article thumbnail

The Dr. Oz Paradox

Bill of Health

Professionals within a professional relationship are subject to a variety of legal constraints, such as informed consent requirements or professional malpractice liability if things go wrong. My story for @dcexaminer on efforts to tame the #covid19 virus: [link]. — Dr. Mehmet Oz (@DrOz) April 3, 2020.

article thumbnail

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1

Bill of Health

However, EUAs are limited to public health emergencies, and RTT is only rarely used, so we concentrate here on EA, which is used by thousands of U.S. The IRB is responsible for the review and approval of the cohort EA protocol, the informed consent form, the consent process, and other materials. patients each year.

FDA 237
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

AI’s Ability to Manipulate Decision Making Requires a Moratorium on Its Use in Obtaining Consent for Biomedical Research

Bill of Health

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.

article thumbnail

We Need to Evaluate Ethics Curricula

Bill of Health

More schools could consider using simulations of common ethical scenarios, where they might ask students to perform capacity assessments or seek informed consent for procedures. There are also questions about how to assess whether students will make more ethical decisions in practice.

article thumbnail

DEA role must be clearly defined in controlled substance Rx via telemedicine, expert cautions

Healthcare IT News - Telehealth

Cohen contended that Congress make permanent COVID Public Health Emergency concessions, rather than renewing the concessions biannually. Patient-centered regulatory framework, including patient engagement and informed consent for AI use.

article thumbnail

Understanding Whistleblower Protections in Healthcare – Legal Obligations and Compliance Implications

AIHC

Under this statute, employees are protected from reprisal for reporting gross mismanagement, fraud, abuse of authority, or dangers to public health and safety. This tool may also be used to identify systemic gaps in institutional policies around consent, safety, and staff protections.

article thumbnail

How to Assess the Impact of Medical Ethics Education

Bill of Health

But many routine practices — assessing capacity, acquiring informed consent, advance care planning, and allocating resources, for instance — are. And given the importance of these endpoints, it is worth determining whether ethics education improves clinicians’ decision making across these domains.