In the course of clinical genetics testing, diagnostics, and/or research, there are often requests for individual-level patient data (e.g. variant details, phenotypic data, family history) to be shared between labs, clinics, or with expert curation efforts for care quality improvement, including informing variant classification, defining phenotype spectrum, and treatment efficacy. Sharing individual-level patient data is useful for variant classification, and may, thus, improve patient care. However, there is uncertainty over what types of data — and at what level of detail and for what purposes — can be shared without explicit consent from patients. To provide further clarification, the GA4GH Regulatory & Ethics Work Stream (REWS) aims to develop best practices in this area.

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Benefits

• Aims to survey current state of practice and opinions on clinical data sharing with an international lens
• Aims to develop guidance on the best practices for what level of detail can be shared without explicit consent from a patient for quality care improvement

Target users

Researchers, clinicians, clinical laboratories, data custodians, and data protection authorities