Health Consumer Protection

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Florida Information Protection Act of 2014 - Florida Means Business When It Comes to Protecting Customers' Personal Information

On June 20, 2014, Governor Rick Scott signed into law the Florida Information Protection Act of 2014 ("FIPA"), which became effective July 1, 2014. FIPA expands the obligations of businesses and government entities that...more

Has your business seen medical identity theft?

Last year, medical identity theft affected nearly two million Americans - 32% more than the year before. This is a staggering number! And considering that today, medical identity theft accounts for 43% of all identity theft...more

FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more

FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how...more

New York Enacts Out-Of-Network Transparency and Coverage Reform

Last month, a woman sued a health plan, claiming that she was intentionally misled about which physicians were participating providers in the company’s online health insurance exchange established under the Affordable Care...more

New HIPAA Reports to Congress Shed Light on OCR Enforcement

The Department of Health and Human Services’ Office for Civil Rights (OCR) has issued two reports to Congress, as required by the HITECH Act. The compliance report details OCR’s enforcement activities for 2011 and 2012 and...more

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more

New Connecticut Pharmacy Rewards Disclosure Bill Took Effect July 1

On June 12th, Connecticut governor Dannel P. Malloy signed into law ”An Act Concerning Pharmacy Rewards Programs And Protected Health Information“. The law went into effect July 1st, and applies to pharmacy retailers in the...more

FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device...

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

Health System Investigated for Leaving PHI in Doctor’s Driveway – Settles with OCR for $800K

While OCR enforcement activity has focused on a covered entity’s safeguarding of ePHI, organizations cannot forget about PHI in non-electronic form. To settle potential violations of the HIPAA Privacy Rule, Parkview Health...more

Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance...more

FDA Issues Draft Guidance on Promotion on Internet and Social Media Platforms

On June 17, 2014, the FDA issued long-awaited draft guidance documents addressing two challenges related to use of social media to communicate about FDA regulated products: dissemination of information in character-limited...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

Data Breach Class Action Not Barred by Lack of Individual Injury in West Virginia

In a potentially groundbreaking decision, the Supreme Court of Appeals of West Virginia reversed a trial court’s order denying class certification in a data breach class action. The case, Tabata v. Charleston Area Medical...more

Health Law Alert: The Deadline for Amending Business Associate Agreements is Quickly Approaching

A key change from 2013’s HITECH “Omnibus” Rule was a requirement that Business Associate Agreements (“BAAs”) be modified to reflect revisions to HIPAA regulations. When the rule was issued on January 25, 2013, Covered...more

Florida Overhauls Its Data Security Breach Notification Law Effective July 1, 2014

On June 20, 2014 Governor Rick Scott approved the Florida Information Protection Act of 2014, overhauling the requirements and steps companies must follow when faced with a potential or actual security breach resulting in the...more

New CFPB initiatives to prevent elder financial abuse and improve financial literacy

The CFPB has issued a new guide designed to help operators and staff of nursing facilities and assisted living residences protect residents from financial abuse. The guide indicates that it is for administrators as well as...more

The AMA Adopts New Telemedicine Guiding Principles

Last week, the American Medical Association (AMA) released new guiding principles on the provision of telemedicine services. The AMA’s guiding principles come on the heels of the Federation of State Medical Board’s (FSMB)...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Changing Financial Landscape for Medical Debts of the Uninsured

The implementation of the ACA has afforded many with the opportunity to obtain insurance coverage. Despite the opportunity, a large number of individuals have either chosen not to enroll in a health plan or have been unable...more

Update: Vermont Legislature Passes Toxic Chemicals Bill

Last month, we wrote about the toxic chemicals legislation bouncing between the Vermont House and Senate. On May 9, 2014, the Vermont Legislature gave final approval to the bill, S.239, which gives the Vermont Department of...more

FDA Launches Huge Online Database of Adverse Events

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

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