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Do You Catch Our Drift? Navigating the Waters of Offshoring and Patient Data

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

Assessing Data Assets in Healthcare: A Discussion with Arti Bedi Pullins

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

Remote Patient Monitoring Innovating Health Tech: A Discussion with Dr. Vipul Kella

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

FemTech Meets DiagnosTech: A Discussion with Dierdre O’Neill

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

Gamification – Playing for Health: A Discussion with Craig Lund

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

CMS Issues CY2025 Medicare Advantage and Part D Final Rule

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

Out in the Open: HHS’s New AI Transparency Rule

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

HHS Announces 42 Part 2 Final Rule to Align with HIPAA

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

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

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

Eye on Privacy: 2023 Year in Review

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

Digital Health to the Rescue – Improving Access to Specialized Care: A Discussion with Viveka Rydell-Anderson

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

AI as an Aid – Emerging Uses in Healthcare: A Discussion with Jim Gatto

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 Tech We Trust? The Case for Transparency: A Discussion with Dr. Laura Tully

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

CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

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

At a Glance: Legal Efforts to Limit Discrimination Through AI

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

California Moves to Protect Medical Information Collected Through Reproductive and Sexual Health Applications

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

Texas Joins States Limiting Use and Disclosure of Genetic Data

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

FTC Proposes Changes to Health Breach Notification Rule Clarifying Application to Health and Wellness Apps

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

State Attorneys General Pen Letter to OCR Advocating for Greater Privacy Protection of Reproductive Health Care Information

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

Don’t Forget Deception: FTC and Biometrics

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

Florida Bans Offshoring of Certain Patient Information

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 Making Moves on a Comprehensive Consumer Privacy Law

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

CMS’s Administrative Simplification Rule Aims to Increase Efficiency and Standardization for Health Care Attachments

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

Telehealth in a Post-PHE World

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

ICYMI: HIPAA and Social Media IRL

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

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