Terms of Reference: Consultant/organisation to test national implementation of the model law on health data governance

Details of work required: We are recruiting a consultant/organisation to support in testing national implementation of the model law on health data governance in approximately six countries in Africa. This will include identifying the best approach to test the practical implementation of the model law and then carrying this out in approximately six countries (to be agreed with Transform Health), in order to develop use cases for its implementation. A model law implementation guide is currently being developed, which would also support this.

Expected duration: the work should be carried out between ~25 July and 21 December 2024

 

Background

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.

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 compatibility across countries to foster greater legal coherence across jurisdictions, which is important to facilitate cross-border data sharing; and importantly to serve as a resource for governments. 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, including through more than 20 national, regional and youth consultations, expert interviews, and a widely disseminated survey to gather feedback on the draft.

The purpose of testing implementation of the model law is to explore and assess how it can be implemented in practice within countries. This would establish practical use cases for its implementation. Through this process we also aim to build further support and buy-in for the model law, both as a resource to support in strengthening national frameworks, as well as for its endorsement by governments through a World Health Assembly resolution and regional mechanisms. A model law implementation guide (containing guidance, options and scenarios for implementation) is also being developed, which would support this implementation exercise. 

 

Scope of work

In support of this work, Transform Health is seeking to recruit a consultant/organisation to lead the testing  of the national implementation of the model of law on health data governance in approximately six countries. This will include the following key activities:

  • Review and ensure a thorough understanding of the model law and its contents and provisions, including the health data governance principles that underpin it, and its intended use and outcomes.
  • Review other documents related to the model law (e.g. on its development; reports from consultations on the model law; national legislative and regulatory landscape assessments of 37 countries which informed the model law; etc) and speak to key people involved in its development to provide further context and fill in any gaps from the information above.
  • Explore and propose potential options for how to approach the testing/practical implementation of the model law, for discussion and agreement with Transform Health.
  • Identify approximately six countries in Africa to carry out the testing of the implementation of the model law, to be agreed with Transform Health. This will be informed by regulatory landscape assessments that have already been carried out in a number of countries, countries that hosted national consultations on the model law, and discussions with regional partners engaging governments on this issue.
  • Identify and reach out to key stakeholders, partners and government counterparts to support and participate in the testing of the model law, including defining roles and responsibilities.
  • Develop an approach to be carried out for the national testing of the model law, including the objectives, parameters, timelines, key stakeholders to be engaged as part of the process (including defining roles and responsibilities), and steps to be carried out. The identified stakeholders and partners should be engaged as part of this process.
  • Test the practical implementation and applicability of the model law on health data governance in approximately six countries, based on the approach developed, and using the implementation guide. This may include:
    • Conducting legislative and regulatory landscape assessments in the countries vis-a-vis the provisions in the model law (building on previous regulatory landscape reviews), and carrying out any additional research and analysis to complement this.
    • Speaking to experts, regulators and other government and non-governmental stakeholders in the countries to complement the research and understand relevant perspectives and needs to support the practical implementation of the model law.
    • Based on the landscape assessments, identifying gaps within the national legislative and regulatory landscape and, based on this, developing recommendations where areas of national legislation and regulation should be updated and/or developed.
    • Together with key government (and other) stakeholders and national working groups, developing a roadmap (a way forward) for the countries of how the recommendations can be implemented in practice, ensuring this is validated and has buy-in of national stakeholders.
  • Write up a final report documenting the approach/process, outcomes, learnings, and recommendations, including use cases for each of the countries that also sets out their respective roadmaps. 

The consultant will work closely with Transform Health, the Africa CDC flagship initiative on Health Data Governance (which is co-lead by Transform Health and Pan African Health Informatics Association/HELINA), and other key regional and national partners, as relevant. 

 

Key deliverables and deadlines

  1. Mapping of potential approaches to test implementation of the model law and mapping of key stakeholders that should be involved in each country. Deadline: 19 August 2024.
  2. Approach and plan to be carried out for the national testing of the model law, including the objectives, parameters, timelines, key stakeholders to be engaged as part of the process (including defining roles and responsibilities), and steps to be carried out. Deadline: 2 September 2024.
  3. Landscape assessment reports that detail the national legislative and regulatory landscape in the approximately six countries vis-a-vis the provision in the model law and identifies gaps and recommendations where areas of national legislation and regulation should be updated and/or developed. Deadline: 23 September 2024.
  4. Test implementation of the model law based on approach/plan. Deadline: Deadline: 25 November 2024.
  5. Roadmap (a way forward) for the approximately six countries of how the model law can be implemented in practice. Deadline: 9 December (TBC depending on testing timelines).
  6. Final report documenting the approach/process, outcomes, learnings, and recommendations, including use cases for each of the countries that also sets out their respective roadmaps. Deadline: 21 December.

Timelines 

  • RFP published: 8 July 2024
  • Deadline to submit proposals for consultancy: 17 July 2024  
  • Consultant selected: 18 July 2024
  • Consultancy start date: ~25 July 2024
  • Deadline for completion of work: 21 December 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 analysing, revising and drafting national laws and regulations and related frameworks. The consultant/organisation should have strong research and analytical skills, with the ability to synthesise findings and make clear recommendations.  The consultant/organisation should ideally have experience engaging with national stakeholders involved in legislative and regulatory processes and the ability to engage diverse stakeholders in such processes. Preference will be given to consultants/organisations based in L/LMICs.

 

Remuneration

The proposed budget for this assignment is approximately US$65,000 – 75,000  (to be agreed based on experience and the proposal).

 

Application process 

To apply, please submit the following to [email protected]  by 09:00 CET on 17 July 2024: 

  • Your CV(s) and cover letter outlining your experience relevant to this consultancy.
  • A brief proposal outlining your approach to this assignment.
  • 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.