Data-driven approaches are increasingly the norm or aspiration in the operation of health systems. The collection, processing, storage, analysis, use, sharing and disposal of health data has grown in complexity. This exponential increase in data use necessitates robust and equitable governance of health data. Countries and regions around the world are instituting health data governance policies and legislation. However, there is not yet a comprehensive, global set of principles to guide the governance of health data across public health systems and policies. The Health Data Governance Principles respond to that need.
The Principles are intended as a resource for, and have applicability to, a range of stakeholders involved in the collection and use of health data, including governments, the private sector, international organisations, civil society, among others. We encourage all stakeholders to endorse the Principles.
We want to see the Principles adopted by governments, technology companies, and other institutions responsible for collecting and managing health data.
Digitisation has allowed an exponential increase in the production and use of health data and data for health. This increased availability of timely data offers huge benefits for practitioners, policymakers, and individuals seeking to improve personal and public health. At the same time, weak governance of health data risks exacerbating health inequities, perpetuating bias and discrimination towards marginalised communities, and undermining individual health and human rights.
The need for stronger health data governance has never been greater. A set of globally accepted principles for health data governance that are regionally and sectorally representative is urgently required to redress the uneven distribution of benefits and harms that we currently see arising from the collection, analysis and use of health data. Consensus on high-level principles is an important step towards the creation of a global health data governance framework that could support the use of digital technologies and data for the public good.
The Principles target governments, technology companies, and other stakeholders that collect and use health data. The Principles should ultimately be applied in the domestication of national and organisational policies related to health data governance and inform a global health data governance framework. The Principles will also be a tool for organisations advocating for equitable, human-rights-based governance of health data and can eventually be used as an accountability mechanism.
Transform Health stewarded the process to develop the Principles, under the leadership of its Policy Circle, which includes digital health and data governance experts from: Asia eHealth Information Network (AeHIN), FIND, Fondation Botnar, the Health Data Collaborative’s Digital and Data Governance Working Group, I-DAIR, IT for Change, Jhpiego, PATH, Philips Foundation / Digital Connected Care Coalition, Red Centroamericana de Informática en Salud (RECAINSA), and Young Experts: Tech 4 Health (YET4H). The following partners were instrumental in supporting the global and regional consultations: PATH, AeHIN, the BID Learning Network, Mwan Events, RECAINSA, Wilton Park, Governing Health Futures 2030 and YET4H. This work was funded by Fondation Botnar.
The process of developing the Health Data Governance Principles was designed to be inclusive and collaborative. To ensure the legitimacy and ownership of the final Principles, Transform Health actively engaged governments, international organisations, civil society, research institutions, and private-sector actors in the co-creation process.
To ensure diversity of perspectives, Transform Health, alongside partners such as PATH, RECAINSA, AeHIN, Governing Health Futures 2030 and Young Experts: Tech 4 Health, has hosted a series of consultations in different regions and with different audiences throughout 2021.
Eight consultations took place:
The first five workshops – four regional and one global – facilitated by PATH for Transform Health, collected insights that fed into the first draft of the Principles. Once the draft principles were ready, the second set of Wilton Park consultations collected further feedback and input from experts and young experts in two separate workshops in July. A third draft of the Principles was shared with stakeholders in advance of a virtual workshop in September. This was followed by a one-month public consultation on a draft set of Principles.
The Principles are a tool and conceptual framework for civil society organisations and other stakeholders to advocate for equitable, human rights-based approaches to health data governance at national, regional, and global levels.
As an initial step, Transform Health and partners will seek endorsement of the Principles from all actors involved in digital health and data including civil society, private sector, and governments. Ultimately, we want to see the Principles adopted by governments, technology companies, and other institutions responsible for collecting and managing health data.
The Health Data Governance Principles are a normative tool to guide the equitable and rights-based collection, processing, storage, analysis, use, sharing and disposal of health data. The Principles are forward looking, representing a common vision for health data governance and the direction an organisation or governments strives to go, in alignment with global best practice. Application of the Principles will vary according to the stakeholder and context(s) in which they are working.
