3 The digital health governance context

Digital health in Malawi is part of a complex and dynamic governance ecosystem. Malawi’s Digital Health Strategy (2020-2025) aims to provide coherent strategic direction in an evolving digital health environment.

3.1 Stakeholder context

Annex 2 shows our formative stakeholder mapping for Special Study 2. As shown in this mapping, there are multiple, overlapping government structures and satellite institutions that are involved in digital health, health information systems, health service delivery (including HIV services) at national and subnational levels. The EMR stakeholder landscape in Malawi is also complex and dynamic. Over the course of the Kuunika Project, there have been significant changes in government leadership and MoH institutional arrangements (following national elections in 2019 and 2020), changes in project leadership, as well as changes in the donor landscape.

Health services in Malawi are provided by public and private (for profit and not for profit) providers. The major not-for-profit provider is the Christian Health Association of Malawi (CHAM) which delivers almost 30% of all health services. Malawi’s health system is organised over four levels namely: community, primary, secondary and tertiary. Community, primary and secondary level care falls under district councils under the leadership of a District Health Officer (DHO) who reports to the District Commissioner (DC).

The Ministry of Health performs the central level functions of policy making, standards setting, quality assurance, strategic planning, resource mobilisation, technical support, monitoring and evaluation and international representation. The Ministry is organised around 14 directorates, with responsibility for HIV/AIDS services falling under the Directorate of Nutrition and HIV/AIDS. Five Zonal Quality Management Offices (QMOs) are an extension of the central level and provide technical support to districts.36

By 2020, the principal government institutions responsible for digital health governance in Malawi were the Ministry of Information, Communication and Technology (ICT) and the Ministry of Health. Table 1 below summarises the respective roles and responsibilities of these ministries and the relevant structures under them.

Table 1: Overview of principal digital health governance structures in Malawi

Institution Role in digital health

Ministry of Information and Communications Technology

The lead ministry on technology development and implementation. It has a decentralised structure, with staff seconded to support other ministries and government. At MoH, the Ministry of ICT is represented by an ICT Section headed by a Deputy Director. At the district level, there is at least one Systems Analyst and Programmer at central hospitals and a Programmer stationed at each District Health Office.

● Department of eGovernment

Ministry of Health

The Ministry of ICT’s Department of e-Governance leads on the development of ICT legislation, policies, strategies and standards for the government. It works closely with the MoH’s ICT Section and has particular responsibility for guiding digital health governance at MoH. Provides strategic leadership on the delivery of quality health services for the population of Malawi – this includes strategic leadership on digital health and health data governance. MoH Departments and Programmes have provided programmatic and subject matter leadership for the design and deployment of digital health solutions in Malawi.

36 Source: http://www.health.gov.mw/index.php/explore/management . Retrieved 25 September 2021.

● Directorate of Planning and

Policy Development

- Central Monitoring and

Evaluation Division (CMED)

o CMED Technical Working

Groups (TWG) and subgroups

- Digital Health Division (DHD)

● Directorate of Quality

Management (QMD)

● Directorate of Nutrition and

HIV/AIDS

● Other MoH Directorates Provide strategic direction through Short, Medium and Long term Plans for the health sector at National and Council level. It has particular responsibility for: health sector budget development and capital investment planning; coordination of donorfunded programmes; and health sector monitoring and evaluation. CMED sits under the DPPD and is responsible for monitoring and evaluation of progress in delivering health sector policies and strategies. It aims to generate high quality information for evidence based decision making, planning and management in the health sector. Its responsibilities extend to the Health Management Information System (HMIS) and data governance. CMED is the key department to provide data standards, SOPs and policy suggestions regarding M&E tasks and HIS development. The M&E TWG is the key instrument of CMED to bring various government, nongovernment and donor stakeholders together to align on different aspects of the M&E work. It oversees several sub-TWGs including: the National Health Data Standard Sub-TWG (covering data standards, architecture and security); the mHealth Sub-TWG (covering mHealth coordination): and the Equity and Access Sub-TWG (covering inclusion and universal health coverage themes).

