News & Analysis as of

Comment Period Digital Health Regulatory Requirements

Foley & Lardner LLP

CY 2026 Medicare PFS Proposed Rule: Telehealth Takeaways

Foley & Lardner LLP on

In July 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule (the Proposed Rule), which included several proposed changes that aim to expand...more

Mintz - Health Care Viewpoints

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more

Akin Gump Strauss Hauer & Feld LLP

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Series of Guidance Documents Aimed at Medical Software Regulation

The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more

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