Lauren Gandle

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Lauren Gandle focuses her practice on healthcare law, including representing insurance companies in litigation and general liability matters. Her experience includes researching legal issues, drafting memoranda on healthcare topics including HIPAA, healthcare research misconduct, and drafting license agreements with hospital systems.

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Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

By Noam Fischman and Lauren Gandle on Posted in Fraud & Abuse & False Claims Act, Healthcare Litigation
How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District Court for the District of Massachusetts. In its ruling denying the motion for summary judgment filed by defendants … Continue Reading

Health Apps Beware: FTC Clarifies Health Breach Notification Rule with Significant Proposed Changes

By Jordan Cohen, Elizabeth F. Hodge and Lauren Gandle on Posted in Health Care Providers, HIPAA, Privacy, and Data Security, Pharmacy, Drugs, Medical Devices & Equipment, Technology
Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement the HBNR’s applicability to a broad swath of direct-to-consumer health and wellness applications (apps) and confirm that a breach of security includes not only … Continue Reading

OCR’s Proposed Rule Finds Fertile Ground for Enhanced Reproductive Privacy Protection

By Jordan Cohen, Elizabeth F. Hodge and Lauren Gandle on Posted in Health Plans, Healthcare Law, HIPAA, Privacy, and Data Security, Hospitals & Health Systems, Physicians
The Department of Health and Human Services Office for Civil Rights (OCR) issued a proposed rule on April 17, 2023, to amend provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to strengthen privacy protections for individuals’ protected health information (PHI) related to reproductive healthcare (the Proposed Rule). The Proposed Rule would … Continue Reading

All Good Things Must Come to an End: The Expiration of OCR’s Enforcement Discretion

By Lauren Gandle, Elizabeth F. Hodge and Jordan Cohen on Posted in Uncategorized
On April 11, 2023, the Department of Health and Human Services’ Office for Civil Rights (OCR) confirmed that four notifications of enforcement discretion regarding enforcement of the HIPAA Privacy, Security, and Breach Notification Rules (the HIPAA rules) during the COVID-19 public health emergency (PHE) will expire at the end of the PHE.1 The notifications, which … Continue Reading

The FTC Sends Another Warning to Digital Healthcare Platforms About Use of Tracking Pixels

By Jordan Cohen, Elizabeth F. Hodge and Lauren Gandle on Posted in Health Care Providers, HIPAA, Privacy, and Data Security, Pharmacy, Drugs, Medical Devices & Equipment, Technology
The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for sharing consumer health information for advertising purposes (see our blog posts on each respective action here and here), and in a post published by the FTC … Continue Reading

The Trebling Effect of (Some) False Claims Act Trials

By Noam Fischman and Lauren Gandle on Posted in Fraud & Abuse & False Claims Act, Healthcare Litigation
There are multiple components to the risk defendants must consider when faced with going to trial for a matter involving the False Claims Act (FCA). Setting aside the incalculable impact that litigation can have on business operations, the statute itself anticipates repayment of the proven overpayment, treble damages, and exposure to a civil statutory penalty … Continue Reading

FTC Cracks Down on BetterHelp’s Sharing of Health Information for Advertising 

By Jordan Cohen, Elizabeth F. Hodge and Lauren Gandle on Posted in Health Care Providers, HIPAA, Privacy, and Data Security, Pharmacy, Drugs, Medical Devices & Equipment, Technology
Following its February settlement with GoodRx, the Federal Trade Commission (FTC) has fired another shot across the bow in its ongoing campaign to protect consumers’ digital health information. Earlier this month the FTC announced a consent order with BetterHelp, Inc., an online mental health counseling service, to resolve alleged violations of the Federal Trade Commission … Continue Reading

State Attorneys General Flex in a Post-Dobbs world – can complying with federal regulatory guidance constitute racketeering activity?

