ONC

News & Analysis as of

HHS/Office of the National Coordinator issues report that health information sharing is being blocked to gain a competitive edge

In a scathing report released last Friday, the Department of Health and Human Services Office of the National Coordinator (ONC) accused hospitals and software vendors of preventing the sharing of health information in order...more

National Roadmap for Health Data Sharing: FTC Advocates Preservation of Privacy and Competition

On April 1, 2015, the Office of the National Coordinator for Health Information Technology (ONC), which assists with the coordination of federal policy on data sharing objectives and standards, issued its Shared Nationwide...more

Washington Healthcare Update

This Week: President’s FY2016 Budget Request... FDA Commissioner Hamburg to step down... Tennessee Medicaid expansion plan rejected by legislature. 1. Congress House House Ways and Means Committee Hosts Hearing...more

CMS, ONC Update Meaningful Use FAQ, Lay Groundwork for HIT Changes

CMS and the Office of the National Coordinator for Health IT (ONC) announced several policy developments last week relating to electronic health record (EHR) technology issues. ...more

CMS, ONC Update Meaningful Use FAQ, Lay Groundwork for HIT Changes

CMS and the Office of the National Coordinator for Health IT (ONC) announced several policy developments last week relating to electronic health record (EHR) technology issues....more

ONC Seeks Comments on Draft Health IT Interoperability Roadmap, Standards Advisory

On January 30, 2015, the HHS Office of the National Coordinator for Health Information Technology (ONC) released a draft “Roadmap” to promote safe and secure exchange and use of electronic health information. The document...more

Details Emerge for President’s Precision Medicine Initiative

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

Final Guidance on 2014 Certified EHR Technology Requirements and Implementation of Stage 3 Meaningful Use Requirements

On September 4, 2014, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) issued a final rule (the “Final Rule”) that adopts, without...more

CMS, ONC Adopt EHR Standards Flexibility for Eligible Providers; Delay Start of Stage 3

On August 29, 2014, CMS and the Office of the National Coordinator for Health IT (ONC) issued a final rule adopting the agencies’ proposal to grant flexibility for eligible providers regarding which edition of certified EHR...more

OIG Report Takes Issue With Oversight of Security Controls for Electronic Health Records

HHS Office of Inspector General (OIG) recently released a report concluding that the entity responsible for overseeing the testing and certification process for electronic health records (EHRs) did not fully ensure that...more

OIG Finds Privacy and Security Risks with ONC EHR Certification Process

It is ironic to learn the Office of Inspector General (OIG) believes the Office of the National Coordinator for Health Information Technology (ONC) essentially has an insufficient compliance program to maintain the privacy...more

Health Care Update - July 2014 #3

In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more

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

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

News from the Health Law Gurus™

News from the Health Law Gurus™ is a weekly summary of notable health law news from around the country with helpful links to related content. Burwell Confirmed as HHS Secretary—Last week, the Senate approved of the...more

The ONC’s Health IT Vision Plan: A Building Under Construction

The HHS Office of the National Coordinator (ONC) released its report “Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure” (the “Vision Plan”) last week to help...more

Proposed health IT strategy aims to promote innovation

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft...more

House committee questions authority of a DHHS staff division to regulate health IT

Is the Office of the National Coordinator for Health Information Technology (ONC) overstepping its statutory authority in pursuing enhanced regulatory activity? A June 3, 2014 letter from the House Committee on Energy and...more

Proposed Rule Responds to Meaningful Use Timeline Concerns

Providers participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs may have more breathing room to implement the criteria for meaningfully using certified EHR technology (CEHRT) for the...more

CMS and ONC Propose Rule to Help Providers Make Use of EHR and to Extend Timeline for Meaningful Use

The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) announced a proposed rule, on May 20, 2014, that would allow providers more flexibility...more

CMS and ONC Issue Proposed Rule Modifying 2014 Requirements for EHR Incentive Programs and Certified EHR Technology

On May 23, 2014, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) issued a proposed rule to modify (i) the meaningful use stage timeline of...more

FDA seeking comments on Health IT report

Exchange of information in an electronic environment (health IT) has provided and continues to provide opportunities to improve the quality, safety, cost and efficiency of health care and encourage patient involvement. ...more

Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more

FDA Releases FDASIA Health IT Report

On April 3, 2014, the Food and Drug Administration (FDA) released the FDASIA Health IT Report (Report). This Report fulfills Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law...more

Recommendations for NextGen Health IT Infrastructure

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute...more

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