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Proposed rules seek to amend and extend protections of the EHR Stark Law exception and Anti-Kickback Statute Safe Harbor

McGuireWoods LLP
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USA
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April 12 2013

On April 10, 2013, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule in the Federal Register that revises the exception

Second in series: FDA draft guidance - mobile medical apps: cheat sheet

McGuireWoods LLP
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USA
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August 3 2011

FDA has decided to regulate mobile medical applications (MMAs) that are either for an intended use that has traditionally been considered a medical device, or affect the performance or functionality of a currently regulated medical device

Federal and Physician Payment Sunshine Law

McGuireWoods LLP
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USA
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November 10 2011

This client alert provides a brief update on the status of the regulations to be issued pursuant to 6002 of the Patient Protection and Affordable Care Act (PPACA), which are commonly known as the Physician Payment Sunshine Act (“Sunshine Act”

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

HHS announces proposed rule for direct patient access to clinical lab results

McGuireWoods LLP
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USA
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September 28 2011

On Sept. 12, 2011, the U.S. Department of Health and Human Services (HHS) announced a proposed rule that would provide patients with direct access to their clinical laboratory results

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

CMS proposes regulations for overpayment reporting

McGuireWoods LLP
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USA
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February 27 2012

Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule to implement Section 6402(a) of the Affordable Care Act (ACA) regarding reporting and returning of overpayments from Medicare and Medicaid

Providers beware: OCR continues aggressive enforcement of the HIPAA Privacy and Security Rules

McGuireWoods LLP
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USA
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April 18 2012

The Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) has just sent another strong signal to healthcare providers and plans that it intends to enforce the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules aggressively, and that it does not intend to give a pass to small healthcare providers or practices

HHS delivers Sunshine Act regulations in time for the holidays: data collection commencement date postponed

McGuireWoods LLP
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USA
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December 16 2011

On Dec. 14, 2011, the U.S. Department of Health and Human Services announced a proposed rule pursuant to 6002 of the Patient Protection and Affordable Care Act, which is commonly known as the Physician Payments Sunshine Act

First in series: FDA draft guidance - mobile medical apps

McGuireWoods LLP
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USA
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July 21 2011

This article is a brief overview of the draft mHealth guidance issued on Tuesday by the FDA (the "Draft Guidance"), and the first in a series presenting and exploring the implications of this long-awaited guidance

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