Science, Computers & Technology, Consumer Protection, Health Law

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

by Fuerst Ittleman David & Joseph, PL on 5/10/2013

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

FDA Issues Two Warning Letters for Social Media Use: FDA Does Not Approve of “Liking” Consumer Claims and Targets Website Search...

by Fuerst Ittleman David & Joseph, PL on 4/29/2013

In 2009, the U.S. Food and Drug Administration (FDA) announced that it intended to release a guidance document explaining how it will regulate industry’s use of social media to advertise products or communicate with...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

by Matthew A. Reed | Sedgwick LLP on 4/26/2013

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - April 2013

by Patrick Malone & Associates P.C. | DC Injury... on 4/3/2013

In This Issue: - A Magician Speaks Out About Fooling People - Science Is the Tortoise... - ...Alternative Medicine Is the Hare - Resources for Sorting Fact from Fiction - Recent Health Care News You Should...more

Genetic Testing and Screening of Children: Ethics and Best Practices

by Antoinette F. Konski | Foley & Lardner LLP on 3/5/2013

The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most...more

Special Edition: Health Law Update - February 28, 2013

by Anne Foster, Cory Fox, Susan Whittaker Hughes, Theodore Kobus III, Jennifer Mills, John Mulhollan, Lynn Sessions, Kimberly M. Wong | BakerHostetler on 3/1/2013

In This Issue: - A Baker's Dozen of Significant Changes From the HIPAA/HITECH Rule 1. Business Associates and Subcontractors 2. Breach Notification 3. Covered Entity Organizational Structures 4. Cloud...more

PHI Breach Reporting Deadline is March 1, 2013

by Thompson Coburn LLP on 2/28/2013

To comply with the HITECH breach notice requirements, HIPAA covered entities are required to report all small breaches of unsecured protected health information (“PHI”) that occurred in calendar year 2012 to the U.S....more

Significant Changes to HIPAA Effective March 26, 2013

by Christie Burbank, Jade Dodds, Susan Steelman | Miller & Martin PLLC on 2/28/2013

The following is a summary of the major changes to HIPAA under the new Final Rule: 1. Breach Notification Standard Lowered — In perhaps the most significant change under the Final Rule, the new regulations considerably...more

FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls

by Ropes & Gray LLP on 2/27/2013

On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more

FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation...

by King & Spalding on 2/27/2013

On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical...more

Deadline Approaches for Reporting 2012 Small Breaches

by Adam H. Greene, Rebecca L. Williams | Davis Wright Tremaine LLP on 2/26/2013

HIPAA covered entities have through Friday, March 1, 2013, to report small breaches of unsecured protected health information that occurred in calendar year 2012 to the U.S. Department of Health and Human Services (HHS). A...more

HIPAA’s New Rules: Expanding Scope, Clarifying Uncertainties, & Reinforcing Fundamentals

by Patricia Shea | K&L Gates LLP on 2/25/2013

On January 25, 2013, the Secretary for the United States Department of Health and Human Services, Office for Civil Rights (the “Department”) officially published the long-awaited final regulations (the “Final Rule”)...more

Maryland Cybersecurity-Related Legislative Developments

by Michael Baader, Dismas Locaria, Anthony Rosso, Ryan Sweigard | Venable LLP on 2/21/2013

The Maryland State Senate is considering several cybersecurity-related bills to advance the state’s efforts to be the epicenter for cybersecurity. Maryland has already enacted several measures to foster cybersecurity...more

The HITECH Final Rule: The New Privacy/Security Rules of the Road Have Finally Arrived

by Nancy Bonifant, Elizabeth Doyle O'Brien, Jennifer Pike, Zachary Portin, Brad Rostolsky, Salvatore Rotella Jr. | Reed Smith on 2/20/2013

Since the 2009 enactment of the Health Information Technology for Economic and Clinical Health Act (the “Act” or “HITECH Act”), compliance efforts associated with the Health Insurance Portability and Accountability Act of...more

