Regulation of Patient Management Software

Health Law Journal, Vol. 18, 2010

40 Pages Posted: 22 Dec 2010 Last revised: 10 Feb 2018

See all articles by James Bryan Williams

James Bryan Williams

University of Toronto - Department of Computer Science; Google Inc.; York University - Osgoode Hall Law School

Jens H. Weber-Jahnke

University of Victoria - Faculty of Engineering

Date Written: December 21, 2010

Abstract

This paper addresses the use of medical device regimes to regulate electronic health record systems. Using Canada as our motivating example, we analyze whether a regulatory framework designed around hardware devices is suitable for use in the software domain. After presenting a thorough summary of the conceptual framework of medical device law, we consider the gaps and issues that arise when considering software systems. Our claim is that medical device regimes are not a suitable tool for the regulation of software, given the unique nature of software systems as engineering artifacts.

Keywords: Medical Device Law, Medical Device Regulation, Patient Management Software, EHR, information technology law, Electronic Health Records, Health Information Technology

Suggested Citation

Williams, James Bryan and Weber-Jahnke, Jens H., Regulation of Patient Management Software (December 21, 2010). Health Law Journal, Vol. 18, 2010. Available at SSRN: https://ssrn.com/abstract=1729275

James Bryan Williams (Contact Author)

University of Toronto - Department of Computer Science ( email )

Sandford Fleming Building
King’s College Road, Room 3302
Toronto, Ontario M5S 3G4
Canada

HOME PAGE: http://www.james-williams.ca

Google Inc.

1600 Amphitheatre Parkway
Second Floor
Mountain View, CA 94043
United States

York University - Osgoode Hall Law School ( email )

4700 Keele Street
Toronto, Ontario M3J 1P3
Canada

Jens H. Weber-Jahnke

University of Victoria - Faculty of Engineering ( email )

PO Box 3055, EOW 248
3800 Finnerty Road
Victoria, British Columbia
Canada

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