Terms of Reference: Consultant/organisation to develop an implementation guide for the model law on health data governance

Details of work required: The consultant/organisation will develop an implementation guide for the model law on health data governance. The purpose of this guide will be to support national implementation of the model law by providing guidance, scenarios, options and steps that can be taken to implement the legislative components it contains, including through the development of national regulations, structures and other relevant provisions, as relevant. The consultant/organisation will also explore different alternatives to identify the best instrument/tool for the implementation guide (e.g. a regulatory playbook, explanatory memorandum, or other options).

Expected duration: the work should be carried out between ~23 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 harmonisation 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 the implementation guide will be to support national implementation of the model law, by providing guidance, options and scenarios for implementation, including through the development of national regulations, structures and other relevant provisions, as relevant.

 

Scope of work

Transform Health is seeking to recruit a consultant/organisation to lead the development of an implementation guide for a model law on health data governance. 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 around 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.
  • Carry out additional research and analysis to identify national regulatory (and related) options, approaches, good practices and needs, to complement and support national legislation, particularly in relation (though not limited) to health data governance.
  • Speak to experts, regulators and other government and non-governmental stakeholders to complement the research and understand relevant perspectives and needs to support the practical implementation of a model law by countries, as well as regulatory needs to strengthen national health data governance approaches.
  • Explore different alternatives to identify the best instrument/tool for the implementation guide (e.g. a regulatory playbook, explanatory memorandum, or other options).
  • Develop an implementation guide for the model law on health data governance, which sets out how the sections/provisions of the model law can be implemented nationally, including articulating clear guidance, options and scenarios in this regard. This should include guidance around the development of national regulation to take forward the legal components in the model law, and identify any complementary structures or other provisions that would be needed.

The consultant/organisation will work closely with the Transform Health Enabling Function (Secretariat), and other coalition partners and working groups, as relevant. A small Advisory group may be set up to provide expert guidance on the development of the implementation guide.

 

Key deliverables and deadlines

  1. Draft implementation guide for the model law on health data governance, which sets out how the sections/provisions of the model law can be implemented nationally, including articulating clear guidance, options and scenarios in this regard. This should include guidance around the development of national regulation to take forward the legal components in the model law, and identify any complementary structures or other provisions that would be needed. The draft guide should also consider the diverse cultural and legal contexts of different countries and provide flexible guidance adaptable to various national contexts. Deadline: 30 September 2024.
  2. Feedback/survey questions to solicit feedback on the draft implementation guide. Deadline 16 September 2024.
  3. Updated implementation guide for the model law on health data governance, which incorporates feedback received. Deadline 28 October 2024.
  4. Brief overview report documenting the process, key documents review and stakeholders consulted to inform the implementation guide. Deadline: 11 November 2024.
  5. Final implementation guide for the model law on health data governance, incorporating feedback from the testing of the model law in 2-3 countries (including using the implementation guide). Deadline TBC depending on testing timelines. [Note: the testing of the model law in 2-3 countries is not under this scope of work] 

 

Timelines 

  • RFP published: 3 July 2024
  • Deadline to submit proposals for consultancy: 14 July 2024  
  • Consultant selected: 18 July 2024
  • Consultancy start date: ~23 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 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.

 

Remuneration

The proposed budget for this assignment is approximately US$25,000 – 30,000 (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 14 July 2024: 

  • Your CV 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.