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Detailed summary and FAQ - new proposed medical device excise tax regulation

McGuireWoods LLP
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USA
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February 8 2012

On Feb. 3, 2012, the Internal Revenue Service issued long-awaited proposed regulations that provide guidance on the excise tax imposed on the sale of medical devices under Internal Revenue Code Section 4191

Affordable Care Act Hangs in the Balance After Oral Arguments

McGuireWoods LLP
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USA
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April 3 2012

From Monday, March 26, 2012, through Wednesday, March 28, 2012, the Supreme Court of the United States held six hours of oral arguments in three pending cases involving constitutional challenges to the federal health reform law, the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (the Act

HIPAA may provide basis for state law private cause of action

McGuireWoods LLP
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USA
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June 23 2011

The Health Insurance Portability and Accountability Act (HIPAA) imposes requirements on healthcare entities involved in the exchange of health information to protect the confidentiality of such information

Proposed HIPAA privacy disclosure accounting

McGuireWoods LLP
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USA
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June 16 2011

On May 30, 2011, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (“Proposed Rule”) modifying the disclosure accounting provisions of the Privacy Rule promulgated pursuant to the Health Insurance Portability and Accountability Act (HIPAA), in accordance with the Health Information Technology for Economic and Clinical Health Act (the HITECH Act

11th Circuit hears oral arguments on health reform law

McGuireWoods LLP
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USA
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June 9 2011

On June 8, 2011, the 11th Circuit heard arguments in the 26-state lawsuit that challenged the Patient Protection and Affordable Care Act (ACA) signed into law last year

FDA relaxes 510(k) requirements on certain IVD and radiological Class I and II devices

McGuireWoods LLP
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USA
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July 13 2011

Responding to demands and criticism from industry and Congress to streamline device approvals, the U.S. Food and Drug Administration (FDA) issued draft guidance on July 12, 2011, proposing to exempt 30 Class I and Class II in vitro diagnostic tests and radiology devices from 510(k) premarket notification requirements

FDA issues draft guidance on modifications requiring 510(k) submissions

McGuireWoods LLP
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USA
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August 18 2011

The U.S. Food and Drug Administration (FDA) recently issued a new draft guidance (2011 Version) to clear up confusion about what types of changes to existing medical devices require new 510(k) submissions and update its 1997 guidance document, "Deciding When to Submit a 510(k) for a Change to an Existing Device."

HHS to give states flexibility in setting minimum essential health benefits

McGuireWoods LLP
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USA
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January 6 2012

The U.S. Department of Health and Human Services (HHS) has issued the Essential Health Benefits Bulletin outlining proposed policies that will give states more flexibility and freedom to implement the “essential health benefits” requirements of the Affordable Care Act (ACA

CMS seeks comments on next stage of meaningful use

McGuireWoods LLP
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USA
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March 2 2012

On Thursday, Feb. 23, 2012, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule for Stage 2 criteria for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs

ONC issues certification standards for EHR

McGuireWoods LLP
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USA
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March 14 2012

On March 2, 2012, the Office of the National Coordinator for Health Information Technology (ONC) published a companion rule to the Centers for Medicare & Medicaid Services (CMS) Stage 2 meaningful use (MU) proposed rule, concerning certification criteria that electronic health record (EHR) technology must satisfy in order to support the achievement of Stage 2 MU

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