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FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

Ugly details emerge on how Big Pharma fueled painkiller scourge

New information has surfaced about Big Pharma’s relentless campaign to sell the public on prescription, opioid painkillers-powerful, addictive drugs whose wide availability and abuse now has become a killer scourge that...more

Can Antitrust Prevent Excessive Drug Price Increases?

The antitrust agencies are often asked to intervene in markets where pricing appears to be excessive to help protect consumers and stabilize markets. In the drug arena, healthcare providers, consumers and politicians have...more

Health Update - September 2016

The Election’s Impact on Healthcare: Preparing for Potential Scenarios - Editor’s Note: Election 2016 will have a major impact on federal and state healthcare policy. To be prepared for all the possibilities, it’s...more

Taking Measure of HIPAA Enforcement

Last month, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced the largest settlement to date for alleged violations of the Health Insurance Portability and Accountability Act (HIPAA)....more

FDA Mandates Black Box Warnings For Opioids And Benzodiazepines

The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants...more

LabMD Seeks To Stay FTC Decision Related To Evidence Of Consumer Harm Pending Appeal

LabMD—a medical testing lab that, the Federal Trade Commission (“FTC”) alleged, exposed consumer personal information through a peer-to-peer (“P2P”) file-sharing network—is now seeking a stay pending its appeal of the FTC’s...more

September Privacy and Security Updates

Although National Cyber Security Month isn’t until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for...more

Don’t Ignore Ransomware Vulnerabilities; You Could Be Violating FTC Act

Last week, the Federal Trade Commission convened a ransomware workshop to discuss the rising epidemic of attacks against U.S. businesses and individuals. In a ransomware attack, a malicious actor tricks a user into...more

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to...more

ONC Releases Enhanced Regulatory Requirements to Improve Transparency for Health Information Technology Products

The Office of the National Coordinator for Health Information Technology (“ONC”) has operationalized regulatory requirements to improve transparency in health information technology (“health IT”). The regulations, which were...more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

FDA Regulatory and Compliance Monthly Recap — August 2016

FDA issues draft guidance on use of real-world data in medical device decision-making - The Food and Drug Administration’s draft guidance provides an overview of how the agency will determine the quality and reliability...more

OCR: No privacy breach is too small

The Office for Civil Rights (OCR) HIPAA enforcement efforts are continuing to increase. This year, the OCR has already announced 10 HIPAA enforcement actions involving fines, which is a 67 percent increase from last year and...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

OCR to Focus More Investigative Resources on Smaller HIPAA Breaches with Less Than 500 Individuals Affected

The Department of Health & Human Services (DHHS) Office of Civil Rights (OCR) recently announced it will devote more resources to investigate smaller HIPAA breaches. Before this announcement, OCR typically opened...more

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

Hackers Steal 600K Records from Health Care Firms – Could Your Wearable Device Be Next?

Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes...more

Healthcare Records Held Hostage: When ransomware attacks

Imagine for a moment that your hospital or physician practice suddenly cannot access its electronic medical records. There hasn’t been a natural disaster. No, instead you are inexplicably staring at a computer screen from an...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

OCR to Increase Investigations of Smaller HIPAA Breaches

HHS Office for Civil Rights will cast a wider net and increase its investigations into smaller HIPAA privacy breaches starting this month. OCR announced a new initiative to increase its efforts examining breaches that affect...more

Lessons for Businesses from FTC’s Opinion on LabMD’s Data Security Practices

The Federal Trade Commission (FTC) has issued an Opinion and Final Order finding that the data security practices of LabMD, Inc. were unreasonable, and therefore constituted an unfair act or practice in violation of Section 5...more

FDA Finalizes Wellness Product Guidance

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

Record-Breaking HIPAA Settlement Sends Strong Message to Covered Entities

This month marked the largest HIPAA settlement to-date for a single entity. Advocate Health Care Network (“Advocate”) agreed to pay $5.5 million and adopt a corrective action plan after an investigation by the Department of...more

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