News & Analysis as of

21st Century Cures Act

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

CMS Gives States Options for Complying with Cures Act Mandate to Cap Medicaid DME Rates

by Reed Smith on

As previously reported, the 21st Century Cures Act prohibits federal financial participation (FFP) payments to the states for certain Medicaid durable medical equipment (DME) expenditures that exceed what Medicare would have...more

FDA Releases 2018 Roadmap: Focus On Digital Health Continues

by Kelley Drye & Warren LLP on

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more

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

by Faegre Baker Daniels on

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

FDA 2017 Year in Review

by McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

by McDermott Will & Emery on

Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

HHS Office for Civil Rights Releases Research-Related HIPAA Guidance Required by 21st Century Cures Act

by Ropes & Gray LLP on

In December 2017, the U.S. Department of Health and Human Services Office for Civil Rights (“HHS OCR”) released two sets of guidance mandated by the 21st Century Cures Act, which was enacted in 2016 (the “Act”). The guidance...more

New FDA Guidance Clarifies Exemptions for Digital Health Software

• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more

FDA Guidance on Decision Support Software: Implications for Industry

by Epstein Becker & Green on

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS...more

American College of Rheumatology Identifies Six Factors for Future FDA Biosimilar Oversight

by Goodwin on

In response to an FDA request for comments regarding existing requirements for biologics and biosimilars, the American College of Rheumatology (ACR) submitted a letter identifying six “minimum components of review and...more

Bah, Humbug! HIPAA Compliance Isn’t Getting Any Easier

As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance...more

Year-End Congressional Hearings Examine Health Policies

by Reed Smith on

This month, Congressional committees held a number of hearings that focused on health policy issues, including the following: House Energy & Commerce Committee hearings on the drug supply chain and patient...more

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

Blog: FDA Releases Digital Health Guidance to Spur Innovation

by Cooley LLP on

On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the regulatory requirements for digital health technologies. By clarifying what is –...more

Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents

by Hogan Lovells on

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and digital health products to bring FDA...more

FDA Issues Guidance on Digital Health

by Stinson Leonard Street on

The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

by Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

FDA Publishes Draft Guidance on CDS Software and Revises Medical Software Policies

by McDermott Will & Emery on

On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On November 27, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Pediatric Information for X-ray imaging Device Premarket Notifications. The guidance outlines FDA’s rationale regarding information that...more

FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products

by Dorsey & Whitney LLP on

Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to...more

Congressional Hearings Focus on Health Policy Issues

by Reed Smith on

A number of Congressional panels have scheduled or held recent hearings on health policy issues, including the following: On November 30, 2017, the House Energy & Commerce Committee is holding a hearing on implementation...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

Digital Health Report - Fall 2017

Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more

Health Care Weekly Preview from ML Strategies - October 2017 #4

As the calendar turns to November, pressure continues to grow in Congress to pass a CHIP package. The relevant House and Senate committees each passed different versions of CHIP, and finding payfors continue to be the main...more

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