Executive Summary

This Special Study forms part of the independent endline evaluation of Kuunika. It was requested by the Bill and Melinda Gates Foundation.

Certain factors relevant to decentralization of the health system and digital data architecture and use are beyond the control of any project, including Kuunika Such factors include the longstanding human resources for health challenges, which are especially acute in rural areas, the fact that many Data Clerks, on whose shoulders rest much of the daily task of data entry, receive too little training and other support and are often co-opted from other roles. Moreover, decisions at national government level as to the extent and detail of any devolution of financial autonomy to Districts and sectors are beyond any project's control.

Therefore, in this report we examine the space available to Kuunika in terms of its engagement with the District, Health Facility and community levels, how it used such opportunities to support those health service planning and delivery structures specific to application and use of the DHIS2 digital data system. In addition we consider how Kuunika has been able to support digital data use at national level. We examine if the project has effectively engaged with Districts and lower levels to optimize impact of its activities and support. We consider such work throughout the Kuunika pivots and its Covid-19 support, thereby reviewing as from the 2016 grant proposal, as well as reinterrogating 2017 baseline and 2019 midline findings specific to District inputs and broader issues of decentralization.

We also consider the principles of aid effectiveness and sustainability: if the commitment to decentralized health structures and effective ownership and/or use of digital data at that level is limited from the side of national government, what traction might any project have? How might a project then best engage more with existing District systems in a predominantly horizontal approach, so as to engage more directly with health planning and service delivery challenges and the effective use of digital data to address those?

One finding is that attention by the project partners to the specifics of decentralization and the ramifications for Kuunika has throughout been limited. As a result, the independent evaluation of Kuunika has hitherto not examined decentralization issues in much detail.

Key findings

1. Decentralization of the health system and digital data is beyond the control of any project, including Kuunika Information is that there are currently (mid-2021 onwards) changes being made at national government level specific to what might be seen as a (re) centralization of digital health data management and (re) focus on DHIS2. Thus the Digital Health Division has been moved back into the MoH Department of Planning and Policy Department.

2. The move might limit, even reduce, districts' and health workers' capacity to review and make speedy use of data; such moves might also have impacts on the building of digital data systems and knowledge culture at District and facility levels.

3. The partial, piecemeal and stop-start implementation of the government policy of decentralization is viewed as a cause of poor governance in the health sector Governance challenges are a significant barrier to achieving a more effective and equitable health system in three key domains: accountability (enforceability; answerability; stakeholder-led initiatives); health resource management (healthcare financing; drug supply); influence in decision-making (unequal power; stakeholder engagement).

4. Districts are the 'missing middle' in many respects in terms of GoM and donor partner engagement with the health sector; there is increased focus on community engagement (and quite rightly, not least for equity considerations), yet Districts are the entry point to the great bulk of health services delivered to Malawians.

5. When Kuunika was being designed, the GoM said it was decentralizing the health system, but most decisions and human resource management continued to be made at the central level. There is a centralized 'push system' in health. Most projects at District level have had to work very closely with the MoH, even if more focused on the Districts; this has been true for Kuunika

6. The MoH is the owner of Kuunika - this has been made clear from project inception. Therefore, has the project made best use of the space available within the predominantly centralized health systems and structure to engage with Districts to build sustainable, standalone use of digital data? The answer is, on balance, no.

7. The cumulative experience of the Kuunika evaluation shows that there needs to be greater genuine ownership of data at the District level and effective use of DHIS2 as a platform for more effective evidence-based planning. This necessitates buy-in from all partners working in any one District and nationally, challenging in a donor landscape currently as fragmented as Malawi; this has obvious implications for effective coordination of digital health initiatives. The District Health Offices should ideally be integral partners in data collection and use

8. Kuunika has invested a very great deal of time, effort and resources into District level capacity development, training on and access to DHIS2 and digital data hardware and systems (e.g. dashboards, the mobile App, Cluster meetings). This was most apparent before 2019, at which point changes in consortium partners and project management, coupled with the sustainability pivot, led to Kuunika being seen as becoming more distant from the Districts (except in Zomba). More recent support to horizontal engagement, e.g. through helping to facilitate setting up Cluster meetings, are often not recognized as having Kuunika inputs, but are seen by those involved as useful channels for debate and decision-making processes.

