News & Analysis as of

ONC Digital Health

McDermott Will & Schulte

HHS announces information blocking enforcement “crackdown”

The US Department of Health and Human Services (HHS) announced its intent to begin actively enforcing the information blocking regulations adopted under the 21st Century Cures Act, in a press release on September 3, 2025, and...more

Orrick, Herrington & Sutcliffe LLP

Privacy and Security Considerations of Mounting the “21st Century Healthcare Experience” Promised by the CMS HealthTech Ecosystem

At a recent “Make HealthTech Great Again” event, the White House and the Centers for Medicare and Medicaid Services (CMS) announced the launch of a digital health technology ecosystem in partnership with private sector...more

Hogan Lovells

HHS ONC proposes new AI / ML requirements for certified Health IT

Hogan Lovells on

On April 11, the U.S. Department of Health & Human Services (HHS) Office of the National Coordinator (ONC) posted a proposed rule entitled, “Health Data, Technology, and Interoperability: Certification Program Updates,...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 2. ONC’s Tripathi: HIPAA Doesn’t Impede Sharing, Requirements Under Info Blocking...

Report on Patient Privacy Volume 23, no 2 (February 2023) When Micky Tripathi’s mom was recently transferred to a rehab facility to recover from a broken hip, the hospital, “right in front of me…printed off her record,...more

Sheppard Mullin Richter & Hampton LLP

FTC and Other Regulators Continue to Signal Interest in Mobile Health Apps

The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on...more

K&L Gates LLP

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

K&L Gates LLP on

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

McDermott Will & Emery

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

McDermott Will & Emery on

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

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