Covered Entities

News & Analysis as of

Federal Court Enjoins Part of ACA Final Non-Discrimination Rule

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide injunction in Franciscan Alliance, Inc. v. Burwell, N.D. Tex., No. 16-cv-108, holding that portions of the final rule issued...more

Time Waits for No One: OCR Announces First HIPAA Settlement for Lack of Timely Breach Notification

On Jan. 9, 2017, the Department of Health and Human Services Office for Civil Rights (“OCR”) announced the first HIPAA enforcement action for failure to timely report a breach. Often investigating and making formal...more

New IRS Reporting Rule Could Bite Unwary Foreign Investors

There are two main sources of reporting requirements for foreign investors in the United States — the Internal Revenue Service and the Bureau of Economic Analysis. The IRS recently upped its game by requiring reports from...more

Orrick's Financial Industry Week In Review

Financial Industry Developments - Prohibition on Dealing or Investing in Industrial or Commercial Metals - On January 3, 2017, the Office of the Comptroller of the Currency (the "OCC") finalized a rule that...more

The Ball Dropped on New Year’s Eve for Some ACA Section 1557 Nondiscrimination Rules

Some employers may want to reconsider their approach to gender transition benefits after a federal court enjoined the U.S. Department of Health and Human Services (HHS) from enforcing its 2016 nondiscrimination regulations...more

Final Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more

NYDFS Modifies, Delays Implementation of Cybersecurity Rules

The modified rules, which still remain among the most prohibitive, could be adopted in final form as early as this month. Since September 2016, the New York State Department of Financial Services (DFS) has been...more

Time is of the Essence When Reporting a Breach of PHI

The failure to timely report a breach of unsecured protected health information (PHI) has cost Presence Health (one of the largest health systems in Illinois) almost half of a million dollars. Earlier this month,...more

Healthcare Provider Obligations For Individuals With Limited English Proficiency

This summer I wrote about the dangers of English-only policies in this age of multiculturalism. These policies tend to emerge more frequently in the healthcare workplace, the reason being – the provision of quality care is...more

New York State Revises “First-In-Nation” Cybersecurity Rules

The New York Department of Financial Services (“DFS”) recently issued a revised version of the cybersecurity rules that it first announced in the fall of last year. The rules apply to a wide range of insurance, banking, and...more

HRSA Releases Ceiling Price and CMP Final Rule

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

Cybersecurity and Data Privacy: Proposed New York State Regulations Updated, Implementation Delayed (1/17)

On September 16, 2016 we informed you of new proposed cybersecurity regulations that would cover all entities regulated by the New York State Department of Financial Services (DFS). On December 28, 2016, DFS released...more

Although Delayed, New York's Aggressive Cybersecurity Law Expected to Affect Financial Services and Insurance Firms

The regulatory environment for cybersecurity is rapidly changing, and state legislatures are not waiting for Congress to act. On December 28, 2016, the New York State Department of Financial Services ("NYDFS") revised a...more

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

New York State Department of Financial Services Modifies Proposed Cybersecurity Regulations and Pushes Implementation Date Back to...

On Dec. 28, 2016, the New York State Department of Financial Services (NYDFS) published a revised version of its “Cybersecurity Requirements for Financial Services Companies” (the “Regulations”). The revised Regulations...more

Health Care Group News: Texas District Court Preliminarily Enjoins Partial Enforcement of Section 1557

In May of last year, the United States Department of Health and Human Services ("HHS") enacted regulations implementing Section 1557 of the Affordable Care Act. These regulations aimed to enhance language assistance and...more

New York Department of Financial Services Revises Cybersecurity Proposal: Greater Flexibility and Delayed Compliance Deadlines

As we previously reported, in December 2016 the New York Department of Financial Services (the “DFS”) announced that it was revising its proposed regulation that would require banks, insurance companies and other financial...more

Federal Judge Blocks Transgender Protections

On Saturday, December 31, 2016, a federal judge in Texas entered a nationwide preliminary injunction barring the enforcement of antidiscrimination protections pertaining to transgender and abortion health services and...more

Portions of Section 1557 of the Affordable Care Act Enjoined by Texas Federal Court – Majority of Regulation Remains Intact.

In May 2016, the Office of Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“DHHS”) issued a Final Rule implementing Section 1557 of the Affordable Care Act (“ACA”). Section 1557 prohibits “covered...more

New York Department of Financial Services Issues Revised Cybersecurity Regulations

With the clock ticking down to the new year, on December 28, 2016, the New York State Department of Financial Services (NYDFS) released highly anticipated revisions to its proposed Cybersecurity Requirements for Financial...more

Looking Back at the HIPAA Resolution Agreements in 2016

In 2016, Health and Human Services’ (HHS) Office for Civil Rights (OCR), the enforcement arm for HIPAA, continued robust enforcement efforts. There were 12 reported resolution agreements (RA) in 2016. An RA is a settlement...more

New York Financial Services Regulator Issues Revisions to Proposed Cybersecurity Regulation

Today, the New York Department of Financial Services (DFS) released a revised version of the proposed cybersecurity regulations that it first issued in September. According to a press release issued by DFS Superintendent...more

Financial Industry Groups Criticize New York Department of Financial Services Cybersecurity Proposal

As we previously reported, in September 2016 the New York Department of Financial Services (the “DFS”) proposed a regulation that would require banks, insurance companies and other financial services institutions regulated by...more

New York Cybersecurity Regulation Delayed

The New York Department of Financial Services (NYDFS) will delay the effective date of their proposed cybersecurity regulation until March 1, 2017. A new draft of the proposed regulation will be published on December 28,...more

21st Century Cures Act - HIPAA & Other Privacy Considerations

On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more

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