Consumer Protection Science, Computers & Technology Health

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FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

Oregon Expands Data Breach Law

The modified law will expand the definition of personal information to include medical information and physical characteristics, and require notification to the state Attorney General. Businesses with customers in Oregon...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

A New Era of HIPAA Enforcement

Traditionally, HIPAA enforcement is assigned to the Department of Health and Human Services’ Office for Civil Rights (OCR). In November 2013, Health and Human Services’ Office of Inspector General sharply criticized OCR’s...more

Upcoming HIPAA Audits May Target Financial Institutions—Here’s How to Prepare

Much like a tornado watch, the conditions appear to be right for a coming storm: the upcoming Phase 2 HIPAA audits. The Department of Health and Human Services Office for Civil Rights (OCR) has begun verifying contact...more

Connecticut Legislature Passes Bill Mandating Identity Theft Protection Services Following Data Breach

Connecticut’s legislature has passed a bill that imposes strict new timing requirements for entities conducting business in the state that experience a data breach, which Governor Malloy reportedly intends to sign into law. ...more

Advocate Health data breach class action suit dismissal upheld by Appellate Court

In August of 2013, four computers of Advocate Health and Hospitals Corporation (Advocate Health) were stolen from one of its offices. The computers contained the names, dates of birth, Social Security numbers, health...more

Medical Informatics Engineering discloses data breach

Electronic health record (EHR) vendor Medical Informatics Engineering and its subsidiary, NoMoreClipBoard, which is a personal health record (PHR) product, notified its EHR clients and PHR individuals that it has been the...more

Is the Competition Bureau Targeting You? New IP Enforcement Guidelines

On June 9, 2015, the Canadian Competition Bureau released updated draft Intellectual Property Enforcement Guidelines (IPEGs) for public comment. The comment period is open until August 10, 2015. It is the third publication of...more

Deeper Dive: Healthcare Incidents Involving More Than 500 Individuals Are Investigated 100 Percent of the Time

We have released the inaugural BakerHostetler Data Security Incident Response Report, which provides insights generated from the review of more than 200 incidents that our attorneys advised on in 2014. The report confirms the...more

All Eyes on Homeopathics: FTC Workshop Signals Targeted Regulatory Scrutiny of Homeopathic Products

On Tuesday, the Federal Trade Commission “FTC” announced it will be hosting a workshop in September to evaluate advertising for over-the-counter homeopathic products. Homeopathy is an alternative medicine practice dating back...more

Doing Business In Connecticut? There's A New Data Security Law You Should Get To Know

This week the Connecticut House of Representatives passed Senate Bill 949, "An Act Improving Data Security and Agency Effectiveness," (the "Act") which includes new or modified State requirements concerning the security of...more

REMS and Antitrust: Latest Litigation Lessons

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

Second Circuit Becomes First Court of Appeals to Address Pharmaceutical “Product Hopping” Under Antitrust Laws in Decision Barring...

Few courts have addressed antitrust challenges to pharmaceutical “product hopping,” i.e., the practice of shifting customers from a drug nearing the end of its patent protection to a modified version that is covered by newer...more

A Deeper Dive: Regulatory Investigations Following a Reported Breach

In our inaugural Data Security Incident Response Report (the Report), we found that regulators inquired about a company’s breach 31% of the time and multi-state state Attorneys General investigations were launched less than...more

Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical...

A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. “Product hopping” refers to the practice of changing the form or...more

Nevada and North Dakota amend state breach notification laws

Nevada has amended its breach notification law, effective July 1, 2015, to include a medical or health insurance identification number and a user name, unique identifier, or e-mail address in combination with a password or...more

CareFirst, Third Major Health Insurer This Year To Be Hit By Cyberattack

On May 20, 2015, CareFirst BlueCross BlueShield (“CareFirst”) announced that it was the latest victim of a major cyberattack, with as many as 1.1 million plan customers affected. Current and former CareFirst members and...more

Healthcare Organizations not Immune from Criminal Attacks on Sensitive Information

This month, the Ponemon Institute released its Fifth Annual Benchmark Study on Privacy & Security of Healthcare Data and its findings are generating a good deal of attention. In the past, the Study has found that most data...more

Nevada Expands PI Definition under Data Breach Law

Becomes the fifth state to amend its data breach statute since January 2015 The definition of “personal information” (“PI”) just got a little bit bigger in the Silver State. On May 13, Nevada Governor Brian Sandoval signed...more

Think You Know Your HIPAA-Related Obligations? Read the ONC’s New Privacy and Security Guide to Find Out

In 2013, we alerted you to the expansion of the definition of the term “business associate” under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Now, the Office of the National Coordinator for Health...more

Blog: CareFirst Discloses Data Breach

CareFirst, a Blue Cross Blue Shield plan serving the Washington D.C. metro area, became another in a line of health insurers to suffer a data breach as a result of hackers. CareFirst and the FBI are examining the breach...more

CareFirst announces breach of 1.1 million records in cyberattack

Following in the footsteps of Anthem and Premera, CareFirst, a Blue Cross Blue Shield plan servicing customers in Maryland, Washington, D.C. and Virginia announced yesterday that it too has been the victim of a...more

CareFirst Suffers Cyberattack, Data Breach of 1.1 Million Customers’ Information

BREAKING NEWS: Health insurer CareFirst BlueCross BlueShield disclosed today that hackers gained access to one of its databases, exposing personally identifiable information for approximately 1.1 million people....more

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