As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more
10/2/2024
/ Algorithms ,
Anti-Discrimination Policies ,
Artificial Intelligence ,
Children's Health Insurance Program (CHIP) ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
Medicaid ,
Medicare ,
PHI ,
Policies and Procedures ,
Section 1557 ,
Telehealth ,
Transparency
On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...more
7/16/2024
/ 21st Century Cures Act ,
ACOs ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Final Rules ,
Government Investigations ,
Health Care Providers ,
Hospitals ,
Information Blocking Rules ,
Medicare Shared Savings Program ,
MIPS ,
OIG ,
ONC ,
PHI
On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more
1/2/2024
/ 21st Century Cures Act ,
Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Certification Requirements ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Executive Orders ,
Final Rules ,
Government Agencies ,
Health Care Providers ,
Information Blocking Rules ,
ONC ,
Regulatory Agencies ,
Regulatory Agenda ,
Regulatory Oversight ,
Reporting Requirements ,
Transparency
On June 27th, Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) posted its final rule (Final Rule), which amends the OIG’s civil monetary penalty (CMP) regulations to implement the...more
6/30/2023
/ 21st Century Cures Act ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Blocking Rules ,
Information Technology ,
OIG ,
Self-Disclosure Requirements ,
Software Developers