Data Access Governance & e-DUA
Multi-tiered genomic access framework, Saudi Personal Data Protection Law (PDPL) compliance, and Electronic Data Use Agreement (e-DUA) signing workflow for Enigma Clinical Platform.
- 3 tiers
- governance tiers
- me-central2
- sovereign region
- Saudi PDPL & NCA
- compliance standards
- 12 months
- token lease period
Three-Tier Data Access Governance Model
To safeguard patient confidentiality, uphold genomic data sovereignty, and comply with the Saudi Personal Data Protection Law (PDPL), Enigma Clinical Platform operates a structured three-tier data access governance architecture. This model balances open global scientific inquiry with stringent institutional controls for individual-level clinical genomes.
Public Summary Access
Aggregated population-level allele frequencies and variant annotations designed for rapid clinical variant classification and global academic reference.
Open to the public, clinicians, diagnostic laboratories, and researchers worldwide without registration.
- Aggregated cohort allele frequencies rounded to 3 decimal places
- GRCh38 variant coordinates and gene annotations
- Clinical significance classifications (ClinVar, ACMG/AMP criteria)
- In silico functional effect predictions and consequence summaries
- Gene-level constraint scores (pLI, LOEUF, mis_z)
- Automated small-cell suppression (cell counts < 5 suppressed)
- Masked singleton frequencies to prevent mathematical re-identification
- Zero individual-level genotypes or raw sequence reads
- Strict k-anonymity differential privacy filters
Registered Researcher
Detailed population genetics metrics and regional sub-population stratifications for verified academic, healthcare, and biomedical researchers.
Accredited biomedical researchers, clinical fellows, genetic counsellors, and postdocs with verified institutional or academic email domains (.edu, .org, MOH, hospital domains).
- Exact unrounded allele counts (AC, AN, Hom, Het, Hemi)
- Regional demographic stratification across Saudi provinces (Central, Western, Eastern, Southern, Northern)
- Runs of homozygosity (ROH) and founder variant frequency registries
- Extended in silico predictors (AlphaMissense, REVEL, SpliceAI, CADD, ESM1b)
- Custom gene panel creation, cohort overlap comparison, and batch variant query up to 10,000 variants
- Pseudonymized demographic groupings
- Digitally signed non-reidentification code of conduct
- Leaky-bucket API rate limiting to prevent automated scraping
- Tamper-evident audit logging of all queried variants and panels
Controlled Clinical & Research Data
Individual-level de-identified genomic records, phenotypic co-occurrence metadata, and raw read-level streaming within a secure sovereign cloud enclave.
Principal Investigators (PIs) and authorized research groups with active Institutional Review Board (IRB) ethical approval and an executed Data Use Agreement (e-DUA).
- De-identified individual-level genotype matrices (multi-sample VCF/BCF)
- Standardized phenotypic co-occurrence data (HPO terms, age bands, broad disease categories)
- Raw sequencing read streaming (BAM/CRAM) via GA4GH htsget secure API
- Full-depth structural variant (SV), copy-number variant (CNV), and mobile element insertion (MEI) callsets
- Access to Sovereign Analytical Sandbox on Google Cloud Confidential VMs in Dammam (me-central2)
- Zero Data Egress policy: compute runs in Dammam cloud enclave; raw files cannot be downloaded
- Customer-Managed Encryption Keys (CMEK) physically located in Saudi Arabia
- Dual-party Data Access Committee review and signed institutional legal guarantee
- Automated egress airlock review for derived summary statistics
- Immutable cryptographic audit ledger recording every file and read access
Governance & Access Comparison Matrix
| Governance Dimension | Tier 1: Public Summary | Tier 2: Registered Researcher | Tier 3: Controlled Clinical Data |
|---|---|---|---|
| Access Authorization | Public (Open access without login) | Verified institutional / academic account + MFA | Formal IRB ethics protocol + DAC approval + signed e-DUA |
| Genomic Resolution | Aggregate allele frequencies rounded to 3 decimals | Exact allele counts (AC, AN, Hom, Het, Hemi) | Individual-level de-identified genotypes & multi-sample VCF |
| Raw Sequencing Reads | Not accessible | Not accessible | Secure streaming (BAM/CRAM) via GA4GH htsget endpoint |
| Regional Stratification | National cohort aggregate only | Provincial breakdown (Central, Western, Eastern, Southern, Northern) | Full sub-cohort & sub-population demographics |
| Phenotypic Metadata | None (Variant-level only) | Aggregated disease association flags (OMIM / Orphanet) | Individual HPO terms, age groups, and co-morbidities |
| Privacy Engine | k-Anonymity (k ≥ 5) & small-cell suppression | Pseudonymized summaries & query rate limiting | Air-gapped Sovereign Analytical Enclave & Confidential VMs |
| Data Residency | Global CDN cache of public summaries | Google Cloud Dammam (me-central2) with sovereign replication | Strictly Google Cloud Dammam (me-central2) with zero foreign egress |
| Token Validity & Lease | Permanent (Unauthenticated) | 12-Month auto-expiring OAuth2 token | 12-Month cryptographic grant (Annual DAC renewal) |
| Data Export Rights | Export summary tables & variant CSV/JSON | Export annotated variant lists & frequency matrices | Zero raw egress; export approved aggregate results only |
Saudi PDPL & Sovereign Regulatory Compliance
Human genomic data constitutes sensitive personal health and biometric data under Saudi statutory law. To ensure strict alignment with Kingdom mandates, Enigma Clinical Platform is engineered according to five foundational security and regulatory principles:
Saudi Personal Data Protection Law (PDPL)
Enacted via Royal Decree No. M/19 and amended by Royal Decree No. M/148, the PDPL mandates rigorous protections for health data. Enigma Clinical enforces strict purpose specification, informed consent verification, lawful secondary research processing, and participant rights oversight coordinated by the institutional Data Protection Officer.
