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Clinical Laboratories New Guidance

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

King & Spalding

OIG Releases Compliance Program Guidance Applicable to All Providers and Suppliers

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On November 6, 2023, OIG released new General Compliance Program Guidance (General CPG). The General CPG applies to all individuals and entities involved in the healthcare industry. The release of the General CPG was not...more

Venable LLP

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

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On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

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As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...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

Holland & Knight LLP

CMS Clarifies Immediate Jeopardy Guidance

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When a surveyor cites "immediate jeopardy" at a provider, supplier or laboratory’s location it can lead to serious consequences, including potential fines and termination from federal healthcare programs. On March 5, 2019,...more

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FDA Commissioner Speaks Out on Compliance and Enforcement

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On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

Foley & Lardner LLP

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

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Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

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