Inside the Evidence Framework Behind Anbefalede Sundhedsapps and the Danish Board for Health Apps

Updated: 3 November 2025

Why this milestone matters
What was endorsed on 27 June 2025
How Denmark assesses apps: the four pillars
Case in point: Hedia Diabetes Assistant
What’s out of scope (for now)
European context: Germany & UK vs Denmark
Who is affected in Denmark
Developer checklist for Denmark
How Odelle Technology can help
Glossary
References & official links
FAQs

Why this milestone matters

On 27 June 2025, Denmark became one of the first countries in Europe to publish an official, government-endorsed list of recommended digital health apps. The Danish Board for Health Apps (Nævnet for Sundhedsapps) evaluated each app using a rigorous, multi-pillar framework covering clinical evidence, real-world effectiveness, usability and accessibility, affordability, and societal value.

This marks a significant shift in European digital health policy: for the first time, Denmark has created a nationally validated, clinician-trusted catalogue of health apps that citizens, GPs, municipalities, and hospitals can safely recommend and integrate into care pathways.

By moving beyond generic “wellness” tools and highlighting only those with verified clinical outcomes (HbA1c, pain reduction, functional scores), validated usability in real patients, compliance with EU MDR and GDPR standards, and clear alignment with national priorities (diabetes, musculoskeletal disease, mental health, primary-care pressure reduction), Denmark is setting a new evidence benchmark for digital therapeutics (DTx) and health apps across the EU.

For developers, this milestone provides a transparent pathway toward national visibility, clinical trust, and system-level adoption—even in the absence of a reimbursement tariff. For policymakers, it demonstrates how evidence-based evaluation can strengthen digital health governance. And for patients, it delivers a simple promise: the apps listed on sundhed.dk have been independently reviewed, validated, and recommended by a public authority.

What was endorsed on 27 June 2025

At its inaugural meeting on 27 June 2025, the Nævnet for Sundhedsapps (Board for Health Apps) formally recommended the following apps, now listed on the Danish national portal Sundhed.dk:

Min Læge (My Doctor)
– Official listing: Min Læge on Sundhed.dk Sundhed
– Role: Supports communication between citizens and general practice, including video/e-consultations, appointment management and medication overview.
Mine Knogler (My Bones)
– Official listing: Mine Knogler on Sundhed.dk
– Role: Provides education, motivation and self-management support for people with, or at risk of, osteoporosis.
Stress Autism Mate (SAM)
– Official listing: Stress Autism Mate on Sundhed.dk
– Role: Designed to help adults with autism monitor stress, track triggers and access coping strategies.
Hedia Diabetes Assistant
– Developer website: Hedia.com Hedia
– Google Play listing: Hedia Diabetes Assistant – Google Play Google Play
– Role: A CE-marked digital therapeutic supporting insulin dosing decisions in adults with type 1 or type 2 diabetes.
SelfBack
– Official listing: SelfBack on Sundhed.dk
– Role: Provides personalised exercise programmes and self-management for adults with non-specific lower-back pain.

How Denmark Assesses Apps: The Four Evidence Pillars

To appear on the national list of Anbefalede Sundhedsapps, every digital health app must pass a structured evaluation conducted by the Danish Board for Health Apps (Nævnet for Sundhedsapps).
The full submission and assessment process is managed through the Danish Medicines Agency (Lægemiddelstyrelsen).
Official submission portal:
https://portal.dkma.dk/SSP
(Danish Medicines Agency – Nævnet for Sundhedsapps application system)

Denmark’s model is built around four evidence pillars that ensure each app is safe, clinically reliable, usable for real patients, and aligned with national healthcare priorities.

1. Evidence of Effect (Clinical & Behavioural Outcomes)

Apps must demonstrate measurable health impact, supported by recognised evidence standards, including:

Randomised controlled trials (RCTs)
Prospective real-world data (RWD) from routine care
Observational cohorts using validated endpoints
Clinically meaningful effect sizes, not just statistical significance

Examples of acceptable, domain-specific outcomes include:

Diabetes: HbA1c reduction (≥0.5%) with hypoglycaemia control
MSK: Pain-score reduction, Oswestry Disability Index, mobility measures
Mental health: PHQ-9, GAD-7, PROMIS scores
Behavioural change: Adherence, engagement, self-management metrics

This ensures the apps listed on sundhed.dk have real therapeutic or functional value, not just good UI or popularity.

2. User Experience & Accessibility (Human-Factors Testing)

Denmark places unusually high importance on human-centred design.
Apps are evaluated for:

Usability testing with representative users, including:
- older adults
- people with comorbidities
- users with low digital literacy
Accessibility aligned with WCAG 2.1 guidelines
Clarity, error-prevention, and safe user pathways
Cognitive load and readability for people with chronic diseases

This reflects Denmark’s goal to ensure recommended apps can be used safely and effectively by the majority of the population, not only tech-confident users.

3. Affordability (Equity & Access Considerations)

The Board assesses whether the app is:

Free or low cost for citizens, and
Cost-neutral for general practice and municipalities where possible.

This is essential to:

Avoid digital inequity
Lower barriers to adoption
Support Denmark’s primary-care capacity
Ensure clinical staff can recommend the app without financial implications

The first endorsed apps on sundhed.dk were deliberately chosen to be free at the point of use, supporting national equity goals.

