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
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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
The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more
ARTIFICIAL INTELLIGENCE -
What is the Privacy Impact of the White House AI Order for Businesses? Posted November 28, 2023
Biden’s sweeping AI Executive Order sought to have artificial intelligence used in accordance...more
2/7/2024
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Biometric Information ,
Biometric Information Privacy Act ,
Consumer Privacy Rights ,
Cross-Border Transactions ,
Cybersecurity ,
Data Breach ,
Data Brokers ,
Data Privacy ,
Data Protection ,
Data Security ,
Healthcare ,
Legislative Agendas ,
New Legislation ,
New Regulations ,
Online Safety for Children ,
Privacy Acts ,
Privacy Laws ,
State and Local Government ,
State Privacy Laws
The 21st-century healthcare landscape has been dramatically shaped by the rise of digitized healthcare solutions aimed at making healthcare more accessible, affordable, and personalized....more
1/17/2024
/ Digital Health ,
Elder Care ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Home Health Care ,
Hospice ,
Life Sciences ,
Mental Health ,
Patients ,
Technology Sector ,
Telehealth
Expansion of AI in Healthcare -
At its core, AI involves the use of data, computers, and algorithms to mimic aspects of human intelligence. The progression from a rules-driven AI to the less artificial and more intelligent...more
In the inaugural episode of Sheppard Mullin’s Health-e Law podcast, renowned expert Dr. Laura Tully, Vice President of Clinical Services at ChatOwl, discussed emerging issues for health-tech’s data collection and use...more
On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed...more
The expanded use of artificial intelligence (AI) in the delivery of health care continues to receive increased attention from lawmakers across the country. Although AI regulation is still in its early developmental stages,...more
10/20/2023
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California ,
Discrimination ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Machine Learning ,
New Legislation ,
State and Local Government ,
State Legislatures ,
Technology
California is taking steps through Assembly Bill 254 (the “Bill”), approved by the State’s Governor on September 27, 2023, to ensure that patient information collected through reproductive or sexual health applications enjoys...more
10/4/2023
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CMIA ,
Data Privacy ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medical Records ,
New Legislation ,
Personal Information ,
Reproductive Healthcare Issues ,
State Privacy Laws
On June 17, 2023, Texas enacted legislation (the “Legislation”) limiting use of genetic data by certain genetic data testing companies, joining a number of other states in tackling the ever-increasing privacy concerns...more
In May, the Federal Trade Commission (“FTC”) proposed changes (the “Proposed Rule”) to the Health Breach Notification Rule (the “Rule”), which, among other items, emphasize that the Rule applies to mobile health applications...more
6/30/2023
/ Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach Notification Rule ,
Mobile Health Apps ,
Privacy Laws ,
Proposed Amendments ,
Proposed Rules ,
Technology Sector
On June 16, 2023, nearly half of the State Attorneys General penned a letter (the “Letter”) to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) advocating for broader privacy protections...more
With the ongoing BIPA litigation activity in Illinois surrounding collection of biometrics, it can be easy to forget that other issues might surround this practice. Last month the FTC reminded companies not to forget general...more
6/14/2023
/ Biometric Information ,
Data Collection ,
Data Privacy ,
Data Security ,
Federal Trade Commission (FTC) ,
FTC Act ,
Machine Learning ,
Privacy Laws ,
Section 5 ,
Tracking Systems ,
Unfair or Deceptive Trade Practices
The Florida Legislature recently amended the Florida Electronic Health Records Exchange Act (the “Act”) to prohibit certain health care providers utilizing certified electronic health record technologies from storing...more
Texas is joining a growing number of states in passing comprehensive privacy legislation intended to safeguard consumer personal data. Specifically, the Texas Data Privacy and Security Act (the “Act”) adds protections for...more
The Centers for Medicare & Medicaid Services (“CMS”), on behalf of the U.S. Department of Health and Human Services (“HHS”), recently issued a proposed rule to adopt standards under the Health Insurance Portability and...more
The once-novel medium of telehealth surged onto the stage as a common sense solution to the COVID-19 pandemic. This surge was facilitated, in part, by certain flexibilities authorized by the Centers for Medicare & Medicaid...more
Social media’s interplay with healthcare privacy presents a constantly evolving challenge. ICYMI (“in case you missed it”), there is an uptick in enforcement and scrutiny IRL (“in real life”) related to communications through...more