Risk Management Considerations for IoMT

The interconnectedness of medical devices has the potential to be a significant benefit to doctors and patients. For example, an MRI machine used to scan a patient's back can send the images directly to the practitioner's office for examination and diagnosis. A linked heart-rate monitor can save a practitioner a lot of time by capturing and detecting transitory abnormalities that aren't visible on a single EKG scan. A linked glucose monitor can track a patient's blood sugar levels in real time and communicate with an insulin administration system. A mood/depression monitor can be used to track changing bodily states that can be used to understand a person's current mental state.

Harm is defined as injury or damage to people's health, as well as damage to property or the environment, according to ISO 14971, and a hazard is a possible source of harm. IoMT introduces a new set of risks. Any IoMT device that can have an effect on a user/patient, such as the introduction of energy (e.g., a pacemaker) or chemical transfer (e.g., insulin delivery), is vulnerable to a rogue agent assuming control of the device, posing a direct threat to the user/physical patient's well-being.

Connected inhalers, digestible sensors, connected contact lenses, and robotic surgery are all potential growth areas for IoMT (Internet of Medical Things).

Read more about how IoMT products require effective risk management and a quality management system, among other important aspects at MDDI

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