News & Analysis as of

Covered Entities Comment Period

Schwabe, Williamson & Wyatt PC

Comments Sought on Proposed Requirements of the Cyber Incident Reporting for Critical ‎Infrastructure Act

On March 15, 2022, the Cyber Incident Reporting for Critical Infrastructure Act of 2022 was signed into law. Generally, CIRCIA requires “covered entities,” defined as entities in certain critical infrastructure sectors, to...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

Bass, Berry & Sims PLC on

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

Davis Wright Tremaine LLP

OCR Proposes Amendments to HIPAA to Safeguard Reproductive Health Care Information in the Wake of Dobbs

Walking a middle path, the HHS Office for Civil Rights (OCR) published proposed amendments to the HIPAA Privacy Rule on April 17, 2023, to further safeguard the privacy of reproductive health care information. This comes in...more

Bass, Berry & Sims PLC

Proposed Changes to HIPAA Privacy Rule Strengthening PHI Protections for Reproductive Health Care Information Have Broad...

Bass, Berry & Sims PLC on

On April 13, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a Notice of Proposed Rulemaking (NPRM) to amend the HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subparts A...more

Holland & Knight LLP

HHS Proposes HIPAA Changes to Protect Reproductive Health Information

Holland & Knight LLP on

The U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rule Making (Proposed Rule) on April 12, 2023, proposing amendments to the Health Insurance Portability and...more

Holland & Knight LLP

Treasury Department's First Repurchase Excise Tax Guidance Contains Rotten "Easter Eggs"

Holland & Knight LLP on

The U.S. Department of the Treasury and IRS intend to issue proposed regulations addressing application of a new excise tax on repurchases of corporate stock under Section 4501 of the Internal Revenue Code (Code). Section...more

McDermott Will & Emery

HHS Goes Back to the Drawing Board on the 340B ADR Process

McDermott Will & Emery on

Citing “policy and operational challenges” with the current 340B Administrative Dispute Resolution (ADR) Process, the US Department of Health and Human Services (HHS) has issued a new Proposed Rule to modify the current ADR...more

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

Foley Hoag LLP on

On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more

BakerHostetler

New York Department of Financial Services Publishes Proposed Second Amendment to Its Cybersecurity Regulation

BakerHostetler on

On Nov. 9, 2022, the New York State Department of Financial Services (NYDFS) published a proposed second amendment to its cybersecurity regulation. This follows its pre-proposed amendment that was published on July 29. ...more

BakerHostetler

NYDFS Proposed Amendments to Its Cybersecurity Rules

BakerHostetler on

​​​​​​​On July 29, the New York Department of Financial Services (NYDFS) released Draft Amendments to its Part 500 Cybersecurity Rules that include a number of significant amendments to the rules, including notification...more

Health Care Compliance Association (HCCA)

Awaiting New Leader, OCR Collects NPRM Feedback, Closes Breach, 14th Access Case

Report on Patient Privacy 21, no. 2 (February 2021) - Unless an extension is granted or the notice of proposed rulemaking (NPRM) is withdrawn, covered entities (CEs) and business associates (BAs) have until late March to...more

Sheppard Mullin Richter & Hampton LLP

The Heart of Employee Rights Under CCPA: Attorney General Modifies Guidance

Transparency and communication are cornerstones of a successful relationship—and the employment relationship is no exception. The California Consumer Privacy Act (“CCPA”) came into effect on January 1, 2020, bestowing two...more

Dorsey & Whitney LLP

California Attorney General Issues Draft Regulations for CCPA

Dorsey & Whitney LLP on

On October 11, 2019, the California Attorney General (the “California AG”) issued draft regulations (the “Draft Regulations”) pursuant to his authority under the California Consumer Privacy Act of 2018 (“CCPA”). The...more

Proskauer - Employee Benefits & Executive...

HHS Proposes to Narrow Scope of Nondiscrimination Regulations under Affordable Care Act

The U.S. Department of Health and Human Services (HHS) recently proposed regulations that scale back nondiscrimination protections under Section 1557 of the Affordable Care Act (ACA). The new regulations, proposed on May 24,...more

Robinson+Cole Health Law Diagnosis

OCR Issues Request for Information Regarding Modification of HIPAA To Promote Care Coordination and Transition to Value-Based Care

On December 14, 2018 the Department of Health & Human Services Office for Civil Rights (OCR) published a Request for Information (RFI) soliciting public input on updates to regulations promulgated under the Health Insurance...more

Sheppard Mullin Richter & Hampton LLP

OCR Seeks Ideas on HIPAA Rule Changes to Promote Value-Based Care and Coordinated Care

The Office for Civil Rights (“OCR”) issued a request for information (“RFI”) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) privacy and security regulations (the...more

Eversheds Sutherland (US) LLP

Vietnam sheds light on impending cybersecurity law

As this eventful year for new privacy and cybersecurity regulations winds down, multinational companies still need to look ahead to new regulations that will come online in 2019, including Vietnam’s Law on Cybersecurity. ...more

Polsinelli

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Bond Schoeneck & King PLLC

Cybersecurity and Data Privacy: New York State Department of Financial Services to Implement Regulations Applicable to All...

Following a public comment period, the New York State Department of Financial Services (DFS) has published a modified version of new regulations, previously issued on September 13, 2016, aimed at creating higher cybersecurity...more

Womble Bond Dickinson

Federal Banking Agencies Propose “Enhanced Cyber Risk Management Standards” For the Largest Banks

Womble Bond Dickinson on

In a major new cybersecurity initiative the federal banking agencies have issued an advanced notice of proposed rulemaking (“APNR”) seeking comment on enhanced cybersecurity standards for banking entities with $50 billion or...more

Stinson - Corporate & Securities Law Blog

The New York State Department of Financial Services Proposes Robust Cybersecurity Rules

On September 13, 2016, the New York State Department of Financial Services (DFS) proposed new rules that would require certain “Covered Entities” to establish and implement cybersecurity programs designed to protect nonpublic...more

Perkins Coie

DOT Shifts Into Gear on Self-Driving Cars and Issues New Automated Vehicles Policy

Perkins Coie on

The National Highway Traffic Safety Administration (NHTSA) has issued a comprehensive policy on “automated vehicles,” more commonly known as self-driving cars. Part of the U.S. Department of Transportation, NHTSA is the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update: New York State Proposes Cybersecurity Regulation for Financial Institutions

New York state has proposed a new regulation — to go into effect January 1, 2017 — that would require banks, insurance companies and other financial services institutions regulated by the New York State Department of...more

Polsinelli

New 340B Dispute Resolution Process: Will It Level the Playing Field?

Polsinelli on

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more

Stinson - Corporate & Securities Law Blog

Fed Wants Limits on Qualified Financial Contracts of Large Banks

The Board of Governors of the Federal Reserve System is inviting comment on a proposed rule to promote U.S. financial stability by improving the resolvability and resilience of systemically important U.S. banking...more

34 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide