Medical device companies and manufactures of other connected devices need to be attentive to the ever-increasing risk of a cybersecurity breach affecting their own devices and the hospitals and other health care organizations where their devices are connected. Taking these challenges into consideration, the FDA has issued several guidance documents concerning cybersecurity for medical devices. Additionally, Reed Smith’s IP, Information & Innovation and Life Sciences Health Industry Group have teamed up to create a Task Force to help medical device and other manufacturers mitigate the risks of a cyber breach and related legal action.
To help mitigate the risks associated with medical devices that may be vulnerable to cybersecurity breaches, the Cybersecurity & Medical Devices Task Force has developed a check list that in-house counsel of medical device companies can use to help identify and address medical device cybersecurity issues. Click here to read the check list. You can also view a PDF here.