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
California’s new Office of Health Care Affordability (OHCA) is set to start pre-closing regulatory review of certain health care transactions on January 1, 2024. As further explained in our previous post, subject to certain...more
California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care transactions beginning January 1, 2024. As further explained in our previous post, subject to...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
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
California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care transactions beginning January 1, 2024. As further explained in our previous post, subject to...more
Governor Gavin Newsom recently signed multiple bills into law as part of California’s ongoing efforts to safeguard access to reproductive and gender affirming health care. The new laws are intended to increase protections for...more
10/12/2023
/ Abortion ,
Anti-Discrimination Policies ,
Birth Control ,
Cal Code of Civil Procedure ,
California ,
CMIA ,
Federal Employees ,
Gender Identity ,
Health Care Providers ,
New Legislation ,
Professional Disciplinary Actions ,
Reproductive Discrimination ,
State Health Departments
January 1, 2024 is rapidly approaching, which is when California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care mergers, acquisitions, affiliations, and other...more
A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this...more
Covered entities, business associates, and any entities that collect health information about consumers online should carefully review the latest joint letter from the Office for Civil Rights (OCR) and the Federal Trade...more
7/25/2023
/ Cybersecurity ,
Data Collection ,
Data Privacy ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Third-Party ,
Tracking Systems
Washington greatly expanded the protection for consumers’ identifiable health information by enacting the “My Health My Data Act” (MHMDA), in an effort to close the gap between HIPAA protections and the laws protecting the...more
The COVID-19 pandemic has coincided with worsening mental health across the country, and California is no exception. Not surprisingly, Governor Gavin Newsom signed into law multiple pieces of mental health treatment related...more
In April, 2020, in an effort to facilitate a national pivot to telehealth in light of the COVID-19 Public Health Emergency (PHE), the U.S. Department of Health & Human Services Office for Civil Rights (OCR) announced a policy...more
5/2/2023
/ Business Associates Agreement (BAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Due Diligence ,
Enforcement ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Public Health Emergency ,
Security Risk Assessments ,
Subcontractors ,
Vendors
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
On February 1, 2023, New York Governor Kathy Hochul announced the Fiscal Year 2024 New York State Executive Budget (the Executive Budget). One component of the Executive Budget’s Health and Mental Hygiene Article VII...more
3/2/2023
/ ACOs ,
Acquisitions ,
Anti-Competitive ,
Enforcement ,
Health Care Providers ,
Healthcare Costs ,
Investment ,
Mental Health ,
Mergers ,
Notification Requirements ,
State Health Departments ,
Unfair Competition
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
Governor Gavin Newsom signed 997 bills into law in 2022, including a substantial number relating to health care. In Part II of our legislative update, we summarize many of the laws relevant to health facilities, a number of...more
12/21/2022
/ CDPH ,
Governor Newsom ,
Healthcare Facilities ,
Hospice ,
Hospitals ,
Licensing Rules ,
Long Term Care Facilities ,
Mental Health ,
New Legislation ,
Pharmacies ,
Skilled Nursing Facility ,
Substance Abuse
Covered Entities and Business Associates should promptly and carefully review their use of online tracking technologies on their websites and mobile apps following a bulletin (Bulletin) published by the U.S. Department of...more
12/8/2022
/ Class Action ,
Compliance ,
Data Collection ,
Dobbs v. Jackson Women’s Health Organization ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Mobile Apps ,
OCR ,
PHI ,
Reproductive Healthcare Issues ,
Risk Assessment ,
Websites
As of the close of the 2021-22 legislative session, Governor Gavin Newsom signed into law health care related legislation tackling issues from management of health care costs to reproductive rights. In Part I of our...more
The health omnibus trailer SB-184, which created the Office of Health Care Affordability (OHCA), is set to usher in a significant change in California’s health care regulatory landscape. Beginning in 2024, certain health care...more
A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more
10/11/2022
/ Anti-Kickback Statute ,
California ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Civil Monetary Penalty ,
Databases ,
Department of Health and Human Services (HHS) ,
Medicaid ,
Medical Devices ,
Medicare ,
New Legislation ,
Open Payments ,
Physicians ,
Prescription Drugs ,
Sunshine Act
A spurt of letters from California Attorney General Rob Bonta to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms...more
9/13/2022
/ Algorithms ,
Artificial Intelligence ,
California ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Costs ,
Hospitals ,
Machine Learning ,
Non-Discrimination Rules ,
Software ,
State Attorneys General
On June 22, 2022, the White House Office of National Drug Control Policy (ONDCP) issued guidance advocating for Congress and federal agencies to make permanent certain telehealth access measures for people struggling with...more
As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled...more
In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more