The White House announced it is launching a health data tracking system early next year that involves an unprecedented partnership between the federal government, providers, payors, and private sector technology companies....more
Starting September 1, 2025, health care practitioners in Texas are required to store electronic health records in the United States under a new Act. This requirement is found in a recently enacted law that also includes...more
8/4/2025
/ Cloud Service Providers (CSPs) ,
Data Privacy ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
New Legislation ,
Privacy Laws ,
Regulatory Requirements ,
State Privacy Laws ,
Texas ,
Third-Party Service Provider
Texas recently enacted a pair of laws aimed at AI governance in the public sector and in healthcare. Starting September 1, 2025, there will be statutory authorization for health care practitioners (HCPs) in Texas to use AI...more
At the end of June, Texas enacted the “Texas Responsible Artificial Intelligence Governance Act” (the “Act”), adding to the patchwork of growing AI laws. This summary addresses the Act’s most significant provisions....more
The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and the regulations promulgated thereunder (collectively “HIPAA”) is a...more
Since the Dobbs v. Jackson Women’s Health Organization decision (which overturned the landmark Roe v. Wade decision), the healthcare industry has continued to grapple with renewed concerns over patient privacy and...more
“Kicking Off Accountable Care” served as the theme for this year’s America’s Physician Groups’ (“APG”) Spring Conference, a three-day event packed with compelling speakers and breakout sessions focused on the state of...more
5/30/2025
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Physicians ,
Risk Management ,
Value-Based Care
In an era where cyber threats are escalating, healthcare has emerged as a critical battleground for security. Its significance has become increasingly crucial as the intersection of healthcare, cybersecurity, and technology...more
On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more
1/9/2025
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Health Technology ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
National Security ,
Public Health
The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards...more
1/6/2025
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
NPRM ,
Privacy Laws ,
Proposed Rules ,
Regulatory Requirements ,
Rulemaking Process
Cyberattacks on healthcare organizations are on the rise, with the number of affected individuals nearly tripling between 2022 and 2024, according to data compiled by the Department of Health and Human Services Office for...more
1/6/2025
/ Cyber Attacks ,
Cybersecurity ,
Data Security ,
Healthcare ,
Hospitals ,
New Legislation ,
New Regulations ,
New York ,
OCR ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
State Privacy Laws
Texas is joining a growing number of states in considering comprehensive laws regulating use of AI. In particular, the Texas Legislature is scheduled to consider the draft “Texas Responsible AI Governance Act” (the “Act”),...more
12/31/2024
/ Artificial Intelligence ,
Corporate Counsel ,
Distributors ,
Healthcare ,
Legislative Agendas ,
Machine Learning ,
New Legislation ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Management ,
Software Developers ,
State Legislatures ,
Texas
As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation...more
12/27/2024
/ Advisory Opinions ,
Civil Monetary Penalty ,
Gainsharing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicare ,
OIG ,
Pay-for-Performance ,
Physicians ,
Value-Based Care
Under the banner of strengthening consumer data protection, Texas is ramping up enforcement of its comprehensive data privacy act, sending a nationwide signal that Texas is serious about safeguarding the personal data of...more
California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health...more
Ethical hackers are becoming crucial allies in the battle against healthcare data breaches and ransomware attacks. In the twelfth episode of Sheppard Mullin’s Health-e Law Podcast, Ilona Cohen, Chief Legal Officer and Chief...more
10/2/2024
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Hackers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Privacy Laws ,
Ransomware
CMS recently published the First Annual Evaluation Report (the “Report”) highlighting its most significant observations in the first year following implementation of the Kidney Care Choices Model (the “KCC Model”). By way of...more
With technology rapidly evolving and jurisdictions appearing blurred, it is increasingly important to be mindful of data flow and use. This is particularly true where patient data is being accessed by offshore subcontractors....more
Gradually, data is being recognized as an asset in an increasingly data-hungry healthcare industry. In the tenth episode of Sheppard Mullin’s Health-e Law Podcast, Arti Bedi Pullins, President and Chief Healthcare Officer at...more
The healthcare sector is undergoing a transformative phase due in large part to the integration of digital technologies into every-day care. At the forefront of this revolution is Remote Patient Monitoring (“RPM”), a...more
Emerging technologies are prompting a revolution in women’s healthcare through advanced diagnostic testing. In the sixth episode of Sheppard Mullin’s Health-e Law Podcast, Deirdre O’Neill, Chief Commercial & Legal Officer at...more
In the rapidly evolving landscape of digital health, gamification has emerged as a powerful tool to enhance patient engagement and improve health outcomes. In the fifth episode of Sheppard Mullin’s Health-e Law Podcast, Craig...more
On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule,...more
4/16/2024
/ Agents ,
Beneficiaries ,
Biosimilars ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Chronic Care Managment (CCM) ,
Compensation ,
Competition ,
Fair Market Value ,
Final Rules ,
Health Care Providers ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part C ,
Medicare Part D ,
Mental Health ,
Policies and Procedures ,
Reporting Requirements ,
Supplemental Benefits ,
Third-Party
The Department of Health & Human Services through the Office of the National Coordinator for Health Information Technology recently updated the process for certification of health information technology. Some of the...more
The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance...more