Hall Render

FEBRUARY 27, 2023

Whistleblowers continue to be one of the federal government’s greatest assets in FCA cases, as whistleblowers filed 652 qui tam suits in 2022 with recovery totaling $1.9 The government initiated 296 FCA cases on its own last year without input of a relator, which is the highest volume of DOJ initiated cases since the 1986 FCA amendments.

Nursing Homes 40

Nursing Homes Fraud Medicaid Medicaid 40

Health Populi

AUGUST 28, 2020

I wrote about this challenge in 2014 in my report for California Health Care Foundation, Here’s Looking at You: How Personal Information Is Being Tracked and Used. This Morning Consult poll revealed large gaps of trust, which did not bode well for America’s ability to implement a rigorous contact tracing program across the nation.

COVID-19 129

COVID-19 Public Health HIPAA Health Insurance 129

The Digital Health Corner

JANUARY 19, 2017

According to the National Institute on Drug Abuse (NIDA) from 2001 to 2014, deaths due to overdoses in the USA were noted as: 8 fold increase due to prescription drugs. It includes prescribing guides, clinical support information, and contact resources. We are all aware of the opioid epidemic and the human destruction in its wake.

ACA 60

ACA Public Health Governance 60

Healthcare Law Blog

MAY 16, 2022

Enrollee Participation in Dual Eligible Special Needs Plan (“D-SNP”) Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators. 1] “We do not offer every plan available in your area.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Healthcare Law Blog

JANUARY 10, 2022

Enrollee Participation in Plan Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of certain D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators. Please contact Medicare.gov or 1-800-MEDICARE to get information on all of your options.”

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

SQA

MAY 24, 2023

Having analyzed over 2000 responses received, the government will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.

FDA 40

FDA Licensing Governance Compliance 40

SQA

AUGUST 2, 2021

ISO 18082:2014, Anesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low pressure connectors for medical gases. government agencies and the private sector to collaborate in providing Americans with timely access to pharmaceuticals. Leveraging data to improve supply chain resilience.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Health Law Advisor

AUGUST 10, 2023

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. 12] FDA Draft Guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (October 2014), available at [link]. [13]

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

NOVEMBER 22, 2022

117 (2014), established that the Brown “at home” standard meant what it said and signified the end of expansive general jurisdiction. But he’s not a resident of Pennsylvania, and this cause of action had no contact with Pennsylvania. . . . [W]here’s Daimler AG v. Bauman , 571 U.S. Then, in Bristol-Myers Squibb Co.

Governance 72

Governance 72

Drug & Device Law

JULY 28, 2022

Indeed, innovator liability strays so far from traditional product liability that it creates personal jurisdictional problems – since the target defendant often has no jurisdictional contacts whatever with the forum state, since it didn’t even sell the product that allegedly caused (very attenuated) harm. 286 (2014)). BMS , 137 S.

Governance 59

Governance 59

Drug & Device Law

MARCH 17, 2022

The district court not only refused any transfer, since the plaintiffs had chosen their forum and were now stuck with it, but also flatly rejected these plaintiffs’ novel nationwide contacts jurisdictional theory. 277 (2014), that involved a plaintiff asserting a purely federal cause of action, that being a Bivens constitutional tort.

Governance 59

Governance 59

Drug & Device Law

MARCH 19, 2024

Plaintiff had surgery in 2014 in which the clips were used. Therefore, plaintiff’s claims could not possible “arise out of or relate to” that defendant’s contacts with Rhode Island. Shortly thereafter she began experiencing several adverse symptoms, including pain. In 2021, a CT scan revealed the clips had migrated.

FDA 52

FDA Fraud Doctors Governance 52