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On December 10, 2020, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a proposed rule that would revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

In its news release, OCR noted that the changes “seeks to promote value-based health care by examining federal regulations that impede efforts among healthcare providers and health plans to better coordinate care for patients.” The proposed changes come on the heels of the recently delayed Information Blocking Rule, which seeks to prohibit interferences with access, exchange, or use of electronic health information (EHI). The key proposed changes are discussed below.Continue Reading Relaxing Privacy Requirements? Department of Health and Human Services Proposes Changes to HIPAA

The U.S. Department of Health & Human Services Office of Civil Rights (OCR) announced that it will refrain from imposing penalties for violations of HIPAA for covered entities or business associates participating, in good faith, in the operation of COVID-19 Community-Based Testing Sites during the nationwide public health emergency. The notice related to the relaxation…

On March 17, 2019, the Department of Health and Human Services, Office of Civil Rights (OCR) announced that it will exercise its enforcement discretion and waive potential penalties for HIPAA violations against healthcare providers that see patients through non-public communication applications during the COVID-19 nationwide public health emergency.

Background on Security Requirements for Telemedicine providers

Under what is commonly referred to as the HIPAA “Security Rule,” CMS requires organizations to have certain safeguards in place to protect patients’ health information. These safeguards require organizations to comply with certain minimum technical and organizational requirements. Part of the technical requirements is that organizations must have security measures in place “to guard against unauthorized access to electronic protected health information that is being transmitted over an electronic communications network.” This requires providers to utilize telehealth platforms that have, at a minimum, certain encryption and integrity controls in place. Furthermore, as an organizational safeguard, the Security Rule requires that telehealth providers enter into Business Associate Agreements with these platforms to ensure the platform will comply with HIPAA and protect patients’ health information.Continue Reading OCR to Waive Penalties for Telehealth Using Popular Communication Applications

fishing pole

For over twenty years, my father was a wholesale seafood supplier. One day over dinner (probably lobster, because that’s just how we rolled), my father tells us that he has hired an off-duty US Department of Agriculture inspector to inspect the fish that his company will be sending out to its grocery store clients. When I asked him if this was a legal requirement, he said it was not (the Department of Health and Human Services, via the FDA, apparently regulates fish, not the USDA). When I then asked him why he was doing it, he said, “If you were in the grocery store and you saw one piece of fish labelled ‘USDA Government Inspected’ and one piece of fish without that label, which one would you buy?” An informal “seal” program had been born!
Continue Reading Your (Privacy) Fate is Sealed…

Metal 2018 and 2017 number on the wooden beach sign standing at the beach.

It’s time for year-behind-us reminisces and year-before-us prognostications and, for those of us with nothing better to do during the last few days of 2017 and first few days of 2018, attention turns to HIPAA enforcement. So what happened and what can we look forward to? If past is prologue, expect the sound of silence as there was nominal Office for Civil Rights (OCR) activity in 2017 and, with the one noisy exception, no actions to cause your ears to burn.
Continue Reading HIPAA New Year!

Boxing glovesAnytime we conduct a training, we can’t help but turn blue in the face repeating over and over again the importance of conducting an accurate and thorough risk analysis of electronic PHI (ePHI). In the event of a breach or an audit, one of the first items the Office of Civil Rights (OCR) will ask for is the risk analysis. The OCR has obviously lost its patience for entities that choose or fail to perform an adequate risk analysis. Earlier this month, Advocate Health Care Center (Advocate Health) agreed to pay a massive $5.55 million to settle multiple violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This settlement is the largest to-date against a single entity.
Continue Reading HIPAA punches a serious blow: Advocate Health enters into $5.5-million settlement for violations

School children raising their hands ready to answer the question.

In this series on establishing security classifications for your company’s information, last week’s post looked at one aspect – the widely varying definitions of Protected Information under state PII breach notification statutes. But if your organization is a covered entity or business associate under the Health Insurance Portability and Accountability Act (HIPAA), the definition of Protected Health information (PHI) is also a key puzzle piece for your classification scheme.

HIPAA establishes national standards for the use and disclosure of PHI, and also for the safeguarding of individuals’ electronic PHI, by covered entities and business associates. Merely having information commonly thought of as “protected health information” does not mean that HIPAA applies. And there are some surprises in which organizations are – and are not – covered by HIPAA. So, that’s the first question to answer – is your company a HIPAA covered entity or business associate?Continue Reading Adding more class to Information Governance (Part 2)

Image copyright Catherine Lane 2015

My New Year’s resolutions will likely be broken early and often in 2016. My consequences are mostly non-monetary: a few more pounds, a little less savings, and not winning the triathlon in my age group. Your consequences, as a HIPAA-covered entity or business associate, for not complying with the Privacy and Security Rules could be much greater, and could put you into serious debt to the HHS Office of Civil Rights (OCR). Therefore, we propose that you resolve now to become fully HIPAA compliant in 2016.

OCR delivered an early holiday gift, wrapped in the Director’s Sept. 23, 2015, report to the Office of Inspector General. In that report, she disclosed that OCR will launch Phase 2 of its HIPAA audit program in early 2016, focusing on noncompliance issues for both covered entities and business associates.

So, grab that cup of hot cocoa and peruse this review of 2014-2015 HIPAA enforcement actions, which should help identify noncompliance issues on which OCR will focus in 2016. 
Continue Reading HIPAA compliance: another year older, but hopefully not deeper in debt