News & Analysis as of

Health Law Alert: HIPAA Enforcement on the Rise, as OCR Audit Program Moves Forward

A recent settlement from New York—involving the largest fine levied to date in the history of HIPAA enforcement, a staggering $4.8 million imposed on two public hospitals—should remind health care providers, health plans and...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

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

Can covered entities run Windows XP and remain HIPAA compliant?

Microsoft recently announced that, after April 8, 2014, it will not longer provide security updates or technical support for Windows XP. Microsoft’s statement that “businesses that are governed by regulatory obligations such...more

HIPAA Housekeeping - Don't Forget Your Annual Report of Small Breaches

If you are a "covered entity" under the Health Insurance Portability and Accountability Act ("HIPAA") and suffer a breach of protected health information, one of your first reactions should be to count the number of affected...more

Volcker Rule Final Regulations: The Effect on Private Fund Sponsors and Investors

In time for the holidays, the long-awaited Volcker Rule final regulations arrived on Tuesday, December 10, 2013. Many of the comments of domestic mutual funds, foreign public funds, insurance companies and foreign banking...more

Ready For HITECH Changes On September 23, 2013? Find Out With This Compliance Checklist For Employer-Sponsored Health Plans

The final regulations implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act were issued in January and compliance is required by September 23, 2013. The final regulations require covered...more

3 Weeks Left: Is Your Business Ready for HIPAA Compliance?

The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of...more

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

HIPAA compliance deadline approaching: Five steps to ensure you are ready

The September 23, 2013 deadline for covered entities, business associates and their subcontractors to comply with new HIPAA rules is fast approaching....more

HRSA Issues Final 340B Orphan Drug Exclusion Rule: Agency’s Narrow Interpretation of Statutory Prohibition Puts Compliance...

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule clarifying the orphan drug exclusion for certain covered entities created by the Affordable Care Act (ACA) (“Final Rule”). The...more

Polsinelli Podcast - HIPAA Changes Overview [Video]

More than two years in the making, the long-awaited final changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) were published by the United States Department of Health and Human Services (HHS) on...more

HIPAA Task Force – May 2013

In this issue: - What Your Business Needs To Do About Hipaa — Now - Action Items for Covered Entities and Business Associates (including Subcontractors) - Changes Impacting Business Associates (including...more

HIPAA Rules Overhaul Ups Compliance Ante

Originally posted in Hartford Business Journal on February 11th, 2013. Attention all medical providers, hospitals and any other covered entity or business associate under HIPAA. On Jan. 17, the U.S. Department of Health...more

New HIPAA Rule Imposes Data Security and Privacy Obligations Directly Upon Vendors and Contractors of Covered Entities

On January 25, 2013, the Department of Health and Human Services ("HHS") published the Final Rule to the Health Insurance Portability and Accountability Act of 1996 ("HIPAA")'s Data Security and Privacy Rules. The Final Rule...more

Breaking Down The HIPAA Rule Changes: Part 2 Of 5 - Changes Affecting Who Is A Business Associate And New Business Associate...

In This Issue: - Expansion of, Clarifications to, and Explicit Inclusions in the Definition of BA - BAs’ Direct Liability Under the Final Rule - BAAs: Required Provisions Under the Final Rule and the Compliance...more

New HIPAA Rules Expand Breach Notification Requirements

If your company is subject to HIPAA, new rules published by the Department of Health and Human Services (“HHS”) will require changes in your policies and practices regarding data breaches....more

McAfee & Taft Healthcare Industry Alert: New HIPAA regulations - Begin your compliance review now

On January 17, 2013, the Department of Health and Human Services issued a final rule amending the Health Insurance Portability and Accountability Act (HIPAA) privacy and security regulations and implementing the Health...more

Breaking Down The HIPAA Changes: Part 1 Of 5 What Covered Entities And Business Associates Need To Do To Comply With The Final...

In This Issue: - Brief Overview of Key Modifications in the Final Rule - Suggested Action Items for Compliance with the Final Rule ..Covered Entities ..Business Associates - Consequences of Noncompliance...more

Sample HIPAA Business Associate Agreement Provisions Published

On January 25, 2013, HHS published sample business associate agreement provisions on its website to help covered entities and business associates comply with the requirements of the HIPAA Omnibus Final Rule, which was...more

New HIPAA/HITECH Rules Bring Few Surprises, but Still Call for Sweeping Changes in Compliance Programs

More than two-and-a-half years after issuing proposed regulations under the Health Information Technology for Economical and Clinical Health (HITECH) Act, on January 17, 2013, HHS released a series of final changes to its...more

New HIPAA Omnibus Rule Implementing Provisions Of The HITECH Act: An Overview Of Changes

Final implementing regulations for many provisions of the HITECH Act (Health Insurance Technology for Economic and Clinical Health Act) were issued by the Department of Health and Human Services (HHS) recently, and appeared...more

Health Law Alert: HHS Publishes Long-Awaited Final HIPAA Omnibus Rule

On Friday, January 25, 2013, the U.S. Department of Health and Human Services (HHS) published the long-awaited final HIPAA Omnibus Rule, modifying the HIPAA Privacy, Security, Enforcement and Breach Notification Rules under...more

HIPAA and HITECH Privacy and Security Rule Update: Final Omnibus Rule

The Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) published today the much anticipated final omnibus rule implementing the Health Information Technology for Economic and Clinical Health...more

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