9. The Covid-19 pivot, centrally facilitated by the MoH with Kuunika and other partner support, has enabled considerable progress to be made by Malawi in terms of tracking the pandemic and developing a response. At District level there are mixed views as to how much such data collection has supported service delivery.

10. Despite being defined in terms of being a District-focus programme in the early days, Kuunika has given relatively limited attention to planning effectively for how it might most coherently and comprehensively support decentralized structures and systems and provide optimal inputs at District level. for access to and use of digital data, through the DHIS2 platform. The temporary involvement of the Districts in Kuunika planning after the first pivot appears to have been short-term and never properly integrated in project planning and processes.

11. Kuunika might be most usefully regarded as sitting in the ‘functions and capabilities’ space, its contribution to decentralization of health services lying in its ability to empower Districts via access to better data to plan, manage and deliver services.

12. The decision to focus on HIV as the data use case, a vertical system owned at the central level (and where key datasets collected and managed by the DNHA were not uploaded to DHIS2), meant there was little space for the District level to engage as an equal partner in management and use of digital data. Initially the Kuunika consortium was almost a parallel MoH, without any attention to decentralized health and data. Kuunika moved also; at one time it was in the HIV Department.

13. Kuunika was somewhat designed in a vacuum, without thinking of communication channels between the project and Districts. The initial big focus in Kuunika was data systemsnot which entity/individuals had access, ownership, etc. Later focus was more on patient outcomes and use of data to support service delivery. That necessitates proper District buy-in if improvements in service delivery are to be achieved - and that step has not been properly taken by the project.

14. At the end of Kuunika phase 1, there is little concrete evidence of sustained, systemic improvements in data use knowledge culture at District level, or of key planning and service delivery documents such as DIP being progressively informed by quality data derived from DHIS2. There continue to be considerable problems of access to DHIS2, of capacity to navigate its programs, of identifying, analysing and using quality data.

15. The existence of DHIS2 data 'super users' demonstrate the possibilities for building a knowledge culture based on interest twinned with capacity. The question is how to maximize such potential without thereby placing unrealistic burdens on individuals.

16. The Blantyre Prevention Strategy is said to be designed based on lessons learned regarding Kuunika District gaps. This new program has the DHO as the lead, from the start. 'We re-thought the process, based on Kuunika challenges with decentralization.'

Overview of three key issues

Decentralization, Districts & Kuunika

• Neither a decentralized 'decision space' for health planning nor functions + capabilities have been effectively supported

• Development of digital health guidelines + systems should be supported more consistently at the District level

• That support should be based on a more coherent approach to the development of an organizational knowledge culture: starting with the users, not the system

• The Covid-19 pivot has not resulted in clear wins for DHOs + Health Facilities (+ perhaps communities): primarily seen as data extraction without effective support.

Sustainability

• Kuunika's key partner is the MoH; however, sustainability of digital health systems requires support to Districts and lower levels, as the central point of service deliveryfor HIV as well as universal health coverage

• The project support to the development of the MoH Digital Health Division represents not only a solid + (it is hoped) sustainable gain; the DHD could also serve as a central point for more aligned + harmonized MoH + partner engagement in work on digital health data systems + use, e.g. if the 'SWAp revival' concept note results in more coordinated inputs

• Kuunika inputs to e.g. the 2020-2025 National Digital Health Strategy represent normative + longer term contributions that can underpin more sustainable digital data architecture

Aid effectiveness

• There continues to be data extraction, imposition of donor partner data systems + indicators, lack of DHO + Council engagement in planning + creation of context-specific plans.

• There is scope (+ urgency) for greater coherence + genuine partnership at District level in digital data collection + use.

• There is fragmentation of effort, due to lack of donor co-ordination across the many health programs and projects. At District level, DHO, Council and Health Facility staff are overwhelmed by multiple demands + reporting formats. This affects the efficacy and efficiency of DHIS2. Alignment of all partners, with the active engagement of District actors, is essential.

• Districts continue to be the 'missing middle' in terms of the digital data architecture

Recommendations for Kuunika phase 2

Recommendation 1: engage throughout with Districts - leadership, ownership and governance

Rationale: the ultimate goal of any data system should be to deliver optimal health services that lead to improved patient outcomes. That necessitates proper District buy-in, which was not embedded into Kuunika from the outset.