DHD is a new structure under CMED that provides strategic and operational guidance and technical leadership on digital health initiatives. It works hand-in-hand with the departments and programmes of MoH to ensure support alignment and integration of digital health interventions – most recently this role included data aggregation and analytics for responding to the COVID-19 pandemic. . QMD was established under MoH in 2016 to provide strategic leadership and coordinate quality management and improvement initiatives across the health sector. From 2019-2020 it was the lead directorate for digital health governance and coordination; however, this role was transferred to DPPD in late 2020. This directorate provides leadership, guidance and strategic direction for the implementation of the national response to nutrition disorders, HIV and AIDS in the country. The Department of HIV/AIDS under this directorate collaborates with the National HIV/AIDS Commission (NAC) under the Office of the President to support multisectoral implementation of the National HIV and AIDS policy and strategic plan. The other directorates under the MoH cover: finance, human resources, clinical services, nursing and midwifery, preventive health, technical support services, health research, reproductive health and safe motherhood. They also include the National Public Health Institute of Malawi. Each of these directorates may be custodians or clients for particular components of the digital health system.

The primary custodian for digital health governance in MoH is now the Directorate of Planning and Policy (DPPD). This directorate works collaboratively with the cross-cutting ICT Section.

Planning and decision-making under DPPD depends on timely flows of data from across the health information system architecture to enable side-by-side comparison of information on health service delivery, drug and commodity consumption, finances and human resources. 37 Mappings of the digital health architecture thus extend to: the District Health Information System 2 (DHIS2); the Laboratory Information Management System (LIMS); the Logistic Management Information System (LMIS); the Integrated Human Resource Information System (IHRIS); the Integrated Financial Management Information System (IFMIS).

3.2 Policy context

Under the Ministry of ICT, the government has developed the eTransactions and Cyber Security Act (2016, the Access to Information Act (2017), the National ICT Policy (2013), and various standards and guidelines. In addition, the Ministry of ICT is implementing a flagship ICT Infrastructure improvement project known as ‘Digital Malawi’. Table 2 below provides an overview of the key government policies and strategies most relevant to digital health in Malawi.

37 See Annex 4 for a 2019 MEASURE Evaluation review of the strength of the Malawi HIS as a source of HIV data.

Table 2: Key digital health legislation, policies and strategies in Malawi

Policy / Strategy Description

eTransactions and Cyber Security Act (2016)

Access to Information Act (2017)

National ICT Policy (2013)

Provides a framework for digital transactions and for the investigation, collection and use of electronic evidence. Part IV of the Act covers data protection and privacy. The Act makes provision for criminalising offences related to computer systems and information communication technologies. Responsibility for implementation of the Act lies with the Malawi Communications Regulatory Authority (MACRA). Provides for access to information that is in the custody of public bodies and private bodies. It also describes the compliance with access to information obligations of information holders. The Malawi Human Rights Commission is designated as the oversight institution for implementation of the Act provided by the Bill. Aims to support the national goal of wealth creation and reduction of poverty through sustainable economic growth and infrastructure development. Policy should be operationalised through the National ICT Master Plan and the ICT Standards & Guidelines.

Malawi National Registration Act (2009)

Data Protection and Privacy Bill (2021)

Health Sector Strategic Plan (HSSP) II, 2017-2022: Towards Universal Health Coverage

National Health Information Systems Policy (2015)

Monitoring, Evaluation and Health Information Systems Strategy (MEHIS), 2017-2022

