In our rapidly evolving technological landscape, the increased generation of health data from more digitalised health systems offers a huge opportunity to advance healthcare and wellbeing. However, it also raises important issues around data rights, privacy, security, sharing and access. This situation brings to the fore the need for adequate regulations and legislation to be in place to ensure the effective and equitable governance of our health data, which facilitates responsible data sharing for public benefit with the needed protections in place. Robust data governance will contribute to stronger health systems, better patient care and improved emergency response – ultimately enhancing health outcomes. At the same time, it is needed to ensure the protection of individual rights and to mitigate risks of data misuse.
What is needed? Agreeing on minimum standards (considerations) for health data governance regulation
To realise this vision, it is important for governments to strengthen their national regulations and legislation governing the collection, ownership and use of health data. However, given the complex and diverse landscape of regulations and legislations in places across countries, as well as gaps within this landscape, we believe that there is value in countries and other stakeholders coming together build consensus around the key elements of necessary and optimal regulations to govern health data – essentially a set of minimum standards (considerations) for health data governance regulations. We believe that minimum standards should be framed around core guiding principles, such as the equity and rights-based Health Data Governance Principles that have already been endorsed by 150+ organisations and governments. And they should form part of a wider health data governance framework.
To build high-level political commitment, alignment and consensus across countries on what is needed, these minimum standards must garner endorsement through a World Health Assembly resolution. They would serve as a guiding resource and benchmark for governments to enhance their national legislation and regulations, whilst also improving harmonisation across countries, which is important to support cross-border data flows, with the needed protections in place.
Through national implementation, this would establish the binding instruments to hold all actors in the country involved in the collection and use of that data accountable; provide various actors in the country with avenues for redress in case people’s rights are being violated or data is being misused; and establish a predictable environment for the private, not for profit and public sectors operating in the country.
A multi-stakeholder process to support the development of a set of minimum standards
While we believe that governments should be in the driver’s seat, an inclusive and consultative multi-stakeholder process is important. To support such a process and feed into and catalyse the development of a set of minimum standards, Transform Health proposes two key phases, including: 1) Regional and national multi-stakeholder consultations and landscape assessments to inform the development of an initial draft; and 2) consultations on a draft set of minimum standards.
As part of this first phase, Transform Health and partners are convening a series of regional and national multi-stakeholder consultations, including in:
- Africa at the Africa HealthTech Summit in Kigali on 19 October and at the HELINA conference in Cape Town on 2 November
- Asia at the AeHIN General Meeting in Jakarta on 6 November
- Latin America at the RECAINSA Digital Health Forum in Panama City on 21 November
- Virtually through an online survey to facilitate wide participation and inputs
- Nationally across various countries
Guided by the Health Data Governance Principles, the consultations aim to learn from and gather insights from stakeholders and experts to identify good practices and approaches currently employed by countries; understand where there are gaps; identify existing international and regional norms and standards that would complement the minimum standards; and hear perspectives on what is needed. We believe that these different components would serve as the building blocks for the development of a draft set of minimum standards. Further consultations will be convened on the draft, to garner input, validation and consensus-building. These consultations present a valuable opportunity for stakeholders to contribute to shaping the future of health data governance.
These phases also aim to actively engage governments, to build buy-in, consensus and ownership and we hope will be followed by Member State-led consultations and negotiations in preparation of a resolution at the World Health Assembly (and other regional decision-making bodies), and subsequently national implementation.
Charting the path towards more effective and equitable health data governance
The need for more effective and equitable governance of health data is undeniable and the development, endorsement, and implementation of a set of minimum standards for health data governance regulations charts a clear path towards that goal. Transform Health believes that an inclusive and consultative process will build the needed alignment and consensus around what is needed. We look to governments to show their leadership in championing this process and endorsing and implementing minimum standards, thereby laying the foundation for a future where health data is a force for public benefit, rooted in trust and accountability.