Recommendation 2: work for greater aid effectiveness - alignment with other partners working on digital health data

Rationale: information from national level respondents is that a 'Sector-wide Approach (SWAp) Revival' Concept Note is in development. There is increasing emphasis on maturing away from a myriad of pilots and toward proven and scaled solutions built on common standards within an architecture.

The consensus appears to be that any such action would seek to re-introduce SWAp principles to alignment, joint planning, working and Monitoring, Evaluation and Learning (MEL), but not (at least initially) any financial disbursements to government entities. Investments and implementation for digital health data require far more harmonization. Application of a number of SWAp principles could potentially link disbursements to District performance, monitored using digital data. This would, however, necessitate genuinely effective support and training to all those engaged with collecting and using data to plan and deliver services.

Kuunika (and the Bill and Melinda Gates Foundation) should continue work with the MoH to support greater alignment and harmonization of all partners' digital health data interventions.

If there is a SWAp-light framework developed for digital health data, Kuunika should consider a role as an integral partner, calling upon cumulative project experience, expertise and its position at the center of national developments.

Recommendation 3: continue to support the MoH Digital Health Division

Rationale: the Digital Data Division should continue to receive Kuunika support; it is the site of government technical capacity. In its inception phase Kuunika 2 should plan for greater DDH coordination with and support to District digital health data systems.

Recommendation 4: ensure digital data systems are designed with users in mind and work to maximise opportunities for all levels to have access to participation, training and ongoing support

Rationale: systems should not be designed without properly thinking of who will use them and how, and the capacity development each individual cadre will need. With hindsight, the adoption of HIV as a data use case for Kuunika may have limited scope and flexibility - collection of HIV data was and remains tightly managed at the national level. Districts and Health Facilities did not have oversight of such data, or effective ownership.

Recommendation 5: build in sustainability from the outset

Rationale: while there is increasing resistance to a 'proliferation of pilots' in the digital health data sphere, Kuunika 2 has options to build on the foundations not only of the project, but to engage closely with the Blantyre Prevention Strategy, which is focused on building Districts systems, capacity and ownership. Such relationships, allied to any development of greater partner alignment and harmonization, could enable not only economies of scale but evidence-based prioritization of interventions proven to be effective.

Recommendation 6: have more focus on equity aspects of digital data systems

Rationale: data are never neutral. Just one point is disaggregation of data - their collection, their identification, their analysis and their use. WHO, UN Women, many civil society organizations and others continue to press for greater equity of data disaggregation, and greater application of such principles in the context of digital data.

1. Introduction

In October 2016, the Bill and Melinda Gates Foundation (BMGF) approved Kuunika: Data for Action, a $10 million, four-year program of support to the Government of Malawi’s Ministry of Health (MoH), to improve the planning and performance of HIV services in Malawi through the use of digital health data. HIV was chosen as a data use case for the project.

Kuunika's Theory of Change can be summed up as:

IT infrastructure investments lead to improved ‘data outputs’: evident and measurable improvements in the amount of time the databases are available to the user (availability) and in the ease with which the data can be retrieved, combined and viewed (accessibility). Many new ways of combining and analyzing data thereby become possible. This potential is realized through training and capacity building to provide users with skills and incentives to use the new data systems. The creation of MoH-wide data governance structures harmonize and maintain data standards, underpinning users’ trust in the quality of the data and further encouraging its use.

Mott MacDonald was appointed at the same time as the independent evaluator of Kuunika, with the aim of generating lessons from the program about how best to introduce new information technology (IT) into existing government systems. There have been three iterations of the evaluation: the 2017 baseline, the 2019 midline and the 2021 endline, as well as a Program Implementation Review in 2019. The three deeper dive Special Studies were all agreed with BMGF and Kuunika. 1

The evaluation has throughout aimed to answer five top-level questions:

As a result of the Kuunika project…

1. Has the quality of [HIV] data improved?

2. Has the use of that data by decision makers and practitioners increased?

3. Has decision-making improved?

4. Have key [HIV] service areas improved as a result?

5. What explains the changes (or lack of them)?

The endline and the three special studies additionally address the following two questions:

6. How effective has Kuunika’s sustainability phase been?

7. What should Kuunika II look like?

1.1 Special Study 3

This study examines the extent to which the Kuunika project may have responded to, or influenced, decentralization processes and outcomes in the Districts where the project has been implemented. The study will consider whether and how the project has supported digital Health Management Information Systems (HMIS) expansion, digital data use, overall knowledge management for enhanced health service delivery at the district level and whether decentralization processes have had any bearing on such work.

