Risk Management for Healthcare Software
For Healthcare Software organizations managing risk means ensuring that software works reliably in real-world situations while keeping patients safe and meeting the regulatory standards. One of the principles of health software and medical device regulations is that safety must be integrated into software from the beginning of the development process rather than relying on testing to verify it. Since testing can only evaluate a limited range of scenarios, Healthcare Software organizations should embed safety considerations into the design phase to mitigate any potential risks.
But how could organizations respond to the applicable regulations, deliver safe software and at the same time achieve their goals efficiently? According to the IEC 62304, manufacturers must prioritize several activities in their efforts to prevent any risks that patients could face. These activities include listing all software systems and their components and understanding how they could result in possible risks when they are associated with a device. To ensure proper understanding of the risk measures as well as correct execution, it is mandatory that staff involved in the risk management process are properly trained and competent to perform their tasks.
In addition, a system must be implemented to monitor the execution of risk measures, including documenting all actions taken, the achieved results as well as any deviations from the initial plan. This step helps in determining if the measures are functioning as intended.
Analyzing whether the risk measures are achieving their intended outcomes is just as important as the previous step. Let’s consider that a specific control was put in place to reduce the likelihood of a software failure. The analysis in this case would determine if the failure rate has decreased as expected.
Gathering relevant data such as incident and testing reports, and user feedback can also provide insights into the performance of the applied risk measures. The results of the analysis will indicate if the measures are sufficient and effective or if additional ones are needed. However, estimating how likely it is for a software failure to result in a danger for its users, can be a difficult task considering the existing data and the changing nature of software. IEC 62304 advises on dedicating efforts towards the prevention and elimination of the failure causes rather than on the prediction of their impact. In a nutshell, organizations should focus on proactive measures such as prevention and mitigation.
Last but definitely not least, if decision makers understand the benefits of high-quality software, efficient quality initiatives are supported which in turn help minimize costs but most importantly are conducive to identifying vulnerabilities and reduce the risks.