Consumer Protection Science, Computers & Technology Health

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Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s...more

Evolving Litigation of Data Breach Claims

An Illinois circuit court judge has dismissed five of six claims in a consolidated class action against Advocate Health and Hospital Corporation arising from a data breach in July 2013. The judge’s dismissal with prejudice...more

Excellus Blue Cross Blue Shield sued for data breach announced last week

Within days of Excellus Blue Cross Blue Shields’ (Excellus) announcement that its data had been accessed by a hacker through a “sophisticated” cyber-attack, two law firms teamed up to file a proposed class action suit last...more

Cure of Security Rule Violations Following Breach of EPHI Cannot Save Covered Entities from $750,000 Settlement; Non-Breach...

More than three years after the Cancer Care Group, P.C. (“CCG”) notified the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) of a breach of unsecured electronic protected health...more

Don’t Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called “Phase 2 Audits” are set to commence...more

Don't Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called "Phase 2 Audits" are set to commence...more

Recent Enforcement Shows the Importance of Encrypting Mobile Devices Containing Protected Health Information

With headlines every day announcing another release of Protected Health Information (PHI), providers are asking themselves – is there a way to protect against these breaches? Beyond improving the security of large...more

Advocate Health class action lawsuit trimmed

Last week, an Illinois judge dismissed with prejudice five of the six claims levied against Advocate Health Care in a consolidated case of ten cases filed against it following the data breach it experienced in July of 2013...more

How to Avoid and Respond to a Cybersecurity Breach

In light of numerous recent data breaches, cybersecurity has emerged as an issue impacting organizations ranging from the local hardware store to the largest multi-national firms in the world. In short, no industry is immune...more

OCR Enters into $750,000 Settlement with Physician Practice for HIPAA Violations

On September 2, the Department of Health and Human Services Office of Civil Rights (OCR) announced a settlement with Cancer Care Group, P.C., a thirteen-physician oncology practice in Indiana related to violations of the...more

Data Breach Response Planning: Laying the Right Foundation

Part of Bradley Arant’s Privacy and Information Security Team’s seven-part Data Breach Toolkit Webinar Series, the “Data Breach Response Planning: Laying the Right Foundation” webinar, led by Paige Boshell and Amy Leopard,...more

OCR settlement reiterates importance of proactive security rule compliance

On September 2, 2015, the U.S. Department of Health & Human Services (HHS) announced that Cancer Care Group, P.C. (CCG), a physician practice located in Indiana, agreed to pay $750,000 as part of a settlement to resolve...more

FCC Guidance on Cellphones Puts the Squeeze on Medical Debt Collectors

In July, the FCC released an order it touted as strengthening “consumer protections against unwanted calls and texts.” It was a series of rulings based on the Telephone Consumer Protection Act meant to clarify the use of...more

Jury Clears UCLA Health in Lawsuit Stemming From Improper Access to PHI by Plaintiff’s Romantic Rival

A UCLA employee and patient now has celebrity-level security on her protected health information (PHI) as maintained by the UCLA Health system, but a jury denied her the $1.25 million in emotional distress damages she sought...more

Hell Freezes Over in California: Private Optometry and Optical Companies Compromise

The California Optometric Association (COA) and national optical companies ended their historic stand-off and agreed on legislation that provides a route for optometrists to co-locate with companies that dispense eyeglasses...more

UCLA cleared in lawsuit alleging breach as to sexually transmitted disease information

UCLA was absolved by a California judge last week in a suit filed by a patient of a UCLA affiliated doctor’s group, who alleged that a temporary worker in the doctor’s office used the doctor’s username and password to get...more

UCLA suffers another data breach

Last week, UCLA notified 1242 patients that their health information may have been compromised in July when a faculty member’s laptop was stolen. UCLA has notified the patients, the Office for Civil Rights and the California...more

10 million Excellus Blue Cross Blue Shield members’ information compromised

Yesterday, Excellus Blue Cross Blue Shield, located in Rochester, NY, announced that it will notify up to 10 million members that it was the victim of a cyber-attack dating back to December of 2013 that exposed their members’...more

Clinically Integrated Networks: Privacy and Security Concerns with Sharing Data

The Centers for Medicare & Medicaid Services (CMS) is changing reimbursement methodologies for healthcare providers from a fee-for-service model to a value-based model. Healthcare providers are responding to the changing...more

HHS Releases Notice of Proposed Rulemaking Updating Rules for Human Subjects Research

On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more

Parties Continue to Challenge the FCC’s July 2015 Declaratory Ruling and Order

On September 4, 2015, both Vibes Media, LLC and Rite Aid Hdqrtrs. Corporation filed petitions for review of the FCC’s July 10, 2015 Declaratory Ruling and Order with the United States Court of Appeals for the District of...more

Time for a HIPAA Security Check-Up!

The 2015 HIPAA Security conference held by the National Institute of Standards and Technology (“NIST”) and the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) kicked off last week with OCR’s...more

UK Patients’ Data Exposed by Group Email

The 56 Dean Street Clinic, which is operated by the Chelsea and Westminster NHS Trust and specializes in HIV and other sexual health services, has apologized for the error which revealed (to all 780 recipients) the full names...more

Physician Group to Pay $750,000 to Settle a HIPAA Violation

In August 2012, a Physician Group—comprising of nearly 20 physicians—reported its HIPAA breach to HHS, which resulted from a laptop bag containing the employee’s laptop and a computer server backup being stolen from an...more

Medical Device Cybersecurity: Maybe Dick Cheney Was Not So Paranoid After All

Dick Cheney famously disclosed a few years ago that he had the wireless function of his pacemaker disconnected while he was Vice President because he was concerned that hackers might fiddle with the device remotely and do him...more

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