Health Law, Consumer Protection, 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

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

Product Liability Advisory - November 2012: BPA Linked to Adverse Reproduction Effects in Rhesus Monkeys

by Mari Spears | Sedgwick LLP on 12/4/2012

A recent study published in the “Proceedings of the National Academy of Sciences” found that Bisphenol A (BPA) can adversely affect fetal development in rhesus monkeys. The study’s findings raise concerns regarding BPA...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

2011-2012 Massachusetts Legislative Session

by Mintz Levin on 10/5/2012

The formal legislative session for 2011-2012 concluded on July 31st. The session was defined by landmark legislation in healthcare cost containment, economic development, energy, and consumer protection. The Legislature will...more

Senators Ask CFPB to Consider Regulation of Medical Debt Collection

by King & Spalding on 8/15/2012

Four Democratic senators recently submitted a letter to Consumer Financial Protection Bureau (CFPB) Director Richard Cordray requesting that the agency consider regulations restricting the use of medical debts in credit...more

ASHRM Annual Conference & Exhibition: Patient Safety Organizations: Legal Update and Practical Solutions After Walgreens Case

by Katten Muchin Rosenman LLP on 8/8/2012

Partner Michael Callahan will speak on "Patient Safety Organizations: Legal Update and Practical Solutions After Walgreens Case" at 9:00 a.m. on Wednesday, October 10, at the American Society for Healthcare Risk Management's...more

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Health Law › Consumer Protection › 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

Big Data Could Save Healthcare System $300+ Billion Annually

Product Liability Advisory - November 2012: BPA Linked to Adverse Reproduction Effects in Rhesus Monkeys

FDA Unveils New System to Track Medical Devices

FDA Unveils New System to Track Medical Devices

2011-2012 Massachusetts Legislative Session

Senators Ask CFPB to Consider Regulation of Medical Debt Collection

ASHRM Annual Conference & Exhibition: Patient Safety Organizations: Legal Update and Practical Solutions After Walgreens Case

California Establishes Centralized Privacy Unit for Enforcement and Education

“But what is it, Doc?” – Health Care Professionals under Professionals under Regulation 1924/2006

Massachusetts Hospital Agrees to Pay $775,000 for Security Breach

HHS Officials Explain Risk Adjustment Methodology

Massachusetts Releases Health Care Cost Containment Legislation

China Solicits Comments on Draft Rules for Writing Periodic Safety Update Reports

Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

First State Attorney General Action under HITECH

Medical Device Patient Safety Act Proposes Two-Step Change to Oversight of Devices

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