Issue 5: Implications of ISO Certification and Licensing of Patient Management Software

Context

On August 31, 2009, Health Canada’s Medical Devices Bureau posted an announcement¹
(file number: 09-122095-269; Subject: Classification of Medical Devices Class I or Class II patient management software) that patient management software may be subject to classification as either Class I or Class II medical devices and will require compulsory licensing. Currently, a large number of patient management software providers are not licensed. This is not a new licensing issue; Health Canada has classified patient management software as medical devices for almost five years. However, this is the first time Health Canada has set a deadline for licensing approval and International Organization for Standardization (ISO) certification, and it is the first time Health Canada has publicly announced that patient management software that allows data to be “manipulated” will be classified as Class II medical devices.

There are implications associated with Health Canada’s announcement for physicians and health care administrators, federal and provincial health ministries, and industry: The disruption in the use or sale of patient management software could potentially compromise the ability of these stakeholders to administer effective health care.  

Objective

The purpose of this report is to identify the issues surrounding this topic and the potential impact that Health Canada’s classification of patient management software as medical devices will have on health care administrators, physicians, federal and provincial health ministries, and industry.

Findings

The main issue concerning all stakeholders is that there is not enough capacity in Canada to support vendors requiring ISO compliance for patient management software categorized as Class II medical devices by the deadline of August 31, 2010.

Federal and provincial health ministries

Health Canada’s decision to classify patient management software as medical devices comes at a time when federal and provincial governments are actively pursuing policy objectives involving the deployment of electronic health records. Indeed, Canada Health Infoway, a federally funded organization, was created to promote and advance electronic health records in Canada. Jurisdictions are also supporting their own eHealth initiatives. Consequently, there is speculation that federal and provincial plans to accelerate the development and adoption of electronic health records solutions across Canada could be delayed.

Manitoba eHealth, a provincial information and communication technology program, is very concerned about the potential impact of Health Canada’s recent notice and its new interpretation of the term “medical device” to include some types of patient management software. Manitoba eHealth’s concern is that Health Canada’s decision may have significant implications for the health care sector in the province, where patient management software currently in wide use may be reclassified as “medical devices” and not meet the new Health Canada requirement to comply with  Medical Device regulations. Roger Girard, the Chief Information Officer of Manitoba eHealth, believes there are very few software packages in Manitoba that meet this standard. He is concerned that software that may become non-compliant as a result of this new interpretation will have to be replaced and that the replacement would be very problematic, resulting in significant costs and disruptions in service. As he put it, “We will certainly even be challenged to identify where all of the non-compliant software is and to determine the responsibility of facilities with respect to its replacement.”