Remove 2017 Remove Governance Remove Licensing
article thumbnail

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years. The sectorialism of the U.S.

FDA 288
article thumbnail

D.C. Court of Appeals Joins Prohibition on Pro Se Pursuit of FCA Claims

Hall Render

government for false or fraudulent claims submitted for federal reimbursement. Because FCA relators pursue the governments claims, several circuits have determined this precludes relators from proceeding pro se. The government declined to intervene and, in a filing with the U.S. Background The FCA, codified at 31 U.S.C.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

COVID-19: An integrated healthcare system is the way forward

Healthcare IT News - Telehealth

Government & Policy Network Infrastructure Telehealth Workflow With dozens of healthcare facilities across the UAE, the country’s healthcare system is evolving faster than elsewhere in the world says Christian Schuhmacher, CEO of King’s College Hospital London in Dubai. And it went beyond just coordinating the immediate response.

COVID-19 204
article thumbnail

Data Breaches Reported by New Jersey Brain and Spine, Highmark Inc. and Dialyze Direct

HIPAA Journal

Webb Mason provided patient data to Quantum Group in 2017 to assist with marketing efforts for Highmark, and that information has potentially been accessed by unauthorized individuals. Notification letters were sent to affected individuals on March 10, 2022. Highmark Inc., Highmark stressed that its own IT systems were not compromised.

HIPAA 135
article thumbnail

Federal Judge Refuses to Dismiss Florida Compounding Pharmacy’s FCA Suit

Pharmacy Law Blog

On December 4, 2017, a Florida federal judge refused to dismiss the federal government’s False Claims Act (FCA) suit against a compounding pharmacy. The federal judge refused the dismissal on the grounds that the government had sufficiently backed its allegations against both the company and its owner. December 4, 2017).

Fraud 52
article thumbnail

Telemedicine: What Slows Down the Healthcare of the Future

HIT Consultant

According to the 2021 survey, the healthcare industry has held the top position in the reported data breach since 2017. Particularly the certification and license are one of the main challenges for nurses in telemedicine. Government cooperation. With all-consuming personal data digitization comes an issue of data security.

article thumbnail

Two NY Home Healthcare Agencies Settle False Claims Act Allegations for $5.4 Million 

Healthcare Compliance Blog

The agencies received millions of dollars in funding from Medicaid, which is funded in part by the federal government, and much of that money was meant to pay the wages and benefits of their aides. million to New York State for conduct between 2014–2017. Under the terms of agreement, one of the agencies has paid $1.6