The study explores Kuunika’s relationship with the Districts and considers the (theoretical and evidenced) potential for digital Health Management Information Systems to contribute to effective decentralization of the health system.

1 See the endline report for detailed discussion of the history of the independent evaluation since 2016.

Over-arching Special Study 3 topics are:

1. How has Kuunika addressed and involved the Districts in project delivery?

2. To what extent have Kuunika outputs been adopted and ‘capabilities created’?

3. Can we look at decentralization and use of data through the lens of Kuunika?

4. To what extent has the pandemic pivot played a part in decentralized data systems?

Key informant questions include: 2

• Has the key informant's organizationseen any changes in the past 5 years in terms of health system decentralization processes?

• What is the current status of decentralization in the context of health service financing, governance, data collection and use and service delivery? Challenges?

• The role of digital data: how can data be used at District and national levels to plan and improve health service delivery?

• Has decentralization specific to health (however limited in scope) had any impacts on the key informant's access and inputs to, and use of, digital health data and data systems in decision making?

• What autonomy and authority do Districts have specific to health planning and service delivery in the context of decentralization?

• (How) has Kuunika addressed Districts’ specific digital data needs and challenges?

• (How) has Kuunika supported Districts in management of digital health data?

• To what extent have Kuunika outputs been adopted and ‘capabilities created’ for digital health data use - at the District level?

• Has Kuunika been agile in identifying and responding to decentralization activities that may have an impact on project work?

• Any changes due to the MoH and Kuunika response to the pandemic, specific to digital data and the role and remit of Districts?

A number of Kuunika evaluation hypotheses are relevant for this special study:

1. The degree of organisational and political decentralization can affect use of evidence in decision making (hypothesis 5)

2. Policy making is often messy and opportunistic - ‘a disorderly set of interconnections and back and forthness' (links into hypotheses 7, 9 and 17)

3. Hierarchical management of information and/or organisational silos can limit access to data and its use. Divisions of responsibilities and ‘silos’ can also limit consideration of evidence (hypothesis 15)

4. Individuals are empowered through access to data (hypothesis 18).

The various iterations of the Kuunika Theory of Change as developed by the evaluation team are also relevant, in order to consider the extent to which not only the project but also its evaluation addressed decentralized processes.

The first two deliverables in the Theory of Change address 'improved system architecture' and 'enhanced accessibility and useability' - key for decentralization. Organizational change is also essential if health systems strengthening specific to digital data collection and use is to be achieved.

The outputs set out in the ToC: 'new data services' and 'new data use skills', as well as the planned outcomes, have been reviewed in the context of decentralized systems and structures

2 See Annex 2 for KII discussion guides.

Mott MacDonald | Independent evaluation of Kuunika: strengthening HIV related health data systems

The draft final ToC shown below was developed by the evaluation team in September 2021; any further refinements will be discussed in the final draft of this Special Study report and in the final full evaluation report

Just to note here that the iterations of the evaluation Theory of Change do not explicitly address decentralized health systems or the role of digital data within those, due to being responsive to the project parameters. However, deeper attention could have been productive; just one example - the first two deliverables - 'improved system architecture' and ‘enhanced accessibility and usability' require effective partnership at all levels of the system in order to contribute optimally towards outputs and outcomes.

Figure 1: Final ToC 092021 reflecting 2018 project pivot, 2019 sustainabilty phase + 2020 Covid18 response

1.2 Special Study 3: approach and sample

The qualitative findings presented here are based on triangulated data collection from literature review, key informant interviews (KII) and focus group discussions (FGD), linked to contribution analysis and examination of the Kuunika evaluation Theory of Change and hypotheses.

The literature review is available upon request from Mott MacDonald. See Annex 1 for references to documents reviewed. It covers the following topic areas:

1. Definitions + debates: decentralisation, devolution, deconcentration

2. Relevant Government of Malawi (GoM) documents

3. District Development Plans and District Implementation Plans (DDP and DIP)

(A number of DDPs and DIPs for the sample Districts have been reviewed for 2017 - 2022 (DDPs) and 2019 - 2021 (DIPs); findings inform this Special Study.)

