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More (MACRA) Data Analysis, Please

On July 1, CMS finalized new MACRA rules that significantly expand how qualified data entities will be allowed to share or sell analyses of Medicare and private claims data to providers, insurers, employers, and others who,...more

Client Alert - The Government Makes a Business Associate Pay: What HIPAA Covered Entities and Business Associates Can Learn from...

The government has entered into its first settlement with a HIPAA business associate, including a $650,000.00 monetary penalty, ushering in a new period of enforcement for third parties who use Protected Health Information...more

HHS: Ransomware Attacks Likely HIPAA Breaches In Absence of Encryption

On July 11, 2016, the U.S. Department of Health & Human Services (HHS) issued a Fact Sheet that provides guidance on (i) how HIPAA Security Rule compliance can assist health care organizations combat ransomware attacks, and...more

Regulatory Authorities Launch The Second Phase Of The HIPAA Compliance Audit Program

As a part of its continued efforts to assess compliance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, the Health and Human Services (HHS) Office for...more

The Long Anticipated HIPAA Audits Are Here!

Phase 2 HIPAA Audits, which the Department of Health and Human Services' Office of Civil Rights ("OCR") announced had "launched" back in March of this year, have now officially begun. On Monday, July 11, 2016, the first round...more

Aveta And The Use Of Confidential Info In FCA Cases

In a recent case in the District of Puerto Rico, United States ex rel. Valdez v. Aveta Inc., et al., No. 15-cv-01140-CCC (D.P.R.), the former president of Puerto Rican-based managed health care provider Aveta Inc., Jose...more

Ransomware Attacks on ePHI May Be a Data Breach Under HIPAA

On July 11, 2016, the Office of Civil Rights (“OCR”) at the Department of Health and Human Services issued new HIPAA guidance regarding the growing epidemic of malicious computer software known as “ransomware”....more

Breach of ePHI Results in $2.7 Million Fine

Oregon Health & Science University (“OHSU”) has paid $2.7 million to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) to settle allegations that it violated the Health Insurance Portability...more

OCR Issues New Guidance on Ransomware and HIPAA

In response to a rising number of ransomware attacks on healthcare systems, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) has issued new ransomware guidance on the HIPAA obligations of...more

OCR Launches Phase 2 HIPAA Audits

On July 11, 2016, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) notified 167 covered entities of their selection for Phase 2 desk audits. The audits will examine compliance with the...more

HHS Issues New Guidance on Ransomware

On July 11, 2016, the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) issued guidance on ransomware attacks. The guidance clarified that a ransomware attack involving electronic protected...more

Cybersecurity News & Notes – July 2016 #3

In Case You Missed It: Court certifies class in suit against Apple. On July 15, 2016, U.S. District Judge Jon S. Tigar certified a class of users of the mobile app Path, who allege that Apple facilitated the app’s access...more

House of Representatives Approves Mental Health System Reform Bill

The House of Representative has overwhelmingly approved a bipartisan bill (H.R. 2646, the Helping Families in Mental Health Crisis Act) to reform the nation’s mental health care system. Key provisions of the legislation...more

Recent Congressional Hearings

Congressional committees held hearings on a wide variety of on health policy issues this month before going on summer recess. Notable hearings include the following...more

OCR Begins HIPAA Phase 2 Audits

What covered entities and business associates can do to prepare for the next round of audits. On July 11, the HIPAA Phase 2 audits commenced when 167 covered entities received notice of a desk audit from the Department...more

Oregon Health & Science University pays $2.7M penalty for data breaches

Oregon Health & Science University (OHSU) has agreed to settle alleged HIPAA violations involving two separate data breaches with the Office for Civil Rights (OCR) for $2.7 million. In the span of three months in 2013,...more

CMS Finalizes Plan to Expand Medicare/Private Claims Data Available for Care Improvement

CMS has published a final rule to allow organizations approved as “qualified entities” to confidentially share or sell analyses of Medicare and private-sector claims data to providers, employers, and other groups who can use...more

Facebook and HIPAA: Strange Bedfellows

As a social media user, you may have experienced Facebook’s targeted advertising. Mere moments after searching for a specific item on Google or visiting another website, your Facebook ads reflect your recent browsing history....more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

Will you be shut-out if your college-age child has a medical emergency?

The time when a child goes off to college can be a stressful time for any parent. You know that you are giving up substantial control over your child’s safety and choices, but you may be relinquishing even more control than...more

HIPAA Audit Program Update—HHS OCR Moves Forward with Desk Audits

As we previously reported, on March 21, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) launched the long-awaited Phase 2 of the audit program that is intended to assess compliance with...more

Recent Enforcement Action: Business Associates Not Off the Hook

Despite the fact that Business Associates have been directly subject to and liable under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (HIPAA) since February 18, 2010 the...more

OCR Sends Notification Letters to Phase 2 HIPAA Auditees

On July 12, 2016, HHS’s Office for Civil Rights (OCR) distributed an e-mail discussing recent developments in Phase II of its HIPAA audit program....more

BYOD Risks under HIPAA – Does Your HIPAA Compliance Program Adequately Address the Ever Increasing Use of Portable Electronic...

Many U.S. employers are now allowing employees to use their own personal handheld devices and laptop computers for work-related purposes. As the age of employer-provided devices is coming to an end and “bring your own device”...more

OCR Releases Guidance on Ransomware & HIPAA

On July 11, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) issued guidance (the “Guidance”) for health care entities relating to ransomware and the Health Insurance Portability and...more

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