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Kristen A. Marotta

Associate

[email protected]

+1.212.692.6246

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Kristen focuses her practice on health care transactions, regulatory matters, and general contracting. Her experience includes counseling clients on both investing in and exiting from the health care space, drafting compliance plans and policies, facilitating deals and conducting due diligence to assess risk, addressing employment issues for health care entities, and assisting companies with formation and reorganization.

Prior to joining Mintz, Kristen was an associate in the health law group in the New York office of a Philadelphia-based national law firm. In that role, she handled a wide variety of compliance inquiries, servicing numerous types of health care providers, including local hospitals and physician practices. Earlier, she was an associate in the health care practice group and a summer associate in the Long Island, New York office of an international law firm, where she was engaged in the health care industry but also represented companies outside of health care in mergers and acquisitions and on general corporate, operational matters.

While attending law school, Kristen externed at William & Mary’s Athletic Compliance Office and a Virginia-based national law firm. She also served as a judicial intern to the Hon. Joseph F. Bianco of the US District Court for the Eastern District of New York. Her law school activities included serving as both a member of the William & Mary Business Law Review and a Marshall-Brennan Constitutional Literacy Project fellow.

Education

  • William and Mary Law School (JD)
  • University of Michigan (BA, with high distinction)

Recognition & Awards

  • Phi Delta Phi Legal Honor Society
  • James B. Angell Scholar, University of Michigan

Recent Insights

News & Press

Viewpoints

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FDA and FTC Continue to Trace and Fight Fraud Related to COVID-19

June 1, 2020 | Blog | By Kristen Marotta, Joanne Hawana

We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud (see here and here). These agencies and their respective law enforcement efforts have yet to slow down and appear to have accelerated as greater coordination begins to take root. As of May 29, 2020, the U.S. Food and Drug Administration (FDA) has issued 64 warning letters to companies making claims about a product alleged to be a COVID cure, treatment, or preventative product, while the U.S. Federal Trade Commission (FTC) had issued many, many more than that. In some cases, these warning letters are joint letters that come from both government agencies, which is never a good sign. The FTC in particular is making announcements on a regular basis about large batches of warning letters being issued, such as this one from May 21 highlighting that 50 more marketers of fraudulent COVID-19 products had received such a missive from the FTC. 
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Yesterday, we blogged on how scammers are trying to monetize on the COVID-19 health crisis for their personal gain. Though the U.S. Food & Drug Administration (FDA) issued a consumer update yesterday saying that there is still no approved vaccine or drug to prevent or treat this disease, companies have continued to market products that claim to prevent, treat, or even cure COVID-19 in an attempt to “help” or profit from distressed, vulnerable Americans. While the FDA is working tirelessly to review possible vaccines, treatments, and cures, Americans should avoid endangering their health or lives by self-medicating. Per the FDA, self-medicating with any new product on the shelf (real or virtual) could not only lead to adverse effects but also could interfere with crucial medications. We are closely monitoring whether Congress will take specific actions on these increasingly prevalent issues in the context of the COVID-19 pandemic.
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As the coronavirus remains to be an active outbreak with cases increasing within the United States, this is a good time to review how HIPAA applies in a public health emergency, including its restrictions and flexibility in these types of situations. Accordingly, last week, the Office for Civil Rights (OCR) released a helpful bulletin on how the HIPAA Privacy Rule comes into play with the coronavirus outbreak and other public health emergencies.
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This Mintz health care post covers HHS’s investigation into the practices of Korunda Medical, LLC, after the Florida-based health care provider failed to comply with HIPAA regulations relating to the Right of Access Initiative.
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5 Key Reasons to Ensure Ongoing Compliance with State Distributor Licensing Requirements

October 31, 2019 | Blog | By Kristen Marotta, Joanne Hawana

Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs. The process for obtaining a license to distribute often requires an extensive application and review by the resident state. Failure to secure appropriate licensing before shipping these kinds of products in interstate commerce can lead to a variety of unwanted scrutiny and negative effects. For instance, the Washington Department of Health has recently been investigating a complaint alleging that Sun Pharmaceuticals distributed medicine samples without the proper license.
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Greater Access to Mental Health Care is on the Horizon

September 18, 2019 | Blog | By Kristen Marotta

Employers and retail giants alike are increasingly inserting mental health into the broader, public conversation around individual healthcare and employee benefits. Various U.S. employers are rolling out employee-based benefit programs to improve employees’ mental health and overall well-being.
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On June 26, 2019, the Office of Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) released Frequently Asked Questions (FAQs) on how HIPAA allows health plans to share protected health information (PHI). The FAQs pose two questions: (1) whether HIPAA permits one health plan to share PHI about individuals in common with a second health plan for care coordination purposes; and (2) whether HIPAA permits health plans to use and disclose PHI to inform individuals about other health plans that it offers, without the individuals’ authorization, if the health plan received the PHI for a different purpose. The former answer is an affirmative “yes,” and the latter is a qualified answer of “yes, in certain circumstances.”
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EMR Company Suffers Double Whammy After HIPAA Breach

June 5, 2019 | Blog | By Kristen Marotta

Medical Informatics Engineering, Inc. (Medical Informatics) and its wholly-owned subsidiary, NoMoreClipboard, LLC, an electronic medical record and software services provider is now liable for a combined total of $1 million to both the federal and state governments after hackers accessed approximately 3.5 million patients’ health records in 2015. The breach, reported to OCR on July 23, 2015, occurred through a compromised user ID and password. Compromised patient information included social security numbers, names, email addresses, health insurance policy information, addresses, dates of birth, and clinical information.
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On June 28, 2018, California passed the California Consumer Privacy Act (CCPA) and then further amended it on September 23, 2018. CCPA breaks new state law privacy ground, and this post addresses some of the confusion surrounding the exemptions for health information.
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Latest HIPAA Breach Involves Medical Records Hack of Business Associate

March 6, 2019 | Blog | By Kristen Marotta, Sarah Beth Kuyers

AltaMed Health Services (AltaMed) and California Physicians Services (doing business as Blue Shield of California (BSC)) recently received notice from their business associate, Sharecare Health Data Services (SHDS), of a hack of SHDS’s network that stores patients’ medical records.  The hacker was able to acquire and/or access patients’ protected health information (PHI) contained in the medical records kept by SHDS on behalf of AltaMed and BSC. The breach of AltaMed’s data was discovered on June 22, 2018, and the breach for BSC was discovered a few days later on June 26, 2018. Upon investigation, however, officials determined that both breaches went undetected for over a month and actually began on May 21, 2018.
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News & Press

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In an article published by HR Daily Advisor, Mintz Associate Kristen Marotta was quoted on legal considerations for human resources professionals and employers, specifically compliance with the Health Insurance Portability and Accountability Act (HIPAA), as they navigate the novel coronavirus (COVID-19)’s impact on the workplace.