As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more
9/18/2024
/ Compliance ,
Consumer Protection Act ,
Dispute Resolution ,
Drug Pricing ,
Healthcare Reform ,
HRSA ,
Pharmaceutical Industry ,
Pharmacies ,
PHRMA ,
Prescription Drugs ,
Section 340B ,
Unfair or Deceptive Trade Practices
As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more
6/28/2024
/ Artificial Intelligence ,
Colorado ,
Compliance ,
Consumer Protection Laws ,
Covered Entities ,
Disclosure Requirements ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medical Devices ,
ONC ,
Risk Assessment ,
Software Developers
As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity performance goals (HPH CPGs) in January 2024 and...more
4/5/2024
/ Compliance ,
Critical Access Hospitals ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Incentives ,
Medicare ,
NIST ,
Penalties ,
Popular
Governor Newsom signed 890 bills and vetoed 156 bills in 2023. Every year, California passes multiple laws that impact health care practitioners and health facilities and, as further described below, 2023 is no exception....more
11/8/2023
/ California ,
Compliance ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hart-Scott-Rodino Act ,
Healthcare ,
Home Health Care ,
Mental Health ,
New Legislation ,
Pharmacist ,
Skilled Nursing Facility
The Office for Civil Rights (OCR) recently offered covered entities and business associates (Regulated Entities) not-so-subtle reminders in its October 2023 Cybersecurity Newsletter that effective sanction policies can...more
10/23/2023
/ Audits ,
Business Associates ,
Compliance ,
Covered Entities ,
Cybersecurity ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
Noncompliance ,
OCR ,
Policies and Procedures ,
Sanctions