Skip to Main Content
HBS Home
  • About
  • Academic Programs
  • Alumni
  • Faculty & Research
  • Baker Library
  • Giving
  • Harvard Business Review
  • Initiatives
  • News
  • Recruit
  • Map / Directions
Faculty & Research
  • Faculty
  • Research
  • Featured Topics
  • Academic Units
  • …→
  • Harvard Business School→
  • Faculty & Research→
Publications
Publications
  • Article
  • Sensors

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

By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern
  • Format:Electronic
ShareBar

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.

Keywords

Wearables; Regulatory Changes; Medical Technology; Medical Devices; Market Access; Market Entry and Exit; Technology; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States; Germany; Belgium

Citation

Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Sensors 21, no. 14 (July 2021).
  • Read Now

About The Author

Ariel D. Stern

Technology and Operations Management
→More Publications

More from the Authors

    • April 18, 2022
    • Harvard Business Review (website)

    Will mRNA Technology Companies Spawn Innovation Ecosystems?

    By: Christoph Grimpe, Timo Minssen, W. Nicholson Price, II and Ariel Dora Stern
    • April 2022
    • NEJM Catalyst Innovations in Care Delivery

    AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care

    By: Ariel Dora Stern, Avi Goldfarb and Timo Minssen
    • March 2022
    • Faculty Research

    Proximie: Using XR Technology to Create Borderless Operating Rooms

    By: Ariel D. Stern and Alpana Thapar
More from the Authors
  • Will mRNA Technology Companies Spawn Innovation Ecosystems? By: Christoph Grimpe, Timo Minssen, W. Nicholson Price, II and Ariel Dora Stern
  • AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care By: Ariel Dora Stern, Avi Goldfarb and Timo Minssen
  • Proximie: Using XR Technology to Create Borderless Operating Rooms By: Ariel D. Stern and Alpana Thapar
ǁ
Campus Map
Harvard Business School
Soldiers Field
Boston, MA 02163
→Map & Directions
→More Contact Information
  • Make a Gift
  • Site Map
  • Jobs
  • Harvard University
  • Trademarks
  • Policies
  • Digital Accessibility
Copyright © President & Fellows of Harvard College