
A new document identifies risk characterization related to software as a medical device (SaMD).
Developed by the International Medical Device Regulators Forum (IMDRF), the January 29 report introduces a general strategy for characterizing software-specific risks, according to the authors. As SaMD involves software, hardware, information technology networks, and people -- as well as system interconnectedness, cybersecurity, speed, and change -- the goal is a unified perspective and standardized language for all stakeholders.
Distinctions can be found throughout the nearly 50-page document, such as:
- SaMD output (i.e., clinical interpretation or intervention, workflow recommendation, and data for use in medical purpose).
- Timing within healthcare tasks or intervention (timing of software output relative to final intervention, final decision, or action in relation to other workflow steps and standard medical practices).
- Degree of autonomy (a spectrum of capacities or liberties to operate independently of a user’s direction, intervention, and oversight).
- Approaches for risk classification (challenging due to the broad range of technologies and characteristics).
The IMDRF document, titled "Characterization Considerations for Medical Device Software and Software Specific Risk," is not intended to replace or conflict with existing risk management practices or the development of technical or process standards related to software risk management activities, the report stated.
IMDRF was established in October 2011 and is made up of a voluntary group of medical device regulators from around the world, including from the U.S. Food and Drug Administration (FDA).
Read the full report here.