News & Analysis as of

Business Associates Data Breach

Business Associates can refer broadly to individuals engaged in business relationships with one another. However, in the HIPAA context, the term has a specific statutory meaning and those characterized as... more +
Business Associates can refer broadly to individuals engaged in business relationships with one another. However, in the HIPAA context, the term has a specific statutory meaning and those characterized as business associates have expanded data protection obligations and duties. Essentially, a business associate under HIPAA is a person or entity that performs certain functions or services which necessitates exposure to protected health information on behalf of a covered entity. Typical business associate functions include: claims processing or administration, data analysis, billing, etc.    less -

Lessons To Be Learned From The Breach Of Nearly 500,000 Individual Health Records Reported In September 2017

by Jackson Lewis P.C. on

A recent report indicates that nearly 500,000 individual health records were breached in September 2017. This figure is taken from the 39 healthcare data breaches involving more than 500 records that were reported to the...more

HIPAA Check: Do You Know What to Do if a Breach Happens to You?

by Williams Mullen on

Breaches happen. They happen to major health systems, and they happen to solo practitioners. They happen to health plans, and they happen to health information technology vendors. In our technology-reliant world, it would be...more

Clinical trials Part II: Privacy, cybersecurity risks, and managing ePHI

by Thompson Coburn LLP on

The ongoing digitization of the drug and medical device industries continues, and, as a result, new considerations have come to the forefront for companies engaged in clinical trials. In Part 1 of this series, we described a...more

Business Associate Resold Fax Machine Containing PHI

Fax machines are still used in the medical community, and these days, faxing may be more secure than emailing as hackers have not yet cracked the task of hacking into old fax machines. All kidding aside, fax machines have...more

Don’t Forget HIPAA’s “Minimum Necessary” Rule When Making Health Information Disclosures

by Nossaman LLP on

When Covered Entities or Business Associates or their counsel analyze whether a particular disclosure of Protected Health Information (or “PHI,” as defined in HIPAA) is permissible, they should be sure also to analyze whether...more

Enhanced HHS HIPAA Breach Reporting Tool May Aid Health Care Industry Data Security Efforts

by Jackson Lewis P.C. on

Secretary Tom Price of the U.S. Department of Health and Human Services (HHS) announced his agency needs “to focus more on the most recent breaches and clarify when entities have taken action to resolve the issues that might...more

Ten Tips For Actions By A Covered Entity After A HIPAA Breach By A Business Associate

by Fox Rothschild LLP on

This blog recently discussed tips for a covered entity (CE) in dealing with a HIPAA business associate (BA). Now, even though you have adopted all of the tips and more, in this dangerous and ever more complex data security...more

How Can Healthcare Organizations Prepare for the Next Cyberattack?

by Latham & Watkins LLP on

HHS OCR issues checklist, iterative guidance in wake of WannaCry and Petya attacks; Anthem breach settlement provides additional lessons. Key Points: ..Healthcare organizations are particularly vulnerable to ransomware...more

HIPAA Settlements in April and May Highlight Key Compliance Concerns for OCR

by Williams Mullen on

After a break in March with no new settlement agreements, OCR returned in April and May with quite a few. The Health Care Data Aware Blog already posted about a $400,000 OCR settlement released April 12, 2017, which can be...more

My Entity Just Experienced a Cyber-Attack! What Do We Do Now?

by Balch & Bingham LLP on

On June 9, 2017, the U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) released a cyber-attack “Quick Response” checklist (the Checklist) for the benefit of HIPAA covered entities and business...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

HIPAA Enforcement Update (February 2017 – April 2017)

by Locke Lord LLP on

In recent months, the Department of Health and Human Services, Office for Civil Rights (OCR) has announced four settlement agreements and one civil monetary penalty to resolve allegations of Health Insurance Portability and...more

HHS OCR Resumes HIPAA Enforcement Action Announcements: Four New Settlements and Penalties Totaling More than $5 million in a One...

by Arnall Golden Gregory LLP on

After a pause of nearly two months, the Department of Health and Human Services Office of Civil Rights (HHS OCR) has resumed its announcement of settlements for alleged HIPAA violations, with four new settlement agreements...more

2017 HIPAA Enforcement – Appears Not To Be Slowing Down

by Snell & Wilmer on

To state the obvious, there has been some uncertainty regarding how the Trump Administration will affect federal agency enforcement efforts. However, at least, in regard to HIPAA Privacy and Security, the U.S. Department of...more

A Draft Won’t Do: OCR Settles with CardioNet $2.5m for Failing to Finalize Policies and Procedures

On April 24, 2017, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that CardioNet, a provider of remote mobile monitoring and rapid response services to patients at risk for cardiac...more

Two HIPAA Mistakes Lead to Fines from OCR

It was a busy April for the Office for Civil Rights (“OCR”) (see our prior post on a settlement from earlier in April). On April 20, OCR announced a Resolution Agreement with Center for Children’s Digestive Health, S.C....more

First HIPAA Settlement Involving a Wireless Health Services Provider

?On April 24, 2017, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that CardioNet, Inc. (CNI) agreed to pay $2.5 million and enter into a Corrective Action Plan (CAP) to settle...more

It’s Just Plain Risky Not to Do A Risk Analysis: Recent OCR Settlement One of Several Resulting from Failure to Analyze and...

by Williams Mullen on

On April 12, 2017, the Office for Civil Rights (“OCR”) announced a settlement and corrective action plan with a Colorado federally-qualified health center, Metro Community Provider Network (“MCPN”), after a 2012 breach of...more

Healthcare Advisory: HHS Announces First Settlement with a Wireless Health Services Provider

by Sherman & Howard L.L.C. on

On April 24, 2017, the Department of Health and Human Services, Office of Civil Rights (“OCR”), announced its first settlement with a wireless health services provider, CardioNet, Inc., for alleged violations of the Health...more

Failure to Implement Business Associate Agreement Results in $31,000 Settlement For Health Care Provider

On April 20, 2017, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Children’s Digestive Health (CDH) agreed to pay HHS $31,000 for its failure to have a business associate...more

Recent HIPAA Privacy and Security Settlements and Lessons Learned

by Perkins Coie on

Although the fate of the Affordable Care Act remains undecided, enforcement of the HIPAA privacy and security regulations by the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services is ongoing,...more

Time Waits for No One: OCR Announces First HIPAA Settlement for Lack of Timely Breach Notification

by Davis Wright Tremaine LLP on

On Jan. 9, 2017, the Department of Health and Human Services Office for Civil Rights (“OCR”) announced the first HIPAA enforcement action for failure to timely report a breach. Often investigating and making formal...more

Looking Back at the HIPAA Resolution Agreements in 2016

by BakerHostetler on

In 2016, Health and Human Services’ (HHS) Office for Civil Rights (OCR), the enforcement arm for HIPAA, continued robust enforcement efforts. There were 12 reported resolution agreements (RA) in 2016. An RA is a settlement...more

November the Worst Month Yet for Healthcare Breaches

We have repeatedly reiterated numerous warnings to the healthcare industry about malware and ransomware [see related posts here and here]. Our predictions have unfortunately become true, as November was the worst month ever...more

AGG Food and Drug Newsletter - December 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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