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Digital Health › Public Comment

Fenwick & West LLP

CMS Seeks Public Input to Modernize the Digital Health Ecosystem for Medicare Beneficiaries

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The Centers for Medicare & Medicaid Services (CMS) has issued a new Request for Information (RFI) aimed at transforming how digital health tools serve Medicare beneficiaries....more

Hogan Lovells

Final FDA electronic systems guidance offers greater compliance flexibility

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The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

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The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Recommendations Regarding Electronic Systems, Records, and Signatures in Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more

Goodwin

On Remote Control: FDA Issues Draft Guidance to Facilitate Use of Digital Health Technologies for Remote Data Acquisition in...

Goodwin on

During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Health Care Compliance Association (HCCA) on

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

McDermott Will & Schulte

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

McDermott Will & Schulte on

The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more

Mintz - Health Care Viewpoints

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

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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

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• 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

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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

K&L Gates LLP

K&L Gates Triage: Digital Health Update: ONC Information Blocking Proposal Aims to Remove Barriers to Data Sharing

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The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic...more

King & Spalding

FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

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On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more

Holland & Knight LLP

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

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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

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