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FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

California Court Grants Hospital Summary Judgment on Data Breach Claim

In its recent decision in Eisenhower Medical Center v. Superior Court, 226 Cal. App. 4th 430(Cal. App. 4th Dist. 2014), the Court of Appeal of California, Fourth District, had occasion to consider whether a medical facility’s...more

A Legal Guide to Privacy and Data Security

A Legal Guide to Privacy and Data Security, a new book offering guidance on a wide variety of privacy and data security laws and how those laws may impact your business, is now available from the Minnesota Department of...more

FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human...more

Florida Information Protection Act of 2014 Goes Into Effect; Regulator Notification Required

Effective July 1, 2014, Florida has repealed its existing data breach law in favor of a new, more stringent, law. Florida has joined the list of states requiring notice to regulators: specifically, an entity must notify the...more

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

A Whistleblower Hotline can protect against 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

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