Healthcare IT Today

DECEMBER 9, 2024

HTI-2 includes an update to the United States Core Data for Interoperability (USCDI) v4, as well as standards and criteria related to public health information exchange and e-prescribingspecifically electronic prior authorization (ePA). There is hard work to be done.

Compliance 81

Compliance Medicaid Medicaid Public Health 81

Hall Render

NOVEMBER 30, 2023

This modification means that all IVDs, including LDTs, will be required to comply fully with FDA’s medical device regulatory requirements, including registration and listing, premarket review, post-market reporting requirements and compliance with the FDA’s Quality System Regulation ( 21 C.F.R. Part 820 ), unless they fall under an exemption.

FDA 40

FDA Public Health Compliance Hospitals 40

Hall Render

JUNE 5, 2024

Stage 4: Effective November 6, 2027 Approximately three and a half years after the publication of the Final Rule, high-risk (Class III) IVDs offered as LDTs must comply with premarket review requirements. The FDA notes that it will continue to exercise enforcement discretion during the review of premarket submissions received by this stage.

FDA 40

FDA Compliance Regulatory Compliance Licensing 40

Verisys

JANUARY 13, 2022

The State of Alabama state of emergency Proclamation by the Governor which extended the public health emergency until Oct. This public health order included: Emergency care in hospitals. The Indiana Executive Order 21-28 was passed to extend the public health disaster emergency only until Dec. California.

US Department of Health and Human Services 52

US Department of Health and Human Services COVID-19 Public Health Telemedicine 52

Healthcare Law Blog

AUGUST 25, 2022

After 2026, the timing for publication is standardized – the February 1 st two years prior to the price applicability date will be the drug publication date. Fifteen more Part D drugs are set to be published in 2027, followed by 15 Part D and Part B drugs, collectively, in 2028. Program Compliance.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 52

FDA Compliance Public Health World Health 52

SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

FDA 40

FDA Licensing Governance Compliance 40