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Northern District of Texas Flashes the ‘Blue Lights’ on OCR’s Pixel Guidance

On June 20, 2024, the Northern District of Texas issued its final order in American Hospital Association, et al. v. Becerra, et al. (AHA), granting the plaintiffs’ (the American Hospital Association, two Texas health systems...more

Diving Deeper into the Revised Health Breach Notification Rule

As we previously reported, the Federal Trade Commission (FTC) recently announced its final changes to the Health Breach Notification Rule (HBNR), vastly expanding the scope of the Rule’s coverage....more

It’s Not Just About Dobbs: HHS Issues Final Rule on Reproductive Health

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) published its long-awaited Final Rule regarding reproductive health privacy. Although it is tempting to benchmark the Final Rule against the Dobbs...more

FTC Vastly Expands Reach of the Health Breach Notification Rule

On April 26, the Federal Trade Commission (FTC) announced its final rule (Final Rule) making changes to the Health Breach Notification Rule (HBNR)....more

Lipstick on a Pig: OCR’s Cosmetic Revisions to Guidance on Tracking Technology in Healthcare Fail to Address Fundamental Issues

When the U.S. Department of Health and Human Services, Office for Civil Rights (HHS OCR) issued its guidance on “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” on Dec. 1, 2022 Original...more

HHS OCR Announces Largest Civil Monetary Penalty Imposed Since 2021 for Snooping Incident

Nearly two months after settlement was reached, the Department of Health and Human Services Office for Civil Rights (HHS OCR) announced on Feb. 6 that it obtained a resolution agreement with Montefiore Medical Center over...more

FDA Forms Digital Health Advisory Committee to Navigate Emerging Technologies

The FDA has announced the formation of the Digital Health Advisory Committee, a group dedicated to navigating the complexities of emerging DHTs like AI/ML, augmented reality and more. This development evidences the FDA’s...more

With New Enforcement Action, FTC Warns Against Health Information Being Used for Advertising Purposes

If the Federal Trade Commission’s (FTC) recent pursuits did not make clear the agency’s deep concerns about the use of health information for advertising purposes, a new enforcement action brought by the FTC against...more

HHS Announces New Divisions to Address Weighty Case Load

On February 27, 2023, the U.S. Department of Health and Human Services (HHS) announced that its law enforcement agency – the Office for Civil Rights (OCR) – will reorganize, adding new divisions to better address the rapid...more

OCR Guidance on Use of Tracking Technologies Warrants Review of Website Tech

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued guidance regarding covered entities’ and business associates’ use of tracking technologies (the Guidance). As discussed in greater detail...more

HHS Proposes New Rule Aligning Part 2 Regulations with HIPAA

On November 28, 2022, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Substance Abuse Mental Health Services Administration (SAMHSA) announced a Notice of Proposed Rulemaking...more

What’s Old Is New Again: OCR Announces $300,000 Settlement Related to Improper Disposal of Physical PHI

​​​​​​​After a long stretch of breach enforcement actions and settlements arising out of alleged technology gaps, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) announced that it settled a case...more

‘Unboxing’ the New NIST Guidance: NIST Publishes Significant Update to Healthcare Cybersecurity Guide

​​​​​​​Without question, healthcare providers and the companies that support them operate in an elevated cybersecurity risk environment. And when a cybersecurity incident occurs, the ensuing regulatory inquiries and/or...more

Recent FTC Post Commits to Protecting Sensitive Health Data After White House Issues Related Executive Order

On July 8, 2022, following the Supreme Court’s decision in Dobbs, the president signed an executive order that called on a number of federal agencies to take steps to protect reproductive rights. He specifically asked the...more

HHS OCR Guidance to 60,000 Retail Pharmacies: Refusal to Fill Rx Based on Potential Pregnancy Termination Concerns Is a Civil...

On July 13, the Department of Health & Human Services (HHS) Office for Civil Rights (OCR) issued guidance to retail pharmacies that refusing to dispense a prescribed medication or making a determination on the suitability of...more

Dobbs Triggers Significant Healthcare and Privacy Law Concerns and Confusion

To help guide entities through the significant confusion and changes that will be evolving for the next several years, BakerHostetler has assembled the Dobbs Decision Task Force (DDTF), led by attorneys in five major areas...more

Office for Civil Rights Provides HIPAA Privacy Rule on Disclosures of Information Relating to Reproductive Healthcare

On June 29, in response to the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the U.S. Department of Health & Human Services Office for Civil Rights (HHS OCR) issued guidance on when entities...more

OCR Announces Four Enforcement Actions

On March 28, 2022, Health and Human Services, Office for Civil Rights (OCR) announced the resolution of four enforcement actions, three resolved in 2021 and one resolved in 2022. There are some interesting aspects of this...more

Privacy-Forward California AG Xavier Becerra Confirmed as Next HHS Secretary

On March 19, 2021, Xavier Becerra was confirmed as the secretary of the U.S. Department of Health and Human Services (HHS). HHS is the federal regulatory body that oversees the Office for Civil Rights (OCR), which is the...more

CISA Updates Advisory on Large-Scale Impending and Credible Ransomware Threat to Healthcare to Include Additional IOCs

On Oct. 28, a joint cybersecurity advisory was published by the Cybersecurity and Infrastructure Security Agency (CISA), the FBI and the Department of Health & Human Services. The advisory warned of an imminent cybercrime...more

The Destruction of Privilege and Work Product Protection for Data Breach Investigations?

Attorneys play an important role in the incident response process. A skilled and experienced attorney can help organizations effectively respond to a security incident in a way that complies with obligations, protects key...more

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