4. Societal Value (Alignment With Danish Health Priorities)

To be endorsed, an app must support at least one of Denmark’s strategic health priorities, including:

Diabetes self-management
Musculoskeletal (MSK) health and rehabilitation
Mental health support
CVD risk prevention
Post-acute recovery pathways
Relief of GP and primary-care pressure
Support for vulnerable populations

The Board assesses how the app contributes to:

Reduced demand on GP visits
Improved patient self-management
Better health literacy
Greater equality in access to care
Integration with existing digital infrastructure (e.g., MedCom standards)

Official overview of recommended apps:
https://www.sundhed.dk/borger/sygdom-og-behandling/om-sundhedsvaesenet/anbefalede-sundhedsapps/

5. Submission Route: Danish Medicines Agency Portal

Developers submit applications through the official Danish Medicines Agency system, which is used for:

App documentation
Clinical evidence submission
Usability/accessibility files
GDPR and CE-marking declarations (where applicable)

Apply here:
https://portal.dkma.dk/SSP

About the Board (Lægemiddelstyrelsen):
https://laegemiddelstyrelsen.dk/da/

Case in Point: Hedia Diabetes Assistant – A CE-Marked Digital Therapeutic for Insulin Dosing

Hedia Diabetes Assistant is one of the strongest examples of why Denmark’s endorsement framework matters. Listed on sundhed.dk and available across Europe, Hedia functions as a CE-marked digital therapeutic (DTx) designed to support insulin dosing decisions in adults with type 1 and type 2 diabetes who use rapid-acting (bolus) insulin.

Official website: https://www.hedia.com
Android listing: https://play.google.com/store/apps/details?id=com.hedia_diabetes_assistant
App Store: https://apps.apple.com/dk/app/hedia-diabetes-assistant/id1444699694

What Hedia Does: Evidence-Based Bolus Calculator

Hedia helps users calculate safer and more accurate insulin doses through a structured decision-support algorithm based on four key clinical inputs:

Carbohydrate intake (CHO counting)
– User-entered or selected from the app’s integrated food database.
Current blood glucose (BG)
– Entered manually or transmitted from compatible glucose meters.
Physical activity levels
– Adjusts insulin sensitivity based on exercise intensity and timing.
Insulin on Board (IOB)
– Calculates remaining active insulin to reduce insulin stacking, a major cause of hypoglycaemia.

This aligns with internationally recognised diabetes management principles used in insulin pumps and advanced decision-support systems.

Why Denmark Endorsed Hedia

The Danish Board for Health Apps identified Hedia as an app that meets the national threshold for:

✓ Clinical evidence & mechanism of action

Demonstrated improvement in daily dosing precision
Validated algorithmic guardrails to prevent over-correction
Real-world adherence and usability data from EU deployments

✓ Usability & patient safety

Clear interface for carbohydrate estimation
Safe defaults for insulin correction factors
Human-factors testing with adults living with diabetes

✓ Alignment with Danish health priorities

Diabetes is one of Denmark’s largest chronic disease burdens
Strong potential for primary-care capacity relief
Supports structured self-management between GP/endocrinology visits

Why Hedia Illustrates Denmark’s New Digital-Health Standard

Hedia is more than an app; it represents the emerging class of regulated digital therapeutics for metabolic disease. Its presence on the official Anbefalede Sundhedsapps list shows that Denmark is endorsing:

Clinically validated algorithms
Apps that reduce healthcare workload
Digital tools that integrate into chronic-disease pathways
Products compliant with EU MDR and data-protection requirements (GDPR, DPIA)

As Denmark expands its national list, Hedia stands as a model for how digital health companies can combine clinical safety, real-world evidence, accessibility, and societal value to gain formal recognition.

What’s Out of Scope (for Now)

While Denmark’s Nævnet for Sundhedsapps evaluates the safety, evidence and usability of digital health apps, the current framework is deliberately limited to assessing the app itself.

This means the following elements are not included in the endorsement decision:

1. Telehealth or teleconsultation services

Video consultations, remote clinician supervision or messaging platforms provided around the app are not evaluated.

2. Human coaching or behavioural-support programmes

Any add-on service involving coaches, clinicians, or care coordinators sits outside the Board’s remit.

3. Paid subscription layers, premium features or bundled service packages

The Board evaluates the core medical device or digital health functionality, not the commercial service model.

4. External clinical pathways or integrated care services

If an app is part of a broader care model (rehabilitation programmes, multi-disciplinary teams, off-platform interventions), only the stand-alone digital component is assessed.

Why this matters for developers

Denmark’s approach emphasises stand-alone clinical value—the app must:

Deliver measurable clinical or behavioural outcomes by itself
Meet EU MDR safety and performance requirements
Demonstrate usability, accessibility and data protection independent of service add-ons
Provide clear risk-control mechanisms without relying on external staff

This prevents companies from “inflating” effectiveness claims based on off-app human interventions, ensuring the evaluation reflects the actual digital therapeutic or digital health product.

Will this change in the future?

Very likely. As hybrid models (app + clinician + coaching) and digital-first care pathways expand across Europe, Denmark may widen the scope to include:

Service quality
Care-model outcomes
Workforce impact
Integration with telemedicine
Cost-effectiveness of service bundles

However, for now, the endorsement is focused strictly on the software product, rather than the surrounding care ecosystem.

European Context: How Denmark Compares to Germany, the UK, France and Belgium

Denmark’s Anbefalede Sundhedsapps framework sits within a rapidly evolving European landscape for digital health evaluation, reimbursement, and clinical assurance. Each country has taken a different approach—some focused on reimbursement, some on evidence and safety assurance, and others on national endorsement.

Below is a clear comparison of Denmark with the major European models.

🇩🇪 Germany: DiGA – Reimbursement Based on Proven Benefit

Germany’s DiGA (Digitale Gesundheitsanwendungen) is the most well-known digital health reimbursement system in Europe.

Key features:

Formal national reimbursement once the app is listed in the DiGA Directory.
Must demonstrate positive healthcare effects (Versorgungsverbesserung), including:
- Clinical benefit or
- Structural/process improvements.
Requires clinical evidence, usually RCTs.
Strict requirements for data protection, interoperability, MDR compliance.
Only a limited number of apps (≈40–50) have successfully passed full approval.

Model type:
Reimbursement-first, evidence-driven, high barrier to entry.

🇬🇧 United Kingdom: DTAC, NICE, ORCHA – Assurance, Not Endorsement

The UK does not have a single national recommendation list for health apps.

