Consumer Protection Health

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Restaurants and Food Retailers Are Now Required to Post Proposition 65 Warning Signs about BPA in All California Locations

As of May 11, 2016, all businesses that distribute or sell food and beverage products in California that potentially contain bisphenol A (BPA) are required to provide a warning under California’s Proposition 65 to consumers....more

The Penn State Hershey–Pinnacle Merger: A Turning Point in FTC’s Enforcement Authority, or Just a Temporary Setback?

As we have reported previously, the Federal Trade Commission recently has taken an aggressive stance in regulating mergers in the healthcare sector. The Commission has racked up a string of victories, but last week the...more

FTC Suffers Setback in Campaign to Slow the Rising Tide of Healthcare Consolidations

The FTC just suffered a major setback in its concerted efforts to challenge the ever growing number of consolidations in the healthcare industry, failing to secure a preliminary injunction to block a hospital merger in...more

A Sweet Win for Hershey Medical Center's Proposed Merger: District Court Denies FTC's Attempt to Block Pennsylvania Hospital...

The district court’s decision may mark a turning point away from purely formulaic reliance on the FTC’s preferred approach and the testimony of self-interested payers....more

FDA to Regulate E-Cigarettes, Cigars and Other Tobacco Products

Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule. On May 10, 2016, the U.S. Food and...more

Superior Court of Pennsylvania Denies Data Breach Class Certification

In an encouraging development for data breach defendants, the Superior Court of Pennsylvania recently affirmed a trial court decision rejecting class certification in a suit filed against two Medicare programs for losing a...more

FDA Outlines Future Medical Device Coordinating Center

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to...more

FTC Finally Loses a Hospital Merger Challenge … Now What?

Handing the Federal Trade Commission (FTC) its first defeat in a federal court hospital merger challenge in more than a decade, a federal district court judge yesterday denied the joint request of the FTC and the Attorney...more

Changes in the regulatory control of the pharmaceutical market - Q1 2016 Review

Until January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP ?ompliance (obtained in the country of origin) to the applicable GMP standards in...more

Senate Finance Committee Updates Report on Physician-Owned Distributorships

The report finds that PODs increase overutilization, lack transparency, and increase the risk of patient harm and warns that hospitals must combat the growing threat of PODs. On May 10, the US Senate Committee on Finance...more

Developing and Implementing an Effective Telemedicine Informed Consent Form

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the...more

Taking poor people to court over unpaid medical bills

Pro Publica- the online, Pulitzer-winning investigative web site-has reported on a disturbing trend in Nebraska, where hospitals and collection agencies have exploited low fees and accommodating courts to sue patients and...more

Facebook, Healthcare Provider Websites and HIPAA

In a class action Complaint filed in the Northern District of California on March 15, 2016, Kiesel Law LLP, on behalf of primary plaintiff Winston Smith and a potential class of others, alleges that Facebook received...more

KIND Litigation – What Issues can Food and Beverage Companies Face When They Use the Term “Healthy”

If you go down the aisle of your neighborhood grocery store, you’ll find the terms “all-natural” or “healthy” emblazoned on a growing number of products—products that often garner higher prices than their competitors. Over...more

FDA Regulatory and Compliance Monthly Recap — April 2016

FDA finalizes guidance on drug design in attempt to reduce medication errors - The finalized guidance revises draft guidance published in 2012 to address public comments calling for clarifications and formatting changes,...more

Tobacco Cases Expose Tension Between Antitrust and Public Health

A recent decision of the European Court of Justice (“ECJ”) regarding the sale of tobacco products highlights a long-standing tension between two sets of laws: antitrust/competition laws, which seek to keep products affordable...more

After New York, Florida Curbs Surprise Bills for Emergency and Out-of-Network Services

It is generally understood that if a managed care member utilizes the services of a non-participating provider, the member could incur significant out of pocket expenses. However, there are instances where a member may...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

Wyoming Medical Center victim of phishing scheme affecting 3,184 patients

Phishing incidents in February that may have compromised the data of 3,184 patients, including their names, dates of birth, medical record and account numbers, dates of service and medical information is causing Wyoming...more

Spring Showers Bring HIPAA Breaches

OCR has announced several recent settlement agreements to resolve violations of the Health Insurance Portability and Accountability Act (“HIPAA”). These settlement amounts range from $25,000 to $3.9 million dollars and...more

OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA)...more

Will Congress vaporize proposals to curb tobacco use, protect kids’ health?

Just days after federal health officials warned about teen-agers’ increasing use of e-cigarettes (vaping) and hookahs, members of a House committee have approved a legislative move that shields vaping manufacturers from...more

Department of Health and Human Services Cracks Down on Vendor Oversight in Recent Hospital Settlements

From the rise in ransomware attacks to inadvertent disclosure of information by subcontractors, the health services industry is reminded that a potential consequence of a data breach is the threat of a regulatory enforcement...more

Health Care E-Note - April 2016

Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurses, technicians, staff, management,...more

FTC Releases "Cheat Sheet" for Developing a Secure Mobile Health Application

The Federal Trade Commission (FTC), in partnership with other federal agencies, has released an online tool that provides developers legal guidance for the creation of mobile health applications (apps). Companies that are...more

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