4. Decentralization reviews and critiques (both specific to Malawi and more widely. Health and other sectors)

5. Digital health - again both Malawi and more widely

6. Decentralization and gender

7. Documents from other projects

8. Kuunika, decentralization and the Malawian health system (Kuunika project documents)

9. Kuunika, decentralization and the Malawian health system (Kuunika evaluation reports)

10. The Covid-19 pandemic and its impacts on Kuunika

Qualitative data collection was conducted between early September and mid-November 2021

Remote KII were conducted with individuals based in Balaka, Blantyre, Machinga and Zomba Districts. Blantyre and Zomba are Districts that have received support from Kuunika (in November 2018 Zomba received an accelerated core package of project support, specifically on the Demographic Data Exchange and the EMR portal), while Balaka has served throughout the evaluation as a comparator District; Machinga was part of the baseline.

The total sample for Special Study 3 was 54, disaggregated into categories of key informant as set out below. More precise details are not provided, because the Proposal submitted to the National Committee for Science and Technology for ethical approval stated that all participation would be anonymous and confidential, in line with approved evaluation principles. All key informants were given informed consent statements and information about the evaluation in advance of discussion.

All key informants were also asked questions about the project and, therefore, contributed to the endline study.

Table 1: Category of key informant

Limitations include restrictions on travel due to the pandemic and the resultant challenges of conducting remote interviews through Microsoft Teams and Zoom. Connectively problems led to a number of missed key informant interviews (KII). The six Health Facility focus group discussions could only be conducted because Professor Maureen Chirwa travelled to each location and convened the FGDs, which were moderated remotely by Dr Janet Gruber.

In addition, there was a distinct lack of enthusiasm at District level to give time for KII. This was the most challenging cadre to engage with; upwards of 10 additional scheduled KII did not take place, despite repeated attempts by Mott MacDonald and CDM. This was the case in both Kuunika and non-Kuunika Districts.

Another limitation is that due to pandemic restrictions it was not possible to undertake dedicated KII or FGD with Health Surveillance Assistants (HSA)/Disease Control Surveillance Assistants (DCSA) or with any representatives of Health Facility, Village or other category of health committee. This had been possible during the baseline and midline evaluations.

2. Decentralization and health and digital data systems in Malawi

We first of all consider decentralization writ large, i.e. not solely as it pertains to the health sector. We then examine Malawian legislative instruments and processes, again not solely in the context of the health sector. Section 2.3 homes in on digital health and the extent to which national instruments on this topic do or do not address decentralized structures. Finally we look at global digital health principles, guidelines and reports and interrogate these for relative degree of attention to subnational levels.

2.1 Definitions of decentralization

These are not unique to Malawi, but are internationally applied definitions and are, therefore, those used in this report

It may be that deconcentration (see below) is the closest actual fit for Malawi - in which operations are decentralised, but decision-making powers are not devolved.

The term decentralization embraces a variety of concepts.

Decentralization refers to the transfer of authority and responsibility for public functions from the central government to subordinate or quasi-independent government organizations and/or the private sector it is a complex multifaceted concept.

Different types of decentralization should be distinguished because they have different characteristics, policy implications, and conditions for success

Administrative decentralization seeks to redistribute authority, responsibility and financial resources for providing public services among different levels of government. It is the transfer of responsibility for the planning, financing and management of certain public functions from the central government and its agencies to field units of government agencies, subordinate units or levels of government, semiautonomous public authorities or corporations, or area-wide, regional or functional authorities.

There are broadly two major forms of administrative decentralization - deconcentration and devolution

Deconcentration redistributes decision making authority and financial and management responsibilities, usually among different levels of the central government.

The overall consensus is that devolution is a form of administrative decentralization. Thus: devolution is the statutory delegation of powers from the central government of a sovereign state to govern at a subnational level.

The transfer of power and authority may involve revenue generation, priority setting, resource management and/or decision making, and the sub-national units may be elected directly by the population, or appointed by the central level or by private entities. These multiple modes of decentralization make it a very complex concept to study in a real world setting.

A key concept in the decentralization debate is decision space = the degree of discretion that peripheral units have within the law, and their ability to ‘bend the law’, with implications for accountability - very much including the ability of actors to demand from or provide information to others within the system (see e.g. Bossert 1998; Tsofa, Molyneux et al 2017).

Another is the 'matching principle': this is widely seen as a basic (but seldom fully or even partially achieved) requirement for an efficient and effective sub-national government. Thus for any public service, the benefit areas (e.g. a Health Facility catchment area) should be matched by the financing areas (areas over which fees or taxes are being levied to finance the service). Moreover, expenditure responsibilities should be matched with revenue sources and revenue capacities should be matched with political accountability.

