Abstract:

Introduction: Venous disorders including chronic venous insufficiency (CVI) and varicose veins substantially impair patients’ quality of life. Digital health tools—especially wellness applications—offer emerging opportunities for self-management, lifestyle modification, and continuous monitoring. However, concerns remain regarding their clinical validity, data protection, usability, and the absence of standardized quality assessment.

Aim: To review the literature on wellness applications relevant to patients with venous diseases and to evaluate the potential role of the European health app quality label CEN-ISO/TS 82304-2 in improving trust, acceptance, and recommendation rates among healthcare professionals.

Methods: A narrative review of contemporary studies on mobile health (mHealth) and wellness apps for venous disorders, physical activity promotion, and chronic disease prevention was performed. Additional emphasis was placed on empirical research assessing the impact of standardized quality labelling on professional recommendation behavior.

Results: Wellness apps demonstrate promising benefits in promoting physical activity, improving adherence to preventive behaviors, and supporting monitoring of key parameters such as hydration, blood pressure, sleep quality, and mobility. Studies on mHealth for venous leg ulcers show feasible patient engagement despite technological limitations. Research on app quality assessment reveals that many commercially available applications lack scientific validation, medical involvement, and quality assurance mechanisms. Importantly, a European experimental vignette study showed that the CEN-ISO/TS 82304-2 quality label significantly increases healthcare professionals’ willingness to recommend wellness apps to patients, irrespective of patient socioeconomic status or app category.

Conclusions: Wellness apps can complement clinical management of venous disorders, but their integration into practice requires robust quality evaluation frameworks. The adoption of the European quality label appears to enhance professional trust and could contribute to safer and broader clinical use. Future research should investigate long-term patient outcomes and the implementation of certified apps in vascular practices.

Keywords: wellness apps; venous disorders; chronic venous insufficiency; mobile health; CEN-ISO/TS 82304-2; quality label; self-management; e-Health.

INTRODUCTION

Chronic venous disease (CVD), including varicose veins and chronic venous insufficiency (CVI), represent one of the most common vascular conditions globally, affecting millions of individuals and contributing to significant morbidity, reduced mobility, and impaired quality of life. Their high prevalence— exacerbated by aging, sedentary lifestyles, and obesity—necessitates innovative strategies for prevention and self-management^1-3. This highly prevalent condition is characterized by venous hypertension arising from valvular incompetence, venous reflux, obstruction, and impaired calf muscle pump function, leading to microcirculatory inflammation and progressive tissue damage. Epidemiological studies demonstrate that CVD affects up to one-third of adults, with symptoms ranging from pain and edema to skin changes and venous ulceration, contributing substantially to reduced mobility and diminished quality of life. Modern evaluation relies on CEAP classification and duplex ultrasonography, which together provide a structured assessment of disease severity and underlying mechanisms, forming the basis for individualized management strategies including lifestyle modification, compression therapy, and procedural interventions^4-10.

Physical inactivity is recognized by the World Health Organization as a major global public health problem, contributing substantially to the rising burden of noncommunicable diseases worldwide. In its Global Action Plan for the Prevention and Control of NCDs 2013-2020, the WHO emphasizes that increasing physical activity through accessible, population-level interventions is essential for reducing cardiovascular and metabolic disease risk—an approach directly relevant to patients with chronic venous disorders, who often benefit from enhanced mobility and structured lifestyle support^11-12.

Digital health tools, and specifically wellness applications, have evolved rapidly over the last decade, becoming increasingly sophisticated in their ability to support personalized health management. These applications commonly integrate features such as guided physical activity programs, diet and hydration monitoring, sleep quality assessment, and continuous biometric tracking through connected wearables. By leveraging real-time data, behavior-change techniques, and automated feedback loops, wellness apps can deliver tailored recommendations that encourage healthier routines and sustained lifestyle modification. For patients with venous disorders, these capabilities are particularly relevant. Regular movement and structured activity reminders can help stimulate the calf muscle pump, a key driver of venous return, while tracking step counts and mobility patterns enables early identification of prolonged sedentary periods that contribute to venous stasis. Hydration and blood pressure monitoring may support maintenance of optimal blood rheology and vascular function, and sleep analytics can identify patterns associated with leg heaviness or nocturnal edema. Moreover, longitudinal biometric data—such as daily step trends, limb temperature, or changes in swelling—can assist in the early detection of deteriorating symptoms, prompting timely clinical evaluation. Collectively, digital wellness tools offer a promising adjunct to conventional venous disease management, helping patients adhere to preventive strategies and enabling clinicians to monitor functional progress between visits^13-20.

