AIHC

SEPTEMBER 5, 2023

Compliance Considerations for Best Outcomes Written in collaboration with the AIHC Volunteer Education Committee Delivering mental health services via telehealth has increased since the COVID-19 pandemic. This information was published due to the end of the COVID-19 Public Health Emergency (PHE) which began May 12, 2023.

COVID-19 59

COVID-19 Telemedicine Compliance Informed Consent 59

Verisys

JANUARY 27, 2022

These license verification requirements have continued to change, so keeping up with regulations in telehealth is vital to compliance. Although telemedicine provides increased access to mental health services, digital visits also present challenges. Clear Communication on Consent and Fees. Written by Verisys.

US Department of Health and Human Services 52

US Department of Health and Human Services Telemedicine Licensing Informed Consent 52

SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

US Department of Health and Human Services 40

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

SQA

APRIL 30, 2021

generic, biosimilar, or hybrid application), informed consent is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. Under Article 82(1) of Regulation (EC) No. European Medicines Agency (EMA) – Biologics.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

HIPAA Journal

JANUARY 16, 2023

It is hoped that, as a tool for public health, AI can be used in the future to predict and track the spread of other infectious diseases by analyzing data from government, healthcare, and other sources. For example: Most people have played a video game against an AI-driven computer. Ethics of AI in Healthcare .

Governance 62

Governance HIPAA World Health Informed Consent 62

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix. Plaintiffs’ own litigation strategy thus opened the door to compliance evidence.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105