Health Consumer Protection

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Is encryption the key to your data security?

With the increased rate of data breaches targeting personal information, an increased public awareness of online privacy, and an increasingly demanding regulatory landscape, large and small businesses are looking to...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

Breach of ePHI Results in $2.7 Million Fine

Oregon Health & Science University (“OHSU”) has paid $2.7 million to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) to settle allegations that it violated the Health Insurance Portability...more

Cybersecurity News & Notes – July 2016 #3

In Case You Missed It: Court certifies class in suit against Apple. On July 15, 2016, U.S. District Judge Jon S. Tigar certified a class of users of the mobile app Path, who allege that Apple facilitated the app’s access...more

Health Law Pulse - July 2016

On June 14, 2016, a federal district court in the Northern District of Illinois denied a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger of Advocate Health Care...more

Congress Passes GMO Labeling Bill – Preempting State Labeling Laws

In response to recent state efforts to regulate the labeling of food products containing genetically modified organisms (GMOs), the U.S. House of Representatives, on July 14, passed S. 764, a Senate-initiated bill...more

FTC Battles Hospital Mergers: What to Watch for in this Summer’s High-Profile Appeals

In a town that is no stranger to landmark hospital merger cases, last month a Chicago federal judge denied the Federal Trade Commission’s (FTC) motion for a preliminary injunction to temporarily block a merger between...more

Entity Fined $650,000 in First HIPAA Settlement with a Business Associate

The possibility of business associates potentially being audited, investigated, and ultimately fined is now a reality. On June 24, 2016, the United States Department of Health and Human Services’ Office of Civil Rights...more

“Your Money or Your PHI”: OCR Releases Guidance on Ransomware

On July 11, 2016, the Office for Civil Rights (OCR) released important new guidance on ransomware for hospitals and other healthcare providers and finally addressed the question of whether electronic protected health...more

FDA Regulatory and Compliance Monthly Recap – June 2016

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions - The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices...more

Physical security still an issue: Pruitt Health suffers breach in break-in

The importance of physical security and the risk associated with the unauthorized access to or loss of paper records is clear from recent experiences of Pruitt Health in South Carolina. On March 2, 2016, an intruder...more

Business Associates Beware! OCR Is Coming For You

Last week, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced the first HIPAA settlement involving a business associate. Catholic Health Care Services of the Archdiocese of Philadelphia...more

Analysis of Health Care Data Breach Litigation Trends

Companies that have a breach involving protected health information ("PHI") worry not only about fines and penalties imposed by the Department of Health and Human Services ("HHS"), but about class action lawsuits. The risk...more

FDA Issues Final Rule on Use of Symbols in Labeling

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Business Associate Settles HIPAA Investigation for $650,000

The U.S. Office for Civil Rights (OCR), the agency responsible for enforcing the HIPAA Privacy and Security rules, has just sent a strong message that business associates are not immune from scrutiny. On June 24, 2016, in a...more

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

Potassium Chloride Should Be Potassium Salt On Food Labels

On June 27, 2016, NuTek Food Science LLC filed a citizen petition with the U.S. Food and Drug Administration that, if granted, will provide great benefits to consumers by helping the FDA and the food industry in their efforts...more

HIPAA Compliance: Navigating a Health Care Minefield

In the two decades since its original passage, complying with the federal Health Insurance Portability and Accountability Act (HIPAA) hasn’t gotten any easier. Enacted with the primary goal of protecting the confidentiality,...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

Some Legislation of Interest

With the end of the 2016 Maryland legislative session and the completion of bill signings by Governor Lawrence J. Hogan, Jr., PK Law highlights several bills of interest to our readers: HB 185: One of the few pieces of...more

One-Two Punch on Hospital Challenges: Is the FTC Down for the Count?

There was a time not long ago when the odds of beating the Federal Trade Commission on a hospital merger antitrust challenge were slim. Two recent defeats, however, may change that some. Late last year, the FTC, in quick...more

For congressional overseers, red flags fly over issues at FDA

Congressional overseers of the federal agency that regulates drugs and medical devices have gotten red-flag warnings about problems at the Food and Drug Administration, including: two separate calls for improvements from...more

OCR Warns of HIPAA Risks in Third-Party Apps

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently issued a warning regarding vulnerabilities in third-party applications used by entities covered by HIPAA. The OCR warning applies...more

DOJ and North Carolina Challenge Anti-Steering and Tiering Provisions in Managed Care Contracts

The Department of Justice’s antitrust division (the “DOJ”)and the State of North Carolina (“NC”) jointly sued, on June 9, 2016, Carolinas HealthCare System (“CHS”), the largest healthcare system in North Carolina, over...more

Why the FDA Needs to Change Its Food Recall Policies

Add this to FDA’s growing list of things to do: improve the food recall initiation process. According to a memorandum published on June 8, 2016, the Office of Inspector General (OIG) of the Department of Health and Human...more

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