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Worried About Misinformation? FDA Is Too. Here’s What You Should Know.

On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists...more

Digital Health ‘From the Inside Out’ Leadership Series: The Power of Public Policy with Amazon Health

We hosted an engaging discussion with Sarah-Lloyd Stevenson and Matt Rubin, two former Faegre Drinker colleagues who now serve on Amazon’s Public Policy team. With more than a decade of experience advocating for health care...more

FDA Grants Small Dispensers More Time, but Nobody Else

The Drug Supply Chain Security Act (DSCSA) (Title 2 of the Drug Quality and Security Act, P.L. 113-54 (Nov 27, 2013)) amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H —...more

ATA Nexus 2024: The Next Chapter for Virtual Care

The American Telemedicine Association (ATA) brought together change-makers and front-line providers from across the telehealth industry for its annual conference, ATA Nexus 2024, on May 5-7, 2024, in Phoenix, Arizona. Below...more

DOJ Proposes Rule to Reschedule Cannabis From Schedule I to Schedule III

On May 16, 2024, the U.S. Department of Justice (DOJ) published its proposed rule to move cannabis from the highly restrictive Schedule I tier under the federal Controlled Substances Act (CSA) to the more loosely regulated...more

Remote Prescribing of Controlled Substances via Telehealth: Stakeholders Urge DEA to Address Geographic Red Flag for Pharmacists

Due to convenience and effectiveness, patients are increasingly seeking care via telehealth, including for conditions that require treatment with medication. During the pandemic, patients gained access to telehealth for...more

What to Know Before Getting Back to the Business of Health Care: FY2023 Omnibus Spending Bill

In late December, Congress passed and President Biden signed into law a $1.7 trillion year-end omnibus spending bill to fund the federal government through FY2023. This alert summarizes the notable health policies and...more

The Race Toward Full DSCSA Implementation

In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more

The Future of Telehealth: A Discussion with American Telemedicine Association CEO Ann Mond Johnson

Once an innovative outlier in the world of health and life sciences, telemedicine has exponentially gained ground in the current landscape shaped by COVID-19 restrictions. Ann Mond Johnson — CEO of the American Telemedicine...more

Online Communications and Content: How Section 230 Reform Has Catapulted into Relevancy

Throughout much of 2020, Members of Congress, the Trump Administration, and even Associate Justice Clarence Thomas have highlighted the reasonableness in reevaluating Section 230 of the Communications Decency Act (47 USC...more

The American Telemedicine Association Leads the Industry Commenting on Medicare Updates to Telehealth Policy

Faegre Drinker professionals Megan Herber, Sarah-Lloyd Stevenson and Libby Baney provide ongoing support to the American Telemedicine Association’s (ATA) policy work. This week, the comment period closed for the calendar...more

A Day in Telehealth History: Access to Telehealth Services Expanded, Requirements to Facilitate Virtual Visits Relaxed in Response...

March 17, 2020, will be a day to remember in the history of telehealth in the U.S. Thanks to a slew of federal policy changes, it is now easier for providers to offer telehealth, more people can access telehealth services,...more

Long-Awaited FDA Report Leaves CBD Stakeholders Longing for More

On Thursday, March 5, the Food and Drug Administration (FDA) submitted its long-awaited report on the agency’s activity related to regulation of cannabidiol (CBD) and CBD-containing products. The FDA was required to submit a...more

Restricted Access to WHOIS Data Jeopardizes Brand Owners Online

As many brand owners know, WHOIS data is the publicly available information on who has registered a particular internet domain name. In layman’s terms, WHOIS records are akin to land title or property tax records: a record of...more

Beware Billing Medicare for Non-Approved Imported Drugs

Dr. Mark Fleckner, a board-certified New York ophthalmologist, will pay almost $7 million to settle civil fraud claims arising from giving patients imported macular degeneration drugs that had not been evaluated or approved...more

In 2018 Strategic Policy Roadmap, FDA Unveils Plans for 2018 Addiction, Drug Competition and Innovation Efforts

On January 11, 2018, the Food and Drug Administration (FDA) released its 2018 Strategic Policy Roadmap, which sheds light on the agency’s key focus areas for the year. This Roadmap builds on some of the FDA’s existing work,...more

Department of Veterans Affairs Releases Long-Awaited Proposed Rule to Allow Telehealth Services Across State Lines

On Friday, September 29, the Department of Veterans Affairs (VA) released its long-awaited proposed rule amending medical regulations to improve access to care for beneficiaries regardless of patient or provider locations....more

Telehealth Remains a Top Priority for Advancing Quality Health Care

Even with the prospect of Obamacare repeal and replace on the backburner for now, the federal government continues to focus on health care. Following August recess, Congress will have less than four weeks to work through...more

Six Ways U.S. Joint Strategic Plan on IP Enforcement Impacts Public Health and Safety

On December 12, 2016, the Office of the U.S. Intellectual Property Enforcement Coordinator (IPEC) in the Executive Office of the President issued a much-awaited interagency plan on intellectual property (IP) enforcement. The...more

Telemedicine for All, As Lame Duck Session Winds Down

Even with the federal legislators poised to head home at the end of the week, two significant telehealth measures continue to work their way through the House and Senate, further evidence that telehealth services have become...more

Trump Administration Forecast: Changes to Key Policies Expected

Donald Trump’s election as president of the United States of America was as unexpected in the polls as the United Kingdom’s vote to embrace Brexit. Now Democrats and Republicans alike are trying to assess how Mr. Trump, a...more

Christmas in July for Wellness Apps and Devices

The Food and Drug Administration (FDA) released a final guidance on July 29, 2016, saying that it does not plan to require pre-market review for low-risk "general wellness products," such as wearable fitness monitors,...more

Trade Facilitation and Trade Enforcement Act Enhances U.S. Intellectual Property Protections

Substantive changes to IP protection in the recently signed Trade Facilitation and Trade Enforcement Act of 2015 (the Act) may be advantageous to U.S. IP owners. However, many of the Act's enforcement tools still need to be...more

Virtual Visits Gaining Ground

Telehealth services are in-demand and, quite literally, on-demand. Patients are increasingly seeking out health services via real-time synchronous audio-video encounters with health care providers (known as “telehealth” or...more

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