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Compliance Update
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Written by Sponsor   
Wednesday, 04 July 2018 00:00
 
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Last Updated on Tuesday, 03 July 2018 12:20
 
HIPAA Violation Results in $4.3M Fine for Cancer Center Print E-mail
Written by Vitale Health Law   
Tuesday, 03 July 2018 12:16
 
If you haven’t taken stringent measures to protect patient privacy, this recent ruling from a U.S. Department of Health and Human Services Administrative Law Judge might spur you into action.
 
The ALJ ruled that University of Texas MD Anderson Cancer Center violated HIPAA Privacy and Security Rules and granted summary judgment to the Office for Civil Rights (OCR) requiring the institution to pay $4.3 million in civil money penalties. This was just the second summary judgment victory in OCR’s history of HIPAA enforcement and the $4.3 million is the fourth largest amount ever awarded to OCR by an ALJ or secured in a settlement for HIPAA violations, according to OCR.

The ruling grew out of an investigation conducted by OCR following three separate data breach reports in 2012-13 involving the theft of an unencrypted laptop from the home of an MD Anderson employee, along with the loss of two unencrypted USB thumb drives that contained the personal health information of more than 33,500 patients.
 
 
Last Updated on Tuesday, 03 July 2018 12:22
 
Complicated Relationships Print E-mail
Written by Jacqueline Bain   
Monday, 04 June 2018 00:00
 
Healthcare providers often have more than one relationship with each other. For instance, a physician may be employed by a hospital and also provide that hospital with medical director services. Or a healthcare consultant may also be a healthcare provider's landlord. Oftentimes, these types of relationships are each memorialized in one or several contracts between the parties. And while, on their face, these contracts may seem to be compliant with applicable healthcare laws, when examined together, compliance and other contract issues may arise.

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Dumpster Diver Demonstrates Importance of Proper Medical Records Storage and Disposal Print E-mail
Written by Vitale Health Law   
Monday, 05 March 2018 00:00

Just because a business closes its doors, it doesn't mean that it no longer is obligated to safeguard patients' protected health information (PHI), as one company recently learned. Earlier this month, the receiver appointed to liquidate the assets of Filefax, Inc. agreed to pay $100,000 out of the receivership estate to settle potential HIPAA violations. Filefax was an Illinois  company that provided storage, maintenance and delivery of medical records. Before it shut its doors in 2016, the U.S. Department of Health and Human Services Office for Civil Rights received a complaint alleging that a "dumpster diver" brought medical records obtained from Filefax to a shredding and recycling facility to exchange for cash. After opening an investigation, OCR confirmed that the medical records of more than 2,100 patients had been left at the shredding facility in February 2015.

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The FDA Inspection and Enforcement Process: A Guide for HCT/P Manufacturers and Providers  Print E-mail
Written by Matthew Fischer, Florida Healthcare Law Firm   
Tuesday, 30 January 2018 00:00

In November 2017, the U.S. Food and Drug Administration (FDA) issued new guidance regarding its current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271(a) and the agency's view on the same surgical procedure exception under 21 CFR 1271.15(b).  Additionally, the FDA issued a notice to all interested stakeholders that the agency intends to initiate increased discretionary enforcement over the next 36 months for HCT/P businesses.  Based on the agency's latest position, it is important for HCT/P manufacturers and providers to understand the inspection process and be prepared to respond accordingly in this heightened regulatory environment.

Last Updated on Wednesday, 31 January 2018 10:28
 
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