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January 2017
Article

Innovation Under Regulatory Uncertainty: Evidence from Medical Technology

By: Ariel Dora Stern

This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34% (7.2 months)... View Details

Keywords: Technological Innovation; Medical Devices and Supplies Industry

September 2020
Article

Regulatory Sandboxes: A Cure for mHealth Pilotitis?

By: Abhishek Bhatia, Rahul Matthan, Tarun Khanna and Satchit Balsari

Mobile health (mHealth) and related digital health interventions in the past decade have not always scaled globally as anticipated earlier despite large investments by governments and philanthropic foundations. The implementation of digital health tools has suffered... View Details

Keywords: COVID-19; mHealth; Digital Health; Design Thinking; Regulation; Intervention; Regulatory Sandbox; Health Care and Treatment; Technological Innovation; Design; Governing Rules, Regulations, and Reforms; India

August 2022
Article

Regulatory Considerations to Keep Pace with Innovation in Digital Health Products

By: John Torous, Ariel Dora Stern and Florence T. Bourgeois

Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a... View Details

Keywords: Emerging Technologies; Governing Rules, Regulations, and Reforms; Innovation and Invention; Medical Devices and Supplies Industry

July 2021 (Revised February 2022)
Technical Note

RegTech: A New Way to Manage Risks

By: Aiyesha Dey, Jonas Heese and James Barnett

A note on regulatory technology (RegTech) describing its evolution, use cases, and the competitive environment in 2021. View Details

Keywords: Regulatory Technology; Change; Financial Management; Governance Compliance; Governance Controls; Technology; Technology Industry; Technology Industry; Technology Industry

Educators

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December 2022
Article

Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics

By: Cheng Gao and Rory McDonald

In nascent industries—whose new technologies are often poorly understood by regulators—contending with regulatory uncertainty can be crucial to organizational survival and growth. Prior research on nonmarket strategy has largely focused on established firms in mature... View Details

Keywords: Technological Change; Innovation; Qualitative Methods; New Categories; Entrepreneurship; Technological Innovation; Governing Rules, Regulations, and Reforms; Risk and Uncertainty; Strategy

2022
Article

Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response

By: Alexander MacKay and Samuel N. Weinstein

Pricing algorithms are rapidly transforming markets, from ride-sharing apps, to air travel, to online retail. Regulators and scholars have watched this development with a wary eye. Their focus so far has been on the potential for pricing algorithms to facilitate... View Details

Keywords: Competition Policy; Regulation; Algorithmic Pricing; Dynamic Pricing; Economics; Law And Economics; Law And Regulation; Consumer Protection; Antitrust Law; Industrial Organization; Antitrust Issues And Policies; Technological Change: Choices And Consequences; Competition; Policy; Price; Governing Rules, Regulations, and Reforms; Microeconomics; Duopoly and Oligopoly; Law

SSRN

1999
Chapter

Biotechnology, Competitiveness and the Regulatory State

By: Arthur A. Daemmrich

Keywords: Technological Innovation; Innovation Strategy; Competitive Advantage; Governing Rules, Regulations, and Reforms; Government and Politics; Policy; Business and Government Relations; Biotechnology Industry

2022
Working Paper

Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data

By: Alexander O. Everhart and Ariel D. Stern

Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so... View Details

Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry

01 Oct 2015
Working Paper Summaries

Efficiencies and Regulatory Shortcuts: How Should We Regulate Companies like Airbnb and Uber?

Keywords: by Benjamin Edelman & Damien Geradin; Web Services

December 2014
Article

The Distinct Effects of Information Technology and Communication Technology on Firm Organization

By: Nicholas Bloom, Luis Garicano, Raffaella Sadun and John Van Reenen

Empirical studies on information communication technologies (ICT) typically aggregate the "information" and "communication" components together. We show theoretically and empirically that this is problematic. Information and communication technologies have very... View Details

Keywords: Communication Technology; Information Technology; Organizational Structure

28 Sep 2015
News

Regulatory Scrutiny Threatens Google's Global Android Domination

Article

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

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... View Details

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

23 Apr 2019
Video

Totodi Technologies Final Pitch New Venture Competition 2019 Alumni Track

22 Aug 2023
News

$5 Billion Intel Deal Scrapped after China Dragged Out Regulatory Approval

2012
Other Unpublished Work

Environmental corporate strategy and advancements in enhanced oil recovery technology among U.S. firms

By: Shon R. Hiatt

This study seeks to address how collective actors can affect technology development and adoption among organizations by creating regulatory uncertainty. Empirically, this paper focuses on the influence of environmental organizations concerned about climate change on... View Details

Keywords: Energy; Technology Adoption; Natural Environment; Governing Rules, Regulations, and Reforms; Corporate Strategy; United States

25 Oct 2019
HBS Seminar

SBBI Seminar: Some Executive Views of Technology on the Future of Work

June 2005 (Revised July 2006)
Background Note

Note on the Convergence Between Genomics & Information Technology

By: David B. Yoffie, Dharmesh M Mehta and Rachel Sha

Focuses on the convergence between the genomics and semiconductor industries, in particular organ printing, DNA computing, biomolecular sensory networks, and DNA microarrays. Explains what this newly converged world looks like based on current research and findings in... View Details

Keywords: Genetics; Information Technology; Business Model; Disruptive Innovation; Information Technology Industry; Information Technology Industry; Information Technology Industry; Information Technology Industry