However, challenges persist: many apps lack scientific rigor, clinical involvement, long-term validation, or appropriate data protection frameworks^21-25. Recognizing these challenges, the European Committee for Standardization (CEN) and the International Organization for Standardization (ISO) introduced the CEN-ISO/TS 82304-2 Technical Specification, a comprehensive framework designed to evaluate the quality, safety, reliability, and usability of health and wellness applications. This specification establishes a standardized, evidence-based scoring system and a consumer-facing quality label, enabling both clinicians and patients to quickly assess whether an app meets essential criteria for clinical robustness, data protection, and user experience. By defining transparent benchmarks across domains such as healthy and safe functioning, data security, ease of use, and technical robustness, the CEN-ISO/TS 823042 label aims to strengthen trust in digital health tools, facilitate professional recommendation, and support safer integration of wellness apps into routine clinical practice—including in fields such as phlebology, where digital self-management tools are becoming increasingly relevant.^26-29.

This short review synthesizes current knowledge on wellness applications relevant to venous disease management and examines the potential impact of the new European quality label on their acceptance by healthcare professionals.

METHODS

A narrative literature review was conducted using evidence from: a) studies on wellness applications, wearable technology, and lifestyle monitoring^13-15,19,20, b) clinical research on mHealth interventions for venous leg ulcers^9,16, c) technology-assisted leg health monitoring¹⁷, d) reviews on mobile apps for varicose vein prevention and self-care¹⁸, e) research on barriers to health app recommendation and the impact of CEN-ISO/TS 82304-2²⁹. Full-text data, figures, and tables from the uploaded documents were integrated. The aim was descriptive synthesis rather than meta-analysis. A summary of evidence gathered is shown in Table 1.

Table 1. Summary of evidence from reviewed studies

List of abbreviations:

MAI – Mediterranean Adequacy Index

TPA – Time spent per week on Physical Activity Index TCI – Target Calorie Index

PSQI – Pittsburgh Sleep Quality Index VLU – Venous Leg Ulcer

CVI – Chronic Venous Insufficiency PA – Physical Activity

BCT – Behavior Change Technique mHealth – Mobile Health

HCP – Healthcare Professional EHR – Electronic Health Record

CEAP – Clinical, Etiological, Anatomical, Pathophysiological (classification of chronic venous disease) ISO – International Organization for Standardization

CEN – European Committee for Standardization

QoL – Quality of Life

RCT – Randomized Controlled Trial

APEASE – Acceptability, Practicability, Effectiveness, Affordability, Side-effects, Equity (evaluation criteria)

RESULTS

Wellness apps for venous disease prevention and self-care

Several studies highlight the clinical relevance of mobile applications designed to improve lower-limb health and prevent venous stasis. Laberiano et al. describe the development of a mobile prototype for varicose vein prevention using design thinking. Patients valued educational content, exercise reminders, and monitoring tools. Wellness apps can encourage daily physical activity, improve adherence to compression therapy, and support early identification of symptoms (Figures 2,3). These findings align with the documented role of physical activity in reducing venous hypertension and improving microvascular perfusion¹⁸.

Wearable technologies supporting venous health

A wide range of wearable technologies now complement wellness apps. Fitness trackers monitor steps, heart rate, and activity levels—are promising key elements in venous return enhancement. Smart compression wearables adjust pressure dynamically, optimizing blood flow, smart hydration devices prevent dehydration, which can increase blood viscosity, whereas wearable blood pressure monitors, smart insoles, echocardiogram (ECG) devices, and sleep monitors provide additional data relevant to venous function (Figure 4). These technologies support a holistic wellness ecosystem, particularly valuable for patients with early venous symptoms or at high vascular risk¹⁷.

Health Applications for venous leg ulcers (VLU)

Evidence from the randomized controlled trial FOOTFIT shows high adherence (>85%) to short daily conditioning exercises tracked via an accelerometer-linked mobile app. Patients reported usability challenges with older technology, yet overall engagement was positive. The intervention demonstrates that mHealth can feasibly assist VLU patients, many of whom are elderly or have limited mobility. This underscores the importance of usability, interface quality, and updated sensor integration¹⁶.

