Public consultation on a draft model law (7-30th April)

 

To fully harness the potential of health data for public benefit and improved health outcomes, while also managing risks, protecting individual rights, and ensuring people’s data is protected from misuse, it is important for governments to strengthen the governance of health data through more robust and equitable legislation and regulation. A model law on health data governance can support this by building consensus around what is needed.

 

A PUBLIC CONSULTATION ON A DRAFT MODEL LAW ON HEALTH DATA GOVERNANCE (7-30 APRIL 2024)

On the 7th of April, World Health Day, Transform Health and partners are launching a period of public consultation on a draft model law on health data governance, which contains core elements, guidance and reference legal text to support more effective and equitable health data governance. The model law aims to build consensus across countries and stakeholders around essential areas that should be addressed through national legislation, while also helping to establish a level of harmonisation in national approaches to foster greater legal coherence across jurisdictions. This, we believe, would strengthen trust and collaboration across countries and facilitate cross-border data sharing, with the needed protections in place. Importantly, the model law serves as a resource for governments by offering guidance and sample text to support them to integrate the principles and standards into their existing national legislation and frameworks, or develop new laws where and if needed.

The public consultation period will run from the 7th until the 30th of April. Through this process we aim to gather stakeholder and expert feedback to strengthen and validate the draft, while building consensus, alignment and broad support around the core elements of the model law. The consultation page contains the model law and survey to provide feedback, in five languages (English, French, Spanish, Portuguese, Arabic). You can also find more information about the model law and the consultation period, resources to support governments and partners wishing to convene consultations and a social media toolkit.

 

WHY IS A MODEL LAW NEEDED AND HOW CAN IT MOVE US TOWARDS MORE EFFECTIVE AND EQUITABLE HEALTH DATA GOVERNANCE?

While several countries and regions are taking steps to strengthen their health data governance legislation and regulation, 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.

 

HOW HAS THE MODEL LAW BEEN DEVELOPED?

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 convened by the Asia eHealth Information Network (AeHIN), the Pan African Health Informatics Association (HELINA) and RECAINSA, 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.

During the public consultation period (7-30 April), we will gather feedback to further strengthen the draft. This will include a widely disseminated public survey; a community forum on the 29th of April that is open to all stakeholders to learn about the Model Law and provide feedback (Register here); 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.

 

WHAT’S NEXT

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.

The model law on health data governance is an important step and opportunity to move us towards more effective and equitable Health Data Governance, laying the foundation for improved public trust in health data systems! 

 

If you have any questions or would like to get involved, email Transform Health at info@transformhealthcoalition.org.