Key frameworks:

DTAC (Digital Technology Assessment Criteria) – baseline safety, data protection, usability, technical standards.
NICE Evidence Standards Framework for Digital Health – defines evidence expectations by risk tier.
ORCHA – independent commercial evaluator used widely by NHS bodies, but not an official NHS endorsement.

Model type:
Safety-first, fragmented adoption, no national app recommendation list.

🇫🇷 France: PECAN – Experimental Funding with Evidence Development

France’s new PECAN (Prise en Charge Anticipée Numérique) framework is designed for digital medical devices (DMN) and some digital therapeutics.

Key features:

Temporary early public funding for digital health tools meeting unmet needs.
Requires initial evidence, with additional data collected during the funded period.
Integrates with CNEDiMTS, HAS, and long-term reimbursement routes.
Prioritises national priorities such as chronic disease, screening, adherence, oncology, and mental health.

Model type:
Coverage with Evidence Development (CED) – early funding + mandatory RWE.

🇧🇪 Belgium: mHealthBelgium Pyramid (M1–M3)

Belgium runs one of the most structured digital health approval systems in Europe.

Three levels:

M1 – CE marking validated (basic safety).
M2 – Interoperability & security validated by eHealth Platform.
M3 – Reimbursement approved by NIHDI (INAMI/RIZIV).

Very few apps reach M3, but the system is transparent and stepwise.

Model type:
Tiered approval → reimbursement, clear regulatory gates.

🇩🇰 Denmark: National Public Endorsement (Anbefalede Sundhedsapps)

Denmark’s approach is fundamentally different from its neighbours.

Key features:

Apps are evaluated by the Danish Board for Health Apps (Nævnet for Sundhedsapps).
Reviewed on four pillars:
- Evidence of effect
- Usability & accessibility
- Affordability
- Societal value
Applications listed on sundhed.dk, the national health platform.
Enables clinician recommendation, improving trust and adoption.
No automatic reimbursement, but strong national visibility.

Model type:
National endorsement, not reimbursement.

Summary: Four Countries, Four Different Paths

Country	Model Type	Evidence Strength	Reimbursement?	National List?	Notes
Denmark	Public endorsement	Medium–High	❌ No	✅ Yes	Focus on evidence, usability, societal value
Germany (DiGA)	Reimbursement catalogue	High (RCT/RWE)	✅ Yes	✅ Yes	Strictest evidence criteria in EU
UK (DTAC/NICE)	Assurance frameworks	Medium	❌ No	❌ No	Safety & evidence aligned, fragmented adoption
France (PECAN)	Early funding with RWE	Medium–High	🔶 Temporary	❌ No	Bridges innovation → reimbursement
Belgium (mHealthBelgium)	Tiered certification	Medium–High	🔶 Yes (M3 only)	❌ No	Very structured, only elite apps reach M3

Why Denmark’s Model Is Distinct

It is not a reimbursement model (unlike Germany or Belgium M3).
It is not simply an assurance model (UK DTAC).
It is not an experimental CED pathway (France PECAN).
It is a national, clinician-facing recommendation list, designed to build public trust, strengthen safety, and support system-level adoption.

This positions Denmark as the EU leader in “evidence-first endorsement”, bridging the gap between:

wellness apps,
regulated medical devices, and
reimbursable digital therapeutics.

Who Is Affected in Denmark

Denmark’s national endorsement system influences every layer of its healthcare ecosystem. The publication of Anbefalede Sundhedsapps on sundhed.dk creates a new, trusted reference point for clinicians, municipalities, patients, and developers.

1. Clinicians & Primary Care Teams

GPs, practice nurses, physiotherapists, diabetes educators and rehabilitation staff now have a vetted, authoritative list of digital tools they can safely recommend.
For frontline clinicians, this means:

Reduced uncertainty about which apps are evidence-based
Clear clinical rationale for recommending specific digital tools
Improved continuity of care, especially for chronic conditions (diabetes, MSK, mental health)
Less administrative burden in evaluating app quality themselves

This supports Denmark’s goal of reinforcing digital self-management and easing GP workload pressure.

2. Municipalities & Regional Health Authorities

Denmark’s municipalities (kommuner) play a central role in prevention, rehabilitation, and long-term condition management.
The national list helps them:

Select safe, proven apps for rehabilitation pathways
Standardise digital tools across regions
Align local purchasing and pilot programmes with national priorities
Reduce duplication of evaluation work

For Regions, it supports structured adoption in hospitals and outpatient care.

3. Patient Organisations & Citizen Groups

Patient associations gain a trusted source of digital health tools to share with their communities.
The benefits include:

Reliable signposting to safe, clinically validated apps
Tools that improve daily self-management and health literacy
Reduced confusion caused by thousands of commercial “health” apps

For citizens, the list provides clarity, safety, and confidence.

4. Digital Health Developers & DTx Companies

For developers, Denmark now offers a transparent, nationally recognised pathway to:

Gain clinical visibility
Demonstrate compliance with MDR, GDPR and usability standards
Build trust among clinicians before reimbursement
Position themselves for future tenders, pilots, and regional contracts
Strengthen their evidence package for Germany (DiGA), France (PECAN), Belgium (mHealthBelgium), and UK DTAC

Crucially, Denmark’s endorsement gives companies a prestigious quality marker, even without a national tariff.

Why this matters overall

The introduction of Anbefalede Sundhedsapps reshapes the digital-health landscape in Denmark by creating:

A trusted national reference list
Stronger alignment between developers, clinicians, and public authorities
A safer digital environment for patients
A more consistent foundation for digital-first care pathways

This positions Denmark as a leader in evidence-based digital health endorsement in Europe.

Developer Checklist for Denmark

What every digital health company must prepare before applying to Nævnet for Sundhedsapps.