Evidence-based wellness app development

The Wellness app studied by Sannino et al. integrates diet tracking and mediterranean diet adherence scoring (MAI), physical activity monitoring (steps, distance, heart rate), sleep quality assessment (PSQI), automated personalized recommendations and behavior change techniques (n=9) embedded into the app design. Pilot studies demonstrated significant improvements in wellness indices and high user satisfaction^13-15.

Lack of scientific validation in commercial apps

Consistent across multiple analyses is the finding that most available wellness apps lack medical involvement. Standardized effectiveness data are rare and only few apps undergo long-term or heterogeneous population testing, while data privacy and security features vary widely. This validates the need for systematic quality assessment frameworks.

The European quality label (CEN-ISO/TS 82304-2)

The recent vignette-based study by Biliunaite et al. provides the strongest evidence to date that the presence of the label (Figure 5) significantly increases healthcare professionals’ willingness to recommend apps. This effect is stable across app type (prevention, self-management, clinical support) and

Table 2. Structure and scoring domains of the CEN-ISO/TS 82304-2 quality label

List of abbreviations:

ISO – International Organization for Standardization CEN – European Committee for Standardization GDPR – General Data Protection Regulation

BP – Blood Pressure

CVI – Chronic Venous Insufficiency EHR – Electronic Health Record DVT – Deep Vein Thrombosis

DISCUSSION

Wellness apps represent a promising adjunct in the prevention and self-management of venous disorders, offering digital support that can complement traditional clinical care. Their potential benefits extend across several dimensions of venous health: (a) encouraging regular mobility and reducing sedentary behavior, thereby stimulating the calf muscle pump and improving venous return; (b) supporting adherence to compression therapy through reminders, tracking tools, and education on correct use; (c) enhancing patient education and autonomy by providing accessible information on risk factors, symptom monitoring, and lifestyle modification; (d) enabling real-time data collection—such as step counts, hydration levels, sleep quality, or limb temperature—which may facilitate early detection of deteriorating symptoms like edema, increasing pain, or reduced mobility; and (e) integrating wearable technology to provide comprehensive, continuous physiological monitoring relevant to venous function. Despite these advantages, several challenges limit widespread adoption. Usability issues—particularly among older adults or those with limited digital literacy—can hinder engagement, while the lack of clinical validation raises concerns about the reliability and accuracy of app-generated recommendations. Long-term adherence remains difficult to achieve, and variability in data security practices across commercially available apps introduces significant privacy and safety risks. This heterogeneity in app quality underscores the need for structured oversight.

The CEN-ISO/TS 82304-2 quality label helps address these gaps by providing a standardized, transparent mechanism for evaluating the safety, reliability, usability, and data protection practices of health and wellness applications. Evidence demonstrates that the presence of this quality label increases healthcare professionals’ willingness to recommend digital tools—an essential step toward integrating certified wellness apps into vascular clinical pathways and improving patient trust. Future directions should include longitudinal clinical trials assessing the impact of certified wellness apps on venous disease progression, recurrence, and patient-reported outcomes; integration of app-based monitoring into European vascular care pathways; the creation of venous disease-specific quality criteria within the ISO framework (e.g., compression adherence, ulcer photography quality, mobility metrics); and the strengthening of multidisciplinary collaboration among vascular surgeons, digital health specialists, behavioral scientists, and patient organizations to ensure real-world feasibility and adoption (Figure 7).

CONCLUSIONS

The expanding digital ecosystem of wellness applications and wearable technologies has created new possibilities for supporting patients with venous disorders, yet their meaningful clinical integration depends on the availability of trustworthy, clinically sound tools. The CEN-ISO/TS 82304-2 quality label provides a structured mechanism to distinguish reliable applications from the broader digital market, offering a foundation for safer and more consistent adoption in vascular practice. Moving forward, coordinated efforts across clinical, technological, and regulatory domains are essential to translate these digital innovations into measurable improvements in venous care. Robust clinical trials, implementation studies, and targeted quality frameworks will be critical to ensure that certified digital tools can be effectively embedded within everyday phlebology workflows (Table 3) and deliver sustained value to patients and clinicians alike.

Table 3. Gaps in current evidence and priorities for future research

List of abbreviations:

CVD – Chronic Venous Disease

CVI – Chronic Venous Insufficiency VLU – Venous Leg Ulcer

EHR – Electronic Health Record RCT – Randomized Controlled Trial QoL – Quality of Life

GDPR – General Data Protection Regulation

ISO – International Organization for Standardization CEN – European Committee for Standardization

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2. PMID: 39096027; PMCID: PMC12052922.