The U.S. Department of Justice (DOJ) announced on January 20 that DePuy Synthes, a subsidiary of Johnson & Johnson, agreed to pay $9.75 million to resolve allegations that it entered into a kickback scheme with an unnamed...more
On June 23, the Department of Health and Human Services Office of Inspector General (OIG) posted on its website an Issue Brief entitled “Medicare Lacks Consistent Oversight of Cybersecurity for Networked Medical Devices in...more
On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted...more
Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study...more
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose...more
The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more
11/13/2020
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Medicare
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently unveiled a new website with updated guidance and resources for mobile health app developers regarding the HIPAA Privacy, Security, and...more
9/25/2020
/ App Developers ,
Application Programming Interface (APIs) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Apps ,
OCR ,
Telehealth ,
Wearable Technology
The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion,...more
7/23/2020
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
False Claims Act (FCA) ,
FBI ,
Fraud ,
Genetic Testing ,
Healthcare Fraud ,
Home Health Care ,
Medicaid ,
Medical Devices ,
Medicare ,
Prescription Drugs ,
Telehealth