News & Analysis as of

Electronic Protected Health Information (ePHI) Information Technology Final Rules

Foley & Lardner LLP

FDA Clinical Investigations: New Guidance on Electronic Systems

Foley & Lardner LLP on

On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more

Robinson+Cole Health Law Diagnosis

ONC’s HTI-1 Final Rule Updates Information Blocking Regulations

On December 13, 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued its final rule entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm...more

King & Spalding

OIG Publishes Final Information Blocking Enforcement Rule

King & Spalding on

On July 3, 2023, OIG published its final enforcement rule (the OIG Rule) permitting imposition of civil monetary penalties (CMPs) for certain actors that engage in information blocking in violation of the information blocking...more

Bricker Graydon LLP

HHS releases final rules on interoperability and information blocking

Bricker Graydon LLP on

On March 9, 2020, two final rules on electronic health information were issued by the Office of National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS)....more

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