National Digital Health Strategy, 20202025

Legislation covering records of births, deaths, and marriages at the village, traditional authority, district, and national levels. Also establishes a registry of everyone in Malawi who is 16 years or older and is a Malawian citizen or has a permanent residence permit, a temporary employment permit, or a business residence permit. This Bill seeks to provide a comprehensive legislative framework for the protection and security of personal data, consolidate data protection provisions currently found in various Acts of Parliament, and protect the privacy of individuals. Recent concerns raised about the Bill include: unclear definitions regarding legitimate data access and cross-border data transfers; the autonomy / enforcement capacity of regulatory authorities such as MACRA, and implications for the National Registration & Identification System. HSSP II contributes to the national development strategy under the Malawi Growth and Development Strategy (MGDS III). HSSP II is supported by policies and governance tools, and is complemented by the national Community Health Strategy which focuses on improving service delivery at the community level. Guiding policy for the effective and efficient management of health information systems in Malawi. This Strategy aims to support a sustainable, integrated national health information system capable of generating and managing quality health information for evidence-based decision making by all stakeholders at all levels of the health system. The Strategy focuses on two objectives relating to monitoring of HSSP II delivery and improved capacity for data use in decisionmaking. This Strategy is the successor to the Malawi eHealth Strategy (2011-2016). It aims to improve the delivery of health services by providing digital health solutions that are harmonised, sustainable, reliable, interoperable, secure and comply with standards to increase efficiency and enable provision of quality services at the point of service. The Strategy focuses on six main objectives relating to: reliable ICT infrastructure; sector capacity for using digital technology to improve service delivery; health data security; improved system interoperability; and improved sharing and accessibility of data across information systems.

Kuunika’s support to the Digital Health Division since 2019 is reflected in the National Digital Health Strategy. This Strategy is well aligned to HSSP II, with a focus on universal health coverage (UHC). The National Digital Health Strategy explicitly aims to support the harmonisation of investments in digital health for improved efficiency and effectiveness. It also adopts a ‘human-centred’ approach with a primary focus on the needs of service providers and adoption of the global principles for digital development.

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The National Digital Health Strategy is also referenced in Malawi’s new five-year Digital Economy Strategy (2021-2026). This Strategy sets new targets for the digital economy and creation of a strong digital ecosystem. Under this strategic framework, the World Bank and other development partners are supporting the GoM with a number of digital initiatives. This has included assistance for a nationwide smart, biometric identity system - the National Registration and Identification System (NRIS). 39 Over 9.1 million Malawian citizens have now been issued with a new biometric identification card.40 The GoM is now aiming to establish secure links between the NRIS with other identity registers to improve citizens’ access to relevant services. The intention is to link: birth registration; the voter registry, the Malawi Business Registration database; the Universal Beneficiary Register (UBR) covering social protection, and health (EMR) registries. 41 The World Bank has recently highlighted the need for such initiatives to be supported by a highly robust legal and regulatory framework on data privacy, data protection, data sharing and data safeguarding.42,43We note it is likely that key areas of Malawi’s national legislation (e.g. the Access to Information Act and the National Registration Act) would need to be updated to protect health data if these system advances proceed (see Figure 5 ).

3.3 Standards and interoperability

Malawi’s Ministry of ICT has defined a set of ICT standards to be used in deployment and use of all ICT products. In addition, MoH has adopted various standards to support the implementation and use of health information systems. These standards are reflected in the National Health Indicators Handbook, the Master Health Facility Registry and the Terminology Registry. MoH also requires adherence to a set of software standards (e.g. HL7, FHIR, SOAP etc).

In addition, steps have been taken towards a set of Standard Operating Procedures and Guidelines to support implementation of digital health solutions (see Annex 5 for a summary of the status of these SOPs). MoH is also seeking to standardise data collection and reporting tools (e.g. a new set of revised selected registers was released in 2018, and CMED is finalising definition of diagnosis coding for reporting purposes).

With regards interoperability, MoH is now following a standards-based approach with the development of key interoperability components based on an Open Health Information Exchange (OpenHIE) framework. Within the Digital Health Division, the Kuunika team is reported to have been playing an important role in developing the Interoperability Layer (including development of the Terminology Registry which comprises definitions for both disease diagnosis and treatment).

38 Principles of Digital Development. Retrieved from: https://digitalprinciples.org/ 39 This initiative started in 2017. 40 World Bank. (2021). Malawi Economic Monitor: Investing in Digital Transformation. June 2021 41 See also: GSM Association. (2019). Digital Identity Country Report: Malawi, London: GSMA 42 World Bank. (2021). World Development Report 2021: Data for Better Lives. Washington, DC: World Bank. 43 World Bank. (2020). Digital Regulation Handbook: Geneva: International Telecommunication Union and the World Bank.