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Smart Wearables for Cardiac Monitoring—Real-World Use beyond Atrial Fibrillation
Article

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

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Health Innovation Hub, Torstr. 223, 10785 Berlin, Germany
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Helios Health Institute, Helios Health, Friedrichstraße 136, 10117 Berlin, Germany
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Herzzentrum Leipzig, Universitätsklinik für Kardiologie, Strümpellstraße 39, 04289 Leipzig, Germany
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Leipzig Heart Institute, Russenstraße 69a, 04289 Leipzig, Germany
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Harvard Business School, Harvard University, Morgan Hall 433, Soldiers Field Road, Boston, MA 02163, USA
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Hasso-Plattner-Institute, Prof.-Dr.-Helmert-Straße 2-3, 14482 Potsdam, Germany
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Author to whom correspondence should be addressed.
Academic Editor: Ki H. Chon
Sensors 2021, 21(14), 4937; https://doi.org/10.3390/s21144937
Received: 14 June 2021 / Revised: 9 July 2021 / Accepted: 13 July 2021 / Published: 20 July 2021
(This article belongs to the Special Issue Smart Wearables for Cardiac Monitoring)
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. View Full-Text
Keywords: medical devices; regulation; market access; smart wearables medical devices; regulation; market access; smart wearables
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MDPI and ACS Style

Brönneke, J.B.; Müller, J.; Mouratis, K.; Hagen, J.; Stern, A.D. Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring. Sensors 2021, 21, 4937. https://doi.org/10.3390/s21144937

AMA Style

Brönneke JB, Müller J, Mouratis K, Hagen J, Stern AD. Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring. Sensors. 2021; 21(14):4937. https://doi.org/10.3390/s21144937

Chicago/Turabian Style

Brönneke, Jan B., Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel D. Stern 2021. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring" Sensors 21, no. 14: 4937. https://doi.org/10.3390/s21144937

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