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Clinical Laboratories Public Health

Holland & Knight LLP

New York State Department of Health Issues Long-Awaited Guidance on Material Transactions Law

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The New York State Department of Health (DOH) has published a set of Frequently Asked Questions (FAQs) to provide guidance on the "Disclosure of Material Transactions" law that took effect on Aug. 1, 2023. Pursuant to Article...more

Alston & Bird

Health Care Week in Review: Congress Races to Avert Government Shutdown; Senators Announce Launch of Make America Healthy Again...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Hinshaw & Culbertson - Health Care

Laboratory Testing Presents Business Opportunities for Community Pharmacies

The role of community pharmacies in health care has evolved and expanded in recent years. Many community pharmacies now offer health and wellness services related to identifying, preventing, and monitoring acute and chronic...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report — Legislative Day 30

Work was swift today in both chambers as lawmakers adjourned quickly in an effort to move to committee discussions on pending legislation. Deliberations are intensifying on HB 81, the proposed spending plan for the state’s FY...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more

King & Spalding

HHS OIG Permits Labs to Offer Free COVID-19 Antibody Tests and Oncology Practices to Offer Free Lodging in Certain Circumstances

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OIG has updated its FAQs regarding the application of its administrative enforcement authorities to arrangements directly connected with COVID-19 with the addition of two new FAQs. On August 4, 2020, the OIG issued an FAQ...more

Bass, Berry & Sims PLC

FDA Issues Updated Guidance on Clinical Trial Conduct during the COVID-19 Pandemic

Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more

Robinson+Cole Health Law Diagnosis

Massachusetts Issues COVID-19 Guidance for Health Care Providers, Payors and Laboratories on Issues Including Telehealth, Elective...

Over the weekend, Massachusetts executive agencies issued an array of further guidance to the healthcare provider community regarding COVID-19. All orders and guidance are available at https://www.mass.gov/2019coronavirus....more

Mintz - Health Care Viewpoints

FDA’s Evolving Response to the COVID-19 (Coronavirus) Outbreak

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at...more

Stinson LLP

Recommended Employer Response to Coronavirus Outbreak

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By now, employers are aware of the coronavirus (officially named COVID-19) and its growing impact on the global supply chain. As the first untraced case of the coronavirus in the United States came to light in California this...more

Franczek P.C.

CDC, OSHA Issue Guidance on Dealing with Coronavirus in the Workplace

Franczek P.C. on

Both the Center for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) have published interim guidance for employers on planning for and protecting their workplaces from exposure...more

Polsinelli

New Laws Impacting California Behavioral Health Care Providers and Labs

Polsinelli on

As part of an increasing trend towards regulation of behavioral health, a pair of new laws have been adopted that will impact certain California behavioral health providers and laboratories, with two proposed companion laws...more

Bass, Berry & Sims PLC

FDA Warns Against Direct-to-Consumer Lab Developed Tests

Bass, Berry & Sims PLC on

Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

Mintz - Health Care Viewpoints

Maryland Legislature Passes Bill Allowing Direct Advertising of Certain Laboratory Tests

The Maryland General Assembly recently passed a bill that permits any person to directly or indirectly advertise diagnostic laboratory tests in the state, with certain limitations. The bill currently awaits the Governor’s...more

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