By Noam Fischman and Lauren Gandle on Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment
Are State Attorneys General expanding their reach in this Post-Dobbs world? On February 1, 2023, twenty state Attorneys General signed letters to both CVS and Walgreens warning the giant retail pharmacies against mailing medications that could potentially be used to induce abortions. These letters are most notable for the legal posture they assume. The state … Continue Reading

Important Update: Georgia Abortion Law Remains in Effect Until Judicial Review

By Noam Fischman, Jeremy Burnette and Lauren Gandle on Posted in Healthcare Litigation
Ruling on the State of Georgia’s November 18, 2022 Emergency Petition for Supersedeas, this past Wednesday (November 23, 2022) the Georgia Supreme Court enjoined the lower court’s decision thereby reinstating the prohibitions on abortion in Georgia codified by the LIFE Act.  Briefly, the LIFE Act prohibits abortive care once cardiac activity is detectable in an … Continue Reading

Breaking News: Georgia Court Overturns State Abortion Law

By Noam Fischman, Jeremy Burnette and Lauren Gandle on Posted in Healthcare Litigation
On June 24, 2022, the United States Supreme Court issued its seminal decision on abortion, Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade and the right to terminate a pregnancy before viability, which Roe had seemingly codified. The Supreme Court’s decision fundamentally altered the constitutional landscape of a woman’s right to make reproductive … Continue Reading

Recent FCA Settlements Warn Providers of Improper Billing Practices

By Noam Fischman and Lauren Gandle on Posted in Fraud & Abuse & False Claims Act
Two recent multi-million dollar False Claims Act (“FCA”) settlements demonstrate the vigor with which the Department of Justice (“DOJ”) is investigating and prosecuting allegedly fraudulent health care billing practices.  These large settlements demonstrate how imperative it is that providers routinely review billing practices with the guidance of counsel.… Continue Reading

Healthcare Providers: Add OCR’s Latest Right of Access Settlements to Your Summer Reading List

By Elizabeth F. Hodge and Lauren Gandle on Posted in Electronic Health Records & Medical Records, HIPAA, Privacy, and Data Security, Hospitals & Health Systems, Physicians
The Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced on July 15, 2022, that it has resolved 11 investigations conducted under the Health Insurance Portability and Accountability Act (“HIPAA”) Right of Access Initiative. These settlements remind providers that, as OCR Director Lisa J. Pino stated, “OCR is … Continue Reading

ALERT! Your COVID-19 Policies and Procedures Need a BOOSTER!

By Lauren Gandle, Kirk S. Davis and Karen M. Buesing on Posted in Healthcare Law, HIPAA, Privacy, and Data Security, Labor Relations & Employment Law
Employers who are conducting automatic COVID-19 testing of employees or gathering test results of employees’ families should beware: the Equal Employ­ment Opportunity Commission (“EEOC”) has issued new guidance limiting the former and has penalized a healthcare practice recently for doing the latter.… Continue Reading

OCR Releases Guidance on HIPAA Compliance When Providing Audio-Only Telehealth

By Elizabeth F. Hodge and Lauren Gandle on Posted in Health Insurers & Managed Care Organizations, Healthcare Law, HIPAA, Privacy, and Data Security, Hospitals & Health Systems
The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) recently released new guidance (the “Guidance”) to help ensure that individuals may continue to benefit from audio-only telehealth services and clarify for health care providers and health plans how they can provide such services while complying with the HIPAA Privacy, Security, … Continue Reading

SCOTUS May Resolve Circuit Split on the Specificity Required of False Claims Act Claims: Relief or More FCA Grief for Providers?

By William J. Spratt, Jr., Jeremy Burnette and Lauren Gandle on Posted in Fraud & Abuse & False Claims Act
Currently, providers have different risks of potential False Claims Act (“FCA”) liability depending on where they are geographically located due to the difference in the standards required by the U.S. Courts of Appeals regarding the level of specificity when relators (whistleblowers) plead FCA violations.  The FCA imposes civil liability on any person requesting government funds … Continue Reading
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