News & Analysis as of

Medical Devices › Healthcare Reform › Digital Health

McDermott Will & Schulte

CMS proposes RPM reimbursement updates, requests information on reimbursing for SaaS

McDermott Will & Schulte on

Over the past several years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to recognize and pay for non-face-to-face services that improve care management...more

McDermott+

Back for seconds: digital health policies in the CY 2026 PFS proposed rule

McDermott+ on

It’s been more than two weeks since the release of the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule. We’ve had a chance to digest our initial helping and now we’re ready for seconds. We thought we would see...more

Akin Gump Strauss Hauer & Feld LLP

HHS to Launch Campaign Promoting Wearable Devices

Akin Gump Strauss Hauer & Feld LLP on

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

Jones Day on

The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

A&O Shearman

New German government: Key plans for the Life Sciences and Healthcare sector

A&O Shearman on

Following the election in February, the party leaderships of CDU, CSU and SPD have agreed on a coalition agreement titled “Responsibility for Germany”. The 146-page document also sets out aspects regarding the healthcare and...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Wilson Sonsini Goodrich & Rosati

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

Wilson Sonsini Goodrich & Rosati on

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more

Morgan Lewis

How a Biden Administration Will Affect FDA’s Regulation of Medical Devices

Morgan Lewis on

Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more

Nossaman LLP

FDA Policy for Mobile Medical Applications

Nossaman LLP on

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more

Hogan Lovells

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software...

Hogan Lovells on

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate...more

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