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Sara Shanti

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Sara Helene Shanti is a partner in the Corporate Practice Group in the firm's Chicago office.

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This blog is the third installment of our Digital Health Trends Series, see previous blog posts here and here.

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008 (“RHA”) after the COVID-19 Public Health Emergency (“PHE”) terminates on May 11, 2023. The proposed rule extends certain flexibilities beyond the PHE and proposes to make permanent certain scenarios, in which a practitioner may prescribe controlled substances without a prior in-person medical evaluation.…

Continue Reading DEA Proposes Rule for Post-PHE Telemedicine

Social media’s interplay with healthcare privacy presents a constantly evolving challenge. ICYMI (“in case you missed it”), there is an uptick in enforcement and scrutiny IRL (“in real life”) related to communications through social media and other public platforms by entities subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).…

Continue Reading ICYMI: HIPAA and Social Media IRL

Regulatory enforcement and large litigation relating to the use of third party trackers on companies’ websites and applications have been on the rise. Tracking often occurs without the companies’ knowledge or consent. Third party tracking on hospital and provider websites has specifically garnered notable media attention. Recently, there has been significant activity by the Federal Trade Commission (“FTC”) under the Health Breach Notification Rule for unauthorized sharing of personal information. It has begun to penalize and impose steep corrective actions, including long-impacting future restrictions, for such violations.…

Continue Reading Web Tracking Creates a Web of Data Privacy Risks

This blog is the second installment of our Digital Health Trends series.

Overview

Digital health services have exploded since the onset of the COVID-19 pandemic, and behavioral health services have seen large increases in utilization. Prior to the pandemic, telehealth visits for mental health or substance use disorder represented less than 1% of outpatient visits, but by mid-2020 nearly 40% of telehealth outpatient visits were for mental health or substance use.[i] Behavioral health is the highest-funded clinical indication within digital health, and digital behavioral health companies raised $1.7 billion in the first three quarters of 2022.[ii] Investments in behavioral digital health services have the potential to transform the healthcare system in several key areas.…

Continue Reading The Transformation in Behavioral Digital Health Services

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the potential for fraud and abuse. In July 2022, the Department of Health and Human Services Office of Inspector General (“OIG”) issue a Special Fraud Alert alerting practitioners to exercise caution when entering into arrangements with telemedicine companies. The issuance of this report is a significant step and reinforces the government’s interest in scrutinizing telehealth arrangements. The Department of Justice (“DOJ”) and the Drug Enforcement Agency (“DEA”) have also launched several high-profile investigations that the industry is monitoring closely. Telehealth providers should carefully review and update their practices given the heightened enforcement climate.…

Continue Reading Recent Developments in Telehealth Enforcement

The U.S. Department of Health and Human Services (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Part 2 (“Part 2”). While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the privacy and security of protected health information generally, Part 2 specifically governs the medical records of federally assisted substance use treatment programs (“SUD Records”).…

Continue Reading Proposal to Overhaul Privacy Law Governing Substance Use Disorder Treatment Records

This blog is the first in our Digital Health Trends series.

Digital health’s explosion in the last few years has led to the proliferation of new technologies and novel solutions to long-standing health problems. FemTech, in particular, has become a major movement in women’s healthcare, and the market appears ready to support this rapid growth. A recent report projects FemTech to grow by approximately 17% over the next five years with a market value over $60 billion.[1] Despite FemTech’s initial focus on access to reproductive health services, the FemTech market has evolved to encompass a broad range of women’s health issues from fertility to cardiovascular disease while increasing access to traditionally stigmatized or ignored health conditions such as menopause, mental health, and sexual health.…

Continue Reading The FemTech Revolution

On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule[1] that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable Care Act (the “ACA”).…

Continue Reading Proposed Rule Leverages Section 1557 for Healthcare Equity

Last month, in Cummings v. Premier Rehab Keller, P.L.L.C., the Supreme Court denied a petitioner’s right to emotional distress damages in a private action brought under federal anti-discrimination laws. The Petitioner, a woman who is both deaf and legally blind, alleged that when she requested an American Sign Language interpreter at Premier Rehab Keller (“Premier”), the clinic denied her request, resulting in her inability to receive treatment. She filed suit under Section 504 of the Rehabilitation Act (“Rehab Act”) and Section 1557 of the Affordable Care Act (“ACA”), two federal statutes that prohibit recipients of federal funding from discriminating in the delivery of services based on disability. The Fifth Circuit dismissed her claim, reasoning that emotional distress damages are categorically unavailable in private actions and cannot be used to enforce either the Rehab Act or the ACA. As explained below, the Supreme Court affirmed the Fifth Circuit ruling.…

Continue Reading Supreme Court Discrimination Case Narrows Scope of Restitution for Individuals

The digital health sector has seen tremendous growth and innovation over the past few years. This momentum introduces new complexities within the legal and regulatory landscape that is trying to…
Continue Reading Top 5 Legal Issues in Digital Health to Watch for in 2022