Regulation of Patient Management Software
Health Law Journal, Vol. 18, 2010
40 Pages Posted: 22 Dec 2010 Last revised: 10 Feb 2018
Date Written: December 21, 2010
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
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