Health Law Advisor

On July 13, 2023, the White House issued the first iteration of its National Cybersecurity Strategy Implementation Plan (the “Implementation Plan”), which will be updated annually. The two overarching goals of the Implementation Plan are to address the need for more capable actors in cyberspace to bear more of the responsibility for cybersecurity and to increase incentives to make investments in long-term resilience. The Implementation Plan is structured around the five pillars laid out in the White House’s National Cybersecurity Strategy earlier this year, namely: (1) defend critical infrastructure; (2) disrupt and dismantle threat actors; (3) shape market forces to drive security and resilience; (4) invest in a resilient future; and (5) forge international partnerships to pursue shared goals. The Implementation Plan identifies strategic objectives and high-impact cybersecurity initiatives under each pillar and designates the federal agency responsible for leading the initiative to meet each objective. The following summarizes some of the key initiatives included in the Implementation Plan that will directly impact critical infrastructure organizations, including healthcare, energy, manufacturing, information technology and financial services.

Establishing and maintaining effective systems to protect sensitive personal data and confidential business information from outside interference while also assuring that privacy interests are protected is among an organization’s highest priorities. Our security and privacy team at Epstein Becker & Green has written extensively about the guidance and best practices issued by federal and state regulatory and enforcement agencies. Execution, monitoring and continually updating these preventive practices define an organization’s first line of defense. But what happens in the event that an organization actually suffers a breach? Is there guidance that might be available, particularly to healthcare organizations, to deal with continuity and disaster planning (BC/DR) directed towards assuring resilience and recovery in the event of a potentially-disastrous cyberattack?

The U.S. Cybersecurity and Infrastructure Agency (CISA) has urged a “Shields Up” defense in depth approach, as Russian use of wiper malware in the Ukrainian war escalates. The Russian malware “HermeticWiper” and “Whispergate” are destructive attacks that corrupt the infected computers’ master boot record rendering the device inoperable. The wipers effectuate a denial of service attack designed to render the device’s data permanently unavailable or destroyed. Although the malware to date appears to be manually targeted at selected Ukrainian systems, the risks now escalate of a spillover effect to Europe and the United States particularly as to: (i) targeted cyber attacks including on critical infrastructure and financial organizations; and (ii) use of a rapidly spreading indiscriminate wiper like the devastating “NotPetya” that quickly moves across trusted networks. Indeed, Talos researchers have found functional similarities between the current malware and “NotPetya” which was attributed to the Russian military to target Ukranian organizations in 2017, but then quickly spread around the world reportedly resulting in over $10 billion dollars in damage.[1] The researchers added that the current wiper has included even further components designed to inflict damage.

On October 18, 2018, the FDA published Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.  This guidance outlined recommendations for cybersecurity device design and labeling as well as important documents that should be included in premarket approval submissions.  This guidance comes at a critical time as the healthcare industry is a prime target for hackers.  On January 22, 2019, the U.S. Department of Homeland Security Industrial Control System Cyber Emergency Team (US-CERT) issued another advisory regarding medical device ...

Our colleague Stuart M. Gerson at Epstein Becker Green has a post on the Health Law Advisor blog that will be of interest to our readers in the health care industry: “NIST Seeks Comments on Cybersecurity Standards For Patient Imaging Devices.”

Following is an excerpt:

The National Institute of Standards and Technology (“NIST) has announced that it will be seeking industry input on developing “use cases” for its framework of cybersecurity standards related to patient imaging devices. NIST, a component of the Department of Commerce, is the agency assigned to the ...

The National Institute of Standards and Technology (“NIST) has announced that it will be seeking industry input on developing “use cases” for its framework of cybersecurity standards related to patient imaging devices. NIST, a component of the Department of Commerce, is the agency assigned to the development and promulgation of policies, guidelines and regulations dealing with cybersecurity standards and best practices.  NIST claims that its cybersecurity program promotes innovation and competitiveness by advancing measurement science, standards, and related ...