Consumer Protection Health

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Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing...more

Latest OCR Enforcement Action: Underbed Storage is Not Appropriate for PHI

Recent enforcement actions by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) have highlighted that, not surprisingly, Covered Entities should not leave medical records in a...more

Do the Restrictions on Advertising with Nutrition and Health Claims also Apply to Communications Addressed Exclusively to Health...

The Court of Justice of the European Union (ECJ) will soon decide on the issue of whether the restrictions on promoting foodstuffs with nutrition and health claims also apply to communications addressed exclusively to health...more

Historic Moment: Husband Reports Wife’s HIPAA Violation Triggering Six Figure Penalty Against Employer

For the second time in history, the Office for Civil Rights (“OCR”) has imposed a civil monetary penalty (“CMP”) against a covered entity for violations of the Health Insurance and Portability Act (“HIPAA”). Lincare, Inc., a...more

Electronic Monitoring Notification and Consent Form Released

The Illinois Department of Public Health has released the Electronic Notification and Consent Form on Friday, January 29, 2016. The Authorized Electronic Monitoring in Long-Term Care Facilities Act (Public Act 099-0430)...more

Postmarket Cybersecurity Recommendations for Medical Devices Issued by the FDA

We’ve blogged about medical device cybersecurity topics. The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity...more

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details...more

FDA Releases Draft Guidance for Medical Device Cybersecurity

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called...more

Centene announces search for missing hard drives containing PHI of 950,000 individuals

Centene Corporation, a health insurer headquartered in St. Louis, announced on January 25, in a press release that it is undertaking an, “ongoing comprehensive internal search for six hard drives that are unaccounted for in...more

FDA Proposes Public Notification of “Emerging Signals”

The Food and Drug Administration has proposed a new policy for earlier public notification of medical device safety issues. These notifications will be in addition to the recall notices, safety communications, and press...more

Cybersecurity Act Of 2015 Aims To Bolster Cybersecurity In Health Care Industry

Section 405 of Title IV of the Cybersecurity Act is tailored specifically to cybersecurity matters affecting public and private health care entities. Section 405 of Title IV seeks to improve the cybersecurity landscape in...more

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

FDA Issues Draft Guidance Governing Postmarket Cybersecurity Risk Management Standards

On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more

Virginia’s Certificate of Need Laws May Stay, Fourth Circuit Says

On January 21, the U.S. Court of Appeals for the Fourth Circuit upheld Virginia’s Certificate of Need (CON) laws, ruling that the scheme does not illegally discriminate against out-of-state health care providers. See Colon...more

Texas Medical Board Appeals Immunity Ruling

In a notice of appeal filed on January 8, 2016, the Texas Medical Board appealed the Western District of Texas’s ruling that the Texas Medical Board was not entitled to state action immunity in an antitrust suit involving...more

PA Court Permits Attorney General to Retain Contingency Counsel to Enforce Consumer Protection Laws Against Long-Term Care...

State and local governments will increasingly use consumer protection law to regulate long-term care facilities, with private plaintiffs’ counsel advocating for a role in government actions. Under GGNSC Clarion LP v....more

FTC Enforcement in Schein: Misleading Statements about Encryption and Cybersecurity

On January 5, 2015, the Federal Trade Commission (FTC) entered into a consent order with dental software manufacturer Henry Schein Practice Solutions, Inc. ("Schein") in connection with allegations that Schein had made...more

FTC and DOJ Urge South Carolina to End Certificate of Need Laws

On January 11, 2016, the Federal Trade Commission (FTC) and Department of Justice, Antitrust Division (DOJ) submitted a letter to Governor Nikki Haley recommending that South Carolina repeal certificate of need laws (CON)...more

When do healthcare defendants want to be accused of malpractice?

Most injury or wrongful death cases against hospitals, health care facilities, and health care practitioners are governed by the procedures in Fla. Stat. 766, also known as the Medical Malpractice Act. This Act itself is...more

Laboratory Developed Tests Emerging in FDA Regulation

Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...more

“Interoperable” Healthcare Data Will Be a Tempting Target

At a panel during last week’s Consumer Electronics Show in Las Vegas, Edith Ramirez, chair of the Federal Trade Commission – America’s top privacy regulator – said she would not wear a Fitbit personal fitness tracker. “I...more

Initiative to Improve Quality After Discharge: New Caregivers’ Laws

This month Indiana, Illinois, California, Oregon, and New Hampshire join 11 other states with newly effective Care Advise Record Enable (CARE) laws requiring hospitals to give patients the opportunity to designate caregivers...more

FTC Brushes Aside AG, Regulators to Attack Local Hospital Merger

The Federal Trade Commission (FTC) continued its relentless focus on combinations in the healthcare industry last month when it filed an administrative complaint challenging a merger of two West Virginia hospitals, In the...more

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