Bill of Health

JULY 14, 2023

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S The World Health Organization supports this ban and in particular describes it as making informed consent impossible in the health care setting.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

HIPAA Journal

JANUARY 16, 2023

This article aims to answer the questions what AI in healthcare is, what are – or what will be – the benefits of AI in healthcare, and how can concerns about the ethics of AI in healthcare be overcome. These concerns are not unique to the United States nor to the healthcare industry.

Governance 68

Governance HIPAA World Health Informed Consent 68

SQA

APRIL 30, 2021

EC Issues Notice on the Handling of Duplicate Marketing Authorization Applications (MAAs) of Pharmaceutical Products under Article 82(1) of Regulation (EC) No. The European Commission (EC) has issued a notice on the handling of duplicate MAAs of pharmaceutical products under Article 82(1) of Regulation (EC) No.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

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 application/notification must be submitted via the EUDAMED database (Article 69 IVDR).

US Department of Health and Human Services 40

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