Several countries and regions are taking steps to strengthen their health data governance legislation and regulation. However, approaches vary and there is no overarching consensus around core areas that should be addressed through national legislation and regulations for the effective and equitable governance of health data.
We believe that there is value in countries and other stakeholders coming together to learn from different approaches and experiences, identify good practices, understand where there are gaps, and build a level of consensus and alignment around what is needed. This would be strengthened by governments taking the model law through the process to endorse a World Health Assembly resolution, and subsequently through national implementation.
Draft Model Law on Health Data Governance
Transform Health and partners have been supporting the development of the draft model law on health data governance. The drafting has been led by a team of legal experts, with guidance from an expert advisory group and feedback from the Africa CDC Flagship Initiative on Health Data Governance working group and the governance circles of Transform Health, a coalition of more than 150 organisations.
The draft has been informed by equity and rights-based principles, among other national, regional and international instruments, commitments and best practice; inputs from multi-stakeholder regional consultations, which consulted nearly 500 stakeholders from across 65 countries to learn from experiences and gather insights and perspectives; and national legislative and regulatory landscape reviews of more than 30 countries.
Give Your Input on the Draft Model Law
We seek your feedback to further strengthen the draft during the public consultation period through 30 April.
In addition, we are organising a community forum on the 29th of April that is open to all stakeholders to learn about the Model Law and provide feedback. We’ll have national and regional consultations; stakeholder-specific consultations and outreach with youth and parliamentarians; and interviews with national, regional and global experts.
The process of developing the model law has been designed to be inclusive and collaborative, to bring in a diversity of perspectives and expertise to inform its development and to ensure its legitimacy and ownership.
Next Steps for Draft Model Law
Following the consultation period, the draft model law will be updated to reflect the feedback received. It will be presented at a World Health Assembly (#WHA77) side event, ‘Stronger Health Data Governance through Country Leadership and Consensus‘, taking place on the 28th of May 2024 in Geneva. The event will bring together experts in this field, together with country leadership, to build the consensus needed to drive this agenda forward.
Government leadership on this agenda is critical. The model law provides a starting point for governments to discuss, negotiate and build consensus around what is needed to strengthen health data governance.
We encourage governments to take the model law forward, through Member State consultations, towards its eventual endorsement through a World Health Assembly resolution and regional processes. As we look towards the 77th World Health Assembly in May 2024, we encourage governments to take action to move this process forward.
By Kirsten Mathieson, Deputy Director & Policy Lead, Transform Health
The draft model law on health data governance is a crucial step towards establishing a comprehensive framework for the effective and equitable management of health data. It’s essential to ensure that this legislation addresses the following key areas:
1. Data privacy and security: Implement robust safeguards to protect personal health information from unauthorized access, breaches, or misuse.
2. Data sharing and collaboration: Establish clear guidelines for sharing health data between healthcare providers, researchers, and other stakeholders to facilitate improved care and innovation.
3. Informed consent: Ensure individuals understand how their health data is used, shared, and protected, and obtain their explicit consent when necessary.
4. Data quality and accuracy: Develop standards for data quality, accuracy, and completeness to guarantee reliable decision-making and research.
5. Data access and portability: Allow individuals to access, correct, and transfer their health data seamlessly.
6. Accountability and transparency: Hold entities handling health data accountable for compliance, and ensure transparency in data collection, use, and sharing practices.
7. Research and innovation: Foster an environment that encourages responsible health data-driven research and innovation while safeguarding ethical standards.
8. Cross-border data flows: Address the legal and ethical implications of health data transfers across borders.
9. Dispute resolution and enforcement: Establish mechanisms for addressing complaints, disputes, and enforcement of health data governance regulations.
10. Continuous monitoring and evaluation: Regularly assess and update the legislation to address emerging challenges and technological advancements.
By addressing these areas, the draft model law can provide a solid foundation for effective health data governance, balancing individual rights, public health needs, and innovation.