protected health information

All posts tagged protected health information

Genetic Testing HIPAA Warning: Legal Considerations

by admin on January 14, 2019 No comments

genetic testing hipaaBy: Jacqueline Bain

You might have recently received a holiday gift of a direct-to-consumer genetic testing kit from Ancestry.com or 23andMe.com (or any other number of companies). So exciting! In our melting pot society, one can’t help but be curious about where they come from and if they are more likely than any other person to be subject to any number of ailments.

Not so fast though! Before you swab yourself and send away your genes for testing, you might consider what you’re exposing yourself to. Direct-to-consumer genetic testing companies, which provide genetic testing directly to consumers without any intervening healthcare provider, are not bound by HIPAA. They are not considered “covered entities”, and therefore not required to use the same protections for genetic information the way a hospital or your doctor would.

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PHI Breach Penalty Dollars Rolling in for Healthcare Enforcement

by admin on November 1, 2018 No comments

PHI BreachBy: Dave Davidson

It has been a busy autumn for the enforcement of health care privacy rights.  Recent activities range from settling the claim for the largest HIPAA violation in US history, to penalties imposed for filming TV shows, to actions initiated by state governments.  All of these actions confirm the serious position taken by regulators nationwide to protect the privacy of protected health information (PHI).

The Big One

On October 15, 2018, Anthem, Inc., an independent licensee of Blue Cross, paid $16 million to settle its claim with the HHS Office of Civil Rights (OCR), for a breach that compromised the PHI of 79 million people.  This was the largest reported breach in history.  The PHI breach occurred in 2015, when hackers initiated a “spearfishing” attack via fraudulent emails.  The government found that Anthem lacked appropriate information system procedures to identify and respond to security breaches, and minimum access controls to stop these kinds of attacks.

In addition to the financial penalty, Anthem agreed to a corrective action plan, in which it agreed to perform a risk analysis, and incorporate the results of the analysis into its existing processes, in order to achieve a “reasonable and appropriate level” of HIPAA compliance.

This settlement is in addition to the $115 million settlement Anthem reached last year with the victims of the breach.

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New HIPAA Guidance for Substance Abuse and Mental Health Information

by admin on January 5, 2018 No comments

HIPAA PHIBy: Dave Davidson

In December 2016, the US Congress passed the 21st Century Cures Act, which, among other things, provided for increased funding for treatment and research of mental health and substance abuse disorders.  That law also required the HHS Office of Civil Rights (OCR) to provide guidance in regards to HIPAA compliance in regards to those types of treatment.  In October 2017, President Donald Trump declared the opioid addiction epidemic to be a public health emergency, which will also result in additional resources being allocated to addressing the crisis.

In connection with both the new law and the President’s declaration, OCR published its HIPAA guidance in December 2017.  The guidance is intended to clarify how and when protected health information (PHI) can be shared in regards to patients in substance abuse and mental health treatment.  According to OCR Director Roger Severino, “HHS is using every tool at its disposal to help communities devastated by opioids, including educating families and doctors on how they can share information to help save the lives of loved ones.”

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HIPAA Security Basics: Keeping your Medical Web-Based Business Compliant

by admin on May 16, 2017 No comments

By: Shobha Lizaso

Medical web-based businesses have been on the rise, while the number of HIPAA enforcement actions by the US Department of Health and Human Services (HHS) has risen exponentially as well. Since the beginning of this year, HHS has announced several large settlements with companies that failed to comply with HIPAA Compliance requirements. For example, in January, HHS announced a $2.2 million settlement with a health insurance company when a breach resulted from a stolen portable USB device containing PHI. Also, In February, HHS announced a penalty of $3.2 million against a medical center for a breach that arose from a theft of an unencrypted laptop containing PHI. This enforcement activity is becoming the norm, so it is best to ensure that your medical website is legally compliant.

If you are handling any PHI on or through your website, you must ensure that your website is up to speed with HIPAA compliance. Here are some recommendations to address the security and privacy of PHI that your website may manage (please note that this is not a comprehensive list):

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HIPAA Compliance: Docs, You’ve Been Hacked. What’s Next?

by admin on August 11, 2016 No comments

HIPAABy: Jacqueline Bain

Healthcare providers have heard the HIPAA disaster stories: a laptop containing patient information is left on the counter at the coffee shop; a thumb drive with patient files goes missing; a rogue employee accesses patient information she has no business accessing; hackers get into a practice’s server and hold the patient information for ransom.

