2017, Compliance, FDA and Public Health - Health Care Compliance Brief

Illinois Opioid Prescribing and Opioid Abuse Training for Dental Healthcare Providers

American Medical Compliance

MAY 13, 2024

Languages: American English Key features: Audio narration, learning activity, and post-assessment Get Certified American Medical Compliance (AMC) is a leader in the industry for compliance, Billing and HR solutions. To become certified, please visit us at American Medical Compliance (AMC).

Compliance

Compliance Public Health Governance FDA

How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

MARCH 5, 2020

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

US Department of Health and Human Services

US Department of Health and Human Services FDA Public Health COVID-19

Digital Documentation: How PDFs Can Help Providers Expedite Care

HIT Consultant

MAY 9, 2022

The legislation mandated healthcare providers to modernize their internal recordkeeping, allowing for the swifter dissemination of medical information to support public health efforts and better medical care. PDF security features like encryption and redaction can help healthcare organizations achieve greater levels of compliance.

FDA

FDA COVID-19 Public Health Compliance

Uncompensated Care and DSH (Medicare disproportionate share hospitals)

AIHC

JANUARY 28, 2022

For more information on filing compliance cost reports, attend the Medicare Cost Report Camp in March 2022 presented by KraftCPAs and sponsored by the American Institute of Healthcare Compliance. This is to allow eligible antimicrobial products to begin receiving the new technology add-on payment sooner. billion in FY 2021, or 2.7

Medicare

Medicare Medicare Hospitals Payment Systems

SQA Regulatory Surveillance Summary 6 | Monthly Update 2021

SQA

DECEMBER 10, 2021

Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021. According to ANVISA Public Consultation 1051/2021 , the regulator plans a six-year rollout of UDI requirements in order to boost traceability and monitoring of medical devices and equipment commercialized in Brazil.

FDA

FDA Compliance Public Health Hospitals

SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

AUGUST 2, 2021

ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process. ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes. United States FDA – Guidances for Devices. b) and 320.31(d)(3)).

FDA

FDA COVID-19 Pharmaceutical Industry Hospitals

SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

AUGUST 8, 2023

Additional concerns were noted with respect to: Temperature/humidity controls Calibration inspection and/or qualification of equipment, including computerized systems Equipment usage logs Release of finished products Change Control Records Quality Agreement(s) Specifications for finished products Retention samples Bausch Health, Canada Inc.

FDA

FDA Compliance COVID-19 World Health

SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA

FDA Compliance COVID-19 Licensing

SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. As a result, the patient received 2.5

FDA

FDA Compliance Licensing World Health

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

US Department of Health and Human Services

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

SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

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

FDA Licensing Governance Compliance

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

APRIL 4, 2024

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years.

FDA

FDA Regulatory Compliance Malpractice Health Insurance

Here are the major issues facing healthcare in 2021, according to PwC

Healthcare IT News - Telehealth

DECEMBER 16, 2020

The virtual trial, to be sure, is not a new concept: One team of researchers counted more than 1,100 trials listed on ClinicalTrials.gov employing connected digital products for remote data collection in both 2017 and 2018, the organization observed. ” The FDA is hinting that some of these changes could be here to stay.

COVID-19

COVID-19 Hospitals Doctors Health Insurance

Hall Render’s Health Provider News – January 28, 2022

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. Where Hospital Price Transparency Compliance Is Lagging. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. State health officer discusses Alabama’s COVID-19 peak. Here’s what’s on tap.

Nursing Homes

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

Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives

Healthcare Law Blog

OCTOBER 25, 2023

iii] The Act also authorizes the CT DCP to impose penalties for instances of non-compliance or violations of the Act. vii] Violations can be subject to a penalty of $1,000 to $3,000 per violation, where each day that an individual is in violation of this law constitutes a separate violation. viii] Chicago, Illinois. ix] Nevada.

Licensing

Licensing Compliance FDA Public Health

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA

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

Federal Preemption of State Attempts To Ban FDA-Approved Abortion Drugs After Dobbs