Kimberly J. Gold

Kimberly J. Gold

Mintz Levin

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Key Takeaways from OIG’s 2015 Work Plan

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more

11/5/2014 - Affordable Care Act CMS Healthcare Healthcare Reform HHS Medicare Medicare Part D OIG

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

A Brave New World of Transparency Reporting: CMS Launches Open Payments Website

September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS)....more

10/1/2014 - Affordable Care Act CMS Open Payments Reporting Requirements Sunshine Act Transparency

OCR Issues Guidance on HIPAA and Same-Sex Marriage

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance last Wednesday to help covered entities and business associates understand the privacy implications of the 2013...more

9/23/2014 - Employee Benefits HIPAA Marriage OCR Same-Sex Marriage

Corporate Practice of Medicine: An Old Doctrine Breathing New Life

New York is one of many states that prohibit the “corporate practice of medicine” (CPOM). The CPOM doctrine generally bars a business corporation from practicing medicine or employing a physician to provide professional...more

6/26/2014 - Corporate Practice of Medicine Healthcare

New York Hospitals to Pay Record $4.8 Million for HIPAA Data Breach

In the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date, two New York hospitals have agreed to pay $4.8 million to settle allegations that they failed to secure thousands of patients’...more

5/13/2014 - Data Breach Electronic Medical Records Healthcare HIPAA Hospitals Non-Judicial Settlement Agreements OCR

Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more

5/8/2014 - FCC FDA FDASIA Healthcare ONC Technology

Connecticut Pharmacy Rewards Program Disclosure Bill Could Cause Headaches

The Connecticut State Senate recently passed a bill that would impose additional disclosure and consent requirements on retailers offering pharmacy rewards programs to consumers. If the bill passes the Connecticut House and...more

5/8/2014 - Disclosure Requirements HIPAA Pharmaceutical Pharmacies Rewards Programs

We have seen this movie before ….. and we all should know that it does not end well.

How much is the cost of doing nothing when it comes to encryption of sensitive data? In the case of electronic protected health information, about $2 million. Two companies have been hit with fines equaling a total...more

4/28/2014 - Cybersecurity Data Protection EHR HHS HIPAA PHI

No More Excuses: Encrypt Your Laptops or Pay Big $

Two companies were hit with fines equaling a total of almost $2 million to settle alleged Health Insurance Portability and Accountability Act (HIPAA) violations involving stolen, unencrypted laptops, the U.S. Department of...more

4/24/2014 - Data Protection Encryption HHS HIPAA OCR

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

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

4/11/2014 - Billing CMS Healthcare HHS Medical Devices Medicare Pharmaceutical Sunshine Act

HHS Extends Medicare Coverage to Same-Sex Couples

The U.S. Department of Health & Human Services (“HHS”) announced last week that same-sex married couples can now qualify for Medicare Part A and Part B special enrollment periods and reductions in late enrollment penalties....more

4/8/2014 - DOMA HHS Medicare Same-Sex Marriage SSA US v Windsor

Unprecedented HIPAA Fine May Mean Increased Scrutiny and Penalties

Triple-S Management Corp. (“Triple-S”), a Puerto Rico-based health insurer, has been fined $6.8 million by the Puerto Rico Health Insurance Administration (“PRHIA”) following a Health Insurance Portability and Accountability...more

2/26/2014 - Data Breach Data Protection Fines Health Insurance Healthcare HIPAA PHI

Data Breach Wall of Shame: 2013's Highlights and Lessons

Since 2009, the HHS Office for Civil Rights (“OCR”) has posted all large data breaches – those that involve 500 or more individuals – online on its so-called “Wall of Shame.” In 2013, 160 large data breaches were reported to...more

1/24/2014 - Cybersecurity Data Breach Data Protection Encryption Healthcare HHS Medical Records OCR Recording Requirements

New York’s Nonprofit Revitalization Act Becomes Law

On December 18, 2013, New York State Governor Andrew Cuomo signed the Nonprofit Revitalization Act of 2013 (the Act) into law, triggering the first overhaul of the New York Not-for-Profit Corporation Law (N-PCL) in more than...more

12/24/2013 - Charitable Donations Charitable Organizations Corporate Governance Corporate Management Executive Compensation Financial Reporting Foreign Corporations Internal Audit Functions Non-Profits

GlaxoSmithKline Announces Further Limits on Payments to Physicians and on Sales Compensation

GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual...more

12/19/2013 - GlaxoSmithKline Healthcare Professionals Pharmaceutical Physician Payments Sales Commissions

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

New York Cracks Down on Executive Compensation for Not-for-Profits

Those powerful words were spoken by New York Governor Andrew M. Cuomo just over two years ago in his announcement of the formation of a task force to combat excessive executive compensation at not-for-profit corporations that...more

11/25/2013 - Andrew Cuomo Charitable Organizations Executive Compensation Healthcare Safe Harbors Sanctions

Hearing to Address HIPAA Accounting of Disclosures

The HHS Office of Civil Rights (OCR) announced that the Health Information Technology (HIT) Policy Committee’s Privacy and Security Tiger Team will hold a virtual, public hearing on Monday, September 30 from 11:45 a.m. to...more

9/26/2013 - Business Associates Covered Entities HHS HIPAA HIPAA Omnibus Rule HITECH OCR PHI

FDA Issues Final Mobile Medical App Guidance

The U.S. Food and Drug Administration (FDA) has issued long-awaited final guidance for developers of mobile medical apps. The final guidance comes more than two years after the FDA published its draft guidance in July 2011. ...more

9/24/2013 - FDA Mobile Apps Mobile Devices Telemedicine

OCR Publishes Model Notice of Privacy Practices

With the September 23, 2013 compliance date for the HIPAA Omnibus Rule only one week away, the Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) have developed...more

9/17/2013 - HIPAA HIPAA Omnibus Rule Notice of Privacy Practices Notice Requirements OCR

Massachusetts Launches New Program to Combat Provider Fraud

Last week, the Massachusetts’ Secretary of Health and Human Services, John Polanowicz, announced the launch of a new $5 million program designed to detect and prevent provider fraud, waste, and abuse in MassHealth, the...more

9/12/2013 - FMAP Fraud Healthcare Healthcare Fraud Medicaid Medicare

Texas Makes Changes to Medicaid Laws and Programs

Texas Governor Rick Perry signed a series of bills into law last week modifying some of the state’s Medicaid statutes and programs. The laws will take effect on September 1, 2013....more

6/20/2013 - CHIP Fraud Healthcare Medicaid Medicare New Legislation

Agencies Seek Comments to Inform Future Health IT Regulation

As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more

6/4/2013 - FCC FDA FDASIA Health Information Technologies Public Comment Risk Assessment

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