Pillar 1

Governance, Policy & National Enterprise Architecture

Laws, institutions, architecture and procurement rules that make digital health investments coherent and sustainable.

Our approach

From “e-chaos” to sovereign, institutional governance. We focus on the regulatory foundation — for example Kenya’s Digital Health Act (2023) and the Digital Health Agency it established. We advise clients on National Enterprise Architectures and vendor-neutral procurement standards that prevent lock-in and ensure fiscal sustainability beyond the project lifecycle, sequenced through a phased roadmap and a small set of binding architecture principles.

Roadmap — Pillar 1

Diagnose & mandate (0–6 months): Inventory systems, pilots and donor projects; baseline maturity assessment; Digital health governance body and steering committee mandated; Moratorium on new non-compliant pilots
Legislate & architect (6–12 months): Digital health law or decree drafted and consulted (data ownership, consent, sovereignty); National Enterprise Architecture and standards catalogue adopted; Standard tender clauses: open standards, data ownership, exit
Institutionalise (12–24 months): Digital health authority/agency operational with budget and staff; Architecture Review Board gate applied before any funding; Secondary regulations: data sharing, hosting, software certification
Sustain (24–36 months): Recurrent costs in the national budget; donor alignment under one plan; Legacy rationalisation; TCO and vendor-performance reviews; Periodic review of the legal framework (AI, cloud, cross-border)

Governance and architecture principles

Country-led, one plan — One national strategy and budget line; partners align to it instead of running parallel projects.
Architecture before applications — No system is funded without passing the national architecture compliance gate.
Open standards by default — FHIR, ICD-11, LOINC and GS1 are mandatory in every tender.
Vendor neutrality and portability — The state owns its data; contracts include open APIs, documentation and exit clauses.
Reuse DPI — Use national ID, payments and data exchange instead of building health-specific copies.
Data sovereignty and privacy by design — Hosting, consent and secondary use follow national law from day one.
Total cost of ownership — Decisions consider recurrent costs, skills and maintenance beyond the project.
Measurable results — Every investment is linked to UHC indicators in the results framework.

Legislative & Institutional Frameworks

A digital health law, a mandated national authority and health data sovereignty rules that give every other investment a legal basis. Software packages: National e-consultation portal, Document & records management.

Draft a Digital Health Act covering data ownership, sovereignty, consent and secondary use
Establish a Digital Health Authority or unit with a formal mandate and steering committee
Issue secondary regulations: data sharing, hosting/localisation, certification of health software
Align health data rules with the national data protection law and cross-border provisions
Review the legal framework every 2–3 years against AI, cloud and cross-border developments
Deliverable: Draft Digital Health Act and regulations
Deliverable: Digital Health Agency charter, structure and budget
Deliverable: Health data governance and sovereignty policy

National Enterprise Architecture

A national reference architecture that every programme and donor project must comply with, ending fragmented pilots and legacy silos. Software packages: Archi / ArchiMate EA repository, OpenHIE reference architecture.

Inventory existing systems, pilots and donor projects (application landscape)
Adopt a reference architecture (e.g. OpenHIE-based) with target and transition states
Set up an Architecture Review Board with a mandatory compliance gate before funding
Maintain an EA repository linking capabilities, applications, data and standards
Rationalise legacy systems and retire duplicates following the EA roadmap
Deliverable: Application landscape inventory
Deliverable: National EA blueprint with target and transition states
Deliverable: Architecture Review Board terms of reference and compliance checklist

Transparent Procurement

Vendor-neutral, standards-based procurement that protects long-term sustainability and avoids lock-in. Software packages: National e-procurement (e-GP) system.

Adopt standard tender clauses: open standards, open APIs, data ownership, exit/transition
Publish procurement plans and contract awards
Use framework agreements and conformance testing against national standards
Prioritise open-source and digital public goods where fit for purpose
Run TCO and vendor-performance reviews that feed future procurement
Deliverable: Standard tender clauses (open standards, data ownership, exit)
Deliverable: Total cost of ownership model
Deliverable: Procurement plan and vendor-performance framework

Illustrative countries and data. Independent PiR2-IT tool aligned with the six pillars of health digital transformation used in World Bank Group HNP practice; not an official World Bank Group product.

Digital Health Transformation Navigator — live demo