California Attorney General (AG) Rob Bonta issued two new Legal Advisories on Jan. 13, 2025, to provide further clarity on the application of California law(s) to businesses, including those in the healthcare industry, that...more
Over the past two years, federal and state government agencies have moved to regulate the deployment of artificial intelligence (AI) in the healthcare setting, including in the utilization management (UM) and prior...more
11/1/2024
/ Artificial Intelligence ,
Biden Administration ,
Congressional Intent ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Med Tech ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
New Legislation ,
Physicians ,
Prior Authorization ,
Regulatory Oversight ,
Regulatory Standards ,
Strategic Planning
The Criminal Division of the U.S. Department of Justice (DOJ) recently updated its Evaluation of Corporate Compliance Programs (ECCP) policy document, which prosecutors rely on to evaluate the effectiveness of compliance...more
10/31/2024
/ Analytics ,
Artificial Intelligence ,
Code of Conduct ,
Compliance ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Enterprise Risks ,
Fraud ,
Health Care Providers ,
Risk Assessment ,
Risk Mitigation ,
Technology
The 2024 Public Health Service (PHS) Policies on Research Misconduct involving PHS-funded research were released by the U.S. Department of Health and Human Services (HHS) through the Office of Research Integrity (ORI) on...more
The National Security Presidential Memorandum-33 (NSPM-33), issued in January 2021, directed federal agencies that fund research and development (R&D) projects to require certain "Covered Institutions" to certify that the...more
7/23/2024
/ Certification Requirements ,
Colleges ,
Compliance ,
Covered Entities ,
Cybersecurity ,
Export Controls ,
False Claims Act (FCA) ,
Federal Funding ,
Government Agencies ,
Hospitals ,
International Travel ,
Medical Research ,
National Security ,
New Regulations ,
Nonprofits ,
OSTP ,
Popular ,
Presidential Memorandum ,
Research and Development ,
Research Funding ,
Scientific Research ,
Training Requirements ,
Universities
Recently, Holland & Knight healthcare attorneys have received questions as to whether the Eliminating Kickback in Recovery Act (EKRA) is still in effect, given the recent expiration of many provisions of the Substance...more
2/15/2024
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Department of Labor (DOL) ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement Actions ,
Fraud and Abuse ,
Health Care Providers ,
Medicaid ,
Medicare ,
Sunset Provisions ,
Virus Testing
Enacted in 2018, the Eliminating Kickbacks Recovery Act (EKRA) remains a source of anxiety and confusion in the clinical laboratory industry. In the four years since EKRA's enactment, U.S. Department of Justice (DOJ)...more