News & Analysis as of

21st Century Cures Act

MedPAC Report: A Wake Up Call For Telehealth

by Cozen O'Connor on

The recent Medicare Payment Advisory Commission (“MedPAC” or “Commission”) report should serve as a shot across the bow to telehealth advocates seeking broader Medicare coverage of telehealth. In reading the telehealth...more

Connected medical device vulnerabilities continue to impact manufacturers, health care

by Thompson Coburn LLP on

Recently, Thompson Coburn’s Life Sciences Decoded blog described several FDA initiatives to increase the safety and reliability of the emerging connected device market and discussed data privacy as it pertains to medical...more

Checklists and Guidance from FDA on the Acceptance Criteria for 510(k) Submissions

by Arnall Golden Gregory LLP on

FDA recently issued a final guidance on the Refuse to Accept Policy for 510(k)s (Guidance). The Guidance outlines the procedures and criteria FDA uses to determine whether a medical device premarket notification (510(k))...more

Advancing Access to Precision Medicine Act - A Bipartisan Bill

by Foley & Lardner LLP on

On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R....more

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

by Knobbe Martens on

Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device....more

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

House, Senate Proposals to Extend Funding for the Federal Government

by Holland & Knight LLP on

Congress moved one step closer to avoiding a government shutdown on Feb. 6, voting overwhelmingly (245-182) to pass a short-term, GOP-backed government funding bill (text; section-by-section) that would keep the federal...more

Alston & Bird Healthcare Week In Review

by Alston & Bird on

On January 29, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on...more

On the Digital Health Frontier: Developments Driving Industry Change in 2018

by McDermott Will & Emery on

As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to...more

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

by Jones Day on

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more

FDA Announces Plans for Alternative Clearance Pathway

by Knobbe Martens on

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more

SAMHSA Final Rule Expands Permitted Disclosures of Substance Use Disorder Information to Subcontractors

The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule (Rule) updating the Confidentiality of Substance Use Disorder Records, 42 CFR part 2 (Part 2), to expand the circumstances under...more

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

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