Total HIPAA

SEPTEMBER 30, 2019

ArcServe offers a variety of solutions for clients who need to comply with government regulations, like HIPAA, GDPR, SOX, etc. They offer their service to users of all operating systems, even those released before 2011. SpiderOak: The HIPAA Compliant Cloud Backup Services Trusted by Government Administrations. to 6:00 P.M.

HIPAA 52

HIPAA Compliance Governance Ransomware 52

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. 15, 2011) [11] FDA, Requirements for Health Care Facilities and Manufacturers, available at [link]. [12] 10] 76 Fed. 8637, 8645 (Feb.

FDA 98

FDA Licensing Hospitals Medicaid 98

C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

JULY 31, 2023

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 2011 WL 13186258, at *2 (C.D. May 17, 2011) (flight simulator and associated training materials were not products subject to strict liability); Heindl v. Wells Fargo Bank , 2011 WL 1833020 (D.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Thus, CEH turned on implied impossibility preemption, specifically an application of Mensing ( 2011+1 ) independence principle. Polansky v.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

JANUARY 30, 2023

Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. 555 (2009), and rated only a “ cf. citation in PLIVA, Inc. Mensing , 564 U.S. Davidowitz , 312 U.S. Moran , 536 U.S. Dow Agrosciences LLC , 544 U.S. Drown , 556 U.S. Mazda Motor, Inc. , Mazda Motor, Inc. , Mensing , 564 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

MARCH 13, 2023

Unlike almost every state in the country, since 1987, Pennsylvania law has prohibited defendants from introducing evidence of their compliance with government and/or industry standards in strict liability design defect cases – generally. E.g. , Lewis v. Coffing Hoist Division , 528 A.2d 2d 590, 593-94 (Pa. Bell Sports, Inc. ,

FDA 59

FDA Compliance Governance Doctors 59