A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain...more
Holland & Knight's Healthcare & Life Sciences Policy Team regularly provides updates through our weekly Health Dose. This special Health Dose: Post-Election Edition is intended to outline the short- and long-term potential...more
11/12/2024
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Congressional Intent ,
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Federal Budget ,
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Health Care Providers ,
Healthcare Reform ,
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NDAA ,
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Public Policy
CMS Regulation -
CMS and ONC Unveil Proposals Transforming Interoperability and Patient Access to Data -
The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health...more
3/1/2019
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Electronic Health Record Incentives ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
ONC ,
Opioid ,
Proposed Rules
On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells