What can I find here?

• HIP User Account creation
• GDPR compliant data processing on the HIP
• Data Governance Principles
• HIP GDPR compliance assessment

Figure 1: Landing page of the Human Intracerebral EEG Platform HIP

HIP User Account creation

Prerequisite – Step 1: Access to the HIP requires a registered EBRAINS user account, which needs to be permitted and authenticated. EBRAINS user accounts are available to users with a legitimate interest (mainly research and development) from Europe and beyond.

Request an EBRAINS user account: https://www.ebrains.eu/page/sign-up

The HIP endeavours to comply with national and international laws and regulations, comprising principles such as intellectual property rights and the protection of privacy, ethical considerations and security regulations when designing rules and conditions for Access and the use of the platform.

Platform Access – Step 2 : Only EBRAINS authorised Users can request access to the HIP. Currently, accreditation for this access is managed by the CHUV Leadership, oversight is granted by the Data Governance Steering Committee.

Before the User tries to log into the HIP with their EBRAINS account he HAS TO request HIP accreditation by contacting either EBRAINS support at support@ebrains.eu, who will forward the request to the HIP team, by contacting directly support@thehip.app, which is the HIP specific support email or alternatively, or by contacting the HIP team via the EBRAINS website: https://www.ebrains.eu/tools/human-intracerebral-eeg-platform

Accredited users access the HIP through a web-based interface https://thehip.app/login, which will provide them with access to all the available tools and relevant own or shared data.

Upon login, users are mandated to accept the HIP Terms of Use and are required to accept the EBRAINS Terms and Policies https://www.ebrains.eu/page/terms-and-policies, to indicate acceptance and compliance with all applicable laws, regulations, rules, and approvals in the use and sharing of the data, including, but not limited to, the General Data Protection Regulation (GDPR).

GDPR-compliant Data Processing on the HIP

Figure 2: Data Flow on the HIP:  This diagram depicts the different legal and regulatory steps to be taken to be allowed to upload data to the institutional private space of the HIP, the process of creating a collaborative project, and the step of putting anonymised data into the public space.

Terminologies: Project Leader – HIP User initiating and responsible for a collaborative project; Project Member – HIP User accredited to contribute to a collaborative project; Data Controller - The natural or legal person who determines the purposes and means of the processing of personal data provided; DTA – Data Transfer Agreement; DPIA - Data Privacy Impact Assessment

Data Governance Principles

Acquisition: Data will be collected by the physicians or clinical researchers during clinical routine or within the framework of a scientific study based on specific research protocols, approved by the corresponding local and national ethical bodies. This includes that Participants consented to the procedure undertaken to collect their data by signature of an informed consent or consented to the re-use of their data for research purposes, according to EU data protection legislation, also by signature of an explicit consent for use or reuse of their data in research projects.

Pre-processing: The HIP requires data to be de-identified / pseudonymised prior to the data upload. Data curation e.g., annotation, to assure data quality is also required. Preferably, data are transformed into the BIDS format prior to upload, this can however also be performed directly on the platform with available tools. Data Pre-processing and planned processing are evaluated in a DPIA. Based on a signed DTA, and by using approved data transfer protocols, users can transfer the pre-processed pseudonymised medical data onto the HIP. Data Providers qualify as Data Controllers for the uploaded data.

Storage & Usage: The data will be stored in the Data Provider's private space on the HIP, where all available tools and workflows can be used to process their own data. It is not possible to share data in the private space with users from other centres. Data controllers decide on the duration of storage of their research data in the HIP in compliance with their legal obligations.

Sharing & Publication: The HIP facilitates data sharing. If the Data controller wants to share their own data with other HIP users to start a new research project or contribute to an existing research project, a dedicated project can be created as a collaborative space on the HIP. Based on fulfillment of regulatory requirements, data can be copied in the respective project space, where accredited Project Members will be able work towards specified research objectives. Each collaborative project has a defined Project Leader, who is responsible for obtaining relevant approvals. All agreements regarding publications and authorship shall be discussed between relevant parties at the start of the project, guidance is available in the Charter. Importantly, at any time Data Providers will keep full control of all scientific activities performed by the HIP community on their data transferred to the HIP collaborative space, and no scientific publication integrating their data shall be submitted without their consent.

Termination: Collaborative projects have defined start and end-dates, after the end of the project, the data will be removed from the collaborative space and the project will be closed. Requirements for data availability after the project end need to be specified.

Re-use: High-quality Data can and should be re-used for new projects, provided relevant approvals are available. This is an important aspect to valorise data and the major efforts going into data curation and pre-processing.

Archiving & Destruction: Storage requirements can be defined in the DTA or Research protocol. Retention policies and long-term storage possibilities for data on the HIP are currently being worked out, if possible, in alignment with EBRAINS policies.

Fair data: Integration of the EBRAINS Knowledge Graph and implementation of data curation workflows are being under preparation to improve FAIRness of data on the HIP, making the metadata accessible and findable, thus fostering new collaborations.

