Co-authors: Mathilde Forslund (Executive Director, Transform Health), Jai Ganesh Udayasankaran (Executive Director, AeHIN), Eric Sutherland (Senior Health Economist, OECD), Craig Burgess (Unit Head Data Coordination, Governance and Partnerships, WHO), Joseline Carias (Chief Operating Officer, RECAINSA), Cyril Seck (Digital Strategy Advisor, Africa CDC), Ulla Jasper (Governance and Policy Lead, Fondation Botnar), Emma Waiyaiya (Executive Director, HELINA)


In the digital age, health data is a vital asset that can significantly enhance healthcare delivery and outcomes. However, the sensitive nature of personal health information necessitates robust legislative and regulatory frameworks that not only unlock its potential but also safeguards individual rights and privacy. Many countries and regions recognise the importance of, and are taking steps to strengthen their legislative environment governing health data. Looking at the current global landscape, it reflects a diversity of approaches. While there cannot be a one-size-fits-all solution that addresses varying levels of maturity across  national contexts, value can be derived by countries working together to build on and learn from current good practices and establish  agreement on what kind of legislative provisions are needed to ensure the effective, equitable and interoperable governance of health data.


A blueprint for stronger health data governance

To support this, Transform Health, Asia eHealth Information Network (AeHIN), the Pan African Health Informatics Association (HELINA) and RECAINSA, OECD, and Africa CDC are spearheading an effort to develop a draft model law on health data governance. This encapsulates core elements, legislative guidance, and reference legal text – establishing a blueprint that can be used by governments as a resource to guide national frameworks. Underpinned by equity and rights-based principles (endorsed by more than 150 organisations and governments) and drawing inspiration from the OECD Recommendation on Health Data Governance (adhered to by 38 OECD member countries) and other national, regional and global instruments and policies, this model law strives to set a global standard for health data legislation.

The model law aims to build consensus across countries around core areas that should be addressed through national legislation, particularly in the age of rapid digital advancements. In doing so, it also helps to establish a level of harmonisation across countries, which is important to facilitate cross-border data sharing. Importantly, the model law serves as a resource for countries who can lift from sections of it, as relevant, to strengthen wider national data protection laws and health regulation. A model law is essentially a template, a flexible framework that can be adapted to suit the legal systems of different countries. It is not prescriptive or imposing in any way, but rather serves as a legislative guide that can strengthen national laws and frameworks on health data governance. 


A collaborative and consultative effort towards a model law

The draft model law has been developed through a bottom up, consultative process, engaging nearly 1000 stakeholders from across the globe. The drafting has been led by a legal team specialising in data governance law, with guidance and input from an expert advisory group, Africa CDC health data governance flagship initiative, and Transform Health’s Policy Circle and other working groups.

The draft model law has been informed by national legislative and regulatory landscape reviews of more than 30 countries, as well as a review of national, regional and international instruments, and relevant strategies, reports and literature. The process also included seven regional multi-stakeholder consultations (convened by AeHIN, HELINA and RECAINSA), which consulted more than 500 stakeholders from across 65 countries to learn from experiences and gather insights and perspectives on what is needed to strengthen health data governance legislation and regulation. 

This was followed by a public consultation period  convened from the 7th to the 30th of April – consulting more than 550 stakeholders and 35 countriesto gather stakeholder and expert feedback on the draft. The consultation period saw the wide disseminated of the model law and feedback survey in 5 languages, as well as 14 national and regional consultations (organised by Transform Health, AeHIN, HELINA, RECAINSA), many of which co-hosted with Ministries of Health, a youth consultation and expert interviews. A revised draft reflecting this feedback will be presented at a side event during the 77th World Health Assembly. 


The 77th World Health Assembly – A pivotal moment for action 

The upcoming 77th World Health Assembly (WHA77), taking place from 27 May to 1 June, is a pivotal moment for government leaders and experts to collectively advance the health data governance agenda.

The draft model law that will be presented on the sidelines of WHA77 is not a final document. Rather it is a starting point for discussion amongst governments. Government leadership is critical to take this forward – in ensuring a robust national legislative environment to govern how data is collected and used, and in establishing consensus around a global standard. This includes the endorsement of a model law through a World Health Assembly resolution, as well as through regional mechanisms that will support national adoption. 

Recognising the urgency for collective action, the Ministries of Health of Cameroon, Indonesia, the Maldives and Sri Lanka, together with the Council of Ministers of Health of Central America and Dominican Republic (COMISCA), Transform Health, OECD, Africa CDC, WHO, the Health Data Collaborative, AeHIN, HELINA and RECAINSA, are co-hosting a side event as a critical step forward. Stronger Health Data Governance through Country Leadership and Consensus’, taking place on 28 May at 18:30-20:00, will bring together government leadership and experts to discuss how we can advance this agenda together.

The journey towards more robust global health data governance is complex, yet imperative. There is growing recognition and consensus of the need to strengthen the health data governance legislative and regulatory environment and political and stakeholder support is growing. By aligning efforts and fostering international cooperation, we can ensure that health data serves the public good, respects individual rights, and contributes to a healthier world for all. The 77th World Health Assembly presents a unique opportunity to transform this vision into reality.