By endorsing the Principles, a government or organisation is demonstrating their commitment to the Principles and intention to use and incorporate them into their policy, programmatic and advocacy work. Endorsing the Principles does not create any legally binding obligations upon organisations or States.
The Principles will be a public good, available for everyone to use and incorporate into their policy, programmatic, and advocacy work with health data. To encourage wide community ownership, they are hosted on their own website, together with resources to support stakeholders to use and champion them.
Other important principles exist, such as the WHO’s data principles (which provide a framework for data governance for WHO) and their ethical principles for the use of AI for health; the Principles for Digital Development and Digital Investment Principles stewarded by the Digital Impact Alliance; as well as OECD’s Recommendation on Health Data Governance and their Principles on Artificial Intelligence. Key normative and technical partners involved in health data governance, such as the WHO and Health Data Collaborative, have been involved in the co-creation of the Health Data Governance Principles.
However, what is distinct about the Health Data Governance Principles is that they are being developed and driven by civil society. The inclusive and consultative process has brought in diverse perspectives and expertise from across geographies, sectors, and stakeholders.
Another key characteristic of the Health Data Governance Principles is that they are grounded in Universal Health Coverage (UHC); take an equity and rights-based approach; and support sustainable and resilient health systems. They include core principles aimed at protecting people and creating public health value, while going beyond this to include forward-looking principles around equitably distributing health benefits, towards delivering UHC.
To remain relevant in the fast-evolving domain of digital health, the Principles will need to be periodically reviewed and updated where necessary. Any future exercises to revise the Principles will need to follow the same spirit of co-creation that shaped the development of the original Principles.
The Health Data Governance Principles have been primarily driven and developed by civil society through an inclusive and consultative, bottom-up process stewarded by Transform Health. This process brought together over 200 contributors from over 130 organisations through eight global and regional workshops covering Sub- Saharan Africa; the Middle East and North Africa; South, East, and Central Asia; Latin America and the Caribbean; and Europe, North America, and the Pacific, followed by a one-month public consultation.
Transform Health stewarded the development of the Health Data Governance Principles, under the leadership of its Policy Circle, whose members include: Marwa Azelmat (Young Experts: Tech 4 Health), Joseline Carias (Central American Health Informatics Network/RECAINSA), Marie Donaldson, Vikas Dwivedi (Palladium Group/Health Data Collaborative’s Digital and Data Governance Working Group), Vidya Mahadevan (Health Data Collaborative’s Digital and Data Governance Working Group), Ulla Jasper (Fondation Botnar), Parminder Jeet Singh (IT for Change), Rigveda Kadam (FIND), Alice Liu (I-DAIR), Beatrice Murage (Philips/ Digital Connected Care Coalition), Erica Troncoso (Jhpiego), and Jai Ganesh Udayasankaran (Asia eHealth Information Network/AeHIN).
This draft of the Health Data Governance Principles was prepared for Transform Health by Anna Volbrecht (PATH) and Akarsh Venkatasubramanian (Transform Health). Valuable inputs were provided by Transform Health colleagues, including Mathilde Forslund, Asmita Ghosh, Louise Holly, Kirsten Mathieson, and Frank Smith. PATH provided important contributions to this work, including Jacqueline Deelstra, Hallie Goertz, Kanishka Katara, Neema Ringo, Dykki Settle, and Anna Volbrecht. Other partners who provided inputs include: Ashley Bennett (Facebook, formerly PATH), Keertana Duppala (FIND), Mark Herringer (Healthsites), Riccardo Lampariello (Terre des Hommes), Angélica Baptista Silva (Fiocruz), and Waruguru Wanjau (Kenya Medical Association).
The following partners were instrumental in supporting the global and regional consultations: PATH, AeHIN, the BID Learning Network, Mwan Events, RECAINSA, Wilton Park, the Lancet/FT Commission on Governing Health Futures 2030 and Young Experts: Tech 4 Health.
This work was funded by Fondation Botnar.