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California Attorney General Releases 2014 Data Breach Report and Recommendations, Finding More of the Same.

On October 28, 2014, Attorney General Kamala Harris released the second annual California Data Breach Report. The report detailed the nature and scope of data breach notifications that her office received in 2013. Her office...more

Company Claims “HIPAA Has No Teeth”, Will Start Notifying Affected Individuals of Security Breaches and Vulnerabilities that Have...

A company named SLC Security, LLC (“SLC”), recently announced that it will begin notifying individuals if it believes it has identified a security breach or vulnerability of a company and it has not received a satisfactory...more

Arrival of Ebola Virus Prompts Policyholders to Assess Insurance Coverage

With news of the Ebola virus arriving in the United States, many companies are moving quickly to protect the health and safety of their employees and customers. At the same time, some insurance providers have already...more

From Second and State: Capitol Wrap – Week of October 2014

As expected, this week blew through the Columbus Day holiday and into a flurry of legislative activity. Dozens of bills went back and forth between the chambers this week, and many have already landed on the governor’s desk....more

Medical Information More Valuable to Hackers Than Credit Card Numbers

In light of the recently reported large healthcare data breaches that have resulted in the potential theft of the personal information of millions of patients, the FBI warned healthcare providers yet again of the dangers of...more

Federal Bills Pursue Comprehensive Data Breach Notification

The recent string of wide-scale data breach disclosures by major retailers has led to a growing call for federal legislation to protect consumer information and establish uniform data breach notification...more

‘Health Care’-Related Calls: Ambiguity at the Intersection of HIPAA and TCPA

The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer Protection Act (TCPA) for health care messages regulated under the Health Insurance Portability and...more

Prepare for Changes to CMS’ Five Star Quality Rating System for Nursing Homes

Choosing a nursing home can be a daunting task for consumers who often have myriad questions regarding the quality of care available at the nursing homes in their areas. To help answer these questions, CMS has created the...more

Food and Beverage News and Trends - Food and Beverage Alert (US): October 2014

School Nutrition Association responds to critical article, sets forth its views on healthy lunches. The School Nutrition Association, which represents school cafeterias across the nation, responded on October 7 to a New York...more

Medical Staff Bylaws: Compliance Gaps and Best Practices - Part 1

In this presentation: - Background - Definitions - Purposes/Preamble - Nature of Medical Staff Membership - Qualifications for Membership - Insurance...more

Good News: California Extends Its Medical Data Breach Notification Requirement From 5 to 15 Days

On Sept. 18, 2014, California’s governor approved Assembly Bill 1755, extending California’s stringent breach notification deadline for medical information breaches from five business days to 15 business days for clinics,...more

California Extends Deadline for Reporting Breaches to the CDPH from 5 to 15 Business Days

On September 18, 2014, California Governor, Jerry Brown, signed Assembly Bill 1755 (“AB1755”) into law, amending breach notification provisions in the California Health and Safety Code applicable to licensed clinics, health...more

FDA Announces More Changes to FSMA Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many...more

Eleventh Circuit Holds That Debt Collector Had “Prior Express Consent” From Debtor Whose Wife Provided Number on Hospital...

This week the Eleventh Circuit held that a debt collector had “prior express consent” from a debtor whose wife had provided his wireless number on a hospital admission form. Mais v. Gulf Coast Collection Bureau, Inc., No....more

Blog: FDA Issues Final Cybersecurity Guidance for Medical Devices

On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber...more

FDA Final Guidance Confirms Role of Medical Device Firms in Cybersecurity Management

On October 2, 2014, the Food and Drug Administration (“FDA”) released the final version of a guidance document entitled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” As discussed in a...more

New Ohio Law Requires Nursing Homes that Admit Sex Offenders to Notify Home Residents

Before September 15, 2014, a loophole in Ohio’s sex offender registration and notification laws allowed for sex offenders to live in nursing homes without the knowledge of the home’s other residents. The law required the...more

Privacy Issues in the Sharing of Genetic Information

Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

Expect Focus - Regulators Are Watching: New Products, New Opportunities, New Risks - Volume III, Summer 2014

In This Issue: - IN THE SPOTLIGHT ..Standard CGL Policy Form Adds Data Breach Coverage Exclusion - LIFE INSURANCE ..Class Claims Against Lincoln National Barred in Section 419 Action – Again ...more

“LoProCo”, 12,915 Complaints, and Other Lessons from OCR/NIST

12,915 complaints were reported in 2013 to the Department of Health and Human Services Office of Civil Rights (“OCR”) according to Illiana L. Peters, Senior Adviser for HIPAA Compliance and Enforcement. Cozen O’Connor...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

Health Update - September 2014

Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign - Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more

Pharmacy Compounding Update: Regulators Search for the Right Formula

Last November, the Compounding Quality Act (‘‘Act’’) became law after a yearlong national debate about whether—and how—to regulate compounding pharmacies after a tainted injectable prepared at a Massachusetts compounding...more

New Arizona Physician Fingerprinting Requirements for Renewal and Initial License Applications

As of September 2, 2014, physicians in Arizona applying for initial medical licenses or renewing their medical licenses are required to submit a fingerprint card along with the application to the Arizona Medical Board in...more

Healthcare Legal News: Volume 4, Number 3 - Special Issue: HIPAA Update

Recent Trends in HIPAA Liability - Since the passage of the 2013 HIPAA Omnibus Rule, there has been a substantial increase in HIPAA enforcement actions brought by the Department of Health and Human Services, including...more

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