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The regulation of cosmetic interventions in the UK: toothless rhetoric or industry overhaul?

This Reed Smith client alert looks at the UK government’s response to the independent review of the regulation of cosmetic interventions in the UK. The key issues In recent years, cosmetic procedures have become widely...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

Eye on Privacy Newsletter - March 2014

In this issue: - Kaiser Foundation Health Plan Settles California Attorney General Charges over Delayed Data Breach Notification - Status of the EU Regulation and the Safe Harbor Framework - FTC Steps...more

Weekly Update from the State House - March 28, 2014: The House met in a Joint Assembly with the Senate to hear Lt. Governor...

Details from Each Chamber - HOUSE: The House worked through their calendar this week. The House met in a Joint Assembly with the Senate on Wednesday to hear Lt. Governor McConnell's address on the State's Aging...more

FTC Commissioner Criticizes Proposed Legislation That Would Permit Health Providers to Negotiate Jointly with Health Insurers

In a February 26 speech before the Connecticut Bar Association, Federal Trade Commissioner Maureen Olhausen expressed strong opposition to proposed legislation that would create an antitrust exemption for collective...more

FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more

FTC Settles Case With Medical Transcription Company

The Federal Trade Commission (FTC) recently announced that it had settled its data privacy case against medical transcription firm GMR Transcription Services, Inc. (GMR) following allegations that GMR had failed to adequately...more

Nursing Home Reporting of Reasonable Suspicion of a Crime in a Long Term Care Facility

Nursing facilities, skilled nursing facilities, hospices that provide services in long term care facilities and independent living facilities that provide services for the developmentally disabled ("facilities") are required...more

Get Ready! HHS OCR Announces Next Round of HIPAA Audits

To combat new risks associated with rapidly evolving health information technology, the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act...more

Health Law Blog: County Government Settles Alleged HIPAA Violations

A small county in Washington has agreed to pay $215,000 to settle allegations that it violated HIPAA by failing to secure electronic protected health information. Skagit County maintained protected health information (“PHI”)...more

Belgium: Beware Of The Barking Privacy Watchdog, She’s Biting

The quietness in the privacy landscape in Belgium is about to drastically change. Reason for the change of pace are the recent major data breaches that were published by the media. The Privacy Commission announced it will...more

$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more

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

DTSC Releases Initial Proposed “Priority Products” List for Safer Consumer Products Regulations

On March 13, 2014, the California Department of Toxic Substances Control (DTSC) released its initial proposed list of “Priority Products” for regulation under DTSC’s Safer Consumer Products program. The three categories of...more

Food And Beverage News And Trends

Food industry proposes front-of-package nutrition information. In the wake of the recently proposed changes to the Nutrition Facts panel labeling, the Grocery Manufacturer's Association proposed its own front-of-package...more

Health Insurer Fined Unprecedented $6.8 Million for HIPAA Violations

Federal fines for violations of the Health Insurance Portability and Accountability Act (HIPAA) may not exceed $1.5 million per incident per year. That's already a big number to think about — but employers also need to...more

Health Care Law Alert: Skagit County Fined $215,000 for HIPAA Violations

Skagit County in northwest Washington state has been fined $215,000 for violations of the HIPAA privacy, security, and breach notification rules. The U.S. Department of Health and Human Services’ Office for Civil Rights...more

FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers

Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of...more

Prop 65 Law Alert: California Proposes Significant Changes to Proposition 65 Warning Requirements

On March 7, 2014, the Office of Environmental Health Hazard Assessment (“OEHHA”), the agency responsible for implementing California’s Proposition 65 (“Prop 65”), issued proposed changes to existing regulations that would...more

OCR Settles Potential HIPAA Violations with County Government for $215,000

To start 2014, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued its first resolution agreement of the year and its first settlement with a county government – signaling that even local...more

CMS Issues Final Rule on Direct Access of Lab Test Results by Patients

On February 3, 2014, the Centers for Medicare and Medicaid Services (CMS) released a final rule that permits patients or their representatives to have direct access to the results of their lab tests. This rule change is...more

Proposed $6.8M Fine Related to Puerto Rico Breach Incident

Triple-S Salud, Inc. (“Triple-S”), a Puerto Rico Health Insurance Administration (“PRHIA”) contractor, filed a Form 8-K indicating that the PRHIA intended to impose a civil monetary penalty of $6,768,000 and other...more

Some Things Better Left Unshared: Social Media and Medical Identity Theft

The Washington Post recently published an article reminding individuals not to tweet or otherwise share information concerning their medical conditions on social media, warning that disclosing such information publicly “is...more

Unique Data Breach Settlement – A Sign Of Things To Come?

A judge in the United States District Court for the Southern District of Florida has approved a $3 million data breach class action settlement agreement between AvMed, Inc. and plaintiffs. The settlement arises out of a...more

First Lady And Nutrition: USDA And FDA Propose Sweeping Food Labeling And Marketing Regulations

Today, First Lady Michelle Obama and the Food and Drug Administration released two long-awaited proposed regulations that would for the first time in 20 years make significant changes to the nutrition information found on...more

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