Bill of Health

NOVEMBER 3, 2023

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. Hahn Professor of Law, Professor of Bioethics, and Co-Director of Law-Medicine Center, Case Western Reserve University School of Law.

Malpractice 284

Malpractice Bioethics HIPAA FDA 284

Bill of Health

DECEMBER 14, 2022

Food and Drug Administration (FDA). For example, physicians and companies offering cytoplasmic and mitochondrial transfer have received Untitled Letters from the FDA. After receiving the letters, these individuals and entities have ceased to provide these techniques in the United States.

FDA 205

FDA COVID-19 Vaccine COVID-19 Bioethics 205

Bill of Health

APRIL 26, 2022

To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates. By James R. A full video of the event is available below.

Bioethics 130

Bioethics Federal Policy Doctors Governance 130

Health Populi

JUNE 29, 2021

The FDA’s approval of the first therapy to treat Alzheimer’s Disease in over twenty years brought attention to a not-yet-convened debate of U.S. The FDA regulatory process and aftermath. health care costs and spending, innovation, and return-on-the-investment (as well as “for whom” do the returns accrue).

Medicare 62

Medicare Medicare FDA Bioethics 62

Health Populi

AUGUST 12, 2021

In this Rise of the Medical Machines, the major risks for health care organizations were that, 68% of health care deployments had more than 10 FDA recalls. . “During the chaos and confusion, threat actors launched cyberattacks,” Ordr observed in the wake of the public health crisis.

COVID-19 174

COVID-19 FDA Public Health Hospitals 174

Bill of Health

MARCH 28, 2022

Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2. By James Lytle. Recent guidance from the U.S.

COVID-19 246

COVID-19 Public Health FDA Hospitals 246

Bill of Health

NOVEMBER 18, 2022

By Aparajita Lath. The Truth Pill , authored by Dinesh Thakur and Prashant Reddy , is a monumental work that convincingly shows that drug regulation is but a myth in India. In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global.

Governance 317

Governance Bioethics FDA Public Health 317

Jane Sarashon

JULY 27, 2022

Apple has progressed its digital health innovations for cardio fitness as an indicator of overall health, with high and low heart rate notifications, the ECG app coupled with the Apple Watch, irregular rhythm notifications, and an FDA-cleared AFib History feature.

US Department of Health and Human Services 52

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

Bill of Health

FEBRUARY 26, 2024

In December 2022, the FDA Modernization Act 2.0 formally ended the FDA’s 1938 mandate to use animal models and opened the doors for organoids to be used as a full replacement for animals in pre-clinical trials. Would they classify as a medical device or biologic under FDA guidelines, or perhaps as a combination product?

FDA 111

FDA Informed Consent Bioethics 111

Bill of Health

SEPTEMBER 28, 2023

By Nikhil Chaudhry and Reshma Ramachandran Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19.

COVID-19 205

COVID-19 COVID-19 Vaccine Pharmaceutical Industry Governance 205

Health Populi

JANUARY 18, 2021

FDA-cleared, the “button” is streamlined as a “stick it and forget it” medical device that can gathered up to 30-days’ worth of vital signs on the patient to whom the device is “stuck.” The BioIntelliSense device garnered a CES 2021 innovation award.

US Department of Health and Human Services 73

US Department of Health and Human Services COVID-19 Electronic Medical Records Hospitals 73

Health Populi

SEPTEMBER 8, 2021

The Pew Trusts recently discussed prospects for the FDA to regulate AI in health care. Scaling and continuous feedback, continuing to adapt the models based on real-life experience that might have been overlooked in the original design.

FDA 68

FDA Governance Fraud World Health 68

Bill of Health

JANUARY 7, 2022

The American booster push was controversial, because the scientific evidence on the need for and effectiveness of boosters was limited, and the White House exerted an unprecedented level of pressure on the FDA and CDC’s ‘independent’ scientific review processes. Ultimately, both the FDA and CDC gave their blessing to boosters.

Public Health 339

Public Health FDA Governance COVID-19 Vaccine 339

Bill of Health

MARCH 7, 2024

Note: FDA approval for at least one indication is necessary for other “off-label” uses of the drug. You need one FDA approval to open the door to other off-label uses. Remember — no other psychedelic is FDA-approved ( yet ). However, the U.S. none can ( legally ) provide psilocybin, LSD, or MDMA ( yet ).

FDA 111

FDA Telemedicine Public Health Doctors 111