Why It Matters -
Businesses should begin to address these issues now so that when COVID-19 vaccines are ready for distribution, they will be too....more
12/16/2020
/ Americans with Disabilities Act (ADA) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Employer Liability Issues ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
OSHA ,
Popular ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Title VII ,
Vaccinations
Why It Matters -
In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more
10/7/2020
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Electronic Health Record Incentives ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Machine Learning ,
OCR ,
Security Risk Assessments
In response to a wave of questions from organizations looking to contribute to the fight against COVID-19, HHS recently clarified the bounds of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, which...more
Following declarations of a public health emergency by President Trump and the Secretary of the Department of Health and Human Services (HHS), HHS continues to loosen legal restrictions in an effort to mitigate harm from the...more
Makers, distributors, program planners and administering entities of coronavirus (COVID-19) countermeasures are protected from liability under a declaration issued by the Department of Health and Human Services (HHS)...more
3/17/2020
/ China ,
Coronavirus/COVID-19 ,
Countermeasures ,
Covered Entities ,
Crisis Management ,
Department of Health and Human Services (HHS) ,
Distributors ,
Emergency Management Plans ,
Immunity ,
Infectious Diseases ,
Manufacturers ,
Pharmaceutical Distribution ,
Popular ,
Public Health
HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more
The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies.
Annually, the Department of Health and Human Services...more
6/15/2015
/ Department of Health and Human Services (HHS) ,
Healthcare ,
Medicaid ,
Medicaid Reimbursements ,
Medicare ,
Medicare Part D ,
OIG ,
Payor Contracts ,
Pharmaceutical Industry ,
Pharmacies ,
Reporting Requirements