Category Archives: Safety

Hazard analysis for Safety-critical Information Systems

There is a notable lack of maturity of prospective hazard analysis methodology for safety-critical information systems (such as clinical information systems). Most methods in this area target only the user interface and are limited to usability studies. We have been researching hazard analysis methods to fill this important gap and defined the ISHA (Information System Hazard Analysis) method, based on earlier foundational work in safety engineering. Today, Fieran Mason-Blakely is presenting our paper at FHIES/SEHC 2014. In this paper, we apply ISHA to the EMR-to-EMR episodical document exchange (E2E) standard developed in British Columbia (which is currently under deployment). Check out our paper for details.


Reform of Food and Drugs act also impact Medical Devices

The proposed bill C-17 to modernize the Canadian Food and Drugs Act has received media attention mainly with respect to its implications on drug safety. It will provide the government with more powers, including the power to recall drugs from the market. However, bill C-17 also applies to medical devices, including software-based medical devices. The bill also puts in place a mandatory reporting requirement of adverse events using drugs and medical devices. This is a step in the right direction. Now all me need is a budget to empower the government to enforce the new regulation.