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HCL Technologies

Regulatory Challenges in Medical Device Cybersecurity

Regulatory Challenges in Medical Device Cybersecurity

Medical devices play a pivotal role in improving global healthcare. Hospitals and medical practitioners are increasingly using networked technology to improve the accuracy and efficiency in monitoring patient health, and delivering healthcare services.

Though these devices play an important role in transforming how healthcare services are provided to patients, they are vulnerable to cyber-attacks and pose a potential cybersecurity risk. The risk posed by an intentional cyber-attack is entirely different from the risk caused by unintentional cyber-attacks, which may be caused due to design or security flaws. Intentional cyber-attacks are constantly evolving. The regulatory framework of the FDA is inadequate for addressing concerns related to rapidly emerging cybersecurity threats.

The whitepaper focuses on the challenges that manufacturers face in adopting regulatory guidelines, and discusses the solutions needed to overcome them.