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HHS’ Last-Minute Holiday Gift: Proposed Changes to the HIPAA Security Rule

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

Healthcare Needs More Hackers: A Discussion with Ilona Cohen

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

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

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

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

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

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

Proposal to Overhaul Privacy Law Governing Substance Use Disorder Treatment Records

The U.S. Department of Health and Human Services (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Part 2 (“Part 2”). While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the...more

Office of Civil Rights Publishes Guidance on Use of Audio-Only Telehealth Services

As telehealth services surged in response to the COVID-19 pandemic, unique compliance challenges likewise developed in unexpected ways. Recognizing these challenges, the Office of Civil Rights (“OCR”) indicated that it would...more

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