Denmark’s endorsement model requires far more than a polished app. To be approved and listed on sundhed.dk, developers must demonstrate clinical effectiveness, safety, real-world robustness, GDPR compliance, and societal value—all aligned with the four pillars used by the Danish Board for Health Apps.

Below is a science-rich, regulator-level checklist that will satisfy Danish evaluators and strengthen EU-wide market access (DiGA, PECAN, mHealthBelgium, NICE DTAC).

1. Clinical Evidence Package (RCT + RWD + Biometric Logic)

SEO keywords: clinical evidence Denmark, real-world data, RCT digital health, effectiveness digital therapeutics

Denmark expects strong evidence demonstrating measurable improvement. Developers should prepare:

Clinical Outcomes Dataset (min. 12 weeks preferred)

HbA1c, TIR (%), hypoglycaemia incidence (diabetes apps)
Oswestry Disability Index (ODI), pain NRS, range-of-motion outcomes (MSK apps)
PHQ-9, GAD-7, PROMIS, adherence metrics (mental health apps)

Study Types Accepted

Randomised Controlled Trials (RCTs)
Prospective cohort studies
High-quality Real-World Data (RWD) with robust methodology:
- external controls
- propensity weighting
- missing-data handling (multiple imputation, etc.)

Algorithmic Explainability

For decision-support or DTx apps:

Mechanism of Action (MoA)
Feature → behaviour → outcome causal pathway
Guardrails (e.g., insulin stacking prevention, red-flag symptom alerts)

Tip: Denmark values “real-life feasibility” as much as strict RCT data. A hybrid RWE-RCT evidence pack performs best.

2. Safety, MDR Compliance & Clinical Risk Management (DCB-0129 Ready)

SEO keywords: MDR digital health, clinical safety file, DPIA GDPR healthcare, algorithm safety

Prepare MDR-compliant technical documentation:

Essential Deliverables

Intended Purpose statement (aligned with EU MDR)
Risk Management File (ISO 14971)
Clinical Evaluation Report (CER) or Performance Evaluation (PER)
Post-Market Surveillance Plan (PMS)
Post-Market Clinical Follow-Up (PMCF) plan
Cybersecurity & data integrity controls
Algorithm change-control protocol

Clinical Safety Requirements

Denmark follows a safety philosophy similar to UK NHS DCB 0129/Digital Clinical Safety:

Hazard log (FMEA / fault-tree)
Clinical Safety Case
Human-factors and usability summative testing
Mitigations for dangerous use (overdose, misinterpretation, misuse, device failure)

3. Usability, Accessibility & Human-Factors Evidence (WCAG + Older Adults)

SEO keywords: usability testing digital health, WCAG 2.1 healthcare, older adult usability, accessibility medical apps

Denmark evaluates real usability in real users, especially:

Older adults
Users with low digital literacy
Populations with chronic diseases and cognitive load challenges

Required UX Evidence

Summative usability report (≥15–20 participants)
Task success rates, error patterns
Time-on-task, learnability, cognitive error analysis
Accessibility compliance with WCAG 2.1 AA
Readability and comprehension for low-literacy groups

Apps with a minimal learning curve score highest.

4. GDPR, Data Governance & Transparency (DPIA Mandatory)

SEO keywords: GDPR medical device, health data compliance, DPIA digital health, data protection apps Denmark

The Board will expect:

Core Documentation

Data Protection Impact Assessment (DPIA)
Lawful basis for processing (GDPR Art. 6 & Art. 9)
Data minimisation & pseudonymisation schema
Consent flows (explicit, revocable, audit-ready)
Privacy-by-design & encryption standards
Third-country transfer statements (if applicable)

Patient Rights Processes

Right to erasure
Right to portability
Access request workflow
Automated processing transparency

Apps that clearly articulate data boundaries outperform all competitors.

5. Interoperability & Technical Standards (MedCom, APIs, FHIR)

SEO keywords: FHIR Denmark, MedCom integration, digital health interoperability, API healthcare apps

To integrate smoothly into Danish care pathways:

Declare interoperability capability (FHIR preferred)
Compatibility with MedCom protocols (primary-care communication standards)
Secure APIs for device integrations (glucose meters, wearables)
Data-export features for clinicians
Audit logs for safety and accountability

6. Affordability & Price Transparency Narrative

SEO keywords: affordability digital health Denmark, equitable access health apps, pricing digital therapeutics

Denmark prioritises equity:

Your dossier should show:

Low or zero cost for citizens
No burden on GP budgets
Clear differentiation between free features and optional paid tiers
Avoiding essential features behind paywalls

7. Societal Value Alignment (Pressure Relief, Prevention, Equity)

SEO keywords: societal value digital health, GP workload reduction, public health digital tools, self-management Denmark

Demonstrate how your app supports national goals:

Primary-care pressure reduction
Chronic disease management
Self-management and behaviour change
Prevention (CVD, diabetes, osteoporosis)
Improved health equity
Reduced rehab demand (Municipalities)

Quantifying impact on GP visits, ED visits, rehab sessions, absences, or medication adherence strengthens your submission.

8. Denmark-Specific Submission Requirements

SEO keywords: apply Nævnet for Sundhedsapps, digital health application Denmark, sundhed.dk endorsement

Submission portal:
https://portal.dkma.dk/SSP

You will need to upload:

Evidence pack (RCT/RWD)
Safety documentation
Accessibility and usability reports
GDPR compliance documents
Pricing model
Societal value narrative
Clinical rationale & intended purpose

9. Bonus: EU Alignment to Strengthen Your Danish Dossier

If you also prepare for:

Germany (DiGA) → Positive Healthcare Effect evidence
France PECAN → Real-world evidence plan
Belgium mHealthBelgium M1–M3 → CE, interoperability, reimbursement
UK DTAC → Safety, security, usability, interoperability

…you automatically strengthen your Danish application.

