TOR: Consultant/Organisation to draft a set of minimum standards for health data governance regulations
Details of work required: Draft a set of minimum standards for health data governance regulations, which would serve as a resource (a guide and benchmark) for countries to strengthen national approaches. The draft set of minimum standards will be informed by the outcomes of 3-6 national and 4 regional multi-stakeholder consultations (consultation reports to be reviewed), inputs from a public survey, landscape assessment reports from six countries, as well as additional research and interviews to supplement this. The additional research and mapping of existing national data regulations/frameworks will be carried out by the consultant to further explore best practices and gaps in health data governance regulatory approaches, as well as to identify existing international and regional norms that would complement the minimum standards.
Expected duration: the work should be carried out between 30 November – 3 May.
More robust, effective and equitable governance of health data is needed to ensure we are fully harnessing its potential for public benefit and improved health outcomes, while also managing risks, protecting individual rights, and ensuring people’s data is protected from misuse. This is important to lay the foundation for improved public trust in health data systems where individuals feel protected, respected and in control of their own data, while allowing institutions working to protect the health and well-being of the population to access and use it for the public benefit.
While several countries are instituting health data governance policies and legislation, there is no overarching consensus around what should be the minimum standards or considerations for national regulations for the effective and equitable governance of health data. Given the complex and diverse landscape of regulations and legislations across countries, as well as gaps within this landscape, we believe that there is value in countries and other stakeholders coming together to build consensus and alignment around what the minimum and optimal regulations should be – essentially to establish a set of minimum standards (considerations) for health data governance regulations.
Transform Health is working with partners to catalyse and feed into the development of a set of minimum standards (considerations) for health data governance regulations, which would form part of a global health data governance framework. Transform Health is supporting a consultative approach to feed into a draft, which aims to gather perspectives and expertise from a range of stakeholders and build consensus, while ensuring that a set of minimum standards are rooted in country best practice; existing norms and standards; and framed around equity and rights-based Principles. This includes convening national and regional multi-stakeholder consultations and disseminating an online survey to gather insights; rapid landscape assessments across a set of countries; as well as further research to map existing national data regulations/frameworks to identify best practices and gaps, and to identify existing international and regional standards and norms that would complement the minimum standards. These inputs would feed into an initial draft set of minimum standards for wide stakeholder consultations. The draft would then be updated based on feedback from these consultations.
The process also aims to actively engage governments, to build buy-in, alignment, consensus and ownership around the set of minimum standards. We hope this would lead to 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.
Scope of work
In support of this work, Transform Health is seeking to recruit a consultant to lead the drafting of a set of minimum standards (considerations) for health data governance regulations. This will include the following key activities:
- Analyse outcomes of 3-6 national and 4 regional multi-stakeholder consultations (consultation reports will be available by 30 Nov); results from an online survey (survey input will be available 30 Nov); and landscape assessment reports from 6 countries (draft reports will be available 15 February).
- Carry out further research to map existing national and regional data regulations/frameworks/policies/laws/standards and identify best practices and gaps in health health data governance regulatory approaches (this will supplement information that will be provided through the consultation reports, online survey and landscape assessment reports from 6 countries).
- Carry out research to identify existing international and regional norms and standards that would complement minimum standards for health data governance regulations (e.g. drawing on existing duty obligations countries have made to respect, protect and uphold basic rights, as set out in different international treaties, commitments, Declarations and Regulations).
- Speak to experts in this field (including an advisory group/list), as relevant, to complement the research and inputs.
- Attend the WHO Executive Board meeting in January 2024 and speak with select governments and stakeholders (approx. 10) to gather early inputs to inform the draft minimum standards.
- Draft a set of minimum standards (considerations) for health data governance regulations, which sets out the necessary and optimal components for national regulations. This should be based on the inputs above and framed around the Health Data Governance Principles (this will be a draft for public consultation).
- Develop a survey and key questions to solicit wide feedback on the draft set of minimum standards (which will be used for the public consultation).
- Attend the 77th World Health Assembly to speak with governments and participate in a side event to gather insights around the draft minimum standards that are out for public consultation.
- Update the draft set of minimum standards (considerations) for health data governance regulations based on the public consultation and interviews with governments and stakeholders.
The consultant will work closely with a small Advisory group/list (which will be set up to provide expert guidance and input on the development of the minimum standards), as well as with the Transform Health Enabling Function (Secretariat), and other coalition working groups, as relevant.
Key deliverables and deadlines
- Summary report that details best practices and gaps in national/regional health data governance regulations, as well as existing international and regional norms and standards that would complement minimum standards for health data governance regulations. Deadline: 1 March 2024.
- Draft set of minimum standards (considerations) for health data governance regulations, which sets out the necessary and optimal components for national regulations (a draft for public consultation). The draft document should also include an introductory framing for the minimum standards and recommendations for their endorsement and implementation. Deadline: 1 March 2024 (initial feedback from Advisory group by 8 April and then revised version published for public consultation by 18 March, with a deadline of 19 April).
- Survey questions to solicit feedback on the draft minimum standards. Deadline 13 March 2024.
- Final draft set of minimum standards (considerations) for health data governance regulations, which incorporates feedback from the public consultation and interviews with select governments/stakeholders. Deadline: 3 May 2024.
- RFP published: 3 November 2023
- Deadline to submit proposals for consultancy: 15 November 2023
- Consultant selected: 24 November 2023
- Consultancy start date: ~30 November 2023
- Deadline for completion of work: 3 May 2024
Profile and experience
We are looking for a consultant/organisation with regulatory/legislative expertise in the areas of health, data governance, or specifically health data governance. We are particularly interested in a consultant/organisation with experience in drafting regulations/legislation/regulatory frameworks. The consultant/organisation should have strong research and analytical skills, with the ability to synthesise findings and make clear recommendations. Preference will be given to consultants/organisations based in L/LMICs.
The proposed budget for this assignment is approximately US$25,000 – 30,000 (to be agreed based on experience and the proposal).
To apply, please submit the following to [email protected] by 09:00 CET on 15 November 2023:
- Your CV and cover letter outlining your experience relevant to this consultancy.
- Your proposed daily rate and number of days to carry out this consultancy, including a breakdown by task/deliverable.
About Transform Health
Transform Health is a global coalition of organisations dedicated to achieving health for all in the digital age. Transform Health sets out to build a global movement that brings together organisations and institutions across different sectors, committed to achieving universal health coverage by 2030 by expanding the use of digital technology and increasing access to data. We campaign and collaborate with the individuals, communities, governments, organisations and institutions that are most affected by the lack of access to equitable, affordable and high-quality healthcare.