Those following artificial intelligence (AI) legal developments are closely watching California, which currently has four bills pending the Governor’s signature that will impact AI development and use. California is at the...more
9/24/2024
/ Artificial Intelligence ,
California ,
Disclosure Requirements ,
Health Care Providers ,
Healthcare ,
Legislative Agendas ,
Machine Learning ,
Regulatory Agenda ,
Risk Mitigation ,
Technology ,
Transparency
Big Picture -
Last week, Texas AG Ken Paxton (R) sued the Department of Health and Human Services (HHS), alleging that the new HHS final rule amending HIPAA regulations to strengthen protections for reproductive health...more
For states, managed care organizations, and providers—who all play a vital role in ensuring access to family planning services and supplies for the nearly 20 million women ages 18-44 enrolled in Medicaid1—the CIB reiterates...more
8/28/2024
/ Abortion ,
Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Contraceptives ,
Dobbs v. Jackson Women’s Health Organization ,
Family Planning Clinics ,
Health Insurance ,
Healthcare ,
Managed Care Contracts ,
Medicaid ,
New Guidance ,
Patient Access ,
Reproductive Healthcare Issues
On July 8, Substance Abuse and Mental Health Services Administration (SAMHSA) released two Notices of Funding Opportunities directing $27.5 million to initiatives addressing behavioral health care for women...more
This year, the federal government has made significant changes to longstanding health care privacy rules, while state lawmakers continue to enact privacy restrictions on consumer health data. These reforms modify legal...more
6/26/2024
/ Breach Notification Rule ,
Code of Federal Regulations (CFR) ,
Consumer Privacy Rights ,
Continuing Legal Education ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement Priorities ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Medical Records ,
Patient Privacy Rights ,
PHI ,
Popular ,
Privacy Laws ,
Reproductive Healthcare Issues ,
Substance Abuse ,
Web Tracking ,
Webinars
On Friday, May 17, Colorado Governor Jared Polis, with noted reservations, signed into law SB205, a consumer protection law which imposes significant requirements on developers and deployers of “high risk” artificial...more
Artificial intelligence (AI) continues to proliferate throughout the health care industry. With each advance comes complex legal and policy questions. Join us for a live webinar to explore these questions—specifically...more
5/14/2024
/ Affordable Care Act ,
Antitrust Provisions ,
Artificial Intelligence ,
Bias ,
Enforcement Actions ,
Ethics ,
FTC Act ,
Health Care Providers ,
Health Technology ,
Non-Discrimination Rules ,
Section 1557 ,
Webinars
The flurry of AI-related activity has certainly begun. Earlier this week, the Department of Commerce’s National Institute of Standards and Technology (NIST) released new draft guidance to improve the safety, security and...more
From the end of the COVID-19 public health emergency (PHE) to the overturning of Roe v. Wade to the growth of AI in health care, multiple forces are converging to remap the health care landscape. In a new webinar, Manatt...more
5/7/2024
/ Artificial Intelligence ,
Equity ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Mental Health ,
No Surprises Act (NSA) ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Preventive Health Care ,
Provider Payments ,
Regulatory Requirements ,
Reimbursements ,
Webinars
Artificial Intelligence (AI) has experienced remarkable growth in recent years, transforming industries and revolutionizing the way we interact with technology. With advancements in machine learning, natural language...more
Abstract Issue:
As states continue to enact new restrictions on abortion since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, access to critical reproductive health and abortion care...more
The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more
4/24/2024
/ Artificial Intelligence ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
OCR ,
ONC ,
Proposed Regulation ,
Regulatory Agenda
In the aftermath of the Supreme Court’s decision to overturn the federal constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization, individual states continue to decide the legality of abortion on a...more
4/16/2024
/ Abortion ,
Arizona ,
AZ Supreme Court ,
Constitutional Challenges ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
FL Supreme Court ,
Florida ,
Healthcare ,
Human Rights ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
State Bans ,
Women's Rights
