This case study was developed to highlight health data governance success stories and illustrate how the Health Data Governance Principles can be applied in a national context. This information was compiled by PATH through desk research and conversations with local digital health experts, including the Kenya Ministry of Health (MOH). It applies legislation, systems, and activities in Kenya against the following four Health Data Governance Principles 1:
In 2013, Kenya shifted to a devolved system of government with two tiers: national and subnational or county. Health is now largely managed by county governments. This includes oversight of county health facilities and pharmacies; ambulance services; and promotion of primary health care. The national government is responsible for national referral health facilities and health policy.2 The rationale for devolution was to allow county governments to design models and interventions that are best suited to the unique health needs of each individual county while encouraging citizen participation in decision making.
The Health Act 2017 is an overarching piece of legislation which provides a framework for the Kenyan health sector. It is meant to support better health care delivery, and ultimately lead to improved quality of care and client health outcomes. It also aims to inform development of other important policy instruments for the realization of the MOH e-health mandate covered in the following sections 3:
The Kenya MOH is currently in the process of drafting an e-health bill for consideration by the legislature. It is envisioned that this bill will provide a legal framework for guiding investment in e-health, facilitate widespread access to health care services and health information, and promote the secure sharing and exchange of client information. The goal is a safe, high-quality health care system that is more equitable and responsive to all Kenyans, transforming the way information is used to plan, manage, and deliver health services.
One of the key tenets of the proposed e-health bill is to establish a national e-health ecosystem that encompasses public and private institutions and health service providers with a view toward providing a progressive and equitable standard of care—including data governance. This bill is expected to cover internal data standards and policies for managing the availability, usability, integrity, and security of data within a health system.
Kenya has made major strides in acknowledging the importance of data in various spheres including health. The Data Protection Act was enacted in 2019, establishing the Office of the Data Protection Commissioner, regulating the processing of personal data, and providing for the rights of data subjects.4 Under this act, data controllers and processors are required to establish and maintain security safeguards to protect personal data.
Key components of the act, include 5:
The Kenya Health Management Information System (KeHMIS) project was started in 2011. The main goal of the effort was to support the MOH, County Health Management Teams, and service delivery partners in advancing health information system (HIS) innovations.
It was developed in three phases:
The KeHMIS project supported the development of a National Data Warehouse (NDW), which serves as a centralized repository for anonymized HIV clinical care patient-level data gathered by health facilities. The NDW is hosted by the National AIDS & STI Control Program and contains data for over 2.2 million patients from over 1200 health facilities. The NDW also acts as an analytics and visualization platform and is used by the MOH, county governments, and other stakeholders to support data-led decision making and strategic planning.7
The KeHMIS project also developed an interoperability layer to facilitate data exchange between various health information systems, promoting data sharing and supporting automated reporting. The interoperability layer is based on the OpenHIE framework and was developed in compliance with Health Level Seven International Standards for Care Coordination and the Aggregate Data Exchange Standard for Aggregate Data Reporting. It was designed to support a variety of standard workflows including client registration, appointment management, prescription and dispensing, viral load management, clinical observations, and automated indicator reporting.8
There are currently eight participating systems connected through the interoperability layer including: Ushari, an automated appointment manager with a default tracing module; Text for Adherence, which uses SMS/USSD for monitoring anti-retroviral drug adherence and reporting; and, Mobile Laboratory, which sends national laboratory results via SMS to health facilities. 9
MYDAWA is Kenya’s first registered online pharmacy. It was founded with the aim of ensuring that every Kenyan can get quality, secure, affordable medicine and wellness products online. 10
MYDAWA developed and manages a pharmacovigilance system that collects data on adverse effects, off label use, medication errors, overdose, and counterfeit products. The system aims to detect, assess, understand, and prevent adverse effects or other drug related problems. The data collected inform product safety profiling and drug labels and are also shared with the Pharmacy and Poisons Board (PPB).
The PPB governs drug manufacturing and regulations, as well as pharmacy practices, within Kenya.11 The PBB uses data from pharmacovigilance systems like MYDAWAs to ensure that there are high standards of safety in the manufacturing, distribution, and sale of drugs, while guaranteeing high quality, safety, and efficacy of medicines and health products.12
Reach52 is a technology social enterprise working to “reach 52% of the world with accessible health services”.13 Their health technology platform supports “offline-first” applications across a range of health areas that work on basic mobile phones and in low-connectivity regions. In Kenya, reach52’s current focus is on reducing micronutrient malnutrition among children and expectant mothers in rural communities of Elgeyo Marakwet and Homa Bay counties.
Reach52 ensures that it represents the vulnerable and marginalized populations through equitable and inclusive data collection. Health workers are drawn from local communities and are trained to ensure that clients understand why their data is being collected and how it will be used. Further, the data being collected align to nutrition status and health indicators tracked by the Ministry of Health.14
Health Data Governance Principles Case Study: Kenya. Fondation Botnar; 2022.
1.Health Data Governance Principles. Foundation Botnar; 2022.
2.Kenya Law website. http://www.kenyalaw.org:8181/exist/kenyalex/actview.xql?actid=Const2010. Accessed April 1, 2022.
3.Kenya Law website. http://kenyalaw.org/kl/fileadmin/pdfdownloads/Acts/HealthActNo.21of2017.pdf. Accessed March 21, 2022.
4.Kenya Law website. http://kenyalaw.org/kl/fileadmin/pdfdownloads/Acts/2019/TheDataProtectionAct__No24of2019.pdf. Accessed April 7, 2022.
5.Deloitte website. https://www2.deloitte.com/content/dam/Deloitte/ke/Documents/risk/Kenya%20Data%20Protection%20Act%20-%20Quick%20Guide%202021.pdf. Accessed April 8, 2022.
6.Kenya Health Management Information System website. About us page. https://kenyahmis.org/about-us/. Accessed March 23, 2022.
7.Kenya Health Management Information System website. Data warehouse page. https://kenyahmis.org/documentation/summary-national-data-warehouse/. Accessed April 6, 2022.
8.Kenya Health Management Information System website. Interoperability page. https://kenyahmis.org/documentation/summary-interoperability/. Accessed March 23, 2022.
9.Kenya Health Management Information System website. Interoperability: Summary IL page. https://kenyahmis.org/documentation/summary-interoperability/. Accessed March 23, 2022.
10.MYDAWA website. About us page. https://mydawa.com/about-us. Accessed March 23, 2022.
11.MOH Pharmacovigilance center. https://pdf.usaid.gov/pdf_docs/PA00K5S6.pdf. Accessed April 1, 2022.
12.Kenya Pharmtec website. Pharmacy and Poisons board page. https://www.kenyapharmtech.com/medical-directory-kenya/pharmacy-and-poisons-board/. Accessed April 7, 2022.
13.Reach52 website. All about us: Who we are page. https://reach52.com/who-we-are/. Accessed March 23, 2022.
14.Kenya Ministry of Health website. https://www.health.go.ke/wp-content/uploads/2020/10/Kenya-Nutrition-Monitroing-and-Evaluation-Framework.pdf. Accessed April 7, 2022.