[09/19/23]
Posted on September 19, 2023 in Firm News
Published by: Hall Render
Hall Render is pleased to announce Paige Robinson has joined the firm in its Denver office. Paige concentrates her practice on advising various health care entities on matters relating to hospital and physician transactions, fraud and abuse and regulatory compliance. Paige enjoys navigating the intricacies of the health care space and offering clients practical... READ MORE
[09/15/23]
Posted on September 15, 2023 in Health Law News
Published by: Hall Render
In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. The Draft Guidance is aimed at researchers conducting clinical trials using psychedelic drugs. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to... READ MORE
Tags: Clinical Pharmacology, Clinical Research, FDA, Food & Drug Administration, Psychedelic Drugs
[09/15/23]
Posted on September 15, 2023 in Health Law News
Published by: Hall Render
This Week (September 15, 2023): Drug Enforcement Administration (“DEA”) officials have been holding pre-regulatory listening sessions with stakeholders to discuss a new special provider registration requirement for practitioners who are prescribing controlled substances through telehealth without first establishing a provider-patient relationship. Why it Matters: The special registration is mandated by the Ryan Haight Act,... READ MORE
Tags: controlled substances, Drug Enforcement Administration, Telehealth, Virtual Care
[09/15/23]
Posted on September 15, 2023 in Health Law News, Health Provider News
Published by: Hall Render
NATIONAL 988 suicide hotline adds support for American Sign Language 3 Takeaways from Physician Compensation Trends Adventist Health completes merger with Montebello’s ailing Beverly Hospital AHA-supported bill to protect health care workers introduced in Senate AHA weighs in on CMS’ proposed ASC payment system AHA submits comments on CY 2024 OPPS proposed rule, including... READ MORE
[09/15/23]
Posted on September 15, 2023 in Health Law News
Published by: Hall Render
The Gilbert Family Foundation, Henry Ford Health and Shirley Ryan AbilityLab announced plans for a $439M inpatient rehab hospital and research facility in Detroit. Plans for the project include a 125,000-sf inpatient tower with 72 beds. According to a recent Bloomberg article, private equity is no longer a reliable last resort as a buyer... READ MORE
Tags: Health Care Real Estate, Health Care Real Estate Briefing
[09/14/23]
Posted on September 14, 2023 in Health Law News
Published by: Hall Render
On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the... READ MORE
Tags: Clinical Research, Decentralized Clinical Trials, Digital Health Technology, FDA
[09/13/23]
Posted on September 13, 2023 in Firm News
Published by: Hall Render
Hall Render is pleased to announce Michael Fiedler has joined the firm in its Detroit office. Michael focuses his legal practice on health care regulatory and transactional matters. Bringing a unique perspective informed by experience in government, health policy and corporate law, Michael assists clients through all aspects of legal and operational matters, with... READ MORE
[09/08/23]
Posted on September 8, 2023 in Health Law News, Health Provider News
Published by: Hall Render
NATIONAL 5 things to know about the new negotiations over Medicare drug pricing AHA releases new guidance for patient data use AHA Opposes Proposed Payment Cuts for Home Health Providers AHA infographic shows behavioral health hospital service trends AHA asks FTC to scrap proposed changes to premerger rules American Heart Association releases new policy... READ MORE
[09/08/23]
Posted on September 8, 2023 in Health Law News
Published by: Hall Render
A group of California tech billionaires spent $800M to acquire nearly 50,000 acres of land between Sacramento and San Francisco to develop what they are calling a “modern metropolis”. The project, if approved, would be one of the largest development projects in the works nationally. While detailed plans have not been released, the project... READ MORE
Tags: Health Care Real Estate, Health Care Real Estate Briefing
[09/08/23]
Posted on September 8, 2023 in Health Law News
Published by: Hall Render
On June 27, 2023, the Food and Drug Administration (“FDA”) issued its Final Guidance for the presentation of “Quantitative Efficacy and Risk Information” in Direct-to-Consumer (“DTC”) promotional labeling and advertisements for prescription drug and biological products, prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs. The Final Guidance provides recommendations on how... READ MORE
Tags: Direct-to-Consumer Promotional Labeling, FDA, Food and Drug Administration, Risk Information