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29 Feb 2024, 5:17 pm by Kurt R. Karst
 The Notice, in part, provided that the required clinical data did not meet the required threshold to receive final approval and Lilly waived its opportunity for a hearing. [read post]
10 May 2017, 3:14 pm by Cynthia Marcotte Stamer
The Resolution Agreement resolves OCR charges the operator of 13 hospitals, eight Cancer Centers, three Heart & Vascular Institutes, and 27 sports medicine and rehabilitation centers violated the Privacy Rule that resulted from an OCR compliance review of MHHS triggered by multiple media reports suggesting that MHHS improperly disclosed the name and other details about a patient arrested and charged with presenting an allegedly fraudulent identification card to office staff at an MHHS’s… [read post]
17 Jan 2018, 3:18 am by Nate Nead
Major Products The IVD product market is segmented into instruments, reagents, services, and data management software. [read post]
6 Nov 2015, 6:58 am
  However, Mylan and Actavis contended that the patent was insufficient in relation to all the other types of pain recited, including neuropathic pain.Some rats may have been harmedduring the making of this inventionThe patent did not state that the data presented show that pregabalin is effective in the treatment of neuropathic pain, nor did it mention central sensitisation at all. [read post]
19 Aug 2021, 9:05 pm by Stacey Tovino
The most recent settlement involved Diabetes, Endocrinology & Lipidology Center, Inc. [read post]
22 Jul 2008, 10:42 am
Ortho-Clinical Diagnostics, Inc., 440 F.Supp.2d 465, 478 (M.D.N.C. 2006); Whiting v. [read post]
27 Aug 2011, 7:55 pm
§ 505(b)(2)-- both enjoying the additional advantage of using the clinical data or literature submitted in support of Miacalcin®. [read post]
9 Nov 2023, 1:48 pm by Cynthia Marcotte Stamer
Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. [read post]
2 Feb 2018, 8:57 am by Cynthia Marcotte Stamer
  Like the $2.3 million HIPAA resolution agreement OCR announced with now bankrupt radiation oncology and cancer care provider 21st Century Oncology, Inc. (21CO) earlier this year,  see, e.g. [read post]
30 Apr 2019, 10:23 am by Cynthia Marcotte Stamer
However, the FAQs also state a covered entity or its business associates won’t be responsible for the security of the data shared to the app unless it sponsors or provides it. [read post]
17 Aug 2009, 10:44 am
Some of these companies may not technically be startups, but I'm measuring the same data each month, so the year-to-year comparisons are valid. [read post]
1 Mar 2017, 12:55 pm by Cynthia Marcotte Stamer
 Stamer also is widely recognized for her extensive work and leadership on HIPAA, FACTA, PCI, IRC and other tax, Social Security, GLB, rade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other informatio [read post]
16 Feb 2017, 3:01 pm by Cynthia Marcotte Stamer
Stamer also is widely recognized for her extensive work and leadership on HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns including policy design, drafting, administration and training; business associate and other contracting; risk assessments, audits and other risk prevention and mitigation; investigation, reporting,… [read post]
8 Jul 2011, 8:38 pm by Jeralyn
The opportunity for scientists to conduct clinical research with marijuana exists under the HHS policy supporting clinical research with botanical marijuana. [read post]
8 May 2023, 12:22 am by INFORRM
The Washington Post has an article that explores the hidden privacy cost to the Clinic. [read post]