Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would...more
12/31/2024
/ Compliance ,
Data Breach ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
Multi-Factor Authentication ,
OCR ,
Proposed Amendments ,
Proposed Rules ,
Ransomware
The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice”...more
10/10/2024
/ Artificial Intelligence ,
Consent ,
Data Collection ,
Data Privacy ,
Data Storage ,
Ethics ,
EU ,
Food and Drug Administration (FDA) ,
GAO ,
General Data Protection Regulation (GDPR) ,
Governance Standards ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
Office for Human Research Protections (OHRP) ,
OIG ,
Popular ,
Research and Development
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
Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It...more
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
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
New Mexico recently became the latest state to receive Centers for Medicare & Medicaid Services (CMS) approval to expand the state’s behavioral health service offerings through mobile crisis intervention teams.
Under...more
With the goal of enhancing health care quality and outcomes for individuals with moderate to severe behavioral health conditions and substance use disorders (SUD), the Centers for Medicare & Medicaid Services (CMS) recently...more
2/6/2024
/ Alternative Payment Models (APM) ,
Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Equity Plans ,
Healthcare ,
MCOs ,
Medicaid ,
Mental Health ,
Merit-Based Point System ,
Reimbursements ,
Substance Abuse
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
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
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
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
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
In response to concerns about the confidentiality of protected health information (PHI) related to reproductive health care less than one year after Dobbs v. Jackson Women’s Health Organization decision, and the prospect of...more
The Centers for Medicare & Medicaid Services (CMS) recently published the Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule (Prior Authorization Proposed Rule), and, if certain components...more
The Federal Trade Commission (FTC) recently kicked off enforcement of its Health Breach Notification Rule (Breach Rule) by taking aim at GoodRx’s use of tracking technologies (e.g. pixels) and the sharing of consumer health...more
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