Healthcare Law Blog

JANUARY 26, 2023

BACKGROUND The Proposed Rule is the latest in a long line of federal legislation and rulemakings governing the conscience rights of healthcare providers and entities. The Church Amendments In the 1970s, the federal government enacted the Church Amendments, 42 U.S.C.

ACA 105

ACA Medicaid Medicaid Compliance 105

SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Health Law Advisor

AUGUST 10, 2023

In the last couple of years, each Fall, FDA has been updating a list of machine learning applications in health care that the agency has cleared or otherwise approved. [1] Although that regulation was published in 2011, FDA still uses it as the foundation for determining whether an organization qualifies as an MDDS manufacturer.

FDA 98

FDA Licensing Hospitals Medicaid 98

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 19, comment d. 19, comment f. See UCC §§2-103(1)(m), 2-105(1). at 1291-92.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JANUARY 30, 2023

280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Bartlett , 570 U.S. Levine , 555 U.S. citation in PLIVA, Inc.

FDA 72

FDA Fraud Governance Medicare 72