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Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
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The cyber breach at Change Healthcare in 2024 stands out as one of the most significant cyber-attacks in recent memory. Its repercussions extend far beyond immediate industry disruptions, resonating deeply in regulatory...more
In April 2024, the Department of Health and Human Services (HHS) finalized revised regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (ACA). The new, final Section 1557 regulations (2024...more
Effective June 25, 2024, the U.S. Department of Health & Human Services’ Office for Civil Rights (HHS) issued a Final Rule modifying the HIPAA Privacy Rule to enhance reproductive health care privacy. This change follows the...more
On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more
The HHS Office for Civil Rights (OCR) has abandoned its appeal of a federal judge’s ruling overturning OCR’s guidance prohibiting covered entities (CEs) and business associates (BAs) from using the web-tracking technologies...more
On September 4, Texas Attorney General (AG) Ken Paxton filed a lawsuit against the Department of Health and Human Services (HHS) Office for Civil Rights (OCR), challenging two key Health Insurance Portability and...more
Seyfarth Synopsis: With the myriad claims for religious accommodation that came out of mandatory COVID vaccination policies, employers have become familiar how to handle requests for religious accommodation in the workplace. ...more
On July 19, Change Healthcare Ince. filed a breach report with HHS Office for Civil Rights (OCR) concerning its mammoth ransomware attack and breach. The organization’s breach report to OCR identifies just 500 individuals as...more
In the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization and subsequent state abortion bans, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services issued a...more
Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. The...more
Over the course of the past few months, the Office of Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC), both of which are divisions of the U.S. Department of Health and...more
In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled in American Hospital Association...more
The U.S. Department of Health and Human Services (HHS) has issued a proposed rule entitled “Nondiscrimination in Health Programs and Activities.” The proposed rule, designed to advance health equity and protect people from...more
On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...more
‘Dear Mary,’ is Troutman Pepper’s Incidents + Investigations team’s advice column. Here, you will find Mary’s answers to questions about anything and everything cyber-related – data breaches, forensic investigations, how to...more
Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more
We are pleased to announce that several of the firm’s practice groups and attorneys were recognized in the 2024 edition of Chambers USA, a directory of leading law firms and attorneys. Chambers and Partners annually...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
It is critical for employers and plan fiduciaries/administrators to stay informed of HIPAA privacy and security-related legal developments because most employer sponsored group health plans — regardless of the employer’s...more
The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the...more
On May 6, 2024, the Department of Health and Human Services (HHS) published its final rule revamping the non-discrimination regulations issued under § 1557 of the Affordable Care Act. The revised rules apply to all...more
Seyfarth Synopsis: New regulations effective August 6, 2024 restore and expand scope of civil rights protections under Section 1557 of the Affordable Care Act....more
United Healthcare Group (UHG) CEO Andrew Witty was in a board meeting on Feb. 21 when officials interrupted with the news that Change Healthcare—a clearinghouse UHG subsidiary Optum had purchased for $1.3 billion in October...more
Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more
Turns out, ignorance really is bliss, at least according to the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), in publishing its final rule on algorithmic discrimination by payers...more