Sovereign Cloud Residency (`me-central2` Dammam)
All raw genomic data, variant databases, and serverless compute pipelines are hosted physically within the Kingdom of Saudi Arabia in Google Cloud's Dammam sovereign region (me-central2). VPC Service Controls enforce a cryptographic boundary prohibiting cross-border data egress without formal dispensation.
NCA ECC-1:2018 Cybersecurity Controls
Data at rest is secured via AES-256 Customer-Managed Encryption Keys (CMEK) managed via Hardware Security Modules (Cloud HSM) in Saudi Arabia. Data in transit is protected by mandatory TLS 1.3 encryption with strict Attribute-Based Access Control (ABAC) verified on every query.
Zero Data Egress & Trusted Research Environment (TRE)
Tier 3 controlled genomic data operates on a “bring-your-algorithm-to-the-data” philosophy. Authorized researchers conduct analysis inside Google Cloud Confidential VMs with zero internet egress; only reviewed statistical aggregates and approved figures can be exported from the secure enclave.
Electronic Data Use Agreement (e-DUA) Terms
The Electronic Data Use Agreement governs access to and handling of non-public genomic data in Enigma Clinical Platform. Both the Principal Investigator and the requesting institution must read and affirm these terms prior to receiving research credentials.
Standard Agreement Terms (Version 2.4 / 2026)
Legal ReferenceArticle 1. Non-Reidentification & Data Subject Protection
The Recipient and all authorized project personnel solemnly pledge never to attempt to re-identify, de-anonymize, or contact any research participant whose data is housed in the Enigma Clinical Platform. The Recipient explicitly agrees not to link, cross-reference, or combine ECP data with any outside public, genealogical, administrative, or clinical datasets that could conceivably reveal the identity of an individual donor or family lineage.
Article 2. Saudi PDPL & Sovereign In-Kingdom Storage Mandate
In strict compliance with the Saudi Personal Data Protection Law (PDPL, Royal Decree No. M/19 and M/148) and the National Cybersecurity Authority (NCA) Essential Cybersecurity Controls (ECC-1:2018), genomic data is recognized as sensitive biometric and health data. All compute, storage, and processing of individual-level records must reside strictly within sovereign infrastructure in the Kingdom of Saudi Arabia (Google Cloud me-central2 Dammam or certified on-premise institutional data centres). Cross-border transmission or export of individual-level data outside the Kingdom without explicit statutory dispensation from the competent Saudi authority is strictly prohibited.
Article 3. Approved Purpose & Prohibited Uses
Data granted under this agreement shall be used solely and exclusively for the non-commercial biomedical research purposes described in the approved IRB protocol and Data Access Request (DAR). Prohibited uses include, but are not limited to: direct commercial exploitation of raw genomic files, health or life insurance underwriting, employment screening, discriminatory population profiling, genealogical ancestry recreation, or forensic law-enforcement purposes without a binding Saudi judicial order.
Article 4. Cybersecurity Hygiene & Mandatory Incident Reporting
The Recipient institution agrees to maintain rigorous security safeguards, including encryption of data at rest (AES-256) and in transit (TLS 1.3), role-based access control with multi-factor authentication (MFA), and audit logging. In the event of any suspected security incident, unauthorized access, credential compromise, or data spill, the Principal Investigator must notify the Data Protection Officer at privacy@enigmagenomics.com within twenty-four (24) hours of discovery.
Article 5. Publication Embargoes, Citations & Acknowledgment
The Recipient agrees to acknowledge the Enigma Clinical Platform (ECP) in all peer-reviewed scientific publications, preprints, conference presentations, and patents resulting from the use of this data. Citations must include the platform canonical URL, dataset DOI, and standard attribution text. Furthermore, researchers must submit a summary of planned publications to the Data Access Committee at least sixty (60) days prior to public submission or disclosure.
Article 6. Auto-Expiring Access Tokens & Annual Re-Certification
Access credentials and cryptographic API tokens are issued for a maximum validity period of exactly twelve (12) months. Thirty (30) days prior to token expiration, the Principal Investigator must submit an annual project progress report, confirm ongoing IRB approval, and re-attest adherence to this e-DUA. Failure to complete annual re-certification will result in automatic token revocation and suspension of access to controlled datasets.
Article 7. Termination, Revocation & Data Destruction
Upon project completion, expiration of IRB approval, or written notice from the Data Access Committee, the Recipient must immediately cease all access to SGP services, securely erase any local cached derivative files, and submit a written Certificate of Destruction within thirty (30) calendar days.
Execute Electronic Data Use Agreement (e-DUA)
Use this interactive form to submit your institutional e-DUA. Tier 2 applications receive fast-track institutional domain verification; Tier 3 requests generate a verified e-DUA execution token required for your Data Access Committee (DAC) application.