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14 Oct 2021, 6:24 am by Andrew Lu
Should you have any questions related to the medical device De Novo classification process, including navigating the new regulations, please do not hesitate to reach out to the health care attorneys at Reed Smith. [read post]
13 Oct 2021, 7:16 pm by Edward J. Cyran
The agencies include the Department of Health and Human Services Office of Inspector General, the FBI, the Drug Enforcement Administration, the Health Care Fraud Unit of the Criminal Division’s Fraud Section, the Health Care Fraud and Appalachian Regional Prescription Opioid Strike Force and the U.S. [read post]
12 Oct 2021, 9:03 pm by Katherine McKeen
No U.S. agency tracks the long-term health effects of egg donation. [read post]
12 Oct 2021, 7:59 am by Jourdan Day
To prove vaccination status, employees must show or provide one of the following: a copy of the record of immunization from a health care provider or pharmacy; a copy of the COVID-19 Vaccination Record Card; a copy of medical records documenting the vaccination; a copy of immunization records from a public health or state immunization information system; or a copy of any other official documentation verifying vaccination with information on the vaccine name, date(s) of… [read post]
11 Oct 2021, 7:59 pm by Cynthia Marcotte Stamer
Along with any exposures specifically applicable to it as a government contractor, depending on the nature of the business and the data it collects, the business also likely falls subject to duties to safeguard the confidentiality and security of wide range of electronic or other personal financial, tax and other data under various federal and state laws such as FACTA, the Internal Revenue Code, the Health Insurance Portability & Accountability Act (HIPAA), state identity theft, and a… [read post]
Large Group Health Insurance: SB 255 will authorize an association of employers to offer a large group health care service plan contract or large group health insurance policy consistent with ERISA if certain requirements are met, including: (1) that the association is headquartered in California; (2) has continuously been a Multi-Employer Welfare Arrangement under ERISA (MEWA) since before March 23, 2010; (3) and that the large group health… [read post]
11 Oct 2021, 11:10 am by Emily Dai
Stephen Morrison, senior vice president and director of Global Health Policy Center at CSIS. [read post]
11 Oct 2021, 7:30 am by Andrew L. Levy and Abbegael Giunta
”  Federal agency workers and military personnel are required to be vaccinated; health care facilities that participate in Medicare or Medicaid must require vaccination for health care workers; certain federal government contractors must ensure that covered employees are vaccinated (see our prior blog post on the Safer Federal Workforce Task Force Guidance under EO 14042); and OSHA has been directed to issue an Emergency Temporary Standard… [read post]
7 Oct 2021, 10:19 pm by Matthew DeVries
 Covered federal contractors must require employees provide one of the following documents: a copy of the record of immunization from a health care provider or pharmacy; a copy of the employee’s COVID-19 Vaccination Record Card; a copy of immunization records from a public health or State immunization information system; or a copy of any other official documentation verifying vaccination that includes vaccine name, date(s) of administration,… [read post]
7 Oct 2021, 10:19 pm by Matthew DeVries
 Covered federal contractors must require employees provide one of the following documents: a copy of the record of immunization from a health care provider or pharmacy; a copy of the employee’s COVID-19 Vaccination Record Card; a copy of immunization records from a public health or State immunization information system; or a copy of any other official documentation verifying vaccination that includes vaccine name, date(s) of administration,… [read post]
7 Oct 2021, 9:03 pm by Jillian Moss
Alexis McGill Johnson, the head of the Planned Parenthood Federation of America called the new rule “a major victory for patients, access to sexual and reproductive health care, and health equity. [read post]
6 Oct 2021, 9:05 pm by Dan Flynn
In 2021, multiple outbreaks of cyclosporiasis cases associated with different restaurants or events were investigated by state public health authorities, CDC, and the Food and Drug Administration (FDA). [read post]
6 Oct 2021, 3:30 am by Eric B. Meyer
The data that must be on any official documentation are the type of vaccine administered, date(s) of administration, and the name of the health care professional(s) or clinic site(s) administering the vaccine(s). [read post]
In addition to new “natural” and “place of origin” filings, a significant trend is also beginning to form with respect to health and nutrient claims, including sugar content (Cleveland v. [read post]