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This document outlines Points to Consider (PtC) for the responsible sharing of human genomic and health data internationally by Health Technologies Industries (HTI). HTI can contribute unique resources, technologies, and expertise to translating genomic discoveries into improvements in human health. International data sharing can further accelerate research and innovation. It can strengthen statistical power and reproducibility, facilitate collaboration and creative re-use of real-world evidence, increase the representativeness of precision medicine databases, and power AI approaches (including machine learning, deep learning and predictive modeling) that support genomic interpretation and clinical decision-making. Yet, research, innovation, and data sharing to advance precision medicine also raise important ethical issues, which include risks to the welfare and privacy of sequenced individuals, their families, and communities. The legal and policy landscape relating to data sharing is rapidly evolving. Relevant norms apply in areas of data privacy and protection law; AI law, governance, and ethical principles; research ethics regulations; and data sharing policies. This PtC tailored for HTI builds on the GA4GH’s Framework for Responsible Sharing of Genomic and Health-related Data (2014, re-approved 2019) and subsequent policies. The Framework is founded on human rights, aiming in particular to activate the right of everyone to share in scientific advancement and its benefits. Relevant Core Elements include: Transparency; Accountability; Data Quality and Security; Privacy, Data Protection and Confidentiality; Risk-Benefit Analysis; and Recognition and Attribution. Implementation of this PtC requires careful attention to the particular context – including the relevant jurisdictions, applicable laws and policies, sectors, companies, data sharing activities, and types of health and genomic data. The PtC is accompanied by Explanatory Notes (Appendix A) and issue-driven Briefs (Appendix B) to set the international context.
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