Valerie Montague represents a variety of healthcare providers, digital health companies, senior living facilities, nonprofit trade associations, life sciences companies and vendors of healthcare providers. Valerie is a Certified Information Privacy Professional/United States (CIPP/US), the preeminent credential in the field of privacy.
I focus my practice on three main areas.
I assist healthcare providers and business associates of all types to comply with the requirements of HIPAA and the HITECH Act, from the development of policies and workforce training to analysis and notification of breaches to guidance through Office for Civil Rights (OCR) investigations. I also advise vendors initiating arrangements with healthcare entities on whether their business triggers HIPAA.
Beyond HIPAA, I counsel healthcare providers on compliance with other federal and state health information confidentiality requirements, as well as cybersecurity best practices.
I advise hospital systems, skilled nursing facilities, physician practices and other healthcare providers on compliance with the Stark Law and the Anti-Kickback Statute, as well as state laws prohibiting self-referrals and fraud and abuse. In Illinois, I work with facilities to navigate Certificate of Need (CON), corporate practice of medicine, telehealth and licensure requirements.
I work with tax-exempt entities in all industries to obtain and maintain federal income tax-exempt status, including group exemptions and reinstatement of tax-exempt status. I advise tax-exempt entities on structure and governance issues as they expand their service lines, create new entities and enter into transactions with third parties, including joint ventures and the creation of for-profit subsidiaries. I also assist tax-exempt hospitals with compliance with Internal Revenue Service (IRS) and state law requirements governing financial assistance and community benefit activities.
As more digital health vendors enter the marketplace in response to patient demand for more convenient and accessible care, both vendors and the providers using these tools will face ever increasing regulatory requirements encompassing everything from privacy and security to licensing to FDA compliance.
American Health Law Association | April 12, 2022
Chicago Healthcare partner Valerie Montague joined the podcast to discuss trends involving enforcement of the Office for Civil Rights’ Right of Access Initiative, including why access to healthcare records remains such a challenging issue, notable recent cases of enforcement and how they align with historical trends, and exceptions to the Right of Access.
Modern Healthcare | September 16, 2021
This article, covering the Federal Trade Commission’s new guidance that health apps and fitness trackers must notify users of data breaches, quotes Chicago Health Care partner Valerie Montague on the FTC’s enforcement and broad definition of a breach, noting companies should review their health data policies and obtain patient authorization when necessary.
Modern Healthcare | June 25, 2021
This article, which discusses concerns surrounding hospitals using electronic health records to promote health services, quotes Chicago Health Care partner Valerie Montague on the right of patients to opt out of their providers’ mailing lists.
Modern Healthcare | May 14, 2021
In this article on the recent cyberattack on Scripps Health, which disrupted the San Diego-based health system’s patient portal and email systems, Chicago Health Care partner Valerie Montague is quoted on HIPAA considerations for health systems when communicating with patients via social media.
Modern Healthcare | November 25, 2020
In this article on the ramped-up enforcement actions by the U.S. Department of Health and Human Services’ Office for Civil Rights against health care providers, Chicago Health Care partner Valerie Montague discusses the importance for providers to train their staff and have a workflow in place.
Modern Healthcare | March 12, 2020
Chicago Health Care partner Valerie Breslin Montague talks about how hospitals can remain in compliance with HIPAA while executing an effective crisis communications plan related to the coronavirus outbreak.
Chicago Health Executives Forum Newsletter | September 25, 2019
Chicago Health Care partner Valerie Breslin Montague wrote this contributed article outlining the factors that organizations should consider when developing a robust incident response plan.
Modern Healthcare | September 07, 2019
This article discussing the 21st Century Cures Act’s ongoing impact on the Food and Drug Administration’s approval process quotes Boston Government Investigations and White Collar Defense partner Hannah Bornstein and Chicago Health Care partner Valerie Montague.
Georgetown University Law Center, J.D.
Marquette University, Honors B.A., cum laude
Illinois
U.S. District Court, Northern District of Illinois
U.S. Court of Appeals, Seventh Circuit
Valerie was selected, through a peer-review survey, for inclusion in The Best Lawyers in America® 2022 in the field of Healthcare Law, and was the Best Lawyers 2022 “Lawyer of the Year” in Chicago for Healthcare Law. Valerie has been listed in Best Lawyers since 2018.
Valerie has been named a Recognized Practitioner in Chambers USA: America’s Leading Lawyers for Business 2022 for Healthcare (Illinois). She has been recognized in Chambers in previous years. She is also recommended in The Legal 500 United States 2021 editorial for Healthcare—Service Providers, and has been recognized in previous years.