News & Analysis as of

Covered Entities Compliance

Officer and director checklist: Complying with the global reach of the New York Department of Financial Services Cybersecurity...

by White & Case LLP on

The New York State Department of Financial Services (NYDFS) issued Cybersecurity Requirements for Financial Services Companies (the "Cybersecurity Regulation") effective March 1, 2017. The regulation imposes tight compliance...more

OCR Identifies Continuing HIPAA Enforcement Issues, Areas of Future Guidance and Regulations

Last week the Health Care Compliance Association hosted its annual “Compliance Institute.” Iliana Peters, HHS Office for Civil Rights’ Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA...more

New York Department of Financial Services Issues New AML and Sanctions Regulations

by Michael Volkov on

The New York DFS finalized its new AML and Sanctions screening regulations. Interestingly, the NYDFS backed off its original proposal to require a Chief Compliance Officer to certify to a compliance “finding” that the...more

Summary of Final Rule Amending HMDA and What It Means for Covered Institutions

by Ballard Spahr LLP on

The Consumer Financial Protection Bureau (CFPB) has released a final rule amending Regulation C, which implements the Home Mortgage Disclosure Act (HMDA), requiring most lenders to report certain information about mortgage...more

Alphabet Soup and Data Security

by Bilzin Sumberg on

In the span of two days, mobile device users learned of two data breaches that could compromise their personal data. In one, Experian (a credit reporting agency) reported that it was hacked, potentially putting 15 million...more

Privacy, Security, Risk: What You Missed At IAPP Conference

by Orrick - Trust Anchor on

Earlier this month, privacy and security professionals from around the globe gathered for “Privacy. Security. Risk. 2015”—the second joint conference between the International Association of Privacy Professionals and the...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

by King & Spalding on

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Is Your HIPAA Compliance Program Ready for the FTC?

by Womble Bond Dickinson on

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

OIG Calls for Stronger HIPAA Compliance Efforts

by Reed Smith on

The OIG has issued two reports calling for stronger ONC oversight of covered entity compliance with HIPAA standards. In the first report, “OCR Should Strengthen Its Oversight of Covered Entities’ Compliance with the HIPAA...more

Reports Instruct Office of Civil Rights to Increase HIPAA Enforcement Activities

On September 29, 2015, the Office of Inspector General (OIG) released two reports that reviewed the Office of Civil Rights’ (OCR) enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The...more

OCR announces launch of Phase 2 of HIPAA audits

Although the Office for Civil Rights (OCR) has indicated in the past that it would start its next round of HIPAA audits, apparently it means business now. In the wake of an Inspector General report that the OCR was merely...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

by Holland & Knight LLP on

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

HHS Proposes Rules for Nondiscrimination in Health Care

by K&L Gates LLP on

On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) proposed new regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). Section 1557 prohibits...more

Don’t Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

by Orrick - Trust Anchor on

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called “Phase 2 Audits” are set to commence...more

340B Guidance: Eight Key Points Covered Entities Should Consider

by BakerHostetler on

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

HRSA Issues 340B Program Omnibus Guidance

by K&L Gates LLP on

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

$750,000 Settlement Agreement Reiterates Importance of HIPAA Security Rule Compliance

On September 2, 2015, the U.S. Department of Health and Human Services ("HHS") announced that it had entered into a Settlement Agreement with an Indiana-based medical practice for alleged violations of the Health Insurance...more

HHS issues fact sheet on HIPAA rules and resources

The Department of Health and Human Services (HHS) has released a fact sheet on the privacy, security, and breach notification rules of the Health Insurance Portability and Accountability Act (HIPAA). Designed to apply to...more

Massachusetts Hospital Agrees to Six-Figure Payment Related to HIPAA Compliance Allegations

St. Elizabeth’s Medical Center (SEMC), a tertiary care hospital based in Brighton, Mass., agreed to pay $218,400 to address deficiencies in its HIPAA compliance activities. The SEMC settlement continues a pattern of...more

Blog: HIPAA FAQ Series: Are Covered Entities and Business Associates Required to Encrypt PHI?

by Cooley LLP on

The Health Insurance Portability and Accountability Act (HIPAA) mandates that both Covered Entities and Business Associates protect the security of Protected Health Information (PHI) in a variety of ways. Specifically,...more

How Transparent is Your Supply Chain? California AG Issues Guidance

by Seyfarth Shaw LLP on

After almost five years since passage, California’s Attorney General has finally produced guidance on The California Transparency in Supply Chains Act of 2010. With the Attorney General at last weighing in (the Resource Guide...more

HIPAA Business Associate Agreements - 7 Things to Know Before the HITECH Deadline

by Holland & Knight LLP on

Covered entities and business associates have only until September 22, 2014 to update business associate agreements that were in place as of January 25, 2013. For those members of the health industry and their vendors that...more

Action Required for Covered Entities, Business Associates and Their Subcontractors

by Robinson & Cole LLP on

Early last year, the Department of Health and Human Services issued final privacy and security regulations (Final Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Final Rule, effective...more

Policyholders Face Heightened Scrutiny Under OCR’s New Permanent Audit Program

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) has notably increased enforcement of compliance with the Health Insurance Portability and Accountability Act (“HIPAA”) and Health Information...more

Free HIPAA Help

by Holland & Knight LLP on

Health care providers, health plans, business associates, and other entities affected by the federal HIPAA privacy and security regulations are quickly running out of excuses for not having a robust HIPAA compliance program...more

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Cybersecurity

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