How Odelle Technology Can Help

Scientific, evidence-driven, EU-ready support for digital health and DTx companies entering Denmark

Introducing a digital health product into Denmark requires more than clinical claims. It demands scientific validation, a rigorous evidence package, a health-economic rationale, and alignment with Denmark’s four-pillar endorsement framework, national priorities, and primary-care pressures.

Odelle Technology provides end-to-end, science-led support for developers seeking inclusion on Anbefalede Sundhedsapps, as well as expansion across Europe (DiGA, PECAN, mHealthBelgium, UK DTAC/NICE).

1. Scientific Gap Analysis vs the Danish Four Pillars

SEO keywords: Danish Board for Health Apps, clinical evidence Denmark, GDPR MDR gap analysis

We perform a structured, regulator-grade diagnostic across:

Clinical evidence strength (RCTs, RWD, observational cohorts, endpoint validity, effect sizes)
Usability and human-factors testing (WCAG 2.1 AA, older adults, low digital literacy)
Affordability & equity narratives aligned with Danish primary-care and municipal budgets
Societal value (impact on GP capacity, rehabilitation burden, chronic-disease pathways, MedCom alignment)

This yields an actionable roadmap to meet Denmark’s scientific and policy thresholds.

2. Evidence Generation: RCT Design, RWE Studies & Outcomes Selection

SEO keywords: real-world evidence Denmark, PROMs, STROBE, CONSORT, digital health RCT

Odelle designs evidence programmes acceptable to both Danish authorities and EU HTA bodies:

Hybrid RCT + RWE study designs suitable for digital therapeutics
Selection of clinically meaningful endpoints (HbA1c, PHQ-9, ODI, PROMIS, TIR, pain NRS)
STROBE- and CONSORT-aligned methodologies
External comparator strategies, propensity weighting, and missing-data management
PMCF study designs aligned with EU MDR requirements
Real-world utilisation studies that quantify GP visits avoided, improved adherence, functional recovery, and behaviour change

Denmark values evidence that is robust yet feasible in real clinical practice, and our methods reflect this.

3. Health Economics for Denmark’s System: BIA, CEA & Capacity-Impact Analysis

SEO keywords: health economics Denmark, budget impact analysis, societal value digital health

Although Denmark’s endorsement does not carry a national tariff, regional and municipal purchasers increasingly demand economic justification.

Odelle builds models tailored to Danish decision-makers:

Budget Impact Analyses (BIA) for municipalities and Regions
Cost-effectiveness frameworks (clinical effect → resource-use reduction → economic value)
Capacity-relief modelling (GP time saved, physiotherapy visits reduced, rehabilitation efficiency)
Equity-sensitive impact modelling for older adults or low-literacy groups
Productivity proxies and absenteeism analyses where appropriate
Modelling integration with MedCom pathways and Kommuner rehabilitation programmes

Our HEOR outputs meet the needs of purchasing committees, public health authorities, and innovation boards.

4. Clinical Safety, MDR & Data Governance Documentation

SEO keywords: MDR digital therapeutics, clinical safety case, DPIA GDPR, DCB 0129

We prepare and strengthen:

Risk Management Files (ISO 14971)
Clinical Safety Cases (aligned to DCB 0129 methodology)
Hazard Logs, FMEA tables, and safety mitigations
CER/PER documentation for EU MDR/IVDR
DPIA and GDPR compliance packs, including lawful-basis mapping and data-flow diagrams
Cybersecurity and algorithm governance documentation
Change-control frameworks for AI-enabled modules

This ensures a fully compliant submission to Danish authorities.

5. Usability, Accessibility & Human-Factors Validation

SEO keywords: WCAG 2.1 AA, user testing, older adults, human-factors engineering

We design and deliver:

Summative usability studies with representative Danish users
Protocols for older adults, neurodiverse users, and low digital-literacy groups
Accessibility validation to WCAG 2.1 AA
Task analyses, error-rate profiling, and safety-critical interaction reviews

This addresses a major pillar of the Danish endorsement model and significantly increases approval likelihood.

6. Danish Policy & Pathway Integration

SEO keywords: MedCom integration, digital self-management Denmark, chronic disease pathways

We map your product into:

Primary-care workflows
Municipal rehabilitation (Kommuner)
Chronic disease pathways (diabetes, MSK, mental health)
Prevention strategies, CVD risk, lifestyle change
MedCom standards for interoperability
Regional digital health priorities

This ensures your evidence submission is aligned with real clinical use in Denmark, not theoretical adoption models.

7. European Expansion Roadmaps (DiGA, PECAN, mHealthBelgium, UK DTAC/NICE)

SEO keywords: DiGA approval, PECAN France, mHealthBelgium M1–M3, NICE digital health

Approval in Denmark strengthens your broader EU strategy. Odelle builds integrated pathways for:

Germany DiGA: Positive Healthcare Effect, RCT/RWE strategy, price negotiation
France PECAN: CED-based funding with real-world evidence
Belgium mHealthBelgium: M1–M3 pyramid progression
UK DTAC & NICE: Safety, evidence, interoperability, HEOR
Nordic region alignment with Finland, Norway, Sweden digital strategies

We ensure your evidence is reusable, your story coherent, and your dossier HTA-ready.

8. Strategic Positioning & Scientific Narratives

SEO keywords: digital therapeutics evidence, scientific storytelling, HTA positioning

We craft:

Scientific value propositions
Clinical pathway narratives
Societal-value arguments for Danish decision-makers
Payer messaging for Regions, Municipalities, and clinical networks
Documentation ready for innovation boards and procurement panels

We translate your evidence into decision-maker language, improving approval and adoption.

Partner with Odelle Technology

To discuss Danish endorsement strategy, evidence generation, or EU market access:

Contact: steven@odelletechnology.com
Website: https://www.odelletechnology.com
Market Access | HEOR | Evidence Generation | Digital Health Reimbursement | EU HTA

Glossary of Terms – Denmark’s Recommended Health Apps (Anbefalede Sundhedsapps)

Anbefalede Sundhedsapps (Recommended Health Apps)

The official national list of evidence-based digital health apps endorsed by the Danish Board for Health Apps (Nævnet for Sundhedsapps). Published on sundhed.dk, the list identifies apps that demonstrate measurable clinical or behavioural benefit, verified usability, accessibility, and societal value. Endorsement implies public trust, not reimbursement.

