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Compliance Update
Sponsor Showcase Print E-mail
Written by Sponsor   
Wednesday, 31 January 2018 00:00
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Last Updated on Wednesday, 31 January 2018 10:33
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
Compliant STEM Cell Therapy & HCT/Ps: Beginner's Guide Print E-mail
Written by Susan St. John | Florida Healthcare Law Firm   
Tuesday, 21 November 2017 00:00
Many practitioners or establishments looking to enhance their practice and offer more treatment options to their patients are considering HCT/P and Stem Cell Therapy in addition to other traditional treatment options. However, before embarking on offering HCT/P or STEM Cell Therapy, a practitioner or establishment needs to carefully consider protocol and procedure for offering HCT/Ps or STEM Cell Therapy.

Last Updated on Friday, 24 November 2017 18:21
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