Cyber-risk services for healthcare manufacturers.
It's clear that cybersecurity in an important part of manufacturing healthcare products. What may not be so clear is what it means to make a secure product.
FDA guidance can be difficult to interpret into product requirements and without enforceable cybersecurity regulation the distinction between manufacturer and provider responsibility can be ambiguous.
Providers are demanding built-in security for connected devices and even making purchasing decisions on cybersecurity features. Level Nine helps navigate cybersecurity regulation and offers extensive experience with healthcare providers to help manufacturers implement differentiating cybersecurity features.
Level Nine Practice Areas
Risk Management & Strategy
Manufacturers are exploring new business opportunities such as data analytics and remote cloud services that combine their products and enterprise IT functions. Risk that was previously contained to a single product is now linked with broader enterprise risk.
Risk Management & Strategy enables manufacturers to explore and track the implications of new business models so they can make strategic cyber-risk decisions.
Cybersecurity is an essential part of product development; however, applying traditional controls in healthcare can undermine the functionality and profitability of the device.
We infuse all phases of the product lifecycle with cybersecurity expertise, balancing regulatory requirements, customer demands, budgetary constraint, and clinical functionality to drive market performance.
Not every threat can be prevented. In the age of the mega-breach organizations aren't judged on the occurrence of the event, but how it is handled.
The professional hackers in our Threat Management practice apply their knowledge of modern threat tactics to configure secure practices on-premise and in the cloud, build detection and response capabilities, conduct post-incident investigations, and test the preparedness of your program.