The Medical Futurist

MAY 18, 2025

Assisting surgeries, disinfecting rooms, dispensing medication, keeping company: believe it or not these are the tasks medical robots will soon undertake in hospitals, pharmacies, or your nearest doctor’s office. Instead of a human, however, they used a mannequin designed for medical training.

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FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

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California Academy of Family Physicians (CAFP)

MAY 14, 2025

Imposes New (State-Only) Medi-Cal Premiums for Undocumented Adults – Implements $100 monthly premiums for undocumented adults aged 19 and older, effective January 1, 2027. Medi-Cal Minimum Medical Loss Ratio – Increases the minimum medical loss ratio for managed care plans, commencing January 1, 2026.

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FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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ABIM

JUNE 12, 2025

McDonald shared more about a pilot model announced last year that would create a pathway for exceptionally qualified international medical graduates (IMGs) successfully completing ACGME-accredited subspecialty fellowship to become Board eligible in Internal Medicine and subspecialties. Community Practice in ABIM Governance* Erica N.

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FDA Law Blog

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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FDA Law Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. There will be two submission deadlines per year on March 31 and September 30, through March 31, 2027.

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