Blog - Health Care Compliance Brief

Artificial Intelligence (AI) and Advancing Quality of Care

AIHC

NOVEMBER 3, 2023

Improving Quality of Care by Addressing Preventable Harm Written by Joanne Byron , BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS Human error is a major cause of patient harm and prevents the delivery of safe, quality care even in today’s heavily regulated environment.

Department of Veterans Affairs

Department of Veterans Affairs Hospitals Compliance Nurses

10 Steps To Avoid Incidents In Healthcare

MedTrainer

MARCH 29, 2024

Following these steps can create a safety culture, enhance communication, improve training and education, implement effective procedures, and continuously monitor and evaluate patient safety efforts. Step 2: Implement Effective Communication Protocols Effective communication is paramount in preventing incidents in healthcare.

Compliance

Compliance Patient Advocacy Telemedicine Compliance Officers

SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. Agents inspected the luggage of travelers who crossed the land borders between Brazil and Paraguay (International Friendship Bridge) and Brazil and Argentina (Tancredo Neves Bridge).

FDA

FDA Compliance COVID-19 Public Health

SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

AUGUST 2, 2021

United Nations Industrial Development Organization, the new handbook , ISO 22000:2018 – Food safety management systems – A practical guide , provides in-depth and practical information to help organizations more effectively implement a food safety management system (FSMS) in accordance with ISO 22000:2018.

FDA

FDA COVID-19 Pharmaceutical Industry Hospitals

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

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

SQA

AUGUST 8, 2023

It is emphasized that all services that perform clinical analysis examinations and distribution centers must implement a Quality Assurance program. In addition, the establishments that perform these exams must ensure the reliability of the tests, through Quality Control management.

FDA

FDA Compliance COVID-19 World Health

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

FEBRUARY 15, 2023

To use the electronic certificate produced and issued by the application system of the NMPA, the applicant shall first register and be authenticated with a real name in the Online Office Hall of the NMPA. China’s drug MAH system has been implemented nationwide since the revised Drug Administration Law came into force in 2019.

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 – July and August 2023

SQA

OCTOBER 18, 2023

The inspection was motivated by complaints received by health surveillance agencies located in different Brazilian states, which reported on irregularities related to the composition of the companies’ products and divergences related to the labeling information of manufacturers and those responsible for the products.

FDA

FDA Compliance Licensing World Health

Skilled Nursing Update: CMS Adds Extra Time to Review 2019 Proposed Regulations That Impacted Key Skilled Nursing Regulations

Hall Render

JULY 18, 2022

The 2019 Proposed Rule aimed to increase the ability of health care professionals to apportion resources to improve resident care by eliminating or reducing requirements that could impede quality care or divert resources away from providing high-quality care. Background. Extra Time. Since the beginning of the COVID?19

Nurses

Nurses COVID-19 Compliance Medicare

CMS’ Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

Healthcare Law Blog

JANUARY 10, 2022

Comments are due by March 7, 2022. CMS believes the establishment and maintenance of such a committee is a “valuable beneficiary protection” to ensure enrollee feedback is heard and to help identify and address barriers to high-quality, coordinate care. Key provisions of the Proposed Rule are summarized below.

Medicare

Medicare Medicare COVID-19 Medicaid

SQA Regulatory Surveillance Summary 6 | Monthly Update 2021

SQA

DECEMBER 10, 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. Three years for Class III (high risk) devices. Guidance for Nomenclature for Generic Names of Medical Software, issued 12 July 2020.

FDA

FDA Compliance Public Health Hospitals

Key Healthcare Provisions of the Consolidated Appropriations Act, 2023

Healthcare Law Blog

JANUARY 6, 2023

1] An “originating site” is the location at which the telehealth eligible individual is located at the time the service is furnished via a telecommunications system. [2]. 1] An “originating site” is the location at which the telehealth eligible individual is located at the time the service is furnished via a telecommunications system. [2].

COVID-19

COVID-19 Medicaid Medicaid Medicare

April-July 2022 State Regulatory Developments

New Jersey Healthcare Blog

JULY 22, 2022

283 and 290 (2022) remain in full force and effect pursuant to the Disaster Control Act, N.J.S.A. 112 shall not be in effect. Effective Date: March 8, 2022. On April 4, 2022, at 54 N.J.R. See Executive Order No. 290 (2022). On April 4, 2022, at 54 N.J.R. Executive Order Nos. 111, 112, and 207 (2020), Nos. See N.J.A.C.

COVID-19 Vaccine

COVID-19 Vaccine Licensing COVID-19 Public Health

How the Fifty States View Electronic Data as a “Product”

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. Rustad, “Products Liability for Software Defects in Driverless Cars,” 32 S.

Governance

Governance Payment Systems Hospitals Licensing

Health Care Compliance Brief