Senators Propose U.S. Cybersecurity Incident Notification Law

In light of the escalation in ransomware and other cyber threats, a bi-partisan group of U.S. Senators has released a cybersecurity notification bill titled “Cyber Incident Notification Act of 2021.” Under the proposed bill, a “covered entity” would be required to report a “cybersecurity intrusion” or “potential cybersecurity intrusion” to the Cybersecurity and Infrastructure Security Agency (CISA) within 24 hours of confirmation of the intrusion.  Covered entities also would be required to submit updated cybersecurity threat information to CISA within 72 hours after the discovery of new information. The requirement for updates would continue until the incident is mitigated or any follow-up investigation is completed.

Although the term “cybersecurity intrusion” would be defined in future rulemaking with public comment, the bill provides, at a minimum, that the term include ransomware if it falls into one of six broad categories. The categories include ransomware involving a nation-state, an advanced persistent threat cyber actor, or a transnational organized crime group. The categories also include ransomware that results in or has the potential to result in harm to national security interests, the U.S. economy, or to public confidence, civil liberties, or public health and safety. In essence, it would encompass most types of ransomware.

The term “covered entity” also is to be defined by future rulemaking but, per the bill, “shall include, at a minimum, Federal contractors, owners or operators of critical infrastructure, as determined appropriate by the Director based on assessment of risks posed by compromise of critical infrastructure operation, and nongovernmental entities that provide cybersecurity incident response services.” CISA’s list of critical infrastructure sectors include: Information Technology, Communications, Healthcare and Public Health, Emergency Services, Financial, Energy, Food and Agriculture, Commercial Facilities, Critical Manufacturing, among others. For a full list of CISA’s current “critical infrastructure” sectors and a detailed discription of each, click here

To incentivize compliance, the law would allow the CISA Director to assess a civil penalty up to 0.5 percent of the entity’s gross revenue from the prior year for each day it violates the requirements under the law or under rules promulgated under the law. The Director would be allowed to “take into account mitigating or aggravating factors, including the nature, circumstances, extent, and gravity of the violations and, with respect to the covered entity, the covered entity’s ability to pay, degree of culpability, and history of prior violations.”

Click here to read the full Senate Bill.

FDA Issues Cybersecurity Guidance to Medical Device Manufacturers

Data transmissionThe U.S. Food & Drug Administration (FDA) has issued guidance setting forth its current thinking on issues related to cybersecurity of medical devices.

Because medical devices increasingly store or transmit sensitive patient health information, there are increased security risks of unauthorized access, modification, misuse or denial of use, or the unauthorized use of this information. Medical devices that connect to other devices or to the Internet or which have USB or other data ports are especially vulnerable. The FDA notes that “[f]ailure to maintain cybersecurity can result in compromised device functionality, loss of data (medical or personal) availability or integrity, or exposure of other connected devices or networks to security threats. This in turn may have the potential to result in patient illness, injury, or death.” Continue reading