Week Eight
Hello! Welcome to this week's Ryan Report. Today, I will profile the FDA press release on their new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
This is an update to the FDA's 2014 premarket guidance, which provides recommendations to industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends to be included in premarket submissions for medical devices with cybersecurity risk. The guidance is meant for manufacturers in order to facilitate an efficient premarket review process and help ensure that medical devices are designed to sufficiently address cybersecurity threats before the devices are on the market.
New recommendations include a cybersecurity bill of materials and the introduction of two tiers of devices: those that present high and standard cybersecurity risk. The bill of materials concept is one that is familiar in other industries, and its purpose is to help healthcare organizations understand the hardware and software components present in medical devices that may contain vulnerabilities. The risk tiers are based on potential to cause harm to patients by cybersecurity threats. High risk devices include implanted devices such as pacemakers, and standard risk includes devices that contain software.
The medical device industry lacks explicit federal regulation regarding cybersecurity. The HIPAA Security Rule just pertains to ePHI, and doesn't contain any explicit provisions for medical device cybersecurity. The FDA is relied upon by the medical device industry to provide guidance and while documentation such as this isn't meant to be prescriptive, it certainly helps advance the security posture of the industry at large.
This is an update to the FDA's 2014 premarket guidance, which provides recommendations to industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends to be included in premarket submissions for medical devices with cybersecurity risk. The guidance is meant for manufacturers in order to facilitate an efficient premarket review process and help ensure that medical devices are designed to sufficiently address cybersecurity threats before the devices are on the market.
New recommendations include a cybersecurity bill of materials and the introduction of two tiers of devices: those that present high and standard cybersecurity risk. The bill of materials concept is one that is familiar in other industries, and its purpose is to help healthcare organizations understand the hardware and software components present in medical devices that may contain vulnerabilities. The risk tiers are based on potential to cause harm to patients by cybersecurity threats. High risk devices include implanted devices such as pacemakers, and standard risk includes devices that contain software.
The medical device industry lacks explicit federal regulation regarding cybersecurity. The HIPAA Security Rule just pertains to ePHI, and doesn't contain any explicit provisions for medical device cybersecurity. The FDA is relied upon by the medical device industry to provide guidance and while documentation such as this isn't meant to be prescriptive, it certainly helps advance the security posture of the industry at large.
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