Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring

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.

Smart Consumer Wearables as Digital Diagnostic Tools: A Review

“…It was able to detect COVID-19 in the pre-symptomatic period as well as the symptomatic phase of the patients, with a precision score of 0.91 (CI: 0.854–0.967) [ 10 ]. Cho et al proposed a one-class SVM method that can detect COVID-19 23.5–40% earlier compared to the method of Mishra et al [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 ,…”

“…Difficulties are associated with their fabrication, as they require miniaturization and the integration of various sensors [ 20 ]. Compared to the conventional lab-based diagnostic methods, these remotely monitored personalized diagnostic methods raise concerns over data security, sharing, and storage [ 21 ]. Regulatory bodies play an important role in this landscape.…”

Digitalisierung im Gesundheitswesen und ihre Effekte auf die Qualität der Gesundheitsversorgung

“…Hier können digitale Lösungen einen zentralen Beitrag zur Erfassung von patientenrelevanten Outcomes leisten. Zu denken ist dabei an die Nutzung von „smart wearables“ (Armbänder zur Erfassung von Vitalfunktionen), die beispielsweise im Monitoring [ 38 ], aber auch im Rahmen von klinischen Studien [ 39 ] durch beziehungsweise am Patienten eingesetzt werden, oder (Smartphone‑)Applikationen zur Erfassung von patientengenerierten Daten zur Messung von Outcomes (Patient-reported Outcomes Measures – PROM; [ 40 ]).…”

Technical, Regulatory, Economic, and Trust Issues Preventing Successful Integration of Sensors into the Mainstream Consumer Wearables Market

“…Import regulations are different across countries as well: the devices may be classified differently (i.e., medical device vs. wellness device) by legislature in the destination country than from the country of manufacturing, which would affect how their importation is regulated. For example, the definition of a medical device is slightly different in the European Union’s (EU) Medical Device Regulation 2017/745 than in the U.S Food and Drug Cosmetic Act [ 50 ]. These logistical challenges are not insurmountable, but require a large capital investment that may not be cost-effective for small companies.…”