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The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The...more

HHS Publishes Guidance on HIPAA and Cloud Computing

On October 7, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance. As discussed below,...more

CMS Proposes “Advancing Care Information” Program to Replace Meaningful Use

The Medicare Access and CHIP Reauthorization Act (MACRA) proposes a new approach, with new branding labels, to paying clinicians for the value and the quality of care that they provide by replacing a patchwork of existing...more

Ready or Not, It’s Time For Phase 2 HIPAA Audits

On March 21st, the HHS Office for Civil Rights (“OCR”) officially launched Phase 2 of the HIPAA Audit Program. Covered Entities and Business Associates need to be prepared for these audits and be on the lookout for emails...more

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

MACRA’s Advancement of EHR Interoperability and Telehealth

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post,...more

Cliff Notes from the Joint OCR/NIST HIPAA Security Conference

As a service to our readers, we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance...more

10/1/2014  /  Encryption , HHS , HIPAA , NIST , OCR , Risk Assessment , Training

CMS Finalizes HIPAA and CLIA Amendments Intended to Increase Patient Access to Test Results

Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and...more

2/5/2014  /  CLIA , Clinical Laboratories , CMS , Healthcare , HHS , HIPAA , OCR

On the First Day of Privacy, The OCR Gave to Me...

Welcome to our series, “The 12 Days of Privacy” as we look to “gifts” that may be received this season and some of the big issues ahead …. Day One – - HIPAA 2014 – Where will the Audit Trail Lead? The year 2013...more

12/9/2013  /  HHS , HIPAA , HITECH , OCR , OIG , Privacy Laws , Privacy Policy

OCR Guidance to Address HIPAA Marketing Turmoil

In response to a recent lawsuit and outcry from a variety of players in the health care market, the Department of Health and Human Services (“HHS”) has committed to issuing guidance by September 23rd (the compliance date for...more

Highlights of the Joint NIST and OCR Safeguarding Health Information Conference

Earlier this week we attended the National Institute of Standards and Technology (NIST) and HHS Office for Civil Rights (OCR) 6th Annual Safeguarding Health Information Conference in Washington, D.C. (the NIST-OCR...more

5/26/2013  /  Audits , HHS , HIPAA , NIST , OCR

The New HIPAA Omnibus Rule & Your Liability — A Detailed Review

As we have reported in this blog, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently released final regulations containing modifications to the HIPAA Privacy, Security, Enforcement, and...more

Finally! HHS Office of Civil Rights Releases HIPAA Omnibus Rule With Sweeping Changes to Compliance Requirements and Enforcement

The final regulations from Department of Health and Human Services Office of Civil Rights (OCR) containing modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (Omnibus Rule) have finally...more

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