2.2 The global digital health context: relative focus on decentralized structures

There has been considerable work carried out in the past two decades in particular to expand and embed the use of digital data systems in the global South. Yet such work frequently lacks attention to decentralized health structures (whether through discussing their potential/actual inputs, possible pitfalls, any evidence for or against such focus, etc), while calling for greater equity of data collection and use, which would presumably require engagement at all levels of a health system, horizontally as well as vertically.

Recent initiatives include the May 2018 71st World Health Assembly Resolution on Digital Health, which demonstrated global recognition of the value of digital technologies to contribute to advancing universal health coverage (UHC) and other health aims of the Sustainable Development Goals (SDGs).

The Resolution urged Ministries of Health to assess their use of digital technologies for health […] and to prioritize, as appropriate, the development, evaluation, implementation, scale-up and greater use of digital technologies, as a means of promoting equitable, affordable and universal access to health for all, including the special needs of groups that are vulnerable in the context of digital health...to consider, as appropriate, how digital technologies could be integrated into existing health systems infrastructures and regulation, to reinforce national and global health priorities by optimizing existing platforms and services (p. 2).

However, the 2018 Resolution did not discuss decentralized aspects of digital health data systems.

Moreover, with respect to the SDGs: none of SDG 3 (Good Health and Wellbeing) targets or indicators makes reference to digital data, indeed to any data, aggregate or disaggregated. SDG 9 and its 9a, 9b and 9c targets tangentially refer to ICT access, more sustainable infrastructure, research capabilities and the like: all relevant to digital health data collection and use, which is nowhere specified.

The 2019 WHO guideline: recommendations on digital interventions for health system strengthening emphasizes the pivotal necessity of digital data for supporting improved health service delivery, while highlighting the challenges ahead

Thus the Guideline states: Amid the heightened interest, digital health has also been characterized by implementation rolled out in the absence of careful examination of the evidence base on benefits and harms. The enthusiasm for digital health has also driven a proliferation of short-lived implementations and an overwhelming diversity of digital tools. (p. i)

Despite the wide-reaching nature of the Guideline, it does not address space for decentralized digital health engagement; the adapted Tanahashi framework model set out in the Guideline fails to include such wider governance and management levels in its overview of opportunities for digital health specific to achieving UHC.

The widely endorsed (including by BMGF) nine Principles for Digital Development, first developed in 2012 3, address issues such as:

Designing with the user: this supports the building of better, more transparent, jointly shared and robust digital data systems designed with the context and user in mind.

Understanding the existing ecosystem: this requires the involvement of 'community members, donors, local and national governments' in an iterative process throughout a project/initiative lifecycle.

3 Principles of Digital Development. Retrieved from: https://digitalprinciples.org/ The Principles are an attempt to unify digital principles and create a community of practice for those who work in digital development. The Digital Principles were first created in consultation with organizations such as BMGF, SIDA, UNICEF, UNDP, the World Bank, USAID and WHO.

Designing for scale: in other words, thinking beyond the pilot and the proliferation of often smallscale, vertical projects that are probably implemented in a limited area - and work from the outset to understand what works.

While not mentioned, this would ideally include attention to the District level; any pilot would build in scale-up strategies from the beginning.

The 2021 World Development Report, entitled Data for Better Lives, does not discuss in any detail the role or remit of decentralized structures (health or other) in the context of building effective, democratic systems with strong governance. It does, however, note the following (NB: without specific reference to decentralized or sub-national structures, unless these are implicitly subsumed under 'government agencies'):

'When government agencies, civil society, academia, and the private sector securely take part in a national data system, the potential uses of data expand and so does the potential impact on development. In fact, the more integrated the system and the more participants involved, the higher is the potential return...Higher degrees of integration require close coordination and shared governance between participants, but such integration is otherwise compatible with a decentralized data architecture...Even though most countries are far away from the aspirational goal of a well-functioning data system, setting sights on this target can provide countries with guidance on the next steps in developing such a system ' (p. 16)

A 2018 report entitled Transforming Health Systems Through Good Digital Health Governance notes that Digital health has been acknowledged as a key building block for UHC and the healthrelated Sustainable Development Goals. However, it argues that while much work is being undertaken across the global South, a holistic approach to digital health, which requires good governance for successful implementation and sustainability throughout the health system, continues to be lacking in many countries

