Transform Health and partners, including AeHIN, HELINA, RECAINSA, OECD and Africa CDC, have supported the development of a draft Model Law on Health Data Governance, which articulates core elements, legislative guidance and reference legal text to strengthen national frameworks, recognising the critical importance of strengthening health data governance for improved health outcomes and UHC. The model law seeks to set a global standard for health data legislation. It aims to build consensus around core areas that should be addressed through national legislation; establish a level of harmonisation across countries, which is important to facilitate cross-border data sharing; and importantly to serve as a resource for governments.
This widely consulted draft Model Law is a starting point for discussion amongst governments. We encourage governments to now take it forward through the necessary process to endorse the Model Law (as part of a global health data governance framework) through a World Health Assembly resolution and regional mechanisms, and ultimately to use it to strengthen national frameworks.
Download the draft Model Law on Health Data Governance:
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 to strengthen the governance of health data through more robust, effective and equitable legislation and regulations.
While several countries and regions are taking steps to address this, approaches vary. By countries and other stakeholders coming together, this provides an opportunity to learn from and build on experiences and good practices, and establish a level of consensus around the essential provisions that should be addressed through national legislation.
As a Model Law, it serves as a blueprint, 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 and resources that can be used by countries (fully or in part) to strengthen national laws and frameworks on health data governance.
The draft model law is informed by equity and rights-based principles (endorsed by more than 150 organisations and governments), and draws inspiration from the national legislative and regulatory landscape reviews of more than 30 countries, the OECD Recommendation on Health Data Governance (adhered to by 38 OECD member countries), among other national, regional and international instruments, commitments and best practice.
It has been developed through a bottom up, consultative process, engaging nearly 1000 stakeholders from across the globe. This has included seven regional multi-stakeholder consultations (convened by AeHIN, HELINA and RECAINSA) bringing together 500+ stakeholders from 65+ countries to inform an initial draft. This was followed by a public consultation period on the draft, which consulted 550+ stakeholders and experts from 35+ countries through 16 national, regional and youth consultations, expert interviews, and a widely disseminated survey to gather feedback on the draft.
The drafting has been led by a legal team specialising in data governance law, with guidance and input from an expert advisory group, the Africa CDC health data governance flagship initiative, and Transform Health’s Policy Circle and other working groups.
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