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60	60	**Figure 2:** MIP Data Governance Flow
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62		-//This illustration depicts how data governance and data flow in the MIP are organised and how the legal framework and data management are interlinked. Decision points are indicated.//
	62	+//T(% class="small" %)his illustration depicts how data governance and data flow in the MIP are organised and how the legal framework and data management are interlinked. Decision points are indicated.//
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64	64	=== MIP concepts and definitions ===
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88	88	Diseases are often known to be medical conditions that are associated with specific symptoms and signs.
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90		-​
	90	+== MIP Data Flow ==
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	92	+​[[image:1728560774193-188.png]]
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	96	+**Figure 3**// MIP Data Flow//
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	98	+//T(% class="small" %)his diagramme illustrates the MIP Data Flow, indicating processing steps prior to data upload and steps after data upload to the MIP.  EHR – electronic health record, MRI - magnetic resonance imaging, ETL - data integration (extract, transform, load), CDE – common data elements, ML – machine learning, GUI – graphical user interface, VM – virtual machine. Data pre-processing: extract data from EHR records and produce pseudonymised data in .csv format; optional Step1: extract brain volumes from MRI images and merge with data extracted from EHR records; Data Quality and Harmonisation: Prepare CDE: if CDE exists – Steps 2B, 4 and 5 are followed; if CDE needs to be prepared, first Steps 2A and 3A need to be performed, followed by Steps 2B, 4 and 5. Data Analysis and ML: anonymised dataset is uploaded either to the federated node in the institution or the dedicated VM on EBRAINS CSCS. Data Analysis can be performed via the Federation Service Layer and User Interface: use of predefined federated algorithms, aggregated results will be retrieved via the GUI.//
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	100	+
	101	+== MIP GDPR compliance assessment ==
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	103	+Several aspects are crucial for demonstrating GDPR compliance. Hereunder is a compliance assessment based on the GDPR core principles:
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	106	+(% style="color:#27ae60" %)**Lawfulness, Fairness, and Transparency (Article 5 GDPR)**
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	108	+**Lawfulness and Fairness:** In alignment with GDPR requirements for lawful processing (Article 6(1)(a)), the MIP legal contracts with Data Providers require that data processing is based on informed consent obtained from data subjects. It requires users to accept the EBRAINS General Terms of Use, adhering to all applicable laws and regulations, including GDPR. Data Transfer Agreements (DTAs) and Data Sharing Agreements (DSAs) provide a legal framework and are mandated before any data transfer or data sharing, ensuring compliance with Article 28(3) regarding processor agreements (GDPR Articles 5(1)(a), 6, and 7). Strict authentication and authorisation procedures are in place, to only provide access to accredited users. Data anonymisation is required before integration in the MIP, which minimises the risk of reidentification, protecting data subjects from potential harm (GDPR Article 6(1)(a)). An additional built in privacy threshold restricts data analysis to receiving aggregate results of at least 10 participant records.
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	110	+**Transparency:** The open-source nature of the MIP promotes transparency by providing accessible source code, fostering community involvement, and offering clear information about data governance, federated queries, and data usage without moving original data from its location. Detailed technical and user documentation is available at [[https:~~/~~/github.com/HBPMedical/mip-docs>>url:https://github.com/HBPMedical/mip-docs]], an interactive user guide is accessible directly on the platform.
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	112	+(% style="color:#27ae60" %)**Purpose Limitation**
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	114	+The MIP processes data for specified explicit, and legitimate purposes related to clinical research of each of the MIP Federations (dementia, traumatic brain injury, epilepsy, mental health, and stroke). Data is not moved or downloaded from the platform, maintaining the integrity of the purpose limitation principle (GDPR Article 5(1)(b)).
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	116	+(% style="color:#27ae60" %)**Data Minimisation**
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	118	+The MIP adheres to the principle of data minimisation by only processing data necessary for the research purposes stated. This includes the use of Common Data Elements (CDEs) to standardise and limit the scope of data collected or re-used. All data is anonymised, minimising the exposure of personal data (GDPR Article 5(1)(c)).
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	120	+(% style="color:#27ae60" %)**Accuracy**
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	122	+MIP includes tools like the MIP Data Catalogue and the MIP-DQC Tool to help data managers/curators to ensure data accuracy and quality before data is integrated. Data validation and cleaning are integral parts of the data preparation process (GDPR Article 5(1)(d)).
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	124	+(% style="color:#27ae60" %)**Storage Limitation**
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	126	+Data within the MIP is kept only as long as necessary for the scientific research purposes. The platform’s architecture, which involves retaining data control at the level of the data provider, mitigates the risks associated with long-term storage, supporting compliance with GDPR’s storage limitation principles (GDPR Article 5(1)(e)). Data Providers can at any time decide that a federation is to be discontinued, either based on the time limits set in the legal contracts or at any time this seems to be appropriate.
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	128	+(% style="color:#27ae60" %)**Integrity and Confidentiality**
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	130	+MIP employs strong authentication, encryption, and a secure VPN for data protection. The federated analysis framework ensures that data remains confidential and is only accessed by accredited users (GDPR Articles 5(1)(f), 25, and 32).
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	132	+(% style="color:#27ae60" %)**Accountability**
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	134	+Data owners are responsible for ensuring ethical compliance and the integrity of research data. MIP’s governance framework enforces accountability among data controllers and processors by maintaining records of processing activities including legal agreements and ensuring that data controllers and processors adhere to GDPR requirements. (GDPR Article 5(2)).
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	136	+(% style="color:#27ae60" %)**Data Protection by Design and by Default**
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	138	+The terms of use of the platform ensures that data is anonymised and remains within the original hospital’s control, reflecting a privacy by design approach. Default privacy settings (e.g., aggregation of results) restrict data analysis, strong authentication and accreditation processes enhance the security of MIP's federations, providing a secure environment for data analysis without exposing individual data (GDPR Article 25).
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	140	+(% style="color:#27ae60" %)**Data Subject Rights**
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	142	+As MIP processes anonymised data, GDPR data subject rights (e.g., access, rectification, erasure) do not directly apply. However, ethical considerations and informed consent ensure that patients’ rights are respected (GDPR Articles 15, 16, 17, and 18, as applicable to the non-anonymised data collection phase). The system's design respects data ownership and control by data controllers, ensuring they can determine accessibility and availability of their data.
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	144	+(% style="color:#27ae60" %)**Data Transfers (Articles 44-50)**
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	146	+The MIP ensures that any data transfers comply with GDPR’s requirements for international data transfers. This is achieved using DTAs and DSAs, ensuring that data transferred across borders is protected under equivalent data protection standards. If data is transferred, secure file transfer solutions are used
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