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FDA recommendations to mitigate and manage cybersecurity threats
The vulnerability of medical devices to threats has grown, as these products are increasingly connected to hospital networks, the internet and other medical devices. There is, therefore, a need for effective cybersecurity to assure the functionality and safety of the medical device. In response, the FDA has developed the guidance document to assist manufacturers in identifying issues related to cybersecurity which should be considered when designing and developing medical devices and preparing for their pre-market submissions. FDA recommends that manufacturers consider cybersecurity risk as a part of the medical device design and development and that they submit documentation to FDA about the identified risks. These manufacturers also should consider putting controls in place that will help mitigate those risks. The document provides recommendations to the manufacturers on plans to provide updates, as well as patches for the operating systems and the medical software.Security measures to be considered by device manufactures
The Food and Drug Administration suggests following security measures which should be considered by medical device manufacturers to protect them from instances of unauthorized access:- Authentications must be used to limit the access for medical devices to trusted users. The various authentication methods such as username and password, biometrics, and smart card or multi-layered authentication can be used.
- Make sure the data is transferred securely to and from the medical device using encryption wherever appropriate.
- Implement functionalities that allow analysts to detect, recognize, log, time, and act upon any security compromises.
- Provide end users with the information regarding appropriate actions to be taken when a cybersecurity event is detected.
Key information for premarket submission
The FDA has also provided an outline for key information to be provided by the manufacturers in their premarket submission for FDA product approval related to medical device cybersecurity. It includes:- Hazard analysis, risks, and design considerations connected to the medical devices.
- Traceability matrix that links the actual cybersecurity controls to the risks that were considered.
- A summary that mentions which controls are in place to make sure the medical device software will maintain its integrity from the point of origin to the point at which device leaves the control of the manufacturer.
- Instructions for use of various cybersecurity controls like firewalls or anti-virus software.
- A summary containing the plan to provide validated software patches and updates through the medical device lifecycle to assure its effectiveness and safety continually.
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