Consumer Protection, Science, Computers & Technology, Administrative Law

The HIPAA/HITECH Final Rule Has Been Released

by Theodore Kobus III | BakerHostetler on 1/18/2013

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

by Elizabeth Johnson | Poyner Spruill LLP on 1/18/2013

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

by King & Spalding on 1/15/2013

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

by Danna Carmi, M. Leeann Habte, Peter McLaughlin, Richard Rifenbark, R. Michael Scarano Jr. | Foley & Lardner LLP on 1/8/2013

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

by Sharon Klein, Anne Davies Newman | Pepper Hamilton LLP on 1/5/2013

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

by Michael Igel | Trenam Kemker on 1/4/2013

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”

by Stephanie Willis | Mintz Levin - Health Law on 1/4/2013

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

by Michael M. Gaba, Shannon Hartsfield Salimone | Holland & Knight LLP on 12/27/2012

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

by Arameh Zargham O'Boyle | Sedgwick LLP on 12/24/2012

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

by John Dodge | Davis Wright Tremaine LLP on 12/20/2012

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

by Amy Malone | Mintz Levin - Privacy & Security on 12/19/2012

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

by Michael Esquivel | Fenwick & West Life Sciences Group on 12/12/2012

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

New Rules Proposed to Protect Children’s Privacy Online

by Janet Raasch | Lawyers.com on 12/12/2012

At one time, parenting was a lot simpler. All parents had to worry about was their child’s behavior in school, on the playground or around the dinner table. Children lived in protected, limited universes and interactions were...more

Before presenting your idea . . .

by Mercedes Kelley Tunstall | Ballard Spahr LLP on 11/15/2012

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

by Ropes & Gray LLP on 11/6/2012

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

by Osler, Hoskin & Harcourt LLP on 11/1/2012

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

by Jeff Ifrah on 11/1/2012

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

by BuckleySandler LLP on 10/23/2012

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

FDA Unveils New System to Track Medical Devices

by Dinsmore & Shohl LLP on 10/22/2012

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Unveils New System to Track Medical Devices

by Dinsmore & Shohl LLP on 10/22/2012

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

Baker & McKenzie: Australian Privacy Breach Notification

by Baker & McKenzie Australia on 10/19/2012

On 17 October 2012, the Attorney-General's Department launched a discussion paper entitled, 'Australian Privacy Breach Notification'. As anticipated in response to the ALRC Report 108: For Your Information: Australian Privacy...more

Pharmaceutical Law Update -- October 2012: FDA Studies Consumers' Understanding of Prescription Drug Direct Advertising and...

by Sedgwick LLP on 10/4/2012

On August 23, 2012, the U.S. Food and Drug Administration (FDA) published a notice announcing proposed research titled “Communicating Composite Scores in Direct-to-Consumer (DTC) Advertising,” designed to study and collect...more

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Consumer Protection › Science, Computers & Technology › Administrative Law

The HIPAA/HITECH Final Rule Has Been Released

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

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

First-Ever HIPAA Settlement Involving Fewer Than 500 Patients Announced

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

First HIPAA Breach Settlement Involving Less Than 500 Patients Announced

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

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

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

Mobile Payments Risks

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

Big Data Could Save Healthcare System $300+ Billion Annually

New Rules Proposed to Protect Children’s Privacy Online

Before presenting your idea . . .

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

App Developers Take Notice: Privacy Guidelines for Mobile Apps Released

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

GAO Urges Federal Actions to Protect Mobile Device Users’ Privacy

FDA Unveils New System to Track Medical Devices

FDA Unveils New System to Track Medical Devices

Baker & McKenzie: Australian Privacy Breach Notification

Pharmaceutical Law Update -- October 2012: FDA Studies Consumers' Understanding of Prescription Drug Direct Advertising and...

Federal Reserve Finds Existing Regulatory Framework Sufficient To Meet Mobile Payments Challenge

Pfizer Chooses Its Battles Wisely

California Green Chemistry Initiative Update

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