ArticleSensors (Basel, Switzerland)2021
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring.
Article in Sensors (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 58 citations in OpenAlex.
- Advances in Wearable Technology: MXene-Based Multifunctional and Biomedical Smart Textiles.ACS omega · 2026Review
- Stimulation Modalities in Wearable Haptic Systems: Single-Mode Feedback to Multiphysics Actuation.Research (Washington, D.C.) · 2026Review
- Implementation Framework to Increase Patient Adherence in Clinical Trials Utilizing Wearable Devices.Research square · 2025Article
- Wearable Technology and Its Potential Role in Cardiovascular Health Monitoring and Disease Management.Health science reports · 2025Article
- [Researches and clinical translation of smart dressings].Zhonghua shao shang yu chuang mian xiu fu za zhi · 2025Review
- Links between self-monitoring data collected through smartphones and smartwatches and the individual disease trajectories of adult patients with depressive disorders: Study protocol of a one-year observational trial.Contemporary clinical trials communications · 2025Article
- Streamlining wearable data integration for EHDS: a case study on advancing healthcare interoperability using Garmin devices and FHIR.Frontiers in digital health · 2025Article
- Development of a patient-centered app in Germany as a special health and organizational support by surveying patients with cardiovascular diseases.Clinical research in cardiology : official journal of the German Cardiac Society · 2024Article
- Ethics of Wearable-Based Out-of-Hospital Cardiac Arrest Detection.Circulation. Arrhythmia and electrophysiology · 2024Review
- The ethical dimension of personal health monitoring in the armed forces: a scoping review.BMC medical ethics · 2024Article
- A Comprehensive Review on Advancements in Wearable Technologies: Revolutionizing Cardiovascular Medicine.Cureus · 2024Review
- Current state of the art and future directions for implantable sensors in medical technology: Clinical needs and engineering challenges.APL bioengineering · 2023Review
- Applications of Smart Material Sensors and Soft Electronics in Healthcare Wearables for Better User Compliance.Micromachines · 2022Review
- Smart Consumer Wearables as Digital Diagnostic Tools: A Review.Diagnostics (Basel, Switzerland) · 2022Review
- Measuring Health-Related Quality of Life With Multimodal Data: Viewpoint.Journal of medical Internet research · 2022Article
- Coupled Multiphysics Modelling of Sensors for Chemical, Biomedical, and Environmental Applications with Focus on Smart Materials and Low-Dimensional Nanostructures.Chemosensors (Basel, Switzerland) · 2022Review
- Technical, Regulatory, Economic, and Trust Issues Preventing Successful Integration of Sensors into the Mainstream Consumer Wearables Market.Sensors (Basel, Switzerland) · 2022Article
- Health app policy: international comparison of nine countries' approaches.NPJ digital medicine · 2022Article
- [Digitalization of healthcare and its effects on quality of care].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern market access are often evolving slowly, sometimes creating market barriers. This article gives a brief overview of the existing clinical studies regarding the use of smart wearables in cardiac monitoring and provides insight into the main regulatory and legal aspects that need to be considered when such products are intended to be used in a health care setting. Based on this brief overview, the article elaborates on the specific requirements in the main areas of authorization/certification and reimbursement/compensation, as well as data protection and data security. Three case studies are presented as examples of specific market access procedures: the USA, Germany, and Belgium. This article concludes that, despite the differences in specific requirements, market access pathways in most countries are characterized by a number of similarities, which should be considered early on in product development. The article also elaborates on how regulatory and legal requirements are currently being adapted for digitally driven wearables and proposes an ongoing evolution of these requirements to facilitate market access for beneficial medical technology in the future.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.