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.

Some of the recently released smartwatch products feature a single-lead electrocardiogram (ECG) recording capability. The reliability of obtaining 3-lead ECG with smartwatches is yet to be confirmed in a large study. This study aimed to assess the feasibility and reliability of smartwatch to obtain 3-lead ECG recordings, the classical Einthoven ECG leads I-III compared to standard ECG. To record lead I, the watch was worn on the left wrist and the right index finger was placed on the digital crown for 30 s. For lead II, the watch was placed on the lower abdomen and the right index finger was placed on the digital crown for 30 s. For lead III, the same process was repeated with the left index finger. Spearman correlation and Bland-Altman tests were used for data analysis. A total of 300 smartwatch ECG tracings were successfully obtained. ECG waves’ characteristics of all three leads obtained from the smartwatch had a similar duration, amplitude, and polarity compared to standard ECG. The results of this study suggested that the examined smartwatch (Apple Watch Series 4) could obtain 3-lead ECG tracings, including Einthoven leads I, II, and III by placing the smartwatch on the described positions.

The Apple Watch is capable of recording single-lead electrocardiograms (ECGs). To incorporate such devices in routine medical care, the reliability of such devices to obtain precordial leads needs to be validated. The purpose of this study was to assess the feasibility and reliability of a smartwatch (SW) to obtain precordial leads compared to standard ECGs. We included 100 participants (62 male, aged 62.8 ± 13.1 years) with sinus rhythm and recorded a standard 12-lead ECG and the precordial leads with the Apple Watch. The ECGs were quantitively compared. A total of 98 patients were able to record precordial leads without assistance. A strong correlation was observed between the amplitude of the standard and SW-ECGs’ waves, in terms of P waves, QRS-complexes, and T waves (all p-values < 0.01). A significant correlation was observed between the two methods regarding the duration of the ECG waves (all p-values < 0.01). Assessment of polarity showed a significant and a strong concordance between the ECGs’ waves in all six leads (91–100%, all p-values < 0.001). In conclusion, 98% of patients were able to record precordial leads using a SW without assistance. The SW is feasible and reliable for obtaining valid precordial-lead ECG recordings as a validated alternative to a standard ECG.

Prostate cancer is the second most diagnosed cancer in the world. Treatment guidelines involve a multitude of therapies, however adherence to them is not fully established, while lack of personalized treatment strategies fails to put the patient as an individual clinical profile at the center of their treatment. We aim to present the concept of a digital treatment analyzer (TA) for the management of prostate cancer (PC) patients, leveraging real-world data (RWD) and predictive modeling to enhance personalized disease management strategies and adherence to PC guidelines, ultimately aiming to optimize therapeutic efficacy and improve outcomes. The TA comprises digital tools integrated into one user-intuitive interface, facilitating the development of patient-specific clinical profiles, classification of patients into matched historical RWD cohorts, presentation of relevant clinical guidelines, visual representation of treatment and outcomes, and mortality risk prediction based on a validated machine learning models. The Medical Information Mart for Intensive Care (MIMIC) IV dataset was utilized, including structured and unstructured data from the patient journey. The developed TA represents a promising approach to enhance personalized disease management strategies and adherence to PC guidelines. By integrating contemporary clinical guidelines, RWD and AI-driven insights, our digital TA aims to optimize therapeutic efficacy and improve patient outcomes. The presented concept demonstrates the potential for using a digital approach that integrates RWD into a treatment journey, to provide healthcare stakeholders with a holistic approach to PC management involving all available modern tools to achieve optimal outcomes.

Background: Mobile health (mHealth) approaches are already having a fundamental impact on clinical practice in cardiovascular medicine. A variety of different health apps and wearable devices for capturing health data such as electrocardiograms (ECGs) exist. However, most mHealth technologies focus on distinct variables without integrating patients’ quality of life, and the impact on clinical outcome measures of implementing those digital solutions into cardiovascular health care is still to be determined. Objective: Within this document, we describe the TeleWear project, which was recently initiated as an approach for contemporary patient management integrating mobile-collected health data and the standardized mHealth-guided measurement of patient-reported outcomes (PROs) in patients with cardiovascular disease. Methods: The specifically designed mobile app and clinical frontend form the central elements of our TeleWear infrastructure. Because of its flexible framework, the platform allows far-reaching customization with the possibility to add different mHealth data sources and respective questionnaires (patient-reported outcome measures). Results: With initial focus on patients with cardiac arrhythmias, a feasibility study is currently carried out to assess wearable-recorded ECG and PRO transmission and its evaluation by physicians using the TeleWear app and clinical frontend. First experiences made during the feasibility study yielded positive results and confirmed the platform’s functionality and usability. Conclusions: TeleWear represents a unique mHealth approach comprising PRO and mHealth data capturing. With the currently running TeleWear feasibility study, we aim to test and further develop the platform in a real-world setting. A randomized controlled trial including patients with atrial fibrillation that investigates PRO- and ECG-based clinical management based on the established TeleWear infrastructure will evaluate its clinical benefits. Widening the spectrum of health data collection and interpretation beyond the ECG and use of the TeleWear infrastructure in different patient subcohorts with focus on cardiovascular diseases are further milestones of the project with the ultimate goal to establish a comprehensive telemedical center entrenched by mHealth.