On March 18, the Biden Administration announced that it is doubling down on its commitment—previously announced during President Biden’s State of the Union address—to transform women’s health research and improve the lives of...more
On March 18, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its December 2022 guidance for HIPAA-regulated entities regarding the use of online tracking technologies...more
3/25/2024
/ Cybersecurity ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Guidance Update ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Technology ,
Mobile App Privacy Guidelines ,
OCR ,
PHI ,
Web Tracking
Last week, Utah governor Spencer Cox signed into law Utah Senate Bill 149 (SB 149), also known the Artificial Intelligence Policy Act (the AI Policy Act). This is the first comprehensive state law on AI in the U.S., creating...more
The health care industry, like most industries, is exploring how to reap the benefits of increasingly powerful artificial intelligence-based technologies while managing the risks they pose. Federal and state policymakers are...more
1/30/2024
/ Artificial Intelligence ,
Bias ,
Discrimination ,
Georgia ,
Health Care Providers ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform
Earlier this week, Governor Kathy Hochul released her Executive Budget proposal totaling $233 billion for State Fiscal Year 2025. The budget proposes several initiatives targeted at improving access to, quality of, and...more
1/23/2024
/ Abortion ,
Employee Benefits ,
Employees ,
Family Planning Clinics ,
Gender Identity ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
LGBTQ ,
Life Sciences ,
Medicaid ,
New Legislation ,
New York ,
Paid Family Leave Law ,
Patient Access ,
Pregnancy ,
Qualified Health Plans ,
Reproductive Healthcare Issues ,
State Budgets ,
State Funding ,
Wage and Hour ,
Women's Rights
Editor’s Note: Manatt Health conducted a survey of all 34 states in which abortion is legal as of November 7, 2023, broadly classifying them based on their Medicaid coverage policies, private or exchange-based insurance...more
1/11/2024
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
Health Insurance ,
Healthcare ,
Human Rights ,
Life Sciences ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Women's Rights
On January 8, 2024, New York Governor Kathy Hochul and the New York Office of Information Technology Services (NY ITS) announced two major initiatives on artificial intelligence (AI) that will impact private and public...more
1/10/2024
/ Artificial Intelligence ,
Automation Systems ,
Cooperation Initiative ,
Corporate Counsel ,
Cybersecurity ,
Data Management ,
Data Privacy ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Machine Learning ,
New York ,
Popular ,
Regulatory Agenda ,
Risk Assessment
The Big Picture -
On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more
12/20/2023
/ Abortion ,
Alliance for Hippocratic Medicine v Food and Drug Administration ,
Article III ,
Certiorari ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Human Rights ,
Life Sciences ,
Medical Necessity ,
Patient Access ,
Pregnancy ,
Prescription Drugs ,
REMS ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Standing ,
Women's Rights
This week, the U.S. Department of Health and Human Services (HHS) took its first step in actually regulating the use of artificial intelligence (AI) in health care. Through its Office of the National Coordinator for Health...more
The Big Picture -
Many health care stakeholders have long relied on the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) guidance regarding an effective compliance program when...more
Changes to the Medicare Telehealth Services List Structure and Updates Process -
Prior to the COVID-19 public health emergency (PHE), the Centers for Medicare & Medicaid Services (CMS) evaluated changes to the Medicare...more
11/14/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Health Technology ,
Medicare ,
Opioid ,
Patient Access ,
Physician Fee Schedule ,
Physicians ,
Public Health Emergency ,
Rural Health Care Providers ,
Telehealth ,
Telemedicine
Last week, California Governor Gavin Newsom signed a package of legislation intended to strengthen the state’s shield laws, which provide protections to patients receiving and providers rendering reproductive health services,...more
10/4/2023
/ Abortion ,
California ,
Confidential Information ,
Electronic Protected Health Information (ePHI) ,
Equal Protection ,
Healthcare ,
Healthcare Reform ,
Human Rights ,
New Legislation ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Women's Rights