HIPAA Journal

JANUARY 16, 2023

In post-acute environments, healthcare providers dedicate a lot of resources to checking vital signs to identify postoperative adverse events. From a patient´s perspective, AI technologies not only improve outcomes and help prevent adverse events in hospitals but can also enhance the remote patient experience.

Governance 68

Governance HIPAA World Health Informed Consent 68

Dossier

JANUARY 19, 2024

According to the World Health Organization , around 1 in every 10 patients is harmed in healthcare, and more than 3 million deaths occur annually due to unsafe care. However, discrepancies in medication lists can lead to errors, adverse drug events, and drug interactions.

Licensing 52

Licensing World Health Hospitals Compliance 52

Bill of Health

JANUARY 18, 2024

Health Systems By design, the PHE Principles depart from the Siracusa Principles which address emergencies as events that require human rights consideration only on the level of response measures.

Public Health 270

Public Health US Department of Health and Human Services COVID-19 COVID-19 Vaccine 270

Total HIPAA

MARCH 17, 2020

The World Health Organization (WHO) has declared the recent coronavirus outbreak, otherwise known as Coronavirus Disease 2019 (COVID-19) , a public health emergency of international concern. If you are a HIPAA Prime subscriber, your compliance documents include a disaster recovery plan. Redundancy.

COVID-19 40

COVID-19 HIPAA Compliance Ransomware 40

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

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 40

FDA Compliance COVID-19 World Health 40

SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products. To be injectable, the product must be registered with the Agency as a medicine or health product.

FDA 40

FDA Compliance Licensing World Health 40

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 40

FDA Compliance COVID-19 Licensing 40

SQA

FEBRUARY 15, 2023

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. The MHRA has not received reports of adverse events involving Belzer UW MPS Machine Perfusion Solution.

US Department of Health and Human Services 40

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

SQA

JULY 8, 2022

Although the manufacturer, Roche Diabetes Care (RDC), has implemented a number of risk minimization strategies to reduce the incidence of these events, the impact of these strategies is inconclusive, and MHRA is taking further action to protect patients. World Health Organization (WHO). WHO Pharmaceuticals Newsletter, No.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

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.

US Department of Health and Human Services 52

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

SQA

OCTOBER 18, 2022

Health Canada also received confirmation from the purchaser of the counterfeit products that they had purchased the kits for personal use. The entire shipment, which contained 435 boxes of the 25-pack, was sent to Health Canada for compliance follow-up. and one distributor, Healthful Plus. Health Advance Inc.

US Department of Health and Human Services 40

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

Healthcare Law Blog

FEBRUARY 26, 2024

The Centers for Disease Control and Prevention is exploring the ability of AI to estimate sentinel events and combat disease outbreaks and the National Institutes of Health is using AI for priority research areas. From a governmental perspective, many federal agencies are embracing the possibilities of AI.

Medicaid 52

Medicaid Medicaid Governance Medicare 52

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. The Agency has worked to combat the irregular practice of using cosmetics as injectables since last year, when the first serious adverse events involving this type of product occurred.

FDA 52

FDA Compliance COVID-19 Public Health 52

Health Law RX

NOVEMBER 5, 2021

An employee is considered “fully vaccinated” two weeks after completing primary vaccination with a COVID-19 vaccine with, if applicable, at least the minimum interval between doses as recommended by the CDC, World Health Organization (“WHO”), or if administered as a part of a clinical trial. Compliance Dates.

COVID-19 40

COVID-19 COVID-19 Vaccine ADA Medicaid 40