Thus: Good governance is needed at all levels local, district, provincial, and national throughout the health information system. This, in turn, supports equitable access and delivery of quality, affordable health services. (Marcelo et al. 2018; p. 4)

Such efforts to entrench good governance in the Malawian digital health context should surely require engagement with and by District health structures, in order to optimize buy-in, ownership and the development of a 'knowledge culture' 4 for planning and service delivery. Relevant here is that in order to develop a knowledge culture, which is a process-driven incremental build, there needs to be support to such activities as well as training; the evidence throughout the independent evaluation is that training on its own is insufficient to increase appetite for, and use of, digital data for planning and to achieve improved service delivery and health outcomes.

Again, it is important to note that no one project can hope to achieve all such outcomes, because there needs to be a national, systemic process running alongside to address decentralization in its broadest sense.

2.3 A brief overview of Malawi decentralization legislation and processes

The box below homes in on the health sector and the extent to which overarching national legislative instruments and reports and also sector strategies address decentralization and decentralized systems and structures.

4 Here 'knowledge culture' refers to a group of behaviours, including responsiveness towards the use of data, positive evidence of individual and organizational practices to support data use, senior staff members actively promoting data use and encouraging users, all of which can develop and sustain evidence-based planning and service delivery.

Literature review 5

• The 1998 Malawi Local Government Act, the key instrument in terms of legislative foundations for decentralization, refers to devolution.

• Political decentralization stalled in 2005. There has at best been 'piecemeal' fiscal + administrative decentralization since then. The 2010 amendments to the 1998 LGA 'clawed back' many aspects of decentralization (p. vii re. both formal + informal recentralization of power and functions). There is lack of coherence/read across between District Development Plans + District Health Implementation Plans (O' Neill, Cammack et al 2014)

• The 1998 LGA left 'referral Health Facilities' within the ambit of the central MoH, but did not clearly define what is meant by a referral Health Facility The 2010 Local Government (Amendment) Bill undermined decentralization + the management of public sector reform. The major lesson provided by Malawi is that there is no automatic relationship between [partial/incomplete] decentralization + efficient public service delivery + development. (Hussein 2012)

• The 2017 National Health Plan II and accompanying Health Sector Strategic Plan II identify the importance of improved governance + strategies to achieve more effective cooperation with stakeholders. The partial implementation of decentralization is viewed as a cause of poor governance in the health sector.

• The current Malawi Health Sector Strategic Plan II 2017 - 2022 (the HSSP II) includes little specific consideration of decentralization. It is unclear whether there has been any coherence between the development of the HSSP II + iterations of the National Decentralization Programme

• Furthermore, the 2020 Malawi Voluntary National Review Report for the SDGs contains minimal discussion of decentralized/District health structures or their role in work towards achievement of the SDGs. Thus the section on SDG3 contains no mention of Districts' role in its achievement, or of the importance of data disaggregated by District and contextual priorities.

• HSSP III is currently under development - there is said to be impetus for achieving one single data reporting system (rather that the existing proliferation of donor-supported mechanisms in addition to DHIS2). In addition, a 'SWAp revival' concept note is under development. There is apparently genuine appetite to ensure HSSP3 applies a more integrated approach to health service delivery, away from programme silos.

The literature review reveals a range of frequently voiced concerns linked to decentralization in Malawi and elsewhere. The points raised in the quotes are echoed in this report.

'Stakeholders view governance challenges as a significant barrier to achieving a more effective and equitable health system. Three categories were identified: accountability (enforceability; answerability; stakeholder-led initiatives); health resource management (healthcare financing; drug supply); influence in decision-making (unequal power; stakeholder engagement)...The partial implementation of the government policy of decentralization was viewed as a cause of poor governance in the health sector.' (Masefield et al 2020)

'The decentralization agenda remains incomplete, even nascent, in Malawi. Genuine decentralized government requires effective coalitions between central and local state and nonstate actors.' (Mohmand & Loureiro 2017)

The following quotes (the first from a Kuunika partner representative) are more specific to decentralization of health data architecture and systems.

