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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

HIPAA Impaired Providers and the ER - What Happens When Your Employee Becomes Your Patient?

I was speaking this week at IAHIMA’s Annual Conference on the issues relating to HIPAA audits and recent updates from OCR and ONC. As part of my program we typically solicit questions prior to the presentation, most of which...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the...more

ONC’s Security Risk Assessment Tool Is Useful but Could Be Improved

The Office of the National Coordinator for Health Information Technology (ONC) released a Security Risk Assessment Tool (SRA Tool) on March 28. According to the User Guide for the SRA Tool, the Tool is designed to help small...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

Hot Off the Press: Tool to Help Providers Conduct Security Risk Assessments

What’s Happening? The Office of the National Coordinator for Health Information Technology (ONC), in collaboration with the HHS Office for Civil Rights (OCR), recently released a jointly developed tool designed to assist...more

CMS Extends Start Date for Stage 3 of Meaningful Use to 2017 Without Extending Timeline for When Providers Must Start Stage 2

The Centers for Medicare & Medicaid Services recently announced a revised timeline for the implementation of Stage 3 “meaningful use” measures for the Electronic Health Records Incentive Programs, but did not extend the...more

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