Emerging Technologies and the Future of Medical Device Regulation

Posted: 17 Jan 2020

See all articles by Marianne Ojo D Delaney PhD

Marianne Ojo D Delaney PhD

American Accounting Association; Centre for Innovation and Sustainable Development (CISD); Centre for Innovation and Sustainable Development (CISD)

Date Written: December 28, 2019

Abstract

In an increasingly impacted environment influenced by emerging technologies such as robotics and artificial intelligence, such technologies will also impact the use and control of medical devices. Regulation of such medical devices can adopt regulatory techniques which apply in the field of financial reporting and in this respect it, is particularly helpful to make reference to the Centre for Audit Quality’s framework which has five key components:
I. Control Environment
II. Risk Assessment
III. Control Activities
IV. Information and Communication
V. Monitoring

In designing an appropriate system for regulating emerging technologies, challenges presented as a result of implementing those technologies, and which constitute and generate the greatest levels of concerns for industry experts and professionals, include; skills and expertise required to operate those technologies, as well as concerns relating to those risks emanating from cyber risks.

Designing tool and techniques which can accommodate and adapt to – as well as ensure that enterprise programs and systems are able to align with the demands presented by emerging technologies, back up plans, namely internal control measures should constitute or rather, also embody part of the fore of concerns.

This paper aims to contribute to the extant literature on the topic by identifying legal and regulatory issues relating to emerging technologies – as well as address the impact and challenges of emerging technologies on current legal and regulatory requirements.

As remarked by the UK Prime Minister on the 24th September 2019 at the United Nations General Assembly, “Designs of emerging technologies should incorporate freedom, openness and pluralism – designs shaped by our values. New advances should reflect our values by design; freedom and control, regulation and transparency….. There is need to agree a common set of principles that will guide emerging technologies, ethical and responsible technologies.”

Hence in addition to the above mentioned objectives, this paper also aims to highlight how a common and multilateral set of agreed principles, shaped by ethical fundamental values, can be adopted to facilitate the advent of emerging technologies.

Keywords: medical devices, FDA, EMA, constitute and generate the greatest levels of concerns for industry experts and professionals

Suggested Citation

Ojo D Delaney PhD, Marianne, Emerging Technologies and the Future of Medical Device Regulation (December 28, 2019). Available at SSRN: https://ssrn.com/abstract=3510522

Marianne Ojo D Delaney PhD (Contact Author)

American Accounting Association ( email )

5717 Bessie Drive
Sarasota, FL 34233-2399
United States

Centre for Innovation and Sustainable Development (CISD) ( email )

United States

Centre for Innovation and Sustainable Development (CISD) ( email )

United States

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