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LDT manufacturers who have not yet developed a sophisticated medical review infrastructure might experience elevated risks when submitting labeling that includes unvalidated claims about safety or effectiveness (i.e., comparative claims about different LDTs without head-to-head clinical trial validation). [read post]
16 May 2024, 3:00 am by Yosi Yahoudai
You’re talking about patients who are often at the most vulnerable medical moment of their life. [read post]
3 May 2024, 3:04 am by Robin E. Kobayashi
Einbund conducted a clinical examination of applicant and issued a report in which he noted that several presenting symptoms were outside of his medical expertise and requested authorization to make referrals to other physicians specializing in neurology, internal medicine, and psychiatry. [read post]
2 May 2024, 6:25 pm by Kurt R. Karst
  FDA notes as evidence of LDTs lacking appropriate analytical and clinical validity that New York State Department of Health Clinical Laboratory Evaluation Program (NYS CLEP) couldn’t approve more than half of initial applications because of deficiencies such as, including inadequate validation data. [read post]
28 Apr 2024, 11:33 am by admin
Egilman, who identified several examples in which disease causation has been established based on animal and clinical case studies alone to demonstrate that ‘doctors utilize epidemiological data as one tool among many ’. [read post]
25 Apr 2024, 6:52 am by Daniel J. Gilman
The Cleveland Clinic, the Mayo Clinic, the Johns Hopkins Health Services Corp. [read post]
19 Apr 2024, 1:59 am by Yosi Yahoudai
”>> RELATED COVERAGE: Families of deceased inmates missing organs demand answers Prison warden empowered to give consent, lawsuits sayThe Alabama Department of Corrections is the largest law enforcement agency in the state, with 28 facilities and nearly 2,000 officers.The University of Alabama at Birmingham Heersink School of Medicine bills itself as one of the nation’s top academic medical centers for research, education and clinical care. [read post]
18 Apr 2024, 9:24 am by Robin E. Kobayashi
[LexisNexis Commentary: The IMR reviewer in this case provides a detailed explanation as to why surgery is necessary to correct applicant’s trauma-related deviated septum. [read post]
16 Apr 2024, 11:41 am by Barrett Ahn
Meadows with the Department of Health and Human Services-Office of Inspector General (DHHS-OIG) asserted that the “DHHS-OIG remains steadfast in holding accountable those who prioritize personal gain over delivering legitimate medical services. [read post]
3 Apr 2024, 1:54 pm by Seamus Kim
” The False Claims Amendments Act of 2023, a bipartisan effort introduced on July 25, seeks to correct a few technical loopholes used to circumvent the FCA. [read post]
3 Apr 2024, 12:44 pm by Robin E. Kobayashi
Independent Medical Review Decisions CAUTION: The Publisher’s Staff has reviewed both overturned and upheld independent medical review (IMR) decisions beginning in 2017. [read post]
18 Mar 2024, 6:00 am by Sherica Celine
For example, depending on their business, companies should also be aware of the confidentiality requirements in Title I of the Americans with Disabilities Act, the FDA’s confidentiality rules during clinical trials, and the Individuals with Disabilities Education Act’s medical information confidentiality requirements (in addition to a wide range of state laws that impact the privacy and confidentiality of health data). [read post]
29 Feb 2024, 9:05 pm by Tyler Hoguet
The Seventh Circuit overturned a decision from a federal judge that barred the prohibition of certain medical and therapeutic treatments for transgender minors. [read post]
29 Feb 2024, 3:23 pm by Richard Hunt
Quest Diagnostics Clinical Laboratories, Inc., 2023 WL 6447226, (C.D. [read post]
21 Feb 2024, 9:45 am by Trent Dykes
Last year the Regional Director of NLRB Region 9 filed a consolidated complaint accusing an operator of spas and medical clinics of violating the National Labor Relations Act (NLRA) by allegedly seeking to enforce its noncompete, non-solicitation and confidentiality agreement. [read post]
8 Feb 2024, 9:05 pm by Tyler Hoguet
Department of Health and Human Services (HHS) issued a final rule implementing changes to the regulations governing methadone clinics and other opioid addiction treatment centers. [read post]
10 Jan 2024, 11:11 am by Roger Bate
Some medications probably aren’t withdrawn quickly enough. [read post]
8 Jan 2024, 2:02 am by INFORRM
The case concerned a medical service provider (MDK) who had processed the personal health data of an incapacitated employee and passed the information to a health insurance fund. [read post]