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Massachusetts to End Public Health Emergency
March 23, 2023 | Blog | By Ryan Rasdall
On March 15, 2023, Massachusetts Governor Maura Healey and Lieutenant Governor Kim Driscoll announced that the state’s COVID-19 public health emergency would end on May 11, 2023, in conjunction with the federal government’s end date for the public health emergency. This announcement by the Healey-Driscoll administration puts state organizations on notice, as required by law, at least 45 days ahead of the changes. As part of this announcement, Governor Healey also announced that she will be (i) rescinding Executive Order 595 which required state employees to be vaccinated against COVID-19, and (ii) proposing new legislation that allows for further flexibility in health care settings.
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FDA Modernizes Mammography Regulations, Provides Facilities with Eighteen-Month Compliance Deadline
March 20, 2023 | Blog | By Joanne Hawana, Jane Haviland
The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?
March 14, 2023 | Blog | By Benjamin Zegarelli, Daniel Herling
The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their upcoming integration into multiple Internet search engines. This development creates exciting opportunities and potentially terrifying risks in the health care space. Inevitably, people will ask AI chatbot-enabled search engines for information on diseases, conditions, medicines, or medical devices and use the response in some way to make certain medical decisions. But what happens when the AI chatbot’s response is inaccurate or even provides advice that may lead to harm if the user follows it? Can AI chatbots be regulated by the U.S. Food and Drug Administration (FDA)? What are the liability implications if a user is harmed? We provide some initial thoughts on such legal issues in this post.
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Federal Trade Commission’s GoodRx Settlement: Not Just a $1.5 Million Penalty
March 8, 2023 | Blog | By Lara Compton, Pat Ouellette
The Federal Trade Commission (FTC) recently kicked off enforcement of its Health Breach Notification Rule (Breach Rule) by taking aim at GoodRx’s use of tracking technologies (e.g. pixels) and the sharing of consumer health data for advertising purposes. According to Samuel Levine, director of the FTC's Bureau of Consumer Protection, the FTC “is serving notice that it will use all of its legal authority to protect American consumers' sensitive data from misuse and illegal exploitation." Bottom line, HIPAA applicability may no longer be as significant of a factor when it comes to the risk presented by collecting, using, disclosing, and maintaining identifiable health information (IHI).
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Telehealth Update: DEA Issues Long-Awaited Proposed Rule on Prescribing Controlled Substances via Telehealth
March 3, 2023 | Blog | By Ellen Janos, Cassandra Paolillo
With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances via telehealth. This post provides continued coverage of telehealth updates and dissects what this DEA's proposed rule could entail.
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New York Proposes Regulatory Review and Approval of Material Health Care Entity Transactions
March 1, 2023 | Blog | By Jean D. Mancheno, Pamela Polevoy, Lara Compton
On February 1, 2023, New York Governor Kathy Hochul announced the Fiscal Year 2024 New York State Executive Budget (the Executive Budget). One component of the Executive Budget’s Health and Mental Hygiene Article VII Legislation is a proposal to require certain “health care entities” to obtain approval from the New York State Department of Health (DOH) prior to consummating a material transaction.
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CMS Proposes New Disclosure of Ownership Regulations for Nursing Facilities - Top Five Takeaways for Private Equity Firms and REITs
February 21, 2023 | Blog | By Lauren Moldawer, Karen Lovitch
Private equity ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. This post highlights the top five takeaways related to the proposed regulations for private equity companies or real estate investment trust ownership.
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Health Care Deal Structures: What Will the Deal Look Like?
February 15, 2023 | Blog | By Pamela Polevoy, Deborah Daccord, Cody Keetch
Deal structure is the foundation of a health care transaction. This post offers practical tips and hypothetical case studies for laying the groundwork for a successful health care transaction.
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FDA’s Digital Health High Notes from 2022
February 13, 2023 | Blog | By Benjamin Zegarelli
There has been a lot of discussion of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023, but we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA). The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things (both described below); however, major digital health policy updates and announcements were few and far between. In this post, we summarize the agency’s key actions in the digital health space in 2022.
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EnforceMintz Newsletter — Quick Hits
February 9, 2023 | Blog | By Karen Lovitch
EnforceMintz — 2022 Saw the Expansion of EKRA Outside of the Addiction Treatment Setting
February 9, 2023 | Blog | By Kathryn Edgerton
EnforceMintz — With Telemedicine Here to Stay, Enforcement Agencies Continued their Scrutiny
February 9, 2023 | Blog | By Karen Lovitch
EnforceMintz — Significant 2022 Regulatory and Policy Developments
February 9, 2023 | Blog | By Samantha Kingsbury
EnforceMintz — Despite Some Setbacks, Enforcement Authorities Continue to Focus on the Opioid Supply Chain
February 9, 2023 | Blog | By Grady Campion
EnforceMintz — 2022 Teed Up Two False Claims Act Issues That the Supreme Court Is Poised to Answer in 2023
February 9, 2023 | Blog | By Samantha Kingsbury, Kevin McGinty
EnforceMintz — The Pandemic May Be Ending, But Fraud Prosecutions Will Keep Coming
February 9, 2023 | Blog | By Cory S. Flashner
EnforceMintz — Medicare Advantage Remains a Top Enforcement Priority
February 9, 2023 | Blog | By Brian Dunphy
Operation Nightingale: Fraudulent Nursing Diploma Scheme and Its Implications on Health Care
February 6, 2023 | Blog | By Sophia Temis
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently partnered with various law enforcement agencies in a multi-state enforcement action aimed at uncovering a nursing degree fraud scheme: Operation Nightingale. This blog post discusses the related enforcement actions surrounding the fraud scheme and the broader implication on healthcare.
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New Group Practice Information Form for the Stark Law’s Self-Referral Disclosure Protocol
February 2, 2023 | Blog | By Rachel Yount
The Stark Law’s Self-Referral Disclosure Protocol (SRDP) will include a new Group Practice Information Form for physician practices to report any noncompliance arising from not fully satisfying the Stark Law’s definition for a “group practice,” effective March 1, 2023. The Centers for Medicare & Medicaid Services (CMS) intends for the changes to reduce regulatory burden and streamline the disclosure process.
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Garland Memo May Provide White Collar Defendants Increased Opportunity for Negotiation While Updated Corporate Enforcement Policy Highlights the Importance the Department of Justice Places on Self-Disclosure, Cooperation, and Remediation
February 2, 2023 | Blog | By Eoin Beirne, Edmund P. Daley, Nick A. LaPalme
Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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