Health Law Advisor

The widespread availability of Artificial Intelligence (AI) tools has enabled the growing use of “deepfakes,” whereby the human voice and likeness can be replicated seamlessly such that impersonations are impossible to detect with the naked eye (or ear). These deepfakes pose substantial new risks for commercial organizations. For example, deepfakes can threaten an organization’s brand, impersonate leaders and financial officers, and enable access to networks, communications, and sensitive information.

In 2023, the National Security Agency (NSA), Federal Bureau of Investigations (FBI), and Cybersecurity and Infrastructure Security Agency (CISA) released a Cybersecurity Information Sheet (the “Joint CSI”) entitled “Contextualizing Deepfake Threats to Organizations,” which outlines the risks to organizations posed by deepfakes and recommends steps that organizations, including national critical infrastructure companies (such as financial services, energy, healthcare and manufacturing organizations), can take to protect themselves. Loosely defining deepfakes as “multimedia that have either been created (fully synthetic) or edited (partially synthetic) using some form of machine/deep learning (artificial intelligence),” the Joint CSI cautioned that the “market is now flooded with free, easily accessible tools” such that “fakes can be produced in a fraction of the time with limited or no technical expertise.” Thus, deepfake perpetrators could be mere amateur mischief makers or savvy, experienced cybercriminals. 

New from the Diagnosing Health Care Podcast: In a recent landmark decision, the U.S. Supreme Court overruled the Chevron doctrine in the case of Loper Bright Enterprises v. Raimondo.

This ruling has significant implications for employers and other entities in the health care and life sciences industries, as it changes the way courts are likely to interpret and apply regulations issued by federal agencies.

On this episode, Epstein Becker Green attorneys George Breen, Stuart Gerson, Rob Wanerman, and Paul DeCamp analyze the fallout of this monumental decision, discuss what it means for entities seeking to challenge ambiguous statutes and regulations, and assess how to proceed from here.

HRSA’s “Audit Reporting Requirement Attestations” arrived in inboxes on Friday, March 22, 2024, and require a response by Friday, April 5, 2024.  The government is under pressure to show that the money distributed under the CARES Act and the American Rescue Plan was used responsibly.  These notices are frustrating and frightening, and a two-week turnaround may seem a bit callous, but the situation could certainly be worse—the government could have simply demanded a return of the funds.  If an organization expended more than $750,000 in a single fiscal year and does not comply ...

On Monday, February 26, 2024, BioMarin Pharmaceutical, Inc. (“BioMarin”) disclosed in its annual filing that the company recently received a subpoena from the U.S. Department of Justice (DOJ) requesting certain documents regarding BioMarin’s sponsored testing programs relating to two of its products, VIMIZIM and NAGLAZYME.[1] BioMarin also stated that the company “produced documents in response to the subpoena and are cooperating fully, but there is no assurance that such sponsored testing programs, or [BioMarin’s] other operations or programs, will not be ...

On February 22, 2024, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2023, which ended on September 30, 2023. While the $2.68 billion in total recoveries continues an upward trend from the $2.24 billion reported in FY 2022, a primary takeaway is the focus on DOJ-driven investigations.

During remarks on February 22 at the Federal Bar Association’s Qui Tam Conference, DOJ Principal Deputy Assistant Attorney General Brian M. Boynton reported that in FY 2023, the United  States was a party to 543 FCA ...

On July 8, 2019, Anthony Camillo, owner of Allegiance Medical Laboratory and AMS Medical Laboratory, was sentenced to 30 months in prison by a federal judge in the Eastern District of Missouri. He was ordered to pay $3.4 million in restitution for violations of the anti-kickback statute, associated conspiracy charges, and illegal kickbacks related to various health care fraud schemes to defraud federal health care benefit programs. Those operating in the clinical laboratory testing space or referring specimens to such laboratories should know that what happened in this case is ...

During a November 29, 2018 speech, Deputy Attorney General Rod Rosenstein announced changes to Department of Justice (“DOJ”) policy concerning individual accountability in corporate cases.  The announcement followed the DOJ’s year-long review of its individual accountability policies and the September 2015 memorandum issued by then-Deputy Attorney General Sally Yates, commonly known as the “Yates Memo.”

While making clear that pursuing individuals responsible for corporate wrongdoing remains a top priority in every investigation conducted by DOJ, Mr ...

Epstein Becker Green's Peter M. Panken and Frank C. Morris, Jr. have authored a post on the Hospitality Labor and Employment Law blog entitled, "Loose Lips Sink Ships: New Liabilities Under The Affordable Care Act."

Following is an excerpt:

The Affordable Care Act ("ACA") requires larger employers (50 or more full time equivalents) to offer "affordable" "minimum value" health care to employees working thirty (30) or more hours per week or face the possibility of significant penalties in some cases.  Thus the cost of staffing with part time employees may be far less than paying for ...