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FDA Releases Guidance for Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has released guidance on the postmarket management of cybersecurity for medical devices, encouraging manufacturers to implement security controls that cover products throughout their entire life cycle.

The U.S. Food and Drug Administration (FDA) has released guidance on the postmarket management of cybersecurity for medical devices, encouraging manufacturers to implement security controls that cover products throughout their entire life cycle.

In 2014, the FDA released guidance for the premarket management of cybersecurity. The recommendations include limiting access to trusted users via various authentication methods, ensuring that only authorized firmware and software can be installed, and implementing features for cyber incident detection, response and recovery.

The new guidance issued by the FDA focuses on managing cybersecurity risks after the devices have been deployed on a hospital’s network, a patient’s home network, or in a patient’s body.

The FDA has advised manufacturers to establish and maintain a process for identifying hazards, evaluating the associated risks, controlling these risks, and monitoring the effectiveness of security controls.

Manufacturers should have a process for monitoring and detecting cybersecurity holes in their devices – both in proprietary software and hardware, and third-party components. Information on vulnerabilities can be obtained from independent researchers, in-house testing, hardware and software suppliers, healthcare facilities, and organizations that specialize in information sharing and analysis.

Once a vulnerability has been found, vendors need to be able to assess its severity and estimate the probability of an exploit based on the availability of exploit tools and the complexity of exploitation. Vendors should also have a process in place for assessing the severity of patient harm if the vulnerability were to be exploited.

Manufacturers are encouraged to maintain a process for quickly deploying patches and updates, before the vulnerabilities are exploited. Routine updates and patches don’t need to be reviewed by the FDA. Furthermore, vulnerabilities don’t need to be reported to the agency, unless they result in adverse events or deaths, or they cannot be patched within 60 days of disclosure.

It’s worth noting that the recommendations are nonbinding, which means manufacturers are not legally required to implement them.

While there haven’t been any reports of cybersecurity vulnerabilities leading to deaths or physical harm, experts have found severe flaws in many medical devices. MedSec recently claimed to have found serious security holes in St. Jude Medical products, but the vendor has denied the allegations and even filed a lawsuit against the security firm.

The healthcare sector has been increasingly targeted by malicious actors. A recent study conducted by TrapX showed that while the number of breached records decreased to roughly 12 million in 2016, compared to nearly 112 million in the previous year, the number of healthcare breaches actually increased from 57 in 2015 to 93 in 2016.

With the value of medical records decreasing, cybercriminals have turned to ransomware attacks and medical device hijacking to make a profit.

Related: Healthcare Industry Can Go Beyond Compliance to Achieve Better Security

Related: Healthcare Was Most Attacked Industry in 2015

Written By

Eduard Kovacs (@EduardKovacs) is a contributing editor at SecurityWeek. He worked as a high school IT teacher for two years before starting a career in journalism as Softpedia’s security news reporter. Eduard holds a bachelor’s degree in industrial informatics and a master’s degree in computer techniques applied in electrical engineering.

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