'Disjointed planning and asymmetric access to information... Despite the mandate to create periodic District Development Plans (DDPs) and District Implementation Plans (DIPs) with associated budgets, funding and resource allocation decisions are mostly determined centrally... Most plans go underfunded and tough decisions must be made about what will get prioritized...After submission to national level, plans are often returned with a prescribed budget reduction and a surprisingly short turn-around time to revise and resubmit leaving little or no room for negotiation backed by specific data. (Smith 2015; pp. 24 - 25)

5 For details of all references see Annex 1.

Lack of attention to gender, equity and other inequalities in Malawian (and other) health system decentralization processes is significant.

'Gender responsive health systems' can be defined as health systems that 'address the gender determinants of health, the gender factors at work in the health system and the resulting gender inequalities'. Achieving gender-responsive health systems requires the integration of gender into decentralization processes and health system governance. ' (Pendleton et al 2015).

The WHO Health Equity Monitor states that: Monitoring health inequalities is essential for achieving health equity. Health inequality monitoring uses health data disaggregated by relevant inequality dimensions ... in order to identify differences in health between different population subgroups. Disaggregated data provide evidence on who is being left behind and informs equityoriented policies, programmes and practices.

2.4 Digital health in Malawi: national instruments and their relative attention to decentralized structures

Literature review

• Key documents relating to digital health are the National Health Information Systems Policy (2015) + the Monitoring, Evaluation and Health Information Systems Strategy (MEHIS), 2017-2022. The 2020-2025 National Digital Health Strategy has recently replaced the 2011-2016 National eHealth Strategy.

• The NHISP: guiding principles include the need to generate locally relevant data; disaggregation by sex, age, geographical areas, income groups so as to 'achieve greater equity, efficiency and quality'; development of data use; holistic approach; robust [e-Health] systems. Stated barriers to effective use of data include: vertical +/or parallel data systems; lack of interoperability; lack of data sharing; too few trained in data management

• MEHIS (not solely e-Health): Reference to lack of co-ordination of MEHIS activities, e.g. multiple teams separately organizing supportive supervision and performance reviews Despite recent efforts to harmonize systems, major weakness of the HIS is existence of vertical/parallel reporting systems. Development partner support concentrates HIS resources in individual programs, ignoring/weakening national HMIS. Despite such discussion, MEHIS does not refer to decentralisation in the context of digital data.

• The NDHS: this comprehensive strategy addresses Districts primarily in terms of resource gaps; ownership + leadership in relation to digital data receive minimal focus. No real discussion of the role of DHIS2; the same is true for decentralization + its ramifications + impacts

• A Kuunika deliverable is development of Standard Operating Procedures 6. MEHIS states 15 are to be completed; 12 are at various stages of development.

Key informant interviews

• Many of the key documents that are supposed to underpin digital data systems are great on paper but weak on implementation - and all too often far too ambitious in terms of indicators. This is especially true at decentralized levels (National level key informant)

• There are now Government and MoH guidelines and strategies, but those tend to leave out the District levelit's as though they are the 'missing middle'. But any national strategy needs to include all levels in planning for use of digital data, otherwise why bother to collect all that information? (National level key informant)

• There are documents, national strategies, the MEHIS - but none of those really thinks about the role of the District, or the Health Facilities. The focus is always on the national level, while most of the health sector work is in the Districts (DHO staff o None of the SOPs under development include detailed attention to decentralized health structures + the role of edata within such a system. o Only two SOPs refer explicitly to Districts' roles + responsibilities: User Support and DQA o E.g. the SOP Guidelines for the Development and Revision of HIS Standard Operating Procedures (no number) defines what a SOP should be, their relevance. The section on roles + responsibilities does not include District structures, while e.g. development partners are addressed. Districts are not explictly mentioned as part of the 'secondary audience' for the SOPs, while donors, CSOs, universities, etc. are. o There is no reference in any of the reviewed SOPs to Data Clerks or HMIS Officers, the cadre of health worker who are tasked with data entry. o SOP 11 - Introduction of new e-Health in the HIS landscape of MoHP Malawi sets out an MoHP defined hierarchy of expertise + 'end users'. Districts + lower levels are in the latter group. member, non-Kuunika District

• One big thing Kuunika has done is to support the development of the 20202025 National Digital Health Strategy. That's important and a major step. But it could have looked more at the Districts, what we can't do, what we could do and how we get from A to B. (DHO staff member, Kuunika District)

The extent to which Malawi's digital data architecture and systems support effective collection and use of disaggregated data at District level - and why this is important - will be considered in the review of the District Implementation Plans (see 4.3 below).