On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR)...more
5/17/2024
/ Administrative Law Judge (ALJ) ,
Affordable Care Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Federal Rules of Civil Procedure ,
Federal Rules of Evidence ,
Final Rules ,
HRSA ,
Office of Pharmacy Affairs (OPA) ,
Section 340B
Preventing discrimination and bias in connection with the use of artificial intelligence (AI) in health care are among the principal current focuses of U.S. Department of Health and Human Services (HHS) and were included in...more
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
As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the...more
1/26/2024
/ Artificial Intelligence ,
Cybersecurity ,
Data Breach ,
Data Security ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Information Blocking Rules ,
Mental Health ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Request For Information ,
SAMHSA ,
Substance Abuse ,
Transparency
The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy...more
1/9/2024
/ Artificial Intelligence ,
Certifications ,
Department of Health and Human Services (HHS) ,
EHR ,
Executive Orders ,
Final Rules ,
Food and Drug Administration (FDA) ,
Governance Standards ,
Machine Learning ,
ONC ,
Regulatory Agenda ,
Risk Mitigation ,
Transparency
The U.S. Department of Health and Human Services (HHS) released a concept paper on December 6, 2023 outlining its action plan to enhance cyber resiliency in the health care sector by proposing certain voluntary cybersecurity...more
In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more
11/7/2023
/ 21st Century Cures Act ,
ACOs ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Critical Access Hospitals ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Information Blocking Rules ,
Investigations ,
Medicare Shared Savings Program ,
OIG ,
ONC ,
Reporting Requirements ,
Social Security Act
On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House...more
11/3/2023
/ Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
LEAP ,
Non-Discrimination Rules ,
Policies and Procedures ,
Privacy Laws ,
Transparency
Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun...more
7/14/2023
/ Advisory Opinions ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Trade Commission (FTC) ,
Final Rules ,
Health Care Providers ,
Health Technology ,
Information Blocking Rules ,
Investigations ,
OIG ,
ONC
As illustrated by a recent Office for Civil Rights (OCR) settlement with a dental practice, health care entities continue to struggle with how to respond to negative online reviews while maintaining compliance with the HIPAA...more
The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal...more
12/21/2022
/ Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Department of Veterans Affairs ,
Federal Health Care Programs (FHCP) ,
Healthcare ,
OIG ,
Payment Systems ,
Telehealth ,
TRICARE
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been busy over the past month announcing new enforcement actions and settlement agreements related to violations of the Privacy...more
Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the...more
Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more
8/1/2022
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLFS ,
Clinical Laboratories ,
Department of Health and Human Services (HHS) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part C ,
PAMA ,
Proposed Amendments ,
Reimbursements
All players in the health and wellness ecosystem should be following developments around the American Data Privacy and Protection Act (ADPPA). If enacted, the ADPPA would be a watershed in the regulation of the privacy and...more
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released a Request for Information (RFI) to obtain industry feedback and inform potential future rulemaking regarding information...more
4/14/2022
/ Civil Monetary Penalty ,
Cybersecurity ,
Cybersecurity Act of 2015 ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
NIST ,
OCR ,
Request For Information ,
Rulemaking Process ,
Social Security Act
The United States Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) leadership announced during last week’s HIMSS 2022 Conference that the agencies will be focusing on...more
The Office of the National Coordinator for Health Information Technology (ONC) published noteworthy information blocking claim submission trends to date in its recent Information Blocking Claims: By the Numbers post on the...more