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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

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

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

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

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

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

HHS Rule Grants Patients Direct Access to Lab Test Results

The U.S. Department of Health and Human Services (HHS) recently published a Final Rule granting patients and their personal representatives access to the patient’s completed laboratory test reports directly from the lab...more

U.S. Privacy and Data Protection: 2013 Year in Review and a Look Ahead to 2014

In Boston, we celebrated Data Privacy Day (January 28) by presenting “U.S. Privacy and Data Protection: 2013 Year In Review and a Prediction of What’s to Come in 2014” for participants in an IAPP KnowledgeNet. Our panel of...more

HIPAA Covered Entities Subject to FTC Act Enforcement of Data Security Practices

On January 16, 2014, the Federal Trade Commission (FTC) unanimously ruled that it has authority to regulate a healthcare provider’s inadequate data security programs in order to protect consumers from business’ failure to...more

Accretive Health Data Breach Leads To Twenty-Year Settlement With The FTC

On December 31, 2013, the Federal Trade Commission ("FTC") announced that Accretive Health, Inc., ("Accretive") agreed to settle charges that the company's inadequate data security measures exposed sensitive consumer...more

Health Update -- Dec 19, 2013

The Debate over Specialty Pharmaceuticals: Is the Promise Worth the Price? - ..What’s the Issue? - Specialty pharmaceuticals are a rapidly growing share of total drug expenditures by public and private health...more

23andMe Named in Class Action Lawsuit

Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more

Compounding Pharmacies Now Subject to Federal Oversight

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act. Title I of this law—entitled the Compounding Quality Act (the "CQA")—allows the federal Food and Drug Administration (FDA) to oversee...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

FDA and 23andMe: Innovation Will Never Prevail If the Innovator Fails to Properly Manage Their Relationship with the Regulator

The FDA order against 23andMe to stop genetic testing shows that in the balance between regulation and innovation, innovation will never prevail if the innovator fails to properly manage its relationship with the...more

The FDA Order Against 23andMe Shows That in the Balance Between Regulation and Innovation...

The FDA order against 23andMe to stop genetic testing shows that in the balance between regulation and innovation the FDA occasionally must address an age old debate...more

The Online Marketer’s Guide To Privacy

I’ve hesitated to write this post because the law is always changing and you can’t cover it all in one blog post (thank goodness for linking). I did a presentation to the Houston Interactive Marketing Association this week...more

The HIPAA Gap Between Employers And Employees

“…HIPAA does not create a duty on the part of employers to protect employees from computer-virus related injuries” This quote, from the Farr v. St. Francis Hosp. & Health Centers case in the Southern District of Indiana,...more

The Reports Of The Death Of Privacy Were Exaggerated: California Breathes New Life Into The Privacy Rights Of Its Residents

In a series of new bills amending existing California privacy laws, the State of California increases the protections presently provided to its residents by broadening the requirements for reporting breach of personal data;...more

Privacy Monday – November 18, 2013

The month of November is quickly slipping by – this is the time to be looking at the 2014 cybersecurity and data privacy goals and updates and planning ahead. Our selected bits and bytes for this Monday...more

Can A State Impose Civil Penalties On A Drug Or Device Company For Using A Federally-Approved Label?

Overview - States have increasingly brought actions under Medicaid fraud or consumer protection statutes seeking civil penalties and restitution from the makers of prescription drugs. Many top-selling drugs have been...more

New California Law Protects Online Account Information

As of January 1, security breach notifications must be provided to consumers when certain account information is compromised. On September 27, California Governor Jerry Brown signed into law Senate Bill No. 46 (S.B....more

Offering health care solutions at consumers' fingertips? What you should know about FDA regulation of mobile medical apps

Over two years after the Food and Drug Administration issued draft guidance on “mobile medical applications,” the agency recently issued its greatly anticipated final guidance. As FDA considered comments from stakeholders...more

Misbranded Drugs: A Danger To Physicians And Patients

Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise...more

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