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CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more

OCR Proposes Regulatory Facelift to the HIPAA Security Rule: Addressing the Current Cybersecurity Environment with More...

On January 6, 2025, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a “Notice of Proposed Rulemaking,” HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected...more

HHS HIPAA Web-Tracking Guidance Takes a Step Back, While Providers Grapple with Latest Challenges

In a narrow but significant ruling in American Hospital Association et al. v. Xavier Becerra, et al., No. 4:23-cv-01110-P, the U.S. District Court for the Northern District of Texas (Hon. Mark T. Pittman) ruled that one...more

HIPAA Privacy Final Rule: Landmark Changes Related to Reproductive Health Care Information

The U.S. Department of Health and Human Services (“HHS”), and Office for Civil Rights (“OCR”) issued a “Final Rule,” HIPAA Privacy Rule to Support Reproductive Health Care Privacy, which was published in the Federal...more

HIPAA Notice of Proposed Rulemaking on Reproductive Health Care Privacy

On April 12, 2023, the Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“Notice” or “NPRM”) to solicit comments on proposed modifications to the HIPAA...more

“First-of-Its-Kind” FTC Breach Enforcement Case on Hot-Button Website Tracking Issue

On February 1, 2023, the Federal Trade Commission (“FTC”) announced that it filed a “first-of-its-kind proposed order” under its Health Breach Notification Rule promulgated pursuant to section 13407 of the American Recovery...more

HHS-OCR Guidance for Online Tracking Technologies

The continued proliferation of tracking technologies has created a landscape of increased exposure for entities serving individuals online. As individuals are increasingly interacting with healthcare services providers...more

HHS OCR Issues New, Post-Dobbs Guidance

In the wake of the Dobbs decision, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued new guidance regarding the privacy of patients seeking reproductive health care. The guidance...more

Cybersecurity and “Recognized Security Practices”: New Statute modifies HIPAA

On January 5, 2020, President Trump signed into law H.R. 7898. This new statute amends the Health Information Technology for Economic and Clinical Health (HITECH) Act to require the Department of Health and Human Services...more

HIPAA Notice of Proposed Rulemaking

On December 10, 2020, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA)...more

Understanding OCR’s Recent Guidance on COVID-19 — COVID-19

Following the outbreak of COVID-19 in late 2019, the U.S Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) has offered guidance to covered entities and business associates regulated by the...more

Important Highlights from the NIST/OCR HIPAA Security Conference Last Week

Every year, the National Institute of Standards and Technology (NIST) and the Department of Health and Human Services, Office for Civil Rights (OCR) jointly sponsor a conference to “address the dynamic and challenging...more

HHS’s Enforcement Discretion Notice May Signal More Potential Violations

The HHS Office for Civil Rights (“OCR”) issued a notice in the Federal Register regarding its Enforcement Discretion (84 Fed. Reg. 18151) on April 30, 2019. HHS announced that HHS will now apply a different cumulative annual...more

Deal Breaker – Cyber Security Risk in Health Care Transactions

Health care organizations’ lack of compliance with the data privacy and security requirements of both state laws and the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy, Security and Breach Notification...more

HIPAA-Covered Entities: It’s Time to Cover Yourself - Are you prepared for Colorado’s new data breach law to take effect?

On May 29, 2018, Colorado Governor John Hickenlooper signed changes to Colorado law that significantly increase potential data breach burdens and financial penalties on entities operating in Colorado.1 Beginning September 1,...more

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