Dianne Bourque

Dianne Bourque

Mintz Levin

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Latest Posts › HHS


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

9/9/2015 - Clinical Trials Comment Period Exemptions HHS Human Rights Informed Consent IRB Medical Research NPRM Proposed Regulation Scientific Research The Common Rule Transparency

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

4/27/2015 - Affordable Care Act CMS EHR Electronic Health Record Incentives Electronic Medical Records GAO Health Care Providers Healthcare HHS HITECH Meaningful Use Medicaid Medicare Medicare Access and CHIP Reauthorization (MACRA) Medicare Part B PQRS Telehealth Telemedicine

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

9/13/2013 - Compliance Deadlines HHS HIPAA HIPAA Omnibus Rule Marketing OCR

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

2/18/2013 - Business Associates Cloud Computing Covered Entities Data Breach ERISA Fundraisers HHS HIPAA Omnibus Rule HITECH Marketing Notice Requirements OCR PHI Privacy Rule Risk Assessment Subcontractors Training

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

1/18/2013 - Business Associates Compliance Covered Entities Data Breach Data Protection HHS HIPAA HIPAA Omnibus Rule Notice Requirements Notifications OCR Patient Privacy Rights PHI Subcontractors

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