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
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
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
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
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