Dianne Bourque

Dianne Bourque

Mintz Levin

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Latest Publications


Just in Time for the Phase II Audits: OIG Criticizes OCR’s Enforcement Efforts

As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of...more

10/1/2015 - Audits Case Management Corrective Actions Covered Entities Documentation HIPAA Medicare Part B OCR OIG PHI Regulatory Oversight

Exellus BlueCross BlueShield – Latest Victim of a “Sophisticated” Health Plan Cyberattack

Exellus BlueCross BlueShield has announced that the personal information of at least 10 million members has been compromised in a “very sophisticated” cyberattack that occurred on December 23, 2013 and was discovered by the...more

9/14/2015 - Blue Cross Credit Monitoring Cyber Attacks Cybersecurity Data Breach Data Privacy Data Protection Data Security Hackers Personal Data Personally Identifiable Information

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

Data Breach Affects Millions of Current and Former Government Workers

The U.S. Office of Personnel Management (OPM) announced that hackers have stolen the personal information of approximately 4 million current and former federal employees, including names, birthdates and social security...more

6/8/2015 - Cyber Attacks Cybersecurity Data Breach Data Protection DHS Hackers Office of Personnel Management (OPM)

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

Could the Anthem Hack Happen Again? New Report Analyzes Insurers’ Cyber Security Programs

The New York State Department of Financial Services (the “Department”) recently released a “Report on Cyber Security in the Insurance Sector” (the “Report”). The Report was released on February 8, 2015, just four days after...more

2/13/2015 - Anthem Insurance Corporate Counsel Cybersecurity Data Breach Data Protection Department of Financial Services Enterprise Risks Insurance Industry Risk Management

Happy Data Privacy Day!

January 28th is Data Privacy Day. Given that privacy is the bedrock on which successful health care delivery is built, I would like to mark the occasion with a few thoughts for our health care industry clients and friends...more


On the Tenth Day of Privacy, OCR Gave to Me…..

……………..a cumbersome C-A-P The U.S Department of Health and Human Services Office for Civil Rights has received tremendous publicity in recent years for its upward-trendingfines and aggressive enforcement of HIPAA...more

12/22/2014 - Data Protection Health Care Providers HIPAA Hospitals OCR PHI Strategic Enforcement Plan

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

Massive Data Breach Affects 4.5 Million Patients in 29 States

Community Health Systems, Inc. (the “Company”), one of the largest hospital organizations in the country, announced via a public filing (Form 8K) made yesterday with the Securities and Exchange Commission (“Report”) that the...more

8/21/2014 - Cyber Attacks Data Breach EHR HIPAA HITECH Hospitals Notice Requirements PHI

D’oh! OCR Confirms that Medical Records Should Not be Left in the Driveway

The most recent Office for Civil Rights (“OCR”) HIPAA enforcement action serves as an important reminder to health care providers of the security risks associated with a mishandled medical records custody transfer and the...more

6/26/2014 - EHR Healthcare HIPAA OCR PHI

Five Lessons from OCR’s Report to Congress on Breaches and HIPAA Rules Compliance

Last week, the HHS Office of Civil Rights (OCR) released two reports required by the Health Information Technology for Economic and Clinical Health (HITECH) Act: (i) the Annual Report to Congress on Breaches of Unsecured...more

6/23/2014 - Data Breach Data Protection EHR Healthcare HIPAA HITECH PHI

SAMHSA to Hold Part 2 “Listening Session”

The Substance Abuse and Mental Health Services Administration (“SAMHSA”) has scheduled a “public listening session” on Wednesday, June 11, 2014, to seek input on potential changes to the federal Confidentiality of Alcohol and...more

5/22/2014 - Drug & Alcohol Abuse Healthcare Medical Records Patients Privacy Laws Public Comment Public Meetings SAMHSA

State Data Security Breach Notification Laws

The general definition of “personal information” or “PI” used in the majority of statutes is: An individual’s first name or first initial and last name plus one or more of following data elements: (i) Social Security number,...more

4/24/2014 - Breach Notification Rule Data Breach Data Protection

Is Your HIPAA Compliance Program Going Out the Window with XP?

April 8, 2014 marks the end of Microsoft’s support for the Windows XP operating system, which means the end of security updates from Microsoft and the beginning of new vulnerability to hackers and other intruders into systems...more

4/9/2014 - Compliance Data Protection HIPAA Technology

Compliance is No Joke: OCR Releases Security Risk Assessment Tool

On March 28, 2014, the Office of Civil Rights (OCR) announced the release of an online and iPad app-based security risk assessment (SRA) tool. The tool is intended to help health care providers in small to medium sized...more

4/1/2014 - Compliance HIPAA OCR Risk Assessment

En Español: HHS Agencies Issue Model Notices of Privacy Practices in Spanish

Last week, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and Office for the National Coordinator for Health Information Technology (ONC) issued model Notices of Privacy Practices (NPPs) in...more

2/24/2014 - Disclosure Requirements Healthcare Native Language Notice of Privacy Practices OCR PHI

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

A New Year’s Resolution (And Corrective Action Plan) From OCR: Physician Practice Cited For HIPAA Violations

The Office for Civil Rights (OCR) is closing out 2013 with a reminder of the importance of an effective HIPAA compliance program. On December 26, 2013, OCR announced a resolution agreement with a Massachusetts physician...more

12/31/2013 - Breach Notification Rule Data Breach Data Breach Plans Data Protection Electronic Medical Records HIPAA HITECH OCR Physicians

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 Clarifies Scope of HIPAA Prescription Refill Reminder Exception

In response to recent litigation as well as concerns from the health care industry and privacy advocates, the Office for Civil Rights (OCR) has published guidance regarding the scope of the refill reminder exception under the...more


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

HIPAA Marketing Rules Prompt First Amendment Challenge

In what is believed to be the first legal challenge to the HIPAA Omnibus Rule (the “Rule”), a vendor of prescription drug adherence services is seeking an injunction to block certain provisions of the Rule related to drug...more

9/11/2013 - ACOs First Amendment Free Speech HIPAA HIPAA Omnibus Rule Hospital Readmission Marketing Medicare Advantage Pharmaceutical Industry Prescription Drugs

Seven-Figure HIPAA Settlement Prompted by Photocopier Breach

The Office for Civil Rights’ (OCR) latest seven-figure fine for HIPAA violations resulted from a failure to remove protected health information or “PHI” from the hard drive of a leased photocopier. The $1,215,780 settlement...more

8/15/2013 - Confidential Information Data Protection HIPAA Medical Records PHI Settlement

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