News & Analysis as of

Health Information Technologies Public Comment

McCarter & English, LLP

ONC Shares Draft Federal Health IT Strategic Plan—A Catalyst for Private Entities

In March 2024, the Department of Health and Human Services—through the Office of the National Coordinator for Health IT (ONC)—released a draft 2024-2030 Federal Health IT Strategic Plan for public comment. A collaborative...more

Nelson Mullins Riley & Scarborough LLP

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

On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more

Foley Hoag LLP - Security, Privacy and the...

Proposed Amendments to HIPAA Regulations to “Empower Patients, Improve Coordinated Care, and Reduce Regulatory Burdens”

Nearly 20 years to the day after the first HIPAA privacy regulations were announced, HHS has posted proposed revisions to HIPAA, evidence that even after twenty years, HIPAA privacy remains a work in progress. These proposed...more

K&L Gates LLP

K&L Gates Triage: ONC Signals Federal Health IT Priorities with 2020-2025 Strategic Plan

K&L Gates LLP on

In this week’s episode, Ryan Severson discusses the Federal Health IT Strategic Plan, which was recently released by the Office of the National Coordinator for Health Information Technology (“ONC”). Mr. Severson discusses...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

Faegre Drinker Biddle & Reath LLP

New Proposed Cybersecurity and EHR Donation Rules

On October 9, 2019, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) simultaneously released a set of proposed rules (the “Proposed Rules”) that, among other...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

CMS Releases Proposed Rule to Advance Interoperability and the Exchange of Medical Record and Plan Information

McDermott Will & Emery on

CMS issued a long-awaited proposed rule aimed at enhancing interoperability and increasing patient access to health information. If finalized, CMS’s proposed rule may require hospitals and payors to make significant...more

McDermott Will & Emery

ONC Proposes to Define Conduct That Is Not Information Blocking under the Cures Act

McDermott Will & Emery on

The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed...more

Foley & Lardner LLP

Health Care Information Exchanges and Price Transparency Initiatives: CMS Requests Input from Providers

Foley & Lardner LLP on

On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule introducing changes to the Medicare physician fee schedule, and soliciting comments from providers on CMS data sharing initiatives....more

Bradley Arant Boult Cummings LLP

CMS Proposes Significant E/M Coding and Documentation Changes - Healthcare Alert

On July 27, 2018, the Centers for Medicare & Medicaid Services (CMS) published its proposed annual update to the Medicare Physician Fee Schedule, which proposes changes to the E/M coding and documentation process that CMS...more

Holland & Knight LLP

CMS Quality Payment Program Changes for 2019

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) is proposing a redesign of incentives under the Merit-Based Incentive Payment System (MIPS) as part of the 2019 Updates to the Quality Payment Program (QPP). This affects...more

Foley & Lardner LLP

INSIGHT: CMS’s Virtual Care Codes Pave New Avenues for Telemedicine Services Delivery

Foley & Lardner LLP on

The Centers for Medicare & Medicaid Services issued a proposed rule introducing monumental changes to the physician fee schedule, paving the way for asynchronous telemedicine and new technologies through a new set of virtual...more

Foley & Lardner LLP

Medicare’s New Virtual Care Codes: A Monumental Change and Validation of Asynchronous Telemedicine

Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services just issued a proposed rule introducing monumental changes to the physician fee schedule, paving the way for asynchronous telemedicine and new technologies through a new set of...more

Proskauer Rose LLP

CMS Issues Proposed Rule with Significant Revisions to the Medicare Physician Fee Schedule and Other Payment Policies

Proskauer Rose LLP on

On July 12, 2018, the Centers for Medicare & Medicaid Services ("CMS") issued a proposed rule that includes proposals to update payment policies and rates for services furnished under the Medicare Physician Fee Schedule...more

Farrell Fritz, P.C.

What are Your Thoughts on the Draft Trusted Exchange Framework?

Farrell Fritz, P.C. on

On January 5, 2018, the United States Department of Health and Human Services released for public comment a draft Trusted Exchange Framework, which seeks to accomplish interoperability with respect to patients’ Electronic...more

Smart & Biggar

Rx IP Update - December 2016

Smart & Biggar on

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

Mintz - Health Care Viewpoints

OCR Launches Platform for Developer HIPAA Questions

The HHS Office for Civil Rights (OCR) has released a new platform to provide mobile health developers (and any other interested stakeholders) a sounding board to ask questions, voice concerns, and “spitball” ideas about HIPAA...more

Mintz - Health Care Viewpoints

Agencies Seek Comments to Inform Future Health IT Regulation

As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more

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