Expanding The Reach Of HIPAA Data Security And Privacy Requirements

by Michael Volkov on 2/18/2013

In this information technology era, it is little wonder that the Obama Administration has made enforcement of data security and privacy protections a top priority. The enforcement emphasis reflects public opinion favoring...more

HIPAA Omnibus Final Rule Imposes New Obligations on Business Associates

by Elizabeth F. Hodge | Akerman Senterfitt on 2/12/2013

On January 25, 2013, the Department of Health and Human Services/Office for Civil Rights (HHS/OCR) published in the Federal Register (78 Fed. Reg. 5566) the long-awaited final rule titled Modifications to the HIPAA Privacy,...more

Blood Bank Settles FTC Complaint About Customer Data Privacy

by Jeff Ifrah on 2/11/2013

Any company that collects personal information about individuals, such as credit card numbers and social security numbers, must be very careful about the way in which it stores and secures that information. Even a blood bank...more

HIPAA Minimum Necessary Standard Should Be Key Component of Policies and Procedures, Now More Than Ever

by Lisa Clark, Elinor Hart | Duane Morris LLP on 2/11/2013

On January 17, 2013, the U.S. Department of Health and Human Services ("HHS") announced the final omnibus rule amending the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") in accordance with the HITECH...more

New HIPAA Regulations Affect Business Associates and Subcontractors

by Amy Gordon, Susan M. Nash, Jamie Weyeneth | McDermott Will & Emery on 2/11/2013

The Health Insurance Portability and Accountability Act omnibus regulations recently released by the U.S. Department of Health and Human Services have significant ramifications for business associates and subcontractors of...more

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

by Katherine Wang | Ropes & Gray LLP on 2/5/2013

The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...more

Final HIPAA Rule Has Sweeping Impact on Covered Entities and Business Associates

by Katten Muchin Rosenman LLP on 1/30/2013

On January 25, 2013, the Department of Health and Human Services (HHS) published the highly anticipated Health Insurance Portability and Accountability Act (HIPAA) Omnibus Final Rule (the “Final Rule”). The Final Rule...more

Overview of 2013 Amendments to HIPAA Privacy, Security, Breach Notification and Enforcement Rules

by Neville M. Bilimoria, Lisa Clark, Erin Duffy, David Loder, Emmy Monahan, Harry Silver, Dmitry Tuchinsky | Duane Morris LLP on 1/30/2013

On January 17, 2013, the federal Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"), issued the long-anticipated final omnibus amendments (the "2013 Amendments") to the Privacy, Security, Breach...more

The Omnibus Final HIPAA Rule Is Here

by Henry Fader, Sharon Klein, Rebekah Monson | Pepper Hamilton LLP on 1/29/2013

On January 17, 2013, the Office of Civil Rights of the U.S. Department of Health and Human Services (HHS) announced the omnibus final rulemaking (Omnibus Rule). According to HHS, this Omnibus Rule is needed to strengthen...more

HHS Issues HIPAA/HITECH Omnibus Final Rule Ushering in Significant Changes to Existing Regulations

by Stacy H. Barrow, Ryan Blaney, Roger Cohen, Herschel Goldfield, Edward Kornreich, Kristen Mathews, Ellen Moskowitz, Richard Zall | Proskauer Rose LLP on 1/29/2013

"Sweeping changes" is how Leon Rodriquez, of the Department of Health and Human Services Office of Civil Rights (OCR), characterized the effect of the final omnibus Health Insurance Portability and Accountability Act (HIPAA)...more

Key Elements of the New “Omnibus” HIPAA Privacy and Security Regulations

by Colin J. Zick | Foley & Lardner LLP on 1/25/2013

On January 18, 2013, nearly four years after the passage of the HITECH Act and its amendments to HIPAA, and nearly three years after it proposed regulatory amendments, the U.S. Department of Health and Human Services (“HHS”)...more

Home

Legal News

Find a Lawyer

Browse Subjects

Subscribe

Pro Services

For Reporters

Science, Computers & Technology › Consumer Protection › Health Law