Introducing Cell and Gene Therapy Orchestration Architecture and Design Principles for Integrators

This lesson outlines the basics of SAP Cell and Gene Therapy Orchestration Architecture and Design Principles. Furthermore, an overview of key external systems that SAP Cell and Gene Therapy Orchestration is interacting with is given.

SAP Cell and Gene Therapy Orchestration is an SAP Industry Cloud Solution for the Life Science industry. This is a concept that SAP follows to provide industry-specific solutions including solutions from partners, that are leveraging the SAP Business Technology Platform to extend the SAP Intelligent Suite capabilities with industry-specific solutions while keeping the core clean and therefore easier to upgrade and operate.

As such, SAP Cell and Gene Therapy Orchestration is built using services of the SAP Business Technology Platform (SAP BTP) and uses open API's and the SAP Integration Suite to connect to external systems for data exchange. Furthermore, we are using the SAP Event Mesh service to publish and receive updates from external systems during the execution of treatment orders. Another service of the SAP BTP that we employ is the workflow management service (part of the process automation suite) to define workflows. Access to SAP Cell and Gene Therapy Orchestration is provided using a standard web browser and the SAP Fiori Launchpad. With a subscription, a customer gets access to a set of tenants running SAP Cell and Gene Therapy Orchestration for non-productive usage (for example for development, test, qualification, training) and one productive tenant for productive usage. This system landscape then can be integrated with other customer on-premise or cloud applications either using SAP Integration Suite or another integration middleware.

Several external services will be typically integrated with SAP Cell and Gene Therapy Orchestration. An ERP system, which can be an SAP ECC or SAP S/4HANA system or a third-party ERP. For a seamless integration with an SAP S/4HANA system, SAP Cell and Gene Therapy Orchestration comes with an SAP S/4HANA integration add-on and integration content for the SAP Integration Suite. To receive treatment requests, SAP Cell and Gene Therapy Orchestration needs to be integrated with the patient management and on-boarding application as well as the Protected Health Information (PHI) data vault. As part of the SAP Cell and Gene Therapy Orchestration subscription, the so called "Data and Document Vault Integration add-on for SAP Cell and Gene Therapy Orchestration" is provided which helps to integrate the PHI data and document vault in the customer system landscape.

SAP Cell and Gene Therapy Orchestration integrates with the Protected Health Information (PHI) Data Vault, ensuring secure handling and management of sensitive patient data. This integration is crucial for maintaining compliance with regulatory standards and safeguarding patient privacy.

Here's an overview of how this integration works:

1. Access Control

   Authorization-Based Access: Only authorized users can access the PHI Data Vault. Access rights are managed through the system's role-based access control (RBAC) settings, ensuring that only personnel with the appropriate permissions and needs can view or manipulate patient data.

2. Data Handling
   • Data Storage: Patient data, including PHI, is securely stored in the customer's PHI Data Vault. This storage solution is designed to meet stringent security and compliance requirements, protecting data against unauthorized access and breaches. Furthermore, SAP Cell and Gene Therapy Orchestration can utilize multiple PHI Data Vaults which can be in different regions ensuring compliance to regulatory requirements.
   • Data Encryption: All data stored in the PHI Data Vault is encrypted both at rest and in transit, ensuring that patient information remains confidential and secure.
3. Integration Points
   • Application Access: From various applications within SAP Cell and Gene Therapy Orchestration, users can access PHI data stored in the Data Vault. This access is controlled and audited to ensure compliance and traceability.
   • Document Linking: Users can link documents containing PHI to relevant entities such as treatment orders, shipments, and processing activities. This functionality is accessible from within the document management system, enabling seamless integration and easy access to necessary documentation.
4. Functionality and Features
   • Viewing and Managing Documents: Users can view, download, and print documents stored in the document vault. They can also upload new documents, ensuring that all relevant documentation is kept up-to-date and accessible.
   • PHI Data Access Control: The system ensures that PHI data access is restricted based on user roles and permissions, preventing unauthorized access and ensuring that only designated personnel can handle sensitive information.
5. Compliance and Security
   • Audit Logs: The system maintains comprehensive audit logs of all access and modifications to PHI data and documents. These logs are critical for tracking changes, ensuring compliance with regulatory standards, and conducting audits.
   • Data Protection Measures: Additional data protection measures, such as regular security assessments, encryption updates, and access reviews, are implemented to maintain the highest standards of data security and compliance.
6. User Interface and Experience
   • Intuitive Access: The integration is designed to be user-friendly, with intuitive interfaces that allow users to access and manage PHI data and documents without compromising security or functionality.
   • Seamless Workflow Integration: The system ensures that PHI data management is seamlessly integrated into the broader workflow of SAP Cell and Gene Therapy Orchestration, enhancing efficiency and reducing the complexity of handling sensitive information by using the SAP Cell and Gene Therapy Orchestration apps that are provided as part of the "Data and Document Vault Integration add-on for SAP Cell and Gene Therapy Orchestration".

By providing this add-on and leveraging its features, SAP Cell and Gene Therapy Orchestration ensures that PHI data and document management is secure, compliant, and seamlessly integrated into the operational workflow, supporting the integrity and confidentiality of patient information.