News & Analysis as of

Electronic Medical Records Comment Period

Manatt, Phelps & Phillips, LLP

FTC Proposed Health Breach Notification Rule Changes Target the Online Collection of Health Data

The Federal Trade Commission (FTC) continues to expand its regulation of health care data to ensure the data remains protected when shared with consumer-facing applications....more

BakerHostetler

ONC's Proposed Rule Updates to the 21st Century Cures Act Regulations

BakerHostetler on

On April 18, the Office of the National Coordinator for Health Information Technology (ONC) formally published its proposed rule titled Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm...more

Holland & Knight LLP

CMS Releases CY 2022 OPPS and ASC Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on July 19, 2021, released its calendar year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed...more

Bricker Graydon LLP

CMS announces proposed rule to improve electronic data exchange and streamline prior authorization

Bricker Graydon LLP on

On December 11, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule designed to improve electronic health care data exchange and streamline the prior authorization process....more

McDermott Will & Emery

ONC Extends Compliance Date for Information Blocking Rule

McDermott Will & Emery on

On November 4, 2020, the US Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule with comment period in the Federal Register that...more

Sheppard Mullin Richter & Hampton LLP

Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on...more

Seyfarth Shaw LLP

New Safe Harbors In A Storm of Risk and Regulations: A Review of the OIG’s Proposed Changes to the Federal Anti-Kickback Laws

Seyfarth Shaw LLP on

In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more

Bricker Graydon LLP

CMS and OIG propose changes to existing rules for donations of electronic health records and new rules for donations of...

Bricker Graydon LLP on

On October 9, 2019, the Office of Inspector General (OIG) released proposed changes to the regulations interpreting the federal Anti-Kickback Statute (AKS). On the same day, the Centers for Medicare and Medicaid Services...more

WilmerHale

Proposed Changes to Stark and Anti-Kickback Regulations May Provide New Flexibility for Healthcare Providers

WilmerHale on

On October 9, 2019, the Department of Health and Human Services (HHS) announced proposals for a number of new and revised exceptions to the Stark Law and safe harbors for the Anti-Kickback Statute (AKS) that are intended to...more

King & Spalding

CMS Proposes Rule Regarding the Exchange of Electronic Health Information Which Impacts Hospitals, Clinicians and Government...

King & Spalding on

On February 11, 2019, CMS issued a proposed rule, to improve access to electronic health information (the Proposed Rule). The Proposed Rule results from the 21st Century Cures Act (the Cures Act), in which CMS and the Office...more

Holland & Knight LLP

CMS Proposed Rule CMS-1694-P — Hospital Pricing and Electronic Medical Records: Increasing Patient Access

Holland & Knight LLP on

On April 24, 2018, the Centers for Medicare and Medicaid Services (CMS) issued for comment a 1883-page proposed rule (CMS-1694-P) (the "Proposed Rule") that aims, among other goals, to increase transparency relating to...more

Polsinelli

CMS Proposes OPPS Reimbursement Adjustments: What Hospital Outpatient Providers Need to Know

Polsinelli on

In early July, the Centers for Medicare & Medicaid Services (CMS) proposed Hospital Outpatient Prospective Payment System (OPPS) reimbursement rule changes that will impact reimbursement payment amounts and requirements for...more

Holland & Knight LLP

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

Foley & Lardner LLP

DC Proposes New Telemedicine Rules: What You Need to Know

Foley & Lardner LLP on

The District of Columbia Department of Health recently issued proposed rules that, if enacted, would constitute the first regulations on telemedicine practice standards in the nation’s capital. Other than a 2014 policy...more

Robinson+Cole Data Privacy + Security Insider

Comment period extended for NIST Cybersecurity Practice Guide

The National Institute of Standards and Technology has announced that due to stakeholder feed-back, the period to submit comments for the draft guide, “Securing Electronic Health Records on Mobile Devices” has been extended...more

King & Spalding

NIST Releases Draft Cybersecurity Practice Guide For Electronic Health Records

King & Spalding on

On July 22, the National Cybersecurity Center of Excellence (“NCCoE”), a U.S. government organization formed in 2012 within the National Institute of Standards and Technology (“NIST”), released a draft Cybersecurity Practice...more

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