Nævnet for Sundhedsapps (Board for Health Apps)

An expert committee operating under the Danish Medicines Agency (Lægemiddelstyrelsen). It evaluates apps submitted for endorsement using four pillars:

Evidence of Effect
Usability and Accessibility
Affordability
Societal Value
The Board’s assessment aims to strengthen safety, interoperability, and clinical relevance before public recommendation.

Evidence of Effect

Scientific verification that an app produces meaningful health outcomes. Accepted evidence includes randomised controlled trials (RCTs), prospective real-world data (RWD), or observational cohorts using validated endpoints (e.g., HbA1c, PHQ-9, Oswestry Index). The effect must be statistically significant and clinically relevant.

Real-World Data (RWD)

Data collected outside controlled trials—routine care, registries, wearables, or app usage logs—are used to demonstrate effectiveness, adherence, and safety under real-life conditions. RWD informs Real-World Evidence (RWE) analyses required for post-market validation and health-economic modelling.

Randomised Controlled Trial (RCT)

A prospective study in which participants are randomly assigned to intervention or control groups. In digital health, RCTs remain the gold standard for establishing causal efficacy but may be supplemented by adaptive or hybrid real-world designs.

Usability & Accessibility

Human-factors engineering that ensures effectiveness, efficiency, and satisfaction for all intended users, including older adults and individuals with limited digital literacy or disabilities. Compliance with WCAG 2.1 and Danish language-access standards is expected.

Affordability

Economic accessibility for citizens and the health system. In Denmark’s endorsement model, affordability means free or low-cost use for the patient and cost-neutrality for primary-care integration. Cost–benefit or Budget Impact Analysis (BIA) supports this dimension.

Societal Value

Alignment with national health priorities—such as chronic-disease prevention, mental-health resilience, and primary-care capacity relief. Demonstrated through outcomes that reduce resource utilisation (e.g., GP visits, rehabilitation sessions) or enhance equity.

CE Mark (EU Conformity)

Certification under EU Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746) showing that a digital health product meets essential safety and performance requirements. CE-marked apps must maintain post-market surveillance and periodic PMCF updates.

GDPR – General Data Protection Regulation (EU 2016/679)

The EU’s data-protection framework governing the processing of personal health data. Apps must provide lawful basis, explicit consent, data minimisation, security, and user rights (erasure, portability). A Data Protection Impact Assessment (DPIA) is mandatory for high-risk processing.

Health Economic Evaluation

Systematic comparison of costs and consequences of health interventions. In Denmark, evaluations often include Cost-Consequence Analysis (CCA) and Budget Impact Analysis (BIA); for EU comparison, Cost-Utility Analysis (CUA) using Quality-Adjusted Life Years (QALYs) may be applied.

PROMs – Patient-Reported Outcome Measures

Validated questionnaires quantifying patient perceptions of health status, function, or quality of life (e.g., PHQ-9, PROMIS, Oswestry Disability Index). Essential for demonstrating patient-centred benefit and real-world engagement.

HbA1c – Glycated Haemoglobin

A biochemical marker reflecting average blood-glucose concentration over ~3 months. A key outcome for diabetes-management apps such as Hedia Diabetes Assistant is that reductions of ≥ 0.5 percentage points are typically deemed clinically meaningful.

PHQ-9 – Patient Health Questionnaire-9

Nine-item depression scale measuring symptom severity and response to therapy. Widely used in mental-health app evaluations.

Oswestry Disability Index (ODI)

Validated questionnaire assessing functional disability in patients with lower back pain. Used as a primary endpoint for musculoskeletal apps like SelfBack.

MedCom

Denmark’s national agency coordinating digital communication standards between general practice, hospitals, and municipalities. Integration with MedCom protocols (e.g., EDI, XML messaging) ensures data exchange and care-pathway compatibility.

sundhed.dk

The national Danish health portal provides citizens and clinicians with official health information, e-services, and the Anbefalede Sundhedsapps list. Operated collaboratively by regions, municipalities, and the state.

Health Technology Assessment (HTA)

A multidisciplinary process evaluating the clinical, economic, organisational, social, and ethical implications of a health technology. While the Board focuses on app endorsement, regional HTA units use similar criteria when considering procurement.

Digital Therapeutic (DTx)

A software-based medical intervention delivering evidence-based therapeutic benefit directly to patients. Many CE-marked apps on the Danish list qualify as DTx products when they provide measurable clinical outcomes.

Coverage with Evidence Development (CED)

A reimbursement model (used in other EU countries) where temporary funding is linked to ongoing data collection. Denmark’s endorsement does not include CED yet but may evolve toward it as RWE maturity increases.

PMCF – Post-Market Clinical Follow-Up

A continuous evidence-generation process is required under MDR to confirm safety and performance after market entry. RWE from Danish primary-care deployment can contribute to PMCF obligations.

References & official links

Denmark – Official Recommended Health Apps (Anbefalede Sundhedsapps)

Official List on Sundhed.dk (Government Portal)
https://www.sundhed.dk/borger/sygdom-og-behandling/om-sundhedsvaesenet/anbefalede-sundhedsapps/

Individual Recommended App Listings

🇩🇰 Danish Medicines Agency (Lægemiddelstyrelsen) – Submission & Regulation

Official Submission Portal (for App Endorsement Applications)

Danish Medicines Agency Submission Portal (SSP):
https://portal.dkma.dk/SSP

About the Danish Medicines Agency (Nævnet for Sundhedsapps)

Overview of the Board for Health Apps:
https://laegemiddelstyrelsen.dk/da/

🇩🇰 Interoperability & Digital Health Infrastructure

MedCom – Denmark’s National Health Data Exchange Authority

MedCom project page for app integration & primary care:
https://www.medcom.dk/

(Note: MedCom does not have a dedicated “apps” branch page; this is the official national interoperability site.)

