Covered Entities Dept. of Health and Human Services

News & Analysis as of

HIPAA Phase 2 Audits: What Has OCR Requested from Auditees to Date?

In our April 8, 2016, advisory, we discussed the U.S. Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) “Phase 2” audit program. Then, we could only make educated guesses about what documents OCR...more

A Closer Look at the OCR’s Guidance on Ransomware

In the wake of several high-profile ransomware infections targeting hospitals and health care organizations, the Department of Health and Human Services Office for Civil Rights (OCR) has issued guidance on the growing threat...more

OCR Plans to More Widely Investigate HIPAA Breaches Affecting Fewer than 500 Individuals

This month the HHS Office for Civil Rights (OCR) has launched an initiative “to more widely investigate the root causes” of HIPAA breaches affecting fewer than 500 individuals, according to an August 18, 2016 OCR email...more

Now is a Good Time to Review Your HIPAA Policies

The HHS Office for Civil Rights (OCR) has announced it is increasing its investigations of breaches of unsecured protected health information (PHI) affecting fewer than 500 individuals. As a reminder, the HIPAA Breach...more

OCR to Increase Efforts to Investigate Breaches Affecting Fewer Than 500 Individuals

The Department of Health and Human Services Office for Civil Rights (OCR) is the federal agency tasked with investigating data breaches involving protected health information (PHI) under the Health Insurance Portability and...more

Section 1557 of the Affordable Care Act Requires Healthcare Providers to Take Certain Steps in 2016 to Promote Equity

Section 1557 of the Affordable Care Act aims to advance healthcare equity. This statutory provision provides that current non-discrimination laws, such as the Civil Rights Act of 1964, will now apply to individuals and...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

It’s Not the Olympics, but OCR Sets New HIPAA Settlement Records

Athletes at the Rio Olympics aren’t the only ones setting records this year. Hoping to send a “strong message” about the importance of safeguarding electronic protected health information (PHI) and conducting mandated risk...more

Blog: Advocate Data Breaches Result in Largest HIPAA Settlement To Date

On August 8th, 2016, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date with Advocate Health...more

HSS Issues New Guidance on Ransomware Attacks Against HIPAA-Covered Entities

Ransomware attacks at hospitals and other healthcare facilities have dramatically increased over the last several years, putting healthcare providers in the uncomfortable position of having to consider paying thousands of...more

Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

The US Department of Health and Human Services (HHS) has recently issued guidance under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and...more

Largest Health & Human Services HIPAA Settlement Wake-Up Call for Covered Entities to Evaluate and Mitigate Risks

On Thursday, August 4, 2016, the U.S. Department of Health & Human Services, Office of Civil Rights (OCR) announced the largest settlement ever with a single entity for multiple potential Health Insurance Portability and...more

HHS Final Rule Extends Anti-Discrimination Protection to Transgender Patients

This past May, the Department of Health and Human Services (HHS) issued a final rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin,...more

HIPAA Wake-Up Call for Financial Institutions: First HIPAA Settlement with Business Associate

It’s a HIPAA first. A business associate has settled a direct enforcement action over allegations that it potentially violated the Health Insurance Portability and Accountability Act (HIPAA). This settlement portends future...more

Ransomware Reporting Requirements & New HHS Guidance

Ransomware is malicious software that denies access to data, usually by encrypting the data with a private encryption key that is only provided once a ransom is paid. Sometimes the ransomware will actually destroy, steal, or...more

2.7 Million Dollar HIPAA Settlement

Last week, Oregon Health & Science University (“OHSU”) agreed to pay $2.7 million to resolve potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule, Privacy Rule, and...more

HHS Releases Guidance On Ransomware And HIPAA

On July 11, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published new guidance on the how HIPAA applies to ransomware prevention and attacks. Specifically, the guidance lays out...more

HHS OCR Guidance on Ransomware Attacks: They Constitute a “Security Incident” and Are Likely a Data Breach

On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in...more

New Materials Help Covered Entities Comply with Nondiscrimination Rules

Last week, the Department of Health and Human Services (“HHS”) released new materials for covered entities to use to comply with Section 1557, the nondiscrimination provision of the Affordable Care Act. Section 1557...more

Ransomware Attack is a Breach – Unless You Can Prove Otherwise

Ransomware is the fastest growing malware threat in the United States, targeting simple home computers to elaborate corporate IT networks. The Federal Bureau of Investigation recently reported an increase in ransomware...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

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 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

New Affordable Care Act and Medicaid Regulations Will Require Covered Entities Providing Healthcare Programs and Services to Have...

There has been a proliferation of ADA lawsuits alleging that websites are not accessible to the blind or deaf. Individuals who are blind or have low vision may require assistive devices and specialized software to access the...more

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