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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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Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.
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House Democrats Weigh Major Tax Changes for Businesses, Funds, and Individuals

October 12, 2021 | Alert | By Gregg M. Benson, Anthony DeMaio

Read about the U.S. House Ways and Means Committee’s proposed tax legislation intended to partially fund the $3.5 trillion Build Back Better Act to fund Democratic priorities.
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Proposed Laws Are One Step Closer to the November 2022 Ballot

September 3, 2021 | Blog | By Steven Baddour, Daniel Connelly, Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd

On Wednesday, September 1st, Attorney General Maura Healey certified 17 out of 30 ballot proposals filed in August to continue on the path to securing a spot on the 2022 ballot.  Of the 17 proposals certified, 16 were initiative petitions including, but not limited to, proposals relative to alcohol reforms, requirements for presentation of identification to vote, and the employment of app-based drivers.  The seventeenth proposal is a constitutional amendment providing for no-excuse absentee voting.
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The second half of 2021 will be a busy stretch for Congress. In addition to the typical must-pass legislation, Democrats controlling both chambers and the White House are committed to several big spending bills, too. This preview is a rundown of these bills, what’s included in them, and how we can expect them to play out.
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