HIPAA is a federal law designed for safe disclosure of patient’s protected health information.  The news headlines showcase giant penalties for violations.  However, Florida healthcare providers should also know that Florida has its own consumer protection statute, called the Florida Information Protection Act.  So while you’re busy worrying about your HIPAA exposure in any of these situations, remember that there is potential State exposure as well.

So what should a healthcare provider do if it believes there has been a hack or some other unauthorized disclosure?  Responses vary based on the situation presented, but below is a good jumping off point:

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Fall 2014 HIPAA Audits: Is Your Business Ready?

by admin on October 9, 2014 No comments

hipaa-audits-imageFile-3-a-7296By: Jackie Bain

Section 13411 of the HITECH Act authorizes and requires the Department of Health & Human Services Office for Civil Rights (“OCR”) to provide for periodic audits to ensure that covered entities and business associates comply with the HIPAA Privacy and Security Rules. OCR conducted its first round of those audits in 2011 and 2012, and has announced that it will begin a second phase.  Unlike the first phase of audits, which were limited to covered entities, both covered entities and business associates are intended to be audited during this second phase.

How will audited businesses be selected?

This fall, OCR will deliver pre-audit surveys to between 550 and 800 covered entities.  OCR is attempting to obtain a fair snapshot of all covered entities, so these pre-audit surveys will be sent to health care providers, health plans, and health clearinghouses. Moreover, the audits will span the gamut of business sizes, from large corporations to solo practitioners. After pre-audit surveys are returned, OCR will randomly select 350 of those covered entities for a full audit.  As a part of these full audits, covered entities will be asked to identify their business associates.  OCR will then select 50 business associates to participate.

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What's Hot on the #OIG Work Plan for 2014?

by admin on February 7, 2014 No comments

OIG crestThe U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released it’s 2014 Fiscal Year Work Plan. If you’ve got the stomach for the long version, click here. Around each fiscal year, the Department of Health and Human Services, Office of Inspector General publishes its annual Work Plan, which provides terrific insight into unique provider behavior and practices the OIG plans to target in 2014.  Medicare providers should pay particular attention to the following targeted areas:

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HIPAA Stings Dermatology Practice

by admin on January 8, 2014 No comments

HIPAAThe US Department of Health and Human Services, Office of Civil Rights is the chief enforcer of HIPAA.  The Office’s recent enforcement of HIPAA with respect to a Massachusetts derm practice is illustrative of how the government views HIPAA and how vulnerable medical practices are. 

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Final Privacy Rule Affects Clinical Research Organizations

by admin on February 13, 2013 No comments

The final HITECH Act rule was published on January 25th, and it includes revisions to HIPAA.  The two things affected by the new rule are (1) compound authorizations, and (2) authorizations for future research.

Compound authorizations are basically authorizations for two separate uses of protected health information (PHI).  The new rule allows combining an authorization for a research study with any other written permission for the same study, such as authorization to participate in the research.  The core elements of a valid authorization remain in place.  The intent is just to provide some flexibility in clinical research settings.

Traditionally, authorizations had to be study specific.  The new rule allows authorizations not to be study specific, but they have to describe future uses or disclosures in a way that patients will understand that their PHI could be used in future research.

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Final Privacy Rule Affects Clinical Research Organizations

by admin on February 5, 2013 No comments

The final HITECH Act rule was published on January 25th, and it includes revisions to HIPAA.  The two things affected by the new rule are (1) compound authorizations, and (2) authorizations for future research.

Compound authorizations are basically authorizations for two separate uses of protected health information (PHI).  The new rule allows combining an authorization for a research study with any other written permission for the same study, such as authorization to participate in the research.  The core elements of a valid authorization remain in place.  The intent is just to provide some flexibility in clinical research settings.

Traditionally, authorizations had to be study specific.  The new rule allows authorizations not to be study specific, but they have to describe future uses or disclosures in a way that patients will understand that their PHI could be used in future research.

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