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CPSC is Now Publicly Posting “Letters of Advice” to its Website

In his keynote address at the annual conference of the International Consumer Product Health & Safety Organization (ICPHSO), Acting Chairman Adler announced that the agency had recently started posting what it calls “letters...more

What's in the Box? FDA Proposes Revisions to Nutrition Facts

On February 27, 2014, the U.S. Food and Drug Administration proposed three rules that would make landmark revisions to the iconic black and white Nutrition Facts panel if finalized. The proposed changes affect all packaged...more

Congress Passes New Drug Compounding Law Increasing Federal Oversight Over Compounding Pharmacies

In the fall of 2012, a meningitis outbreak sickened more than 750 people, killing 64 people and leaving many others with pain and nerve damage. The meningitis was traced back to tainted injectable steroids manufactured at a...more

U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill"), which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal...more

The HIPAA/HITECH Final Rule Has Been Released

The long awaited HIPAA/HITECH Final Rule is out. The final rule is effective March 26, 2013, but covered entities (CEs) and business associates (BAs) will have 180 days beyond the effective date to come into compliance....more

Brace for Impact – Final HITECH Rules Will Require Substantially More Breach Reporting

HHS has finally issued its omnibus HITECH Rules. Our firm will issue a comprehensive summary of the rules shortly, but of immediate import is the change to the breach reporting harm threshold. The modification will make it...more

First HHS OCR Settlement for HIPAA Breach Involving Less Than 500 Patients Sends Message to Providers

On January 2, 2013, HHS announced that the Hospice of North Idaho (HONI) agreed to pay $50,000 and enter into a Corrective Action Plan (CAP) as part of a settlement involving a breach of unsecured electronic protected health...more

First-Ever HIPAA Settlement Involving Fewer Than 500 Patients Announced

On January 2, 2013, the U.S. Department of Health and Human Services (HHS) announced a settlement with the Hospice of North Idaho (HONI) for potential HIPAA violations....more

De-Identifying Protected Health Information: OCR Issues Long-Awaited Guidance

The HIPAA Privacy Rule is intended to protect individually identifiable health information by limiting its use and disclosure. But the Privacy Rule expressly permits the de-identification of that information, and in doing so...more

First HIPAA Breach Settlement Involving Less Than 500 Patients Announced

ALL PROVIDERS ARE OFFICIALLY ON NOTICE. In a move that signals just how seriously the federal government is taking its enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the U.S....more

First OCR Resolution for Data Breach Involving Less than 500 Patients: No Breach is “Too Small”

The Department of Health and Human Services, Office for Civil Rights (OCR) reached its first settlement for a breach involving data regarding less than 500 individuals. Under the December 2012 settlement, the Hospice of...more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Medical Device Law Update - December 2012: FDA and Industry Form “Consortium” to Improve Device Approval Process

In response to wide criticism of the Food and Drug Administration’s (FDA) current review process, leaders of industry, academia and government have joined forces to create the Medical Device Innovation Consortium (MDIC), an...more

Big Data Could Save Healthcare System $300+ Billion Annually

According to a recent report released by Rock Health, Big Data has the potential to save the healthcare system more than $300 billion per year by improving poorly coordinated care, reducing fraud and abuse, and improving...more

Product Liability Advisory - November 2012: BPA Linked to Adverse Reproduction Effects in Rhesus Monkeys

A recent study published in the “Proceedings of the National Academy of Sciences” found that Bisphenol A (BPA) can adversely affect fetal development in rhesus monkeys. The study’s findings raise concerns regarding BPA...more

FDA Unveils New System to Track Medical Devices

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Unveils New System to Track Medical Devices

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

2011-2012 Massachusetts Legislative Session

The formal legislative session for 2011-2012 concluded on July 31st. The session was defined by landmark legislation in healthcare cost containment, economic development, energy, and consumer protection. The Legislature will...more

Senators Ask CFPB to Consider Regulation of Medical Debt Collection

Four Democratic senators recently submitted a letter to Consumer Financial Protection Bureau (CFPB) Director Richard Cordray requesting that the agency consider regulations restricting the use of medical debts in credit...more

ASHRM Annual Conference & Exhibition: Patient Safety Organizations: Legal Update and Practical Solutions After Walgreens Case

Partner Michael Callahan will speak on "Patient Safety Organizations: Legal Update and Practical Solutions After Walgreens Case" at 9:00 a.m. on Wednesday, October 10, at the American Society for Healthcare Risk Management's...more

California Establishes Centralized Privacy Unit for Enforcement and Education

California Attorney General Kamala D. Harris recently announced the creation of a new task force designed to enforce consumer privacy laws and to prosecute those companies - located both within and outside the state - that...more

“But what is it, Doc?” – Health Care Professionals under Professionals under Regulation 1924/2006

Changes in the epidemiological profile in Western countries during the last three decades have shown an increasing trend in the development of non-transmissible chronic diseases in the adult population. Nutrition-related...more

Massachusetts Hospital Agrees to Pay $775,000 for Security Breach

Following a two year investigation by the Massachusetts Attorney General’s Office (“AGO”), a local Massachusetts hospital has agreed to pay $775,000 to resolve allegations that it failed to protect the personal and...more

HHS Officials Explain Risk Adjustment Methodology

On May 7th and 8th, the Center for Consumer Information and Insurance Oversight (CCIIO) held a public meeting on risk adjustment, the process through which, under the Affordable Care Act (ACA), funds are transferred from...more

Massachusetts Releases Health Care Cost Containment Legislation

Massachusetts continues to be at the national forefront of health care reform. Since becoming the first state in the nation to expand access aimed at universal health care coverage through Chapter 58 of the Acts of 2006,...more

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