Digital health shifted from a “nice‑to‑have” to a system imperative during COVID‑19. The World Health Organization (WHO) responded with a global strategy to help countries scale digital health safely and equitably, and in November 2022 it published “Monitoring the implementation of digital health: an overview of selected national and international methodologies.” For product leaders and regulatory teams in digital health, this document is not a “how to regulate” playbook; it is a measurement playbook that shows what to track, how to compare progress across countries, and where the evidence gaps still are. The report underpins the WHO Global Strategy on Digital Health 2020–2025, which calls for consistent monitoring so decisions are driven by comparable, high‑quality data. See the WHO monitoring overview and strategy documents for scope and context. (WHO Europe, 2022; WHO Global Strategy 2020–2025).
What the WHO November 2022 guidance actually covers
The guidance reviews national and international indicator frameworks used to monitor digital health maturity—spanning governance, adoption, use, data infrastructure and re‑use—and explains why internationally agreed indicators are still limited. It also synthesizes lessons from country case studies to show how monitoring feeds into policy and investment choices. In short, it tells decision‑makers what to measure so they can assess whether digital health is improving access, quality, safety and system performance. (WHO Europe, 2022).
What it does not cover: medical‑device regulatory pathways
Manufacturers should note the distinction: the WHO monitoring overview does not set device‑specific regulatory expectations for Software as a Medical Device (SaMD) or AI/ML devices. For those, regulators align through IMDRF documents such as SaMD Key Definitions and the Good Machine Learning Practice (GMLP) guiding principles, which inform how agencies approach AI/ML medical devices across the product lifecycle. (IMDRF SaMD Key Definitions; IMDRF GMLP N88:2025).
Why monitoring matters to digital health manufacturers
For companies planning EU or multi‑country scale‑up, what gets measured gets adopted. Payers and ministries increasingly look for comparable indicators to benchmark telehealth, citizen EHR access, data interoperability and equity. WHO’s analysis highlights that while monitoring has improved since the pandemic, evidence systems still struggle to keep pace with rapid innovation—especially around governance, health‑data reuse and system‑wide interoperability. (WHO Europe, 2022).
Four monitoring domains manufacturers should build into their go‑to‑market plans
Telehealth effectiveness and sustainability. Post‑pandemic, OECD countries expanded telemedicine at speed, but sustainability requires data on quality, access, outcomes and financial impact. OECD’s work outlines leading practices and shows where countries are meeting the mark—and where they are not—providing a lens manufacturers can use to frame clinical and economic value arguments. (OECD, 2024; see also OECD Working Paper 116).
Citizen access to health data. The European Commission’s Digital Decade monitoring includes a composite eHealth indicator tracking citizens’ online access to electronic health records—what data are accessible, through which technologies, and with what population coverage—helping companies anticipate variability in user activation and integration demands. (European Commission, 2024).
Equity and digital‑health literacy. WHO’s European Health Information Gateway now hosts indicators and country profiles covering telehealth, mHealth, literacy and big‑data analytics. If your product depends on remote access or self‑management, plan for measurable equity outcomes and the ability to disaggregate performance across priority groups. (WHO/Europe indicators).
Interoperability and data reuse. WHO stresses that monitoring must capture technical and operational readiness to share and reuse health data, not just app counts or user numbers. Local integration, standardized vocabularies, and data‑provenance controls are increasingly pre‑conditions for public procurement and reimbursement. (WHO Europe, 2022).
Regional benchmarks you can leverage in evidence plans
The Nordic eHealth Research Network, backed by the Nordic Council of Ministers, maintains one of the world’s most mature indicator sets for digital health—useful as a benchmark for adoption, service quality and outcomes when planning pilots in Europe’s most advanced markets. The latest 2025 benchmarking report and earlier methodology publications show how indicators evolved to support policy and procurement decisions. (Nordic Council of Ministers, 2025; background methodology: DiVA portal).
What this means for your product, evidence and market access strategy
Manufacturers that align product telemetry and study designs with the indicators policymakers actually track shorten the distance from pilot to scaled deployment. WHO’s monitoring agenda and the EU’s digital‑policy metrics translate directly into product requirements: demonstrable quality and safety at scale, equitable reach across populations, integration into national data spaces, and transparent reporting on usage and outcomes. If your solution overlaps with regulated functions (decision support, diagnosis, triage), pair this monitoring strategy with IMDRF and local regulatory guidance for SaMD/AI so that clinical evidence, change control and post‑market monitoring satisfy both policy and regulatory expectations.
How MDx CRO helps digital health manufacturers turn monitoring into market traction
MDx CRO works with digital health and SaMD teams to translate monitoring frameworks into actionable study endpoints, KPIs and regulatory‑ready evidence. We map your product to WHO and EU indicator sets, design real‑world evaluation that demonstrates equitable access and clinical impact, and align your documentation with IMDRF principles when your software meets the definition of a medical device. Explore our support for Clinical Research and Regulatory Affairs, or contact us to scope a country‑by‑country expansion plan.
