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Special Report: Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more

OCR Issues Proposed Modifications to HIPAA Privacy Rule to Remove Barriers to Coordination of Care and Reduce Regulatory Burden

On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of...more

ONC and CMS Delay Enforcement Dates for Certain Provisions of the 21st Century Cures and Interoperability Final Rules, and OIG...

On April 21, 2020, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) announced that they will...more

COVID-19 Relief Law Includes Major Changes to Substance Use Disorder Confidentiality Law

As part of the CARES Act signed into law on March 27, 2020, Congress included a provision directing the secretary of Health and Human Services (HHS) to modify long-standing regulatory restrictions under the federal substance...more

HHS Releases Draft Federal Health IT Strategic Plan for 2020-2025

The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more

OCR Requests Information from Stakeholders on Significant Changes to the HIPAA Rules

The US Department of Health and Human Services, Office for Civil Rights (OCR) published a long-awaited Request for Information seeking feedback on whether and how the HIPAA Rules should be revised to better promote...more

21st Century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

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