News & Analysis as of

Covered Entities Rulemaking Process

Ogletree, Deakins, Nash, Smoak & Stewart,...

Biden Administration Announces New Measures to Safeguard Americans’ Sensitive Personal Data

On February 28, 2024, the Biden administration announced new cybersecurity-related measures, including an executive order (EO) and advance notice of proposed rulemaking (ANPRM), intended to address the bulk flow of Americans’...more

McDermott Will & Emery

What Makes a Patient a “Patient”? Court Rejects Restrictive 340B Definition

McDermott Will & Emery on

On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more

Perkins Coie

New Rules for Climate Commitment Act Designed To Rein in Compliance Costs

Perkins Coie on

The Washington Department of Ecology (Ecology) recently announced rulemaking intended to clarify a key cost containment provision of the Climate Commitment Act (CCA), the state’s carbon emissions cap-and-trade program. The...more

Perkins Coie

CISA Seeks Input on New Cybersecurity Reporting Requirements

Perkins Coie on

President Biden signed into law the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA) on March 15, 2022. The background and contours of CIRCIA are discussed in a previous update. CIRCIA authorizes and...more

Wyrick Robbins Yates & Ponton LLP

Any Port in a Storm? OCR Seeks Comments on HIPAA “Safe Harbor” for Recognized Security Practices

Earlier this month, HHS’s Office for Civil Rights (OCR) issued a Request for Information (RFI) seeking comments on a statutory provision adopted last year that provides a quasi-safe harbor for entities that have voluntarily...more

Eversheds Sutherland (US) LLP

The Cyber Incident Reporting for Critical Infrastructure Act of 2022

The Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA), passed as part of the omnibus spending bill on March 15, 2022, will require critical infrastructure companies - which could include financial...more

Sheppard Mullin Richter & Hampton LLP

Cybersecurity Act Signed Into Law Creates New Reporting Obligations

President Biden recently signed into law the Cyber Incident Reporting for Critical Infrastructure Act of 2022 as a part of a larger omnibus appropriations bill.  The new law sets out mandatory reporting requirements for...more

Foster Garvey PC

New Reporting Requirements for Critical Infrastructure and Businesses

Foster Garvey PC on

The Cyber Incident Reporting for Critical Infrastructure Act of 2022 ("the Act") was signed into law by the President on March 15, 2022, as part of the Consolidated Appropriations Act. The purpose of the Act is to educate...more

Health Care Compliance Association (HCCA)

Facing Escalating Attacks, AHA Presses OCR to Expedite Security Practices Rule

Report on Patient Privacy 21, no. 12 (December, 2021) - Amid the letters of congratulations to new HHS Office for Civil Rights (OCR) Director Lisa Pino is a plea from the American Hospital Association (AHA): “victims” of...more

WilmerHale

Congress Passes Bill to Mitigate Penalties for Potential HIPAA Violations

WilmerHale on

On December 19, the Senate passed H.R.7898, which the House of Representatives had previously passed on December 9. This law amends the Health Information Technology for Economic and Clinical Health (HITECH) Act to require...more

Cozen O'Connor

NYC Council Considers Legislation to End At-Will Employment in the Fast Food Industry

Cozen O'Connor on

The New York City Council has proposed additional legislation that would have a major impact on businesses falling within the broad definition of “fast food establishments” and has scheduled a hearing on the bills for...more

Mintz - Privacy & Cybersecurity Viewpoints

Congressional Privacy Action – Part 1: The Senate

As 2020 gets underway, Congress will continue to deliberate on federal privacy legislation in the second session of the 116th Congress. The California Consumer Privacy Protection Act (CCPA) went into effect on January 1, and...more

Latham & Watkins LLP

California Consumer Privacy Act Draft Regulations: What’s New, What’s Next

Latham & Watkins LLP on

Covered businesses have much work to do to revise disclosures, implement choice mechanisms, and design compliant data subject request programs. Key Points: ..The Attorney General’s draft regulations, released on October...more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

Polsinelli on

This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

Perkins Coie

New York and New Jersey Make an Early Effort to Regulate Artificial Intelligence

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In recent years, the use of artificial intelligence (AI) solutions in every sphere of the economy has increased dramatically. In response to its rapid growth, governments are scrambling to regulate the new technology. Most...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

Foley & Lardner LLP

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

Foley & Lardner LLP on

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

Davis Wright Tremaine LLP

President Obama’s Proposed Privacy Bill of Rights - Part 3: Who’s Covered

This week we have brought you a multi-part series analyzing the Obama administration’s proposed Consumer Privacy Bill of Rights, which would require greater transparency by businesses in their privacy practices, and grant...more

Foley Hoag LLP

DC District Court Strikes Down 340B Orphan Drug Rule

Foley Hoag LLP on

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

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