Hall Render

NOVEMBER 30, 2023

Phased Enforcement Strategy : The FDA delineates a detailed five-stage plan to transition from a policy of enforcement discretion to full regulation of LDTs as medical devices by 2028. FDA is also interested in comments on leveraging other public health programs (e.g., Please provide data to support such an approach.

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HIT Consultant

SEPTEMBER 30, 2022

As we emerge from a public health crisis that magnified and exacerbated health disparities, the need to address social determinants of health (SDOH) has reached a pivotal moment. In both social and healthcare, the pressure is mounting to address key drivers of health and amplify value-based care models. .

Public Health 52

Public Health Health Outcomes Doctors Hospitals 52

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

SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 52

FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 40

FDA Compliance Public Health Governance 40

SQA

FEBRUARY 15, 2023

ICMRA recognizes that AMR is a complex, multifaceted problem and calls for better coordination across all sectors, including public health, animal health, and the environment, through a ‘One Health’ approach. Tackling AMR is one of ICMRA’s strategic priorities.

US Department of Health and Human Services 40

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

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The difference between the term incident and the new term serious incident introduced in the Regulation are also discussed in detail.

FDA 40

FDA Licensing Governance Compliance 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The difference between the term “incident” and the new term “serious incident” introduced in the Regulation are also discussed in detail.

FDA 40

FDA Licensing Governance Compliance 40

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. Negotiation-Eligible Drugs.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Healthcare Law Blog

JANUARY 6, 2023

The high level summary below of some of the Act’s more notable components that are significant in the healthcare arena is not meant to be an exhaustive list of all health policy changes or provisions included in the Act. Telehealth.

COVID-19 52

COVID-19 Medicaid Medicaid COVID-19 Vaccine 52

Healthcare It News

JULY 10, 2024

The Office of the National Coordinator for Health Information Technology on Wednesday published its long-awaited Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability proposed rule for public comment.

Public Health 325

Public Health Medicaid Medicaid Medicare 325

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

New Jersey Healthcare Blog

JANUARY 12, 2022

Below are the most recent health care related regulatory developments as published in the New Jersey Register from October-December 2021: On October 4, 2021, at 53 N.J.R. 103, which declared a Public Health Emergency for the state in response to COVID-19. Effective September 28, 2028. On November 1, 2021, at 53 N.J.R.

Licensing 40

Licensing Medicaid Medicaid Nurses 40

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).

Compliance 81

Compliance Medicaid Medicaid Public Health 81

Hall Render

MARCH 11, 2022

How Nonprofit Hospitals, Health Systems Compensate Executives. Encompass Health’s home health unit attracts acquisition interest-sources. COVID-19 cases dwindle, but Alabama lawmakers continue push for public health reform. State health officer reflects on progress 2 years into pandemic.

COVID-19 40

COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40

Hall Render

SEPTEMBER 6, 2024

Carolina Neurosurgery & Spine Associates in Charlotte hires new CEO Cone Health could see $1.7B

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Kaiser Health News

NOVEMBER 27, 2023

These issues are expected to take center stage during the nationally televised 90-minute debate on Fox News, which could have major reverberations for the presidential contest next year and could even help shape the 2028 field of White House contenders. California bans short-term health plans. California Newsom became the first U.S.

COVID-19 Vaccine 117

COVID-19 Vaccine COVID-19 Medicaid Medicaid 117