With the growth of digital health, healthcare innovation, telehealth solutions, and remote monitoring capabilities, care delivery has increasingly become more technology and internet driven.
However, with this transition to cloud and internet based applications, the risk for cyber attacks and security breaches has also significantly increased, rendering the entire healthcare system incredibly vulnerable.
Recognizing this growing concern, late last month, the Food and Drug Administration (FDA) issued a detailed note providing the guidelines for security measures, specfiically for medical devices. The note explains: “A person who submits an application or submission […] for a device that meets the definition of a cyber device under this section shall…: 1) submit to the Secretary a plan to monitor, identify, and address, as appropriate, in a reasonable time, post market cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures; 2) design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure…”
As the wireless and remote monitoring…
