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10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

Breaking News: FTC Vacates ALJ’s Ruling and Finds LabMD Liable for Unfair Data Security Practices

In a ruling issued this morning, the Federal Trade Commission found that LabMD, the defunct Atlanta-based cancer detection lab, failed to protect patient information and is liable for unfair data security practices. The...more

FTC Delays Ruling in LabMD Appeal

The Federal Trade Commission has decided to put off until late July a decision about whether to overturn a ruling by the agency’s chief administrative law judge in the closely watched data security action against LabMD, the...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety,...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

Howard Young on Coming Changes To The Healthcare Space [Video]

Howard Young, co-head of the healthcare practice at Morgan Lewis, talks about some of the major forces driving change and consolidation within the healthcare industry. According to Young, innovations in technology and changes...more

FDA Regulatory and Compliance Monthly Recap — February 2016

FDA publishes guidance on human factors review for devices, combination products - The FDA published two draft guidance documents and one final guidance document to address the incorporation of human factors studies in...more

Six-Figure January HIPAA Enforcement Activities Highlight Importance of Maintaining Privacy Protections

The U.S. Department of Health & Human Services’ (“HHS”) Office for Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) were each involved in the resolution of high profile privacy matters in January 2016. The two...more

ALJ Upholds $239,800 In Civil Monetary Penalties For HIPAA Violations

Home health care provider Lincare, Inc. must pay $239,800 in civil monetary penalties for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule, according to a February 3, 2016...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

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

A Return to Evanston: FTC Revisits Old Ground in Yet Another Hospital Merger Challenge

Last week, the Federal Trade Commission (“FTC” or “Commission”) authorized staff to file an administrative complaint and to seek in federal court a temporary restraining order and a preliminary injunction to block the...more

FDA Plans Workshop to Address Cybersecurity in Medical Devices

Two months after finalizing its first guidance on cybersecurity, the FDA has announced a public workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” to continue to address a growing...more

Company Prevails in Challenge to FTC Data Security Complaint

A recent decision by the Federal Trade Commission (FTC) Chief Administrative Law Judge (ALJ) dismissed the FTC’s complaint against LabMD, Inc. (LabMD) asserting the company’s alleged failure to protect consumer data in two...more

Stakeholders Say Biosimilars Names Should Be Meaningful and Memorable

FDA has received comments from more than 170 groups on its proposal for naming biosimilars. Biosimilar makers, insurers and pharmacies largely oppose distinct nonproprietary names (also known as proper names) for...more

Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s...more

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

Blog: Kim Kardashian Drug Endorsement Results in FDA Warning Letter

The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and...more

New Law Establishes A Bill Of Rights For CCRC Residents And Streamlines Several Statutory Requirements For CCRCs

On June 23, 2015, Governor Malloy signed into law Public Act. No. 15-115, An Act Establishing a Bill of Rights for Residents of Continuing-Care Retirement Communities ("the Act"). The Act establishes several protections for...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

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