News & Analysis as of

21st Century Cures Initiative

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

by Hogan Lovells on

Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

ONC’s Draft Trusted Exchange Framework: Seeking Nationwide Interoperability for Health Information Networks

by Ropes & Gray LLP on

On January 5, 2018, the Office of the National Coordinator for Health Information Technology (“ONC”), an office within the U.S. Department of Health and Human Services, released its Draft Trusted Exchange Framework (the...more

What are Your Thoughts on the Draft Trusted Exchange Framework?

by Farrell Fritz, P.C. on

On January 5, 2018, the United States Department of Health and Human Services released for public comment a draft Trusted Exchange Framework, which seeks to accomplish interoperability with respect to patients’ Electronic...more

Health Care Industry Must be Mindful of ‘Information Blocking’

by Polsinelli on

Under the 21st Century Cures Act (Cures Act), the Health and Human Services (HHS) Secretary is mandated to have promulgated regulations by Dec. 13, 2017 that, among other requirements, prohibit “information blocking” as a...more

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

by Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

FDA Issues Draft Guidances to Scale Back Regulation of Digital Health Software

by Ropes & Gray LLP on

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued two draft guidance documents that describe types of software functions that FDA will not regulate, including FDA’s long-awaited policy on clinical...more

FDA Issues Draft Guidance on Breakthrough Devices Program

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

21st Century Cures Act Qualified Small Employer Health Reimbursement Arrangements (“QSEHRAs”) May Not Be the Total Cure

by Winstead PC on

QSEHRAs are designed for employers that are not applicable large employers under the employer shared responsibility tax (Code section 4980H). QSEHRAs may only be offered by employers with fewer than 50 full-time employees (as...more

Finding Common Ground in the Healthcare Debate: Federal, State, and Local Governments Respond to the Opioid Epidemic

As stories and statistics of the opioid crisis become increasingly prevalent in our national discourse, we are seeing a stronger, more innovative, and more aligned push for interventions across communities, government...more

New FDA Final Guidance on Medical Device Panel Meetings Provides Certain Changes to Timelines and Procedures

by Hogan Lovells on

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or, panel meetings). The document,...more

DOL Releases Draft Model Form for Mental Health Parity Disclosure Requests

by Ballard Spahr LLP on

The U.S. Department of Labor (DOL) recently released a draft model form for plan participants to request disclosures from group health plans and insurers about restrictions on mental health coverage. The form is designed to...more

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

New Guidance on Coverage for Eating Disorders

by Tucker Arensberg, P.C. on

The Departments of Labor, Treasury, and Health and Human Services recently released a frequently asked question (“FAQ”) regarding the implementation of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction...more

Do the Waive – FDA Implements Informed Consent Waivers for Minimal Risk Studies

by Hogan Lovells on

On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more

FDA’s Software Pre-Cert Program: More Details Revealed

by Hogan Lovells on

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

FDA User Fee Reauthorization Legislation Enacted by Congress

by Ropes & Gray LLP on

On July 12, 2017, the House of Representatives passed H.R. 2430, the FDA Reauthorization Act of 2017 (FDARA), and on August 3, 2017, the Senate followed suit by passing FDARA without amendment by a vote of 94-1. The President...more

FDA Announces New Digital Health Innovation Programs

by Ropes & Gray LLP on

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the Food and Drug Administration (“FDA”) has announced new plans to streamline the development and availability of high...more

Here Comes the Rain: Employers Offering Mental Health Benefits Should Prepare for More Scrutiny

Employers can expect some challenging information requests about the mental health and substance abuse benefits offered to employees and their dependents through group health plans, if a draft form released by federal...more

FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework

by Ropes & Gray LLP on

In his first public statement as Commissioner of the Food and Drug Administration (“FDA”) on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes. In a...more

FDA Steps Up on Medical Device Innovation

by Mark Mansour on

At long last, FDA has the makings of a coherent and forward-thinking policy to address the widening gap between industry's ability to innovate and FDA's regulatory capacity. Consistent with the mandate of the 21st Century...more

21st Century Cures: What's In the Box?

by Mark Mansour on

One of FDA’s most important tasks in the coming months will be the implementation of the 1,000 page long 21st Century Cures bill, enacted last year. We have assembled a quick, bullet-pointed summary of some of the major...more

How Washington Can Help Biotechs

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Trump, Gottlieb, and the Cures Act: What Pharmaceutical Manufacturers Need to Know

by Epstein Becker & Green on

The 21st Century Cures Act (“Cures Act”), signed into law by former President Obama on December 13, 2016, sets out a bold agenda for the Food and Drug Administration (“FDA”). Among other things, the Cures Act strives to...more

President’s budget ax takes a big whack at medical, scientific funding

The Trump budget for the federal government would be a huge step back from investment in medical research with consequences for many years in progress on promoting health and fighting disease....more

As patients sue over insulin’s skyrocketing costs, Trump thunders, confuses

Just under a century ago, a team of Canadian scientists made the breakthrough that led to widely available insulin as an effective treatment for diabetes, which then was a deadly disease. The researchers, who won the Nobel...more

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