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Webinar: The Inflation Reduction Act - Are You Ready?

August 19, 2022 | Webinar | By Anne S. Levin-Nussbaum, R. Neal Martin, Courtney O. Taylor

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ML Strategies Outlook: Federal Action Post-Dobbs Decision

July 25, 2022 | Blog | By Pamela Mejia, Ellen Janos, Kaitlyn Sprague

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Look Ahead: Upcoming Congressional Work Period – July 2022

July 11, 2022 | Blog | By Alexander Hecht, Christian Tamotsu Fjeld, Courtney O. Taylor, Anthony DeMaio, R. Neal Martin, Pamela Mejia

The next three weeks will be full of activity in Washington D.C., as the House of Representatives and Senate are working to push their legislative agendas to garner support from their constituents ahead of an August recess and before political “silly season” officially kicks in ahead of the upcoming mid-term elections in November. Here’s our latest update on what you can expect in Congress during the July work period.
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Understanding the American Data Privacy and Protection Act

June 8, 2022 | Blog | By Christian Tamotsu Fjeld, Cynthia Larose

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Massachusetts Information Security and Privacy Act Sent to “Study”

June 2, 2022 | Blog | By Cynthia Larose, Daniel Connelly

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Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and Drug Administration (FDA). Mintz previously published this wonderful explanation of the process complete with an estimated timeline for how this year’s reauthorization was likely to go. As a reminder, the current authorization for FDA’s various human product user fee programs – with the exception of the over-the-counter drug program that was freshly created in 2020 – will expire on September 30, 2022 with the end of the federal government’s fiscal year, unless they are renewed by Congress before that time.
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Massachusetts for ARPA-H

May 3, 2022 | Blog | By Anthony DeMaio

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Major Update in Data Privacy Laws Proposed in Massachusetts

February 3, 2022 | Blog | By Daniel Connelly, Kaitlyn Sprague, Taylor Shepherd

On February 2, 2022, the Massachusetts Legislature’s Joint Committee on Advanced Information Technology, the Internet and Cybersecurity released a new draft of a bill designed to provide mechanisms for how personal information is used and to control how companies use such information.  This 65-page bill, known as the “Massachusetts Information Privacy and Security Act” or “MIPSA”, would be the first major piece of legislation related to data privacy passed since the Legislature updated the data breach legislation in 2019.
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Governor Baker Releases Eighth Budget Recommendation

January 26, 2022 | Blog | By Daniel Connelly, Kaitlyn Sprague, Taylor Shepherd

Today, Governor Charlie Baker released his Fiscal Year 2023 (FY2023) budget recommendations.  This is the unofficial start of “budget season” in Massachusetts that will culminate with a legislative conference committee agreeing on a budget bill sometime around late June or early July.
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Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

January 5, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.
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On December 22, 2021, FDA took another step in rolling back enforcement policies implemented in response to the COVID-19 pandemic by publishing guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic once the Public Health Emergency for COVID-19 ends. The Transition Plan Guidances will help device manufacturers prepare for the end of the PHE and continue to commercialize devices necessary for the long-term response to COVID-19.
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Webinar Recording: Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook

December 7, 2021 | Webinar | By Alexander Hecht, Ellen Janos, Karen Lovitch, Kate Stewart

Over the past year, the demand for health care via telehealth has continued to skyrocket as a result of the COVID-19 pandemic and the public’s increased comfort with obtaining health care goods and services virtually. Join Ellen Janos, Karen Lovitch, Kate Stewart and Alex Hecht as they demystify the current status of laws and regulations, untangle the web of legislation before Congress related to the expansion of telehealth services, discuss recent enforcement activity, and look ahead to trends we see on the horizon.  
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Energy & Sustainability Washington Updates - December 2021

November 30, 2021 | Blog | By R. Neal Martin

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