Health Consumer Protection

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Update on the DOJ's Criminal Investigation into Generic Pharmaceuticals

The Department of Justice Antitrust Division's (DOJ's) investigation into the generic pharmaceutical industry may be expanding. On March 15, 2015, a third generic manufacturer disclosed that it received a subpoena from the...more

U.S. Supreme Court case examines authority of state health care licensure boards and patient safety

Many individuals may find comfort in the knowledge that their doctors, dentists and other healthcare professionals are required to pass rigorous testing in order to receive their licenses. These licenses are issued by each...more

Tax Policy Update

NUMBER OF THE WEEK: $900 billion. The amount of additional taxes that would fall on businesses and families under Republicans’ budget plans, according to a “fact check” by the Associated Press in a story with a title made of...more

Health Update - March 2015

Supporting Informed Decision Making in the Health Insurance Marketplace: A Progress Report - Editor’s note: As Affordable Care Act (ACA) implementation moves forward and the marketplace continues to evolve, there is a...more

"Surprise Medical Bills" Law

Consider the following scenario. You are a patient who had a colonoscopy performed by a physician who participates in your health insurance plan. A week later, you receive two “surprise” medical bills from an anesthesiologist...more

OCR’s Enforcement of HIPAA’s Privacy and Security Rules Continues with Robust 2014

With the news of the recent cyber-attack and resulting data breach at health insurance giant Anthem Inc., the buzz around data security and privacy is again high. The Anthem breach serves as a reminder to those entities...more

Health Care E-Note - March 2015

In This E-Note: - Health Care Reform in America: The Good, The Bad and The Ugly - The Federal False Claims Act - Violations of Conditions of Payment or Conditions of Participation? - State Regulatory...more

FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

Health Sector Under ACCC Spotlight In 2015

ACCC ENFORCEMENT PRIORITIES - The Australian Competition and Consumer Commission (ACCC) has released its enforcement priorities for 2015, with the Chairman of the ACCC giving a speech on the topic last week. Each year,...more

Premera Blue Cross Targeted by Hackers – 11 Million Individuals Compromised

Premera Blue Cross (“Premera”) announced this week that it has been the target of a sophisticated cybersecurity attack in which the information of approximately 11 million individuals has been compromised. This announcement...more

Lessons Learned from Recent Data Security Breaches, Part Two

Because controlling access is essential to protecting privacy of PHI under HIPAA, the HITECH Security Rule essentially requires that a covered entity control physical and electronic access to the data system by implementing...more

NY Attorney General Enters into Far-Reaching Settlement with Largest Credit Reporting Agencies

New York Attorney General Eric Schneiderman recently announced that his office reached a landmark settlement with the nation’s three leading credit reporting agencies (CRAs) that will require them to significantly reform,...more

State Legislatures React To Latest Health Data Breaches By Updating State Data Breach Notification Laws And Encryption...

Recent, large-scale breaches of health information have served to highlight the fact that federal agencies have only rarely assessed penalties against companies as a result of these breaches, while many states do not have...more

Premera Cyber-Attack Announced: Defining Your Obligations as an Employer

On March 17, 2015, Premera announced a data breach involving the personal information of more than 11 million individuals resulting from what it characterized as a sophisticated, targeted cyber-attack. Employers and plan...more

Montana Tweaks Data Breach Statute

The Big Sky Country’s data breach statute is going to see some small changes come October. On Feb. 27, 2015 Montana Governor Steve Bullock signed H.B. 74 into law, amending the state’s data breach notification statute. Among...more

Blog: Another Large Scale Data Breach Announced by Premera Blue Cross

Premera Blue Cross revealed Tuesday it was hit by a sophisticated cyber attack potentially exposing personal data for approximately 11 million of its members including members, employees and others with whom it does business,...more

Health Law Alert: Top 10 Takeaways from Alessandra Swanson & MSBA HIPAA Discussion

On Feb. 13, the Health Law Section of the Minnesota State Bar Association (MSBA) sponsored an event on HIPAA enforcement in 2015. The MSBA hosted Alessandra Swanson of the Office for Civil Rights, U.S. Department of Health &...more

FDA Issues New Rules for Testing of Reusable Medical Devices

The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices. ...more

No State Action Antitrust Immunity for North Carolina Dental Board: Implications for the Health Care Sector

On February 25, 2015, the Supreme Court of the United States held that the North Carolina Dental Board (“Board”) was not insulated from federal antitrust liability under the so-called “state action” doctrine when it engaged...more

Can Mergers Between Healthcare Providers in Different Markets Raise Antitrust Concerns? "Yes," Say Top Enforcers at FTC and DOJ

In reviewing mergers of healthcare providers, government antitrust enforcers have historically focused on horizontal mergers between competing providers—in particular, those that result in high market shares in a specific...more

New York Attorney General and Credit Bureaus Reach Deal Affecting Furnishers of Information to Credit Bureaus

The New York Attorney General announced a settlement with credit bureaus Equifax, Experian and TransUnion regarding credit reporting policies and practices, including methods of addressing inaccuracies identified by...more

Anthem Data Breach Requires Plan Sponsor Attention

On January 29, 2015, Anthem Inc., one of the largest managed health care companies in the country, disclosed that the sensitive personal data of almost 80 million current and former participants in its network was breached in...more

Lessons Learned from the Anthem Cyber-Attack and Corresponding “HIPAA Actions”

Anthem Inc. (“Anthem”), the nation's second-largest health insurer, disclosed on Wednesday, February 4, 2015, that it was the victim of a major cyber-attack. According to Anthem, the attack exposed personal information of...more

The 'Palmetto Put-Down' Endangers Drug Cos. Nationwide

On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...more

State Data Breach Notification Law Updates

State legislatures are not waiting for Congressional action on a national data breach notification standard. Montana — Montana has amended its 10-year old breach notification law (see Mintz Matrix) to expand the...more

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