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Consumer Protection Laws And Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...more

Congress Passes New Drug Compounding Law Increasing Federal Oversight Over Compounding Pharmacies

In the fall of 2012, a meningitis outbreak sickened more than 750 people, killing 64 people and leaving many others with pain and nerve damage. The meningitis was traced back to tainted injectable steroids manufactured at a...more

Intimate Images & Cyberbullying – Assessing The Canadian Response

Earlier this week, the Canadian government introduced Bill C-13, Protecting Canadians from Online Crime Act. The proposed legislation covers a lot of ground, including the introduction of a suite of new investigation powers...more

Has the FTC Met Its Match?

Companies across the Country should be following the Federal Trade Commission’s (“FTC”) civil suit brought against Wyndham Worldwide Corporation and Wyndham Hotels and Resorts, LLC (“Wyndham”) entitled Federal Trade...more

U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill"), which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal...more

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the...more

DOE Boldly Goes Where It’s Not Allowed

In an astonishing display of chutzpah, the Department of Energy has proposed to regulate computer servers as “consumer products” (link). Only in a bureaucrat’s mind could a computer server be considered a consumer product...more

Wyndham Case Challenges FTC’s Authority Over Cybersecurity

Over the past decade the Federal Trade Commission has brought cybersecurity enforcement actions against various private companies, imposing tens of millions of dollars in monetary penalties and requiring companies to maintain...more

The HIPAA/HITECH Final Rule Has Been Released

The long awaited HIPAA/HITECH Final Rule is out. The final rule is effective March 26, 2013, but covered entities (CEs) and business associates (BAs) will have 180 days beyond the effective date to come into compliance....more

Brace for Impact – Final HITECH Rules Will Require Substantially More Breach Reporting

HHS has finally issued its omnibus HITECH Rules. Our firm will issue a comprehensive summary of the rules shortly, but of immediate import is the change to the breach reporting harm threshold. The modification will make it...more

First HHS OCR Settlement for HIPAA Breach Involving Less Than 500 Patients Sends Message to Providers

On January 2, 2013, HHS announced that the Hospice of North Idaho (HONI) agreed to pay $50,000 and enter into a Corrective Action Plan (CAP) as part of a settlement involving a breach of unsecured electronic protected health...more

First-Ever HIPAA Settlement Involving Fewer Than 500 Patients Announced

On January 2, 2013, the U.S. Department of Health and Human Services (HHS) announced a settlement with the Hospice of North Idaho (HONI) for potential HIPAA violations....more

De-Identifying Protected Health Information: OCR Issues Long-Awaited Guidance

The HIPAA Privacy Rule is intended to protect individually identifiable health information by limiting its use and disclosure. But the Privacy Rule expressly permits the de-identification of that information, and in doing so...more

First HIPAA Breach Settlement Involving Less Than 500 Patients Announced

ALL PROVIDERS ARE OFFICIALLY ON NOTICE. In a move that signals just how seriously the federal government is taking its enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the U.S....more

First OCR Resolution for Data Breach Involving Less than 500 Patients: No Breach is “Too Small”

The Department of Health and Human Services, Office for Civil Rights (OCR) reached its first settlement for a breach involving data regarding less than 500 individuals. Under the December 2012 settlement, the Hospice of...more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Medical Device Law Update - December 2012: FDA and Industry Form “Consortium” to Improve Device Approval Process

In response to wide criticism of the Food and Drug Administration’s (FDA) current review process, leaders of industry, academia and government have joined forces to create the Medical Device Innovation Consortium (MDIC), an...more

Mobile Payments Risks

The Federal Deposit Insurance Corporation (FDIC) recently published a report in the agency’s “Supervisory Highlights” journal concerning the growth of mobile payments and the responsibility of banks and non-bank third parties...more

Nickelodeon Target of Privacy Complaint; Final COPPA Amendments to be Released Tomorrow

The Center for Digital Democracy (CDD) filed a complaint yesterday asking the Federal Trade Commission (FTC) to investigate violations of the Children’s Online Privacy Protection Act (COPPA) by Nickelodeon and mobile...more

Big Data Could Save Healthcare System $300+ Billion Annually

According to a recent report released by Rock Health, Big Data has the potential to save the healthcare system more than $300 billion per year by improving poorly coordinated care, reducing fraud and abuse, and improving...more

Before presenting your idea . . .

I regularly work with technology innovators to help them get their ideas cleaned up for financial institutions and to give them a headstart in understanding the types of risk concerns and controls that financial institutions...more

California AG Threatens Enforcement of Privacy Policy Disclosure Laws Against App Providers

Opening up a potential new enforcement risk for all providers of apps, California Attorney General Kamala D. Harris announced on October 30 that she is sending notices to up to 100 providers of mobile apps claiming that their...more

App Developers Take Notice: Privacy Guidelines for Mobile Apps Released

On October 29, 2012 the Privacy Commissioners of Canada, Alberta and British Columbia published a detailed guidance document on privacy considerations for developing mobile apps. All mobile app developers and all...more

Why California AG’s Online Privacy Crackdown Makes a Big Difference

Companies that run websites must comply with laws and rules requiring the maintenance of personal privacy. While federal requirements such as those applicable to financial privacy and children’s privacy gain significant...more

GAO Urges Federal Actions to Protect Mobile Device Users’ Privacy

On October 11, the GAO released a report on its examination of how the mobile industry collects location data and the resulting impact on consumers. According to the report, privacy advocates expressed concerns that consumers...more

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