App Store Sources for Verification & Downloads

Apple App Store (DK region)

https://apps.apple.com/dk/

Google Play Store (DK region)

https://play.google.com/store/apps

FAQs – Denmark’s Nationally Recommended Health Apps (Anbefalede Sundhedsapps)

1) Does endorsement come with reimbursement or a fixed tariff?

No. Denmark’s national endorsement does not create reimbursement, a fixed tariff, or a per-use fee.
The list on sundhed.dk is a quality and safety endorsement, not a payment mechanism.
Any funding is arranged separately through:

Municipal purchasing agreements
Regional tenders
Hospital contracts
Pilot programmes or innovation projects

There are no national reimbursement amounts linked to endorsement decisions.

2) How do Danish organisations actually pay for endorsed apps?

Payment happens at the local level, not nationally.
Common routes include:

Municipal service contracts (rehabilitation, prevention, chronic care)
Regional purchases for hospitals
Short-term funded pilots
Public–private collaborations or grants

Denmark has not introduced a DiGA-style national app tariff.

3) Why is endorsement valuable if it does not guarantee reimbursement?

Endorsement removes the biggest adoption barrier: clinical trust.

Listing on sundhed.dk:

De-risks recommendation by clinicians
Shortens due-diligence time for municipalities and Regions
Increases patient safety
Makes digital tools discoverable and credible
Improves equity by providing a vetted national list

It is a high-signal quality mark, even without funding attached.

4) What was endorsed first, and when?

On 27 June 2025, the first five apps were endorsed:

Min Læge
Mine Knogler
Stress Autism Mate (SAM)
Hedia Diabetes Assistant
SelfBack

The list expanded on 16 September 2025 to include:

Meta Learn
MinSpiral

All endorsed apps appear on sundhed.dk with detailed profile pages.

5) Are there public figures showing how much revenue endorsed apps receive?

No. Endorsement is not linked to financial compensation.
Any revenue would arise only from:

Separate contracts with municipalities or Regions
Grants
Pilots or tenders

There are no public reimbursement values associated with endorsement.

6) What are the Board’s four assessment pillars, and how scientific is the evidence bar?

Apps are evaluated using four pillars:

Evidence of effect (RCTs, prospective studies, high-quality RWD using validated endpoints such as HbA1c, PHQ-9, ODI, PROMIS, TIR, pain scales)
Usability and accessibility (tested with intended users, including older adults and low-literacy groups; WCAG 2.1 alignment)
Affordability
Societal value (alignment with national health priorities)

The evidence bar is scientific and clinically grounded, with emphasis on real-world feasibility.

7) What counts as “clinically meaningful” improvement in Denmark?

Denmark does not publish fixed thresholds, but international and payer-accepted MCIDs apply:

Diabetes: ≥0.5% HbA1c reduction, improved TIR, fewer hypoglycaemic events
MSK: Oswestry Disability Index improvement; ≥12-week sustained pain reduction
Mental health: PHQ-9 or GAD-7 score improvement plus functional gains and reduced service use

High-quality RWD with design controls (propensity weighting, external controls, missing-data strategies) is acceptable where RCTs are not feasible.

8) Where do I submit an application?

Through the Danish Medicines Agency (Lægemiddelstyrelsen) portal:
https://portal.dkma.dk/SSP

The application covers:

Clinical evidence
Usability/accessibility
Safety and data protection
Pricing and affordability
Societal value

9) Is a CE mark mandatory?

If your app is a medical device under EU MDR/IVDR, yes — a CE mark is required.
You must provide:

Intended purpose
Classification rationale
Safety and performance evidence

Non-medical or wellness apps do not require CE marking but must still meet expectations for safety, transparency, and GDPR compliance.

10) Are app-plus-service models included in the evaluation?

Not currently.
Denmark assesses the app alone — not teleconsultations, coaching services, or human-supported programmes.
Service bundles may be purchased locally, but they are not part of the endorsement decision.

11) How often is the national list updated?

The Board meets periodically.
New apps were added in September 2025, confirming this is an ongoing, iterative process, not a one-time event.

12) What clinical-safety and AI-governance documentation should be included?

Recommended components include:

Algorithm change-control policy
Guardrails for high-risk functions (e.g., insulin-dose calculators, triage features)
Post-Market Surveillance (PMS) plan
Post-Market Clinical Follow-Up (PMCF) strategy
Human-factors testing with representative users
MDR-aligned risk-management file (ISO 14971)

13) How is Denmark’s model different from Germany’s DiGA?

DiGA = reimbursement based on demonstrated benefit
Denmark = endorsement (quality signal), no automatic tariff
The UK (DTAC) is safety assurance only, not a national recommendation list
Belgium (mHealthBelgium) has tiered certification leading to reimbursement
France (PECAN) offers temporary funding with RWE requirements

Denmark is the only EU country offering national endorsement without reimbursement.

14) What endpoints matter most to Danish primary care and municipalities?

Endpoints that demonstrate capacity relief and clinical relevance score highest:

Reduced GP or physiotherapy visits
Improved self-management and adherence
MECE behaviour-change indicators
Pain/function outcomes
Engagement in older or low-literacy groups
Integration with MedCom workflows

These directly support the societal value pillar.

15) Can clinicians recommend endorsed apps directly to patients?

Yes.
This is one of the primary purposes of the list: a safe, vetted directory clinicians can confidently recommend.

16) What documentation strengthens a submission?

A strong dossier includes:

Study protocol + statistical analysis plan
CONSORT-aligned RCT or STROBE-quality RWD
Clear mechanism-of-action logic model
Usability and accessibility testing reports
DPIA/GDPR mapping
MDR risk file and safety mitigations
Pricing and affordability narrative
Societal-value mapping to Danish priorities

17) What has changed since June 2025?

