data within a clinical context.
• IT Professionals: This group is responsible for the technical integration and maintenance of the platform. It is advisable that IT staff have a foundational knowledge of the HL7 FHIR standard and experience with clinical software integration to ensure a smooth and secure deployment.

This structured approach to compliance, maintenance, and user guidance directly supports the quality-based criteria outlined in the AOK Sachsen-Anhalt tender.

Alignment with AOK Sachsen-Anhalt Award Criteria

This section explicitly demonstrates how the features, technical merits, and regulatory compliance of Legit.Health Plus directly map to the quality-based award criteria, which constitute 70% of the total evaluation score. We are confident that our solution not only meets but exceeds the expectations for each criterion, representing the most robust and forward-thinking choice for AOK Sachsen-Anhalt.

Criterion: Functional and Technical Excellence

Legit.Health Plus represents the highest level of functional and technical excellence in the field of teledermatology. This is evidenced by:

• State-of-the-Art AI: Utilization of advanced AI architectures, including the Vision Transformer (ViT), ensures cutting-edge analytical performance.
• Dual-Capability Analysis: The platform’s unique combination of clinical sign quantification and interpretative ICD category analysis provides clinicians with a depth of information unparalleled by simpler systems.
• Embedded Quality Assurance: Integrated models like DIQA automatically ensure that the system operates on high-quality, clinically useful images, guaranteeing the reliability of its outputs.

Criterion: Concept for Seamless Care Integration

Our platform provides a robust and proven concept for achieving the "nahtlosen Übergang" (seamless transition) between teleconsultation and the broader healthcare ecosystem. This is achieved through:

• An API-First Architecture: The REST API design provides maximum flexibility for integration into any current or future clinical workflow system used by AOK or its partners.
• Adherence to Gold Standards: Strict compliance with the HL7 FHIR standard is the technical cornerstone that guarantees interoperability with Electronic Health Records and other systems, fulfilling a core objective of the tender.

Criterion: Solution Cohesion and Reliability

Legit.Health Plus presents a complete and conceptually sound ("Schlüssigkeit des Konzeptes") solution built on a foundation of reliability and trust. The cohesion of our concept is demonstrated by the integration of:

• Regulatory Rigor: Its certification as a Class IIb medical device provides the highest level of assurance regarding its safety, quality, and clinical validity.
• Guaranteed Performance: Clear, enterprise-grade service level metrics, including 100% service availability, ensure the platform is always available for clinicians and patients.
• Proactive Lifecycle Management: A defined 5-year operational lifetime supported by a comprehensive maintenance and security plan demonstrates a commitment to a long-term, low-risk partnership.

Ultimately, AI Labs Group S.L. is not a mere technology vendor; we are the strategic partner best equipped to ensure AOK Sachsen-Anhalt's success in delivering next-generation digital healthcare.

About AI Labs Group S.L.

AI Labs Group S.L. is the legal manufacturer, developer, and provider of the Legit.Health Plus platform. We are a dedicated MedTech company focused on leveraging artificial intelligence to create certified medical devices that empower healthcare professionals and improve patient outcomes.

Detail Information Legal Manufacturer AI Labs Group S.L. Address Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia (Spain) SRN (Single Registration Number) ES-MF-000025345 Contact Email office@legit.health Contact Phone +34 638127476