Jennifer S. Geetter
Subscribe to Jennifer S. Geetter's PostsJennifer S. Geetter advises global life sciences, health care and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws. Jennifer represents a broad range of clients. Read Jennifer Geetter's full bio.
Texas AG’s Landmark AI Settlement: A Wake-Up Call for Health Tech & AI Companies
By Jiayan Chen, Dale C. Van Demark, Jennifer S. Geetter, Shawn C. Helms and Grayson I. Dimick on Oct 3, 2024
Posted In Digital Health, Employee Benefits, Health and Welfare Plans
Healthcare providers, payors, and other healthcare organizations should be aware of a recently announced, “first-of-its-kind” settlement between the Texas attorney general and a healthcare generative artificial intelligence (AI) company resolving allegations that the company made a series of false and misleading statements about the accuracy and safety of its AI products. The settlement highlights the...
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Federal Court Invalidates Key Part of HHS OCR Bulletin Regarding Application of HIPAA to Online Tracking Technologies
By Ryan S. Higgins, David Quinn Gacioch, Jennifer S. Geetter, Daniel F. Gottlieb and Edward G. Zacharias on Aug 27, 2024
Posted In Digital Health, Employee Benefits, Health and Welfare Plans
In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled that the US Department of Health and Human Services Office for Civil Rights exceeded its authority in certain respects in sub-regulatory guidance. The guidance concerned HIPAA’s application...
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FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance
By James Ravitz, Jennifer S. Geetter, Jiayan Chen, Paul Gadiock, Jeff Weinstein, Marissa Hill Daley, Nathan Gray and Karis Jackson on Aug 20, 2024
Posted In Employee Benefits, Health and Welfare Plans
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance provides valuable information about what steps the FDA will expect sponsors to take to promote adequate representation across demographic characteristics in...
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FTC Amends Health Breach Notification Rule to Regulate Health Apps and Expand Breach Notification Requirements
By Jennifer S. Geetter, Edward G. Zacharias, Alya Sulaiman, Kyle E. Hafkey and Abby Higgins on Jun 26, 2024
Posted In Digital Health, Privacy and Data Security
On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a compliment and counterpart to the breach notification requirements established under the Health Insurance Portability and Accountability Act (HIPAA) for HIPAA-regulated entities. Specifically, the HBN Rule requires that...
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OCR Update on Tracking Technologies Provides Little Relief for HIPAA-Regulated Entities
By Jennifer S. Geetter, David Quinn Gacioch, Elliot R. Golding, Daniel F. Gottlieb, Ryan S. Higgins and Edward G. Zacharias on May 14, 2024
Posted In Digital Health, Employee Benefits, Health and Welfare Plans, Privacy and Data Security
On March 18, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) issued an update to its December 1, 2022, bulletin titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.” In releasing the 2024 update, OCR stated that its purpose was to “increase clarity for regulated...
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Healthcare Payors and Providers and AI Companies Voluntarily Commit to AI Principles
By Jennifer S. Geetter, Purnima Boominathan and Jayda Greco on Jan 17, 2024
Posted In Digital Health, Employee Benefits, Health and Welfare Plans, Privacy and Data Security
The Biden administration recently announced that 28 healthcare payors and providers intend to implement and adhere to voluntary commitments for the safe, secure and trustworthy development and deployment of artificial intelligence (AI) in healthcare. The signatory companies aligned around the FAVES principle—namely, that AI should lead to healthcare outcomes that are fair, appropriate, valid, effective...
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FTC Proposes Health Breach Notification Rule Amendments
By Jennifer S. Geetter, Edward G. Zacharias and Purnima Boominathan on Jun 20, 2023
Posted In Digital Health, Employee Benefits, Health and Welfare Plans
At a recent open Commission meeting, the Federal Trade Commission (FTC) voted unanimously to issue a Notice of Proposed Rulemaking to amend the Health Breach Notification Rule (HBNR). The FTC’s proposed amendment aims to codify the HBNR’s application to digital health and mobile technologies. However, several aspects of the proposed amendment lack clarity and are...
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HHS Issues Guidance on Requirements Under HIPAA for Online Tracking Technologies, Addressing Privacy and Security Concerns Related to Health Information
By Jennifer S. Geetter, Elliot R. Golding, Amy C. Pimentel, Scott Weinstein, Edward G. Zacharias and Marine Margaryan on Dec 20, 2022
Posted In Privacy and Data Security
On December 1, 2022, the Office for Civil Rights (OCR) at the US Department of Health and Human Services (HHS) issued a Bulletin on the obligations of covered entities and business associates (regulated entities) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules (HIPAA Rules) when using online tracking...
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The “New” Digital Healthcare Delivery System
By Michael Ryan and Jennifer S. Geetter on Nov 18, 2021
Posted In Digital Health, Employee Benefits, Health and Welfare Plans
Although digital health solutions have long been a key area of strategic growth for the healthcare industry, the COVID-19 crisis accelerated what it means to deliver safe and effective digitally-based care. As the United States shifts focus from short-term crisis response to longer-term solutions, what does a digitally-driven healthcare industry look like, and how can...
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All Hands on Deck: How Employers Can Expedite Vaccine Roll-Out for Employees and Their Loved Ones Using the Closed Point of Dispensing (CPOD) Model
By Jennifer S. Geetter on May 25, 2021
Posted In Health and Welfare Plans
McDermott Will & Emery lawyers Jennifer S. Geetter and Allyn N. Rosenberger recommend that employers consider using a “closed point of dispensing” model to expedite COVID-19 vaccinations for their workforce by arranging for health care providers to inoculate employees using government-provided vaccines. Access the article.
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