The September 2025 expansion confirmed that:

The Board’s process is continuous, not one-off
The remit remains assessment and endorsement, not reimbursement
Denmark intends to maintain and evolve the list as digital health matures

18) How should a HEOR model be structured without a national tariff?

Use a buyer-perspective model for municipalities and Regions:

Unit costs for avoided visits and rehabilitation sessions
Productivity proxies (only where appropriate)
Sensitivity ranges for engagement and attrition
Distributional impacts for equity (age, literacy, socioeconomic groups)
RWD demonstrating shifts in service utilisation

This matches how digital tools are funded in Denmark.

19) Where can patients and clinicians read the official listings?

On sundhed.dk, the national public health portal:
https://www.sundhed.dk/borger/sygdom-og-behandling/om-sundhedsvaesenet/anbefalede-sundhedsapps/

Each app has a dedicated profile explaining:

Purpose
Target group
Evidence of effect
Usability/accessibility findings
Why it was recommended

20) Who runs the Board, and how official is it?

The Nævnet for Sundhedsapps is administered by the Danish Medicines Agency (Lægemiddelstyrelsen) — the national body regulating medicines and medical devices.

It is a formal government mechanism, not an industry programme.

Final Quick Answers

Is endorsement the same as reimbursement?

No — endorsement = quality signal. Reimbursement = separate decision.

Do I need a CE mark?

Yes, if your app is a medical device under MDR/IVDR.

Are telehealth or coaching services included?

No — the app alone is assessed.

What evidence is acceptable?

Best-available structured evidence: RCTs where feasible; otherwise, prospective RWD or observational cohorts using validated endpoints.

Denmark’s Recommended Health Apps. How to win?

Inside the Evidence Framework Behind Anbefalede Sundhedsapps and the Danish Board for Health Apps

Contents

Why this milestone matters

What was endorsed on 27 June 2025

How Denmark Assesses Apps: The Four Evidence Pillars

1. Evidence of Effect (Clinical & Behavioural Outcomes)

2. User Experience & Accessibility (Human-Factors Testing)

3. Affordability (Equity & Access Considerations)

4. Societal Value (Alignment With Danish Health Priorities)

5. Submission Route: Danish Medicines Agency Portal

Case in Point: Hedia Diabetes Assistant – A CE-Marked Digital Therapeutic for Insulin Dosing

What Hedia Does: Evidence-Based Bolus Calculator

Why Denmark Endorsed Hedia

✓ Clinical evidence & mechanism of action

✓ Usability & patient safety

✓ Alignment with Danish health priorities

Why Hedia Illustrates Denmark’s New Digital-Health Standard

What’s Out of Scope (for Now)

1. Telehealth or teleconsultation services

2. Human coaching or behavioural-support programmes

3. Paid subscription layers, premium features or bundled service packages

4. External clinical pathways or integrated care services

Why this matters for developers

Will this change in the future?

European Context: How Denmark Compares to Germany, the UK, France and Belgium

🇩🇪 Germany: DiGA – Reimbursement Based on Proven Benefit

🇬🇧 United Kingdom: DTAC, NICE, ORCHA – Assurance, Not Endorsement

🇫🇷 France: PECAN – Experimental Funding with Evidence Development

🇧🇪 Belgium: mHealthBelgium Pyramid (M1–M3)

🇩🇰 Denmark: National Public Endorsement (Anbefalede Sundhedsapps)

Summary: Four Countries, Four Different Paths

Why Denmark’s Model Is Distinct

Who Is Affected in Denmark

1. Clinicians & Primary Care Teams

2. Municipalities & Regional Health Authorities

3. Patient Organisations & Citizen Groups

4. Digital Health Developers & DTx Companies

Why this matters overall

Developer Checklist for Denmark

1. Clinical Evidence Package (RCT + RWD + Biometric Logic)

Clinical Outcomes Dataset (min. 12 weeks preferred)

Study Types Accepted

Algorithmic Explainability

2. Safety, MDR Compliance & Clinical Risk Management (DCB-0129 Ready)

Essential Deliverables

Clinical Safety Requirements

3. Usability, Accessibility & Human-Factors Evidence (WCAG + Older Adults)

Required UX Evidence

4. GDPR, Data Governance & Transparency (DPIA Mandatory)

Core Documentation

Patient Rights Processes

5. Interoperability & Technical Standards (MedCom, APIs, FHIR)

6. Affordability & Price Transparency Narrative

7. Societal Value Alignment (Pressure Relief, Prevention, Equity)

8. Denmark-Specific Submission Requirements

9. Bonus: EU Alignment to Strengthen Your Danish Dossier

How Odelle Technology Can Help

1. Scientific Gap Analysis vs the Danish Four Pillars

2. Evidence Generation: RCT Design, RWE Studies & Outcomes Selection

3. Health Economics for Denmark’s System: BIA, CEA & Capacity-Impact Analysis

4. Clinical Safety, MDR & Data Governance Documentation

5. Usability, Accessibility & Human-Factors Validation

6. Danish Policy & Pathway Integration

7. European Expansion Roadmaps (DiGA, PECAN, mHealthBelgium, UK DTAC/NICE)

8. Strategic Positioning & Scientific Narratives

Partner with Odelle Technology

Glossary of Terms – Denmark’s Recommended Health Apps (Anbefalede Sundhedsapps)

Anbefalede Sundhedsapps (Recommended Health Apps)

Nævnet for Sundhedsapps (Board for Health Apps)

Evidence of Effect

Real-World Data (RWD)

Randomised Controlled Trial (RCT)

Usability & Accessibility

Affordability

Societal Value

CE Mark (EU Conformity)

GDPR – General Data Protection Regulation (EU 2016/679)

Health Economic Evaluation

PROMs – Patient-Reported Outcome Measures