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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

A New Sheriff in Town: Federal Trade Commission Enforcement of Medical Information Security

A recent court decision found that the Federal Trade Commission (FTC) has authority to enforce the requirements for security of Protected Health Information, or PHI, as defined under the Health Information Portability and...more

HIPAA Breaches: What They Are and What You Can Do to Protect Your Clients

45 CFR §§ 164.400-414– otherwise known as the HIPAA Breach Notification Rule– requires all entities and businesses covered by HIPAA to disclose any breaches of unsecured protected health information (PHI). In order to protect...more

Update Your Business Associate Agreements Now

As you may recall, new provisions of the HIPAA regulations went into effect on September 23, 2013. Included were new requirements for Business Associate (BA) Agreements. The new regulations, however, grandfathered certain...more

September 22, 2014: Quickly approaching deadline to amend business associate agreements

The HIPAA Omnibus Rule, enacted last year, made a number of changes to the HIPAA privacy, security and breach notification rules. Some of these changes affected business associate provisions of the HIPAA privacy and security...more

Imagination-in-Pleading Award

When Oklahoma Blue Cross-Blue Shield terminated Dr. Gude’s provider agreement, he decided to fight back. He sued the Blues in federal court, alleging they had violated—and this is the imaginative part—Oklahoma’s Consumer...more

Face video scan can trigger data protection breach?

Data protection breaches of health related sensitive data might occur through a mere video scanning an individual’s face according to a recent research....more

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a...more

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

FBI Warning to Health Care Sector Holds True

In April of this year, the FBI issued a Private Industry Notification (PIN) to the health care industry warning of the “likely increase [in] cyber intrusions against health care systems.” In the same month, and into June of...more

Massive Data Breach Affects 4.5 Million Patients in 29 States

Community Health Systems, Inc. (the “Company”), one of the largest hospital organizations in the country, announced via a public filing (Form 8K) made yesterday with the Securities and Exchange Commission (“Report”) that the...more

Class Action Plaintiffs Look to Fair Credit Reporting Act for Private Relief from Data Breaches Involving Health Information

A recent class action brought against the University of Miami (“University”) previews what could become an emerging trend among plaintiffs’ class action attorneys to seek damages for the unauthorized disclosure of personal...more

Hospital Operator Reports 4.5 Million Patients’ Data Stolen in Cyberattack

The Tennessee-based acute-care hospital chain Community Health Systems, Inc. (CHS), reported on August 18 that information on approximately 4.5 million patients was stolen from the company. CHS is one of the largest hospital...more

4.5 Million Patients’ Information Stolen by Hackers

Community Health Systems Inc. (“CHS”), a Tennessee-based hospital provider, has reported it was the target of data hackers who were able to obtain identification information belonging to approximately 4.5 million CHS...more

Community Health Systems' HIPAA Breach: Significant Lessons for Health Care and Non-Health Care Companies

On August 18, 2014, Community Health Systems, Inc. (CHS) publicly confirmed, in a filing with the Securities and Exchange Commission (CHS filing), that its computer network was attacked between April and June 2014 by hackers...more

Chinese Hackers Infiltrate Health System Network – Information of 4.5 Million Individuals Stolen

Community Health Systems, Inc. (“CHS”) reported yesterday that the information of approximately 4.5 million individuals has been affected by a Chinese cyber-attack. CHS and its affiliates own and operate 206 hospitals in 29...more

Hospital Network Reports Large HIPAA Breach

Community Health Systems announced yesterday, August 18th, that hackers broke into its computers and stole data on 4.5 million patients. ...more

Massachusetts Enforces Data Security Regulations Against Out-of-State Entity

On July 23, 2014, the Massachusetts Attorney General announced a consent judgment with an out-of-state Rhode Island hospital, Women & Infants Hospital of Rhode Island (“WIH” or the “Hospital”), resolving a lawsuit against WIH...more

Privacy Tuesday – August 2014

We are just two Mondays away from Labor Day, the traditional end of summer in the United States. Here are some privacy tidbits to get your week started. See especially Jake Romero’s piece on the new Delaware data...more

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