Compliance Update

Sponsor Showcase Print E-mail
Written by Sponsor   
Tuesday, 06 March 2018 00:00
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Last Updated on Tuesday, 06 March 2018 18:42
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
Healthcare Compliance: Providers Must Use Plans They Have in Place Print E-mail
Written by Jacqueline Bain, Florida Healthcare Law Firm   
Tuesday, 23 January 2018 00:00

In 2015, Assistant Attorney General Leslie Caldwell spoke publicly about the importance for every healthcare provider to not only have a compliance program on its shelf, but also being sure that the compliance program is "tailored to the unique needs, risks and structure of each business or industry." Assistant Attorney General Caldwell explained, "the adequacy of a compliance program is a factor when [the DOJ] decide[s] how and whether to prosecute a company.  The lack or insufficiency of a compliance program can have real consequences for a company when a violation of law is discovered."

Last Updated on Wednesday, 24 January 2018 16:34
What You Should Know About OCR's HIPAA Privacy Audits Print E-mail
Written by Vitale Health Law   
Tuesday, 19 December 2017 19:27
Have you received a request from HHS Office for Civil Rights (OCR) asking that you provide the name of your privacy official along with any additional criteria? If you have, then you likely are aware that you may be the focus of a HIPAA privacy audit.

Last Updated on Tuesday, 19 December 2017 19:31
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