On April 29, 2024, FDA finalized the long-awaited rule to assert authority over the regulation of laboratory developed tests (LDTs) under FDA’s existing regulatory framework for medical devices under the Federal Food, Drug,...more
The Biden administration has issued guidance and FAQs on mandatory insurance coverage of OTC COVID-19 testing. Effective January 15, 2022, plans are required to cover 8 individual at-home over-the-counter COVID-19 tests per...more
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
11/30/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Rulemaking Process ,
Stark Law ,
Trump Administration
On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the third and by far the largest stimulus package passed by Congress to respond to the COVID-19 outbreak. As discussed...more
In February of 2019, the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued a Proposed Rule that, if adopted, would upend the current prescription drug rebate system. According to HHS-OIG,...more
I. Introduction -
In May 2018, the Department of Health and Human Services (HHS) introduced a “Blueprint” and Request for Information setting forth proposed actions and policies as a means to purportedly help lower...more
While the Biologics Price Competition and Innovation Act (BPCI) was originally enacted under the Obama Administration as part of the Affordable Care Act, it appears that the Trump Administration will continue to take steps to...more
On December 19, the US Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) released a report indicating continued cybersecurity vulnerabilities among HHS’ four operating divisions based on FY...more
Editors’ Note: This is the second of a multi-part end-of-year series examining important trends in data privacy and cybersecurity during the coming year. Click here for our previous entry on HIPAA Compliance. Up next: ...more
A mere month and a half after the WannaCry strain of ransomware caused major havoc in European and Asian countries, another major ransomware attack hit large institutions across Europe and the United States yesterday. ...more
Those “in the know” in the cybersecurity world have been aware for more than a year of the threat posed by ransomware, a type of malware that locks victims’ access to their files until they pay a ransom. But discussion of...more
The Department of Health and Human Services (HHS) will soon launch a healthcare focused cybersecurity initiative modeled on the Homeland Security Department’s National Cybersecurity and Communications Integration Center...more
Introduction -
Cybersecurity was a prominent factor in 2016 in all aspects of government, business and personal affairs. Russian and other foreign national hacking has the potential to spark a new form of cold...more
2/16/2017
/ Cloud Computing ,
Cloud Service Providers (CSPs) ,
Cyber Attacks ,
Cyber Threats ,
Cybersecurity ,
Cybertheft ,
Energy Sector ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Sharing ,
Internet of Things ,
Popular ,
Ransomware ,
Trade Secrets
The Trump Administration has taken office at a time when cybersecurity has increasingly entered the public consciousness as a major challenge facing both the United States government and the business community. Cyberattacks...more
Editor’s note: This is the fourth in a continuing end-of-year series. See our previous posts on trade secrets, state regulation and law enforcement, and HIPAA compliance. Our last two posts will focus on the energy...more
In Case You Missed It: U.S. Major party platforms address cybersecurity. The two major parties have released their 2016 election platforms, both of which include cybersecurity planks. The Republican platform’s perspective...more
On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in...more
7/25/2016
/ Breach Notification Rule ,
Business Associates ,
Covered Entities ,
Cyber Attacks ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Encryption ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Ransomware
The recently-released Pokémon Go has quickly emerged as a cultural phenomenon, with legions of players using their phones to “catch” Pokémon that emerge all around them, visible (thankfully) only to players. While catching...more
The FBI recently released an article discussing the spate of ransomware attacks on a variety of different entities, including hospitals. In the article, the FBI warned that ransomware attacks and the cybercriminals carrying...more
Hospitals are increasingly the target of hackers, particularly in the form of “ransomware.” What follows is a primer on ransomware and how to avoid being a target of it....more
While eyes have been peeled on the U.S. Department of Justice's efforts to obtain a court order to hack the iPhone of one of the San Bernardino killers, garnering far less scrutiny is law enforcement’s more routine use of...more