Public data: Data Controllers might wish to make their data public, which will require anonymisation of the data and transferring them to the HIP public space. Relevant ethical approval needs to be provided. Thereafter, the Data Controllers will have no more control on how, and by whom, the public data might be used, including in terms of scientific publications and authorship. Requirements for appropriate acknowledgment together with the attributed license will be published alongside the public dataset in the EBRAINS Knowledge Graph.
 

Summary of legal steps to be followed, depending on the purpose of the processing or project:

• Patient consent for usage of data for research purposes (specific, general, re-use)
• Ethical clearance for research projects and planned processing
• DPIA * under preparation
• Data Transfer agreement
• Collaboration Agreement
• Data Use agreement

HIP GDPR compliance assessment

Illustration from: GDPR - Back to Basics | URM Consulting

Several aspects are crucial for demonstrating GDPR compliance. Hereunder is a compliance assessment for the HIP, based on the GDPR core principles:

• Lawfulness, Fairness, and Transparency

Lawfulness: The HIP ensures that data processing is based on informed consent obtained from data subjects (participants), aligning with GDPR requirements for lawful processing (Article 6(1)(a)). It requires users to accept the EBRAINS General Terms of Use, HIP General Terms and Conditions, adhering to all applicable laws and regulations, including GDPR.

DPIAs*, Data Transfer Agreements (DTAs) and approved research protocols 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).

**The HIP Data Protection Impact Assessment (DPIA) is currently under full revision and will become functional upon final approval by the CHUV DPO. Per Article 35(3)(b) of GDPR a Data Protection Impact Assessment is required whenever processing is likely to result in a high risk to the rights and freedoms of individuals and at least in the case of large-scale processing of sensitive data.

Fairness: Ethical compliance is ensured by obtaining informed consent before data entry into the HIP, getting ethical approvals of projects and signing data transfer agreements (DTA or DSA) prior to data sharing. Data pseudonymisation is required before integration in the HIP, which minimises the risk of re-identification, protecting data subjects from potential harm (GDPR Article 6(1)(a)). FAIRification efforts to display metadata of datasets on the HIP in the EBRAINS Knowledge Graph are underway.

Transparency: The open-source nature of the HIP promotes GDPR transparency by providing accessible source code, fostering community involvement, and offering comprehensive documentation with clear data flows, empowering stakeholders to review data processing practices and ensuring accountability. The HIP requires that data is processed based on informed consent obtained from participants (GDPR Articles 12, 13), whose data are collected as part of real-world clinical data and according to ethically approved research protocols for research studies. Also, there is detailed user documentation at https://hip-infrastructure.github.io/build/html/index.html . 

• Purpose Limitation

Data is collected for specified, explicit, and legitimate purposes, including clinical research and collaboration within the scientific community. The HIP restricts data use to these defined purposes. Data Controllers define the specific research projects and publications their data can contribute to (GDPR Article 5(1)(b)). Data collected during clinical practice (real-world data), e.g., iEEG data, are provided on the HIP with the specific purpose of creating a cohort of sufficient size to perform meaningful scientific analysis, as these data are very scarce.

• Data Minimisation

Only high-quality data necessary for research is stored and processed, including pseudonymised iEEG data, neuroimaging data, and other relevant health-related data. Data must be pseudonymised and/or anonymised prior to upload to the platform, reducing the risk of unnecessary data exposure. The HIP employs a 3-tiered architecture and implements strict control on data access and sharing (GDPR Article 5(1)(c)).

• Accuracy

Data curation is required before moving from the private to the collaborative space, ensuring data quality and accuracy (GDPR Article 5(1)(d)). This curation aspect is especially important for projects that work collaboratively on data from different centres.

• Storage Limitation

In principle, Data controllers decide the duration of data storage in compliance with legal obligations, ensuring that data is not retained longer than necessary for its intended purpose (GDPR Article 5(1)(e)). Additionally, the HIP will have boundaries and policies for data storage volume and duration, that need to be respected.

• Integrity and Confidentiality

HIP adopts privacy by design principles, ensuring secure data storage and transfer. Pseudonymisation and anonymisation techniques protect personal data, and the platform architecture prevents local data downloads, mitigating misuse risks. Access to private and collaborative spaces is restricted to authorised and accredited users only, with data access permissions managed at user or group levels (GDPR Articles 5(1)(f), 25, and 32).

• Accountability

HIP ensures that data controllers are responsible for their data and its use, managing it throughout its lifecycle, from collection to sharing and publication. Users must comply with GDPR and other applicable laws, and the platform includes mechanisms for accreditation and oversight by the Data Governance Steering Committee. Data Transfer Agreements (DTA) and Data Use Agreements (DUA) are in place, outlining responsibilities and compliance with GDPR (GDPR Article 5(2)).

• Data Protection by Design and by Default

HIP’s 3-tier architecture and privacy-aware environment demonstrates compliance with data protection principles by design. Access to different data spaces is tightly controlled, and data is always pseudonymised or anonymised before sharing (GDPR Article 25).

• Data Subject Rights

Patients' rights to access, rectify, and erase their data are respected. The responsibility lies with the Data controllers, who can remove their data from private and collaborative spaces, ensuring compliance with GDPR rights (GDPR Articles 15, 16, 17, and 18).

• Data Transfers (Articles 44-50)

The HIP 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.