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This is the second article in our two-part series on Cybersecurity in the Age of Industry 4.0, focusing on the legal implications and potential liabilities manufacturers face from cyberattacks, as well as practical...more
As the manufacturing sector continues to embrace the hyper-connected era of Smart Manufacturing, known as Industry 4.0, more and more organizations are integrating advanced automation, artificial intelligence (AI), the...more
As discussed in our previous blog post, the Cybersecurity and Infrastructure Security Agency (CISA) is proposing a significant new rule to bolster the nation’s cyber defenses through mandatory incident reporting. While...more
As the manufacturing industry increasingly relies on advanced technology such as the industrial internet of things, automation and big data, manufacturers are particularly susceptible to cyberattacks. Manufacturing operations...more
Lately, I have been asked a lot about security in Business Central and how good it is… Permissions, Roles, Field Level Permission with an APP, and so on. How do you know if anything has been compromised, or if you have a...more
On December 15, 2023, the Cybersecurity & Infrastructure Security Agency (CISA) issued a Secure by Design Alert and guidance on “How Manufacturers Can Protect Customers by Eliminating Default Passwords.”...more
Revisiting…Are Automakers Making Sufficient Efforts to Protect Customer Data? As a follow-up to our previous article and webinar, “Are Automakers Making Sufficient Efforts to Protect Customer Data?", we are addressing the...more
In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more
In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more
For the second year in a row, the manufacturing industry has fallen victim to more cyberattacks than any other major business sector. Indeed, according to IBM Security’s X-Force Threat Intelligence Index, nearly 25 percent...more
The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more
To help protect against criminal ransomware and cyberattacks, modern manufacturing plants should ensure they have reasonable physical, administrative, and technical safeguards in place....more
Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
Our clients in financial services, technology, and manufacturing industries, take note of this important new piece of legislation. On March 21, 2022, President Biden warned American businesses to prepare for imminent...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
For many manufacturers, data privacy and protection laws may seem like legal concerns that apply to other, more consumer-facing companies. While that may be largely true, given the ubiquitous nature of data, no business can...more
I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more
Since the Colonial Pipeline and JBS meat manufacturing security incidents, attention is finally being paid to the cybersecurity vulnerabilities of critical infrastructure in the U.S. and in particular, the potential effect on...more
Oil jumped for a second straight day, with futures near $70/barrel as fallout from the U.S.’s drone-strike assassination of Iran’s Qassem Soleimani continues to raise “the prospect of disruptions in the world’s most important...more
One can prorogate all one wants, but raise the ire of British MPs, and a price will be paid, my friends. So goes the story for PM Boris Johnson, against whom British lawmakers “rose up” on Monday to “prevent him from taking...more
The United States Treasury Department came out with a report last week that concludes that business email compromises (BEC) are costing U.S. companies more than $301 million per month. The report confirms that the two...more
Although many thought that WannaCry was in the rear view mirror, a recent report by Artemis, based on client experience, found that health care organizations and manufacturing companies are still being hit with the ransomware...more
A boom in automobile technology and connectivity in 2018 further boosted expectations of consumers regarding the integration and functionality of their devices and vehicles. Automobile manufacturers have responded by...more
In November, Tyler wrote about insurance issues raised by both the European Union’s General Data Protection Regulation (GDPR) and the California Consumer Privacy Act, which goes into effect on January 1, 2020. California’s...more