Executive summary

Background

Funded by the Bill and Melinda Gates Foundation (BMGF), the Kuunika Project (2016-2021) aimed to establish a strong base of high-quality digital health data for decision-making in the Malawi health sector. Malawi’s HIV/AIDS programme was the first ‘use case’.

Special Study 2 is part of Mott MacDonald’s final independent evaluation of the Kuunika Project. This study addresses digital health governance themes, with a focus on four questions relating to: delivery of a Demographic Data Exchange (DDE); implementation and aid effectiveness issues; the policy and regulatory environment; and lessons learnt.

The study methodology included a comprehensive desk review, eight key informant interviews and two group discussions with the Kuunika team. An extensive formative literature review supported benchmarking against global standards. Limitations of the study (e.g. remote data collection and the small number of key informants available for interview) are acknowledged. These limitations have partly been mitigated by intensive triangulation against secondary data sources.

Summary of main findings

1. Why the Demographic Data Exchange step was not completed

Key points from the triangulated data analysis were:

● The DDE was part of the early vision for the digital health architecture: The DDE was conceived as one modular component (or ‘building block’) of the digital health architecture for the HIV/AIDS programme (the ‘use case’). The DDE was intended to prevent duplication / loss of Electronic Medical Record (EMR) records when clients moved between health facilities. The DDE formed one component of an Expanded Health Data Exchange that would allow client demographic data (only) to be shared ‘horizontally’ across EMR modules. ● A shifting ecosystem: Since the initial design phases of Kuunika, there have been significant ‘shifts’ in the digital health and operational ecosystem that have disrupted implementation. These ‘shifts’ have included: technological advances and changes in the

Malawi’s wider digital landscape; shifts in donor EMR investments; changes in political and institutional leadership; reconfiguration of the

Kuunika consortium, and a shift in Kuunika’s focus to the Digital Health Division. In addition, the global COVID-19 pandemic has presented both challenges and opportunities. ● Contributions to the Expanded Health

Data Exchange: Despite the shifting ecosystem, Kuunika has made significant contributions to the Expanded Health Data

Exchange and related system components in keeping with a building blocks approach.

These contribution have included registry services (such as the Terminology Service and Facility Registry) and domain services (such as the Logistics Management

Information Service and the Health

Management Information Service).

Global standards benchmarking

Principles of Digital Development: Overall, evidence points to good efforts by Kuunika to promote the nine global principles of digital development which focus on: the end user, data quality, scale, sustainability, collaboration, ecosystems; open standards / sources, reuse and data quality, privacy and security. However, timely delivery of a DDE was hampered by a shifting ecosystem, challenges of designing for scale and sustainability (e.g. lack of system maturity, evolving technology competing operational priorities, alignment challenges), and difficulties in collaborative working. Data privacy and security considerations are likely to need additional prioritisation as the modular OpenHIE framework is rolled out.

● Advancing a new digital health vision: Since 2019, Kuunika has supported development of a National Digital Health Strategy, 2020-2025. Alongside this, Kuunika’s role in the national Digital Health Division has involved consensus-building on an updated vision for the digital health architecture based on a modular OpenHIE framework. Under this vision, the

DDE feature would over time be replaced by a master Client Registry and an Electronic

Health Record (EHR) system; EMRs would then become one ‘point of care’ input to a common Interoperability Layer. Kuunika is now systematically advancing realisation of this digital health vision through collaborative working, while keeping government in the ‘driving seat’.

2. Role of implementation & aid effectiveness issues

Key points from the triangulated data analysis were:

● Stakeholder mappings point to a complex and dynamic Kuunika stakeholder landscape (see Annex 2). A rapid ‘force field’ analysis reveals potential ‘fault lines’ within and across key stakeholder groupings, including: the Kuunika consortium; key international donors; the

Government of Malawi; and other Implementing Partners. Narrative analysis suggests

Kuunika Project progress can be mapped against how well these ‘fault lines’ have been negotiated over time. ● A fragmented digital health landscape: Successive situation analyses29 have shown

Malawi’s digital health landscape is / remains highly fragmented. Available evidence suggests digital health investments primarily serve the disease focus of donors and their reporting systems. Commentaries indicate that, among donors and government, there has also been a lack of harmonised Supplier procurement, weak digital health curation and, hitherto, lack of buy-in to a shared interoperability infrastructure. ● New opportunities: Kuunika’s role in the Digital Health Division is generally seen as positive for improving the technical leadership, capacity and credibility of government. The

Digital Health Strategy, 2020-2025, along with mapping of a coherent digital health architecture (based on the OpenHIE framework), and contributions to key building blocks (such as the Interoperability Layer) are also reported to provide opportunities for improved partner collaboration and alignment.

Kuunika suggests this has been demonstrated by recent work on digital platforms and analytics for the COVID-19 response. ● Some concerns: Although Kuunika’s role in the Digital Health Division is widely seen as catalytic, there are some concerns about a potential conflict of interest if Kuunika partners continue to compete for implementation resources. Some observers suggest Kuunika’s role should be translated into a formal capacity development plan and exit strategy to ensure sustainability is not compromised by ‘capacity substitution’.

Global standards benchmarking

Principles of aid effectiveness: Donors supporting the HIV/AIDS programme broadly adhere to aid effectiveness principles of country ownership and strategy alignment. However, key informants suggest there is now scope for donors to strengthen adherence to aid effectiveness principles (including those relating to harmonisation, managing for aligned results and mutual accountability) by working through existing partner forums to advance the new Digital Health Strategy and roadmap. But this would need to be accompanied by a greater focus on systems thinking and substantial investments in institutional strengthening and governance capacity.

29 For example, Vital Wave. (2019). Assessment of EMR Systems in Malawi: Initial Landscape Assessment. Prepared for MoH, Malawi.

3. Role of intellectual property regulation, data privacy & governance standards

Key points from the triangulated data analysis were:

● The Department of e-Governance under the Ministry of Information and Communications

Technology (ICT) leads on the development of ICT legislation, policies, strategies and standards for the Government of Malawi. The Department of e-Governance seconds specialist staff to the MoH’s ICT Section and has particular responsibility for guiding digital health governance at MoH. Key informants suggest there is scope for closer collaboration between the Digital Health Division and the Department of e-Governance at national and sub-national levels – especially as digital health initiatives are scaled up. ● Key digital legislation and policies are in place in Malawi. These include the eTransactions and Cyber Security Act (2016); the Access to Information Act (2017), the

National Registration Act (2009), the National ICT Policy (2013) and, for MoH, the National

Health Information Systems Policy (2015). Malawi is also a signatory to several international and regional instruments for protecting data privacy. In addition, the new Data Protection and

Privacy Bill, 2021, aims to provide a comprehensive legislative framework for the protection and security of personal data – although there are stakeholder concerns about the ambiguity of some terminology, the autonomy / capacity of key regulatory authorities, and implications for the National Registration and Identification System (NRIS). ● Intellectual property regulation: Malawi has five main intellectual property laws covering trademarks, patents and copyright. Existing legislation and policies also cover issues of data sovereignty and the transfer of data across borders. Key informants suggest this legislation is rarely harnessed restrict data reporting to donors, although the requirement of national health research ethics committees (e.g. the National Health Sciences Research Committee) are increasingly stringent. ● Standard Operating Procedures (SOPs): In keeping with Kuunika’s listed deliverables, 12

SOPs relating to digital health governance are in progress. Drafts are in place for nine key SOPs (see Annex 5), but three important

SOPs on data security, data review meetings and quality management approaches have not yet been drafted. Drafted SOPs have been awaiting finalisation and ratification since 2020. ● Governance capacity in the Digital Health

Division: Governance positions on policy and standards compliance in Digital Health

Division have been identified, but these positions have not yet been filled.

Global standards benchmarking

Global Digital Health Index: Overall, available evidence suggests Malawi’s regulatory environment is now reasonably good when measured against standard global indicators on leadership, governance and policies. However, weaknesses remain in resource allocations for implementation and enforcement, operational guidelines tailored to each system level, and policies on crossborder data security and data sharing.

4. Lessons for future programming

Key lessons by question theme were:

Theme

DDE delivery

Aid effectiveness

Regulatory environment Key lessons

• Sustainability of digital health building blocks is likely to be enhanced when there is reference to an updated digital health and information system architecture, and when there is wider stakeholder buy-in on the shared vision, strategy and roadmap. • Elements involving exchange of personal health records must be aligned to the wider governance, regulatory and standards environment – especially with respect to data privacy, security and access. • An understanding of the ecosystem requires a focus on the stakeholder, governance and political economy ecosystem, as well as the digital ecosystem. Seconded technical assistance (TA) can be on the front line of mediating the stakeholder ecosystem – distinct skill sets are required. • There is scope to build on existing partner forums to convene diverse stakeholder groupings and build consensus around implementation of a joint digital health roadmap. • Investments in a patient-centred ‘use case’ are likely to be more sustainable & scalable if partners retain a system focus and there are complementary investments in effective digital health governance at all system levels. • Particular attention needs to be given to data protection and cybersecurity threats.

New digital health solutions should be accompanied by key assessments, such as threat risk and privacy impact assessments. There is scope for working more closely with the ICT

Ministry, international collaboration, and contributing to legislative dialogue e.g. on Malawi’s

Data Protection & Privacy Bill. • Sound digital health governance requires long-term investment, and needs to extend to effective mechanisms for implementation, staff capacity building and oversight, and standards compliance at each system level. Finalisation / roll-out of key SOPs could be a relatively quick win, but this is a process heavy task area that needs focused leadership.

Conclusion and recommendations

Findings from the four study questions, suggest the Kuunika team has been highly adaptive to the dynamic programme context and has built constructively on the experience and lessons of the early project phases. Recommendations from this study include specific recommendations and general recommendations for BMGF and the Government of Malawi. The general recommendations are also relevant to other development partners.

Specific recommendations:

● Support the Digital Health Division. Recognise the strategic benefits of a knowledgeable and trusted team embedded in the Digital Health Division that can respond to digital health opportunities and priorities. Seconded TA needs to be high-calibre with distinct skill sets.

Ensure there are clear guidelines on preventing conflict of interest. ● Prioritise governance capacity. Support efforts to ensure the Digital Health Division has appropriate capacity on digital health governance, standards and compliance – governance officers should work closely with the ICT Ministry and prioritise finalisation of the digital health SOPs. ● Support Kuunika to develop a capacity development plan that includes skills transfer approach and an exit strategy.

General recommendations:

● Promote the principles of responsible ‘global digital health citizenship’ and partnership among all key role-players. This means convening around a single shared digital health vision, strategy and roadmap. These should be based on a modular digital architecture and be consistent with open source and open standards principles. ● Invest for scale and sustainability from the outset. This means thinking beyond the programme ‘use case’ to consider each solution’s horizontal and vertical linkages within a wider systems architecture. Consider complementary investments in digital health governance capacity at all system levels